Publications Discover our most recent publications here. Our Medical Research & Development team has made important contributions to clinical and outcomes research that have influenced the evolution of clinical trial design, translational medicine and the development of novel therapies. 2025 1 items Placebo Rates in Crohn’s Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis Solitano V, Hogan M, Singh S, Danese S, Peyrin-Biroulet L, Zou G, Yuan Y, Sands BE, Feagan BG, Dulai PS, Narula N, Ma C, Jairath V. Placebo Rates in Crohn's Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis. Gastroenterology. 2025 Feb;168(2):344-356. doi: 10.1053/j.gastro.2024.10.009. Epub 2024 Oct 15. PMID: 39414161. 2024 18 items Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials Rivas A, Ahmed NS, Yuan Y, Qasim A, O'Gorman DB, Feagan BG, Jairath V, Bredenoord AJ, Dellon ES, Ma C. Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials. Aliment Pharmacol Ther. 2024 Nov 14. doi: 10.1111/apt.18382. Epub ahead of print. PMID: 39543931. Efficacy and Safety of Advanced Combination Treatment in Immune-Mediated Inflammatory Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Solitano V, Yuan Y, Singh S, Ma C, Nardone OM, Fiorino G, Acosta Felquer ML, Barra L, D'Agostino MA, Pope J, Peyrin-Biroulet L, Danese S, Jairath V. Efficacy and safety of Advanced Combination Treatment in immune-mediated inflammatory disease: A systematic review and meta-analysis of randomized controlled trials. J Autoimmun. 2024 Nov 6;149:103331. doi: 10.1016/j.jaut.2024.103331. Epub ahead of print. PMID: 39509741. Responsiveness of Different Disease Activity Indices in Moderate-To-Severe Ulcerative Colitis Solitano V, Panaccione R, Sands BE, Wang Z, Hogan M, Zou G, Peyrin-Biroulet L, Danese S, Cornfield LJ, Feagan BG, Singh S, Jairath V, Ma C. Responsiveness of different disease activity indices in moderate-to-severe ulcerative colitis. Med. 2024 Sep 26:S2666-6340(24)00345-3. doi: 10.1016/j.medj.2024.09.001. Epub ahead of print. PMID: 39368474. Management of Complications in Patients With an Ileostomy: An Umbrella Review of Systematic Reviews for the Endotrial Consortium Solitano V, Vuyyuru SK, Yuan Y, Singh S, Narula N, Ma C, Hanzel J, Hutton M, Van Koughnett JA, Rieder F, Jairath V. Management of complications in patients with an ileostomy: an umbrella review of systematic reviews for the EndOTrial Consortium. Int J Colorectal Dis. 2024 Sep 21;39(1):147. doi: 10.1007/s00384-024-04714-8. PMID: 39304546; PMCID: PMC11415412. Reliability of CT Enterography for Describing Fibrostenosing Crohn Disease Rieder F, Ma C, Hanzel J, Fletcher JG, Baker ME, Wang Z, Guizzetti L, Shackelton LM, Rémillard J, Patel M, Niu J, Ottichilo R, Santillan CS, Capozzi N, Taylor SA, Bruining DH, Zou G, Feagan BG, Jairath V, Rimola J; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. Reliability of CT Enterography for Describing Fibrostenosing Crohn Disease. Radiology. 2024 Aug;312(2):e233038. doi: 10.1148/radiol.233038. PMID: 39105638; PMCID: PMC11366669. Reliability of MR Enterography Features for Describing Fibrostenosing Crohn Disease Rieder F, Baker ME, Bruining DH, Fidler JL, Ehman EC, Sheedy SP, Heiken JP, Ream JM, Holmes DR 3rd, Inoue A, Mohammadinejad P, Lee YS, Taylor SA, Stoker J, Zou G, Wang Z, Rémillard J, Carter RE, Ottichilo R, Atkinson N, Siddiqui MT, Sunkesula VC, Ma C, Parker CE, Panés J, Rimola J, Jairath V, Feagan BG, Fletcher JG; Stenosis Therapy and Anti-Fibrosis Research (STAR) Consortium. Reliability of MR Enterography Features for Describing Fibrostenosing Crohn Disease. Radiology. 2024 Aug;312(2):e233039. doi: 10.1148/radiol.233039. PMID: 39105637; PMCID: PMC11366673. Reliability of Intestinal Ultrasound for Evaluating Crohn’s Disease Activity Using Point-of-care and Central Reading Goodsall TM, An YK, Andrews JM, Begun J, Friedman AB, Lee A, Lewindon PJ, Spizzo P, Rodgers N, Taylor KM, White LS, Wilkens R, Wright EK, Zou L, Maguire BR, Parker CE, Rémillard J, Novak KL, Panaccione R, Feagan BG, Jairath V, Ma C, Bryant RV. Reliability of Intestinal Ultrasound for Evaluating Crohn's Disease Activity Using Point-of-care and Central Reading. Clin Gastroenterol Hepatol. 2024 Aug 28:S1542-3565(24)00773-0. doi: 10.1016/j.cgh.2024.08.007. Epub ahead of print. PMID: 39209200. Performance of Bowel Preparation Quality Scales in Patients With Crohn’s Disease Solitano V, Siegel CA, Korzenik JR, Maratt JK, Rex DK, Maguire B, Bressler B, Grossmann J, Sedano R, McDonald JWD, Remillard J, Shackelton LM, Zou G, Feagan BG, Ma C, Jairath V. Performance of bowel preparation quality scales in patients with Crohn's disease. Aliment Pharmacol Ther. 2024 Oct;60(8):1042-1050. doi: 10.1111/apt.18210. Epub 2024 Aug 11. PMID: 39129393. Re-Evaluating Methods for Assessing Differences in Response in Ileal vs. Colonic Crohn’s Disease: A Post-hoc Analysis of the FITZROY Trial Ma C, Feagan BG, Wang Z, Zou G, Smith MI, Shackelton LM, Sands BE, Panaccione R, D'Haens GR, Vermeire S, Jairath V. Re-evaluating Methods for Assessing Differences in Response in Ileal vs. Colonic Crohn's Disease: A Post-hoc Analysis of the FITZROY Trial. J Crohns Colitis. 2024 Jul 20:jjae113. doi: 10.1093/ecco-jcc/jjae113. Epub ahead of print. PMID: 39030919. Endoscopic Scoring Indices for Assessing Disease Severity in Familial Adenomatous Polyposis: Systematic Review Silverman AL, Bouchiba H, Aelvoet A, MacDonald J, Dekker E, Zayadi A, Le J, Feagan B, Jairath V, Ma C, Samadder J. Endoscopic scoring indices for assessing disease severity in familial adenomatous polyposis: Systematic review. Endosc Int Open. 2024 Jun 18;12(6):E799-E809. doi: 10.1055/a-2330-8037. PMID: 38904059; PMCID: PMC11188755. Scoring Indices for Perianal Fistulising Crohn’s Disease: A Systematic Review Vuyyuru SK, Solitano V, Singh S, Hanzel J, Macdonald JK, Danese S, Peyrin Biroulet L, Ma C, Jairath V. Scoring Indices for Perianal Fistulising Crohn's Disease: A Systematic Review. J Crohns Colitis. 2024 Jun 3;18(6):836-850. doi: 10.1093/ecco-jcc/jjad214. PMID: 38126903. Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn’s Disease Khanna R, Feagan BG, Zou G, Stitt LW, McDonald JWD, Bressler B, Panaccione R, Shackelton LM, VanViegen T, Loftus EV Jr, Daperno M, Jairath V, D'Haens G, Sandborn WJ. Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn's Disease. Inflamm Bowel Dis. 2024 Apr 25:izae089. doi: 10.1093/ibd/izae089. Epub ahead of print. PMID: 38661492. Pharmacological Therapies for the Management of Fistulizing Crohn’s Disease: A Systematic Review and Meta-Analysis Vuyyuru SK, Solitano V, Narula N, Lee MJ, MacDonald JK, McCurdy JD, Singh S, Ma C, Jairath V. Pharmacological Therapies for the Management of Fistulizing Crohn's Disease: A Systematic Review and Meta-Analysis. J Crohns Colitis. 2024 Apr 23;18(4):589-603. doi: 10.1093/ecco-jcc/jjad185. PMID: 37933849. Operating Properties of Disease Activity Indices in Pediatric Inflammatory Bowel Disease: A Systematic Review Colman RJ, Solitano V, MacDonald JK, Ma C, Griffiths AM, Jairath V, Crowley E. Operating Properties of Disease Activity Indices in Pediatric Inflammatory Bowel Disease: A Systematic Review. Inflamm Bowel Dis. 2024 Mar 28:izae060. doi: 10.1093/ibd/izae060. Epub ahead of print. PMID: 38547511. Systematic Review: Defining, Diagnosing and Monitoring Small Bowel Strictures in Crohn’s Disease on Intestinal Ultrasound Lu C, Rosentreter R, Delisle M, White M, Parker CE, Premji Z, Wilson SR, Baker ME, Bhatnagar G, Begun J, Bruining DH, Bryant R, Christensen B, Feagan BG, Fletcher JG, Jairath V, Knudsen J, Kucharzik T, Maaser C, Maconi G, Novak K, Rimola J, Taylor SA, Wilkens R, Rieder F; Stenosis Therapy and Anti‐Fibrotic Research (STAR) consortium. Systematic review: Defining, diagnosing and monitoring small bowel strictures in Crohn's disease on intestinal ultrasound. Aliment Pharmacol Ther. 2024 Apr;59(8):928-940. doi: 10.1111/apt.17918. Epub 2024 Mar 4. PMID: 38436124. Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn’s Disease Clinical Trials Crowley E, Ma C, Guizzetti L, Zou G, Lewindon PJ, Gee MS, Hyams JS, Rosen MJ, von Allmen D, de Buck van Overstraeten A, Shackelton LM, Remillard J, Schleicher L, Dillman JR, Rimola J, Taylor SA, Fletcher JG, Church PC, Feagan BG, Griffiths AM, Jairath V, Greer MC. Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials. Inflamm Bowel Dis. 2024 Mar 1;30(3):357-369. doi: 10.1093/ibd/izad134. PMID: 37524088. Identification of Immune Cell Markers Associated With Ulcerative Colitis Histological Disease Activity in Colonic Biopsies Lefevre PLC, Wang Z, Teft W, Zou G, Van Viegen T, Linggi B, Jairath V, Feagan BG, Pai RK, Vande Casteele N. Identification of immune cell markers associated with ulcerative colitis histological disease activity in colonic biopsies. J Clin Pathol. 2024 Feb 28:jcp-2023-209327. doi: 10.1136/jcp-2023-209327. Epub ahead of print. PMID: 38418201. Determining the Optimal Treatment Target in Patients With Ulcerative Colitis: Rationale, Design, Protocol and Interim Analysis for the Randomised Controlled VERDICT Trial Jairath V, Zou G, Wang Z, Adsul S, Colombel JF, D'Haens GR, Freire M, Moran GW, Peyrin-Biroulet L, Sandborn WJ, Sebastian S, Travis S, Vermeire S, Radulescu G, Sigler J, Hanžel J, Ma C, Sedano R, McFarlane SC, Arya N, Beaton M, Bossuyt P, Danese S, Green D, Harlan W 3rd, Horynski M, Klopocka M, Petroniene R, Silverberg MS, Wolanski L, Feagan BG. Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterol. 2024 Feb 8;11(1):e001218. doi: 10.1136/bmjgast-2023-001218. PMID: 38336367; PMCID: PMC10870790. 2023 19 items Use of External Control Arms in Immune-Mediated Inflammatory Diseases: A Systematic Review Zayadi A, Edge R, Parker CE, Macdonald JK, Neustifter B, Chang J, Zhong G, Singh S, Feagan BG, Ma C, Jairath V. Use of external control arms in immune-mediated inflammatory diseases: a systematic review. BMJ Open. 2023 Dec 9;13(12):e076677. doi: 10.1136/bmjopen-2023-076677. PMID: 38070932; PMCID: PMC10729249. Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn’s Disease Activity Solitano V, Schaeffer DF, Hogan M, Vande Casteele N, Pai RK, Zou G, Pai RK, Parker CE, Rémillard J, Christensen B, Danese S, Peyrin-Biroulet L, Panaccione R, Sands BE, D'Haens G, Feagan BG, Ma C, Jairath V. Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn's Disease Activity. Clin Gastroenterol Hepatol. 2023 Dec 4:S1542-3565(23)00969-2. doi: 10.1016/j.cgh.2023.11.032. Epub ahead of print. PMID: 38056798. Efficacy and Safety of Advanced Oral Small Molecules for Inflammatory Bowel Disease: Systematic Review and Meta-Analysis Solitano V, Vuyyuru SK, MacDonald JK, Zayadi A, Parker CE, Narula N, Peyrin-Biroulet L, Danese S, Feagan BG, Singh S, Ma C, Jairath V. Efficacy and Safety of Advanced Oral Small Molecules for Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. J Crohns Colitis. 2023 Nov 24;17(11):1800-1816. doi: 10.1093/ecco-jcc/jjad100. PMID: 37317532. Case Report: Medical Management of Acute Severe Ulcerative Colitis Sudheer Kumar Vuyyuru, DM,1,2 Vipul Jairath, MD, PhD,1,2,3 Jurij Hanžel, MD, PhD,2,4 Christopher Ma, MD, MPH,2,5 and Brian G. Feagan, MD1,2,3: Case Report: Medical Management of Acute Severe. Gastroenterology & Hepatology Volume 19, Issue 10 October 2023 Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study Lebwohl B, Ma C, Lagana SM, Pai RK, Baker KA, Zayadi A, Hogan M, Bouma G, Cellier C, Goldsmith JD, Lundin KEA, Pinto-Sanchez MI, Robert ME, Rubio-Tapia A, Sanders DS, Schaeffer DF, Semrad CE, Silvester JA, Verdú EF, Verma R, Wu TT, Feagan BG, Crowley E, Jairath V, Murray JA. Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study. Gastroenterology. 2024 Jan;166(1):88-102. doi: 10.1053/j.gastro.2023.08.051. Epub 2023 Sep 11. PMID: 37704112. Systematic Review With Meta-Analysis: Medical Therapies for Treatment of Ulcerative Proctitis Aruljothy A, Singh S, Narula N, Moran GW, Vuyyuru SK, Hogan M, Zayadi A, MacDonald JK, Caron B, Danese S, Peyrin Biroulet L, Ma C, Jairath V. Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis. Aliment Pharmacol Ther. 2023 Oct;58(8):740-762. doi: 10.1111/apt.17666. Epub 2023 Aug 17. PMID: 37589498. Efficacy and Safety of IL-12/23 and IL-23 Inhibitors for Crohn’s Disease: Systematic Review and Meta-Analysis Vuyyuru SK, Solitano V, Hogan M, MacDonald JK, Zayadi A, Parker CE, Sands BE, Panaccione R, Narula N, Feagan BG, Singh S, Jairath V, Ma C. Efficacy and Safety of IL-12/23 and IL-23 Inhibitors for Crohn's Disease: Systematic Review and Meta-Analysis. Dig Dis Sci. 2023 Sep;68(9):3702-3713. doi: 10.1007/s10620-023-08014-z. Epub 2023 Jun 28. PMID: 37378711; PMCID: PMC10981469. Standardizing Scoring Conventions for Crohn’s Disease Endoscopy: An International RAND/UCLA Appropriateness Study Khanna R, Ma C, Hogan M, Zou G, Bessissow T, Bressler B, Colombel JF, Danese S, Daperno M, East JE, Hookey L, Loftus EV Jr, McDonald JWD, Panaccione R, Peyrin-Biroulet L, Rutter M, Sands BE, Vermeire S, Rémillard J, McFarlane SC, Sandborn WJ, D'Haens GR, Feagan BG, Jairath V. Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2938-2950.e6. doi: 10.1016/j.cgh.2023.05.029. Epub 2023 Jun 10. PMID: 37308036. Targeting IL-23 for IBD: Rationale and Progress to Date Vuyyuru SK, Shackelton LM, Hanzel J, Ma C, Jairath V, Feagan BG. Targeting IL-23 for IBD: Rationale and Progress to Date. Drugs. 2023 Jul;83(10):873-891. doi: 10.1007/s40265-023-01882-9. Epub 2023 Jun 2. PMID: 37266801. Effect of Storage Time on Peripheral Blood Mononuclear Cell Isolation From Blood Collected in Vacutainer CPT™ Tubes Linggi B, Cremer J, Wang Z, Van Viegen T, Vermeire S, Lefevre P, Shackelton LM, Jairath V, Teft W, Vande Casteele N, Verstockt B. Effect of storage time on peripheral blood mononuclear cell isolation from blood collected in vacutainer CPT™ tubes. J Immunol Methods. 2023 May 29;519:113504. doi: 10.1016/j.jim.2023.113504. Epub ahead of print. PMID: 37257687. Systematic Review and Meta-Analysis of Randomised Controlled Trials: Medical Therapies for the Treatment and Prevention of Pouchitis Alphonsus L, De Silva TA, Ma C, MacDonald JK, Hanzel J, Beaton M, Bessissow T, Kayal M, Sedano R, Singh S, Jairath V. Systematic review and meta-analysis of randomised controlled trials: Medical therapies for the treatment and prevention of pouchitis. Aliment Pharmacol Ther. 2023 Aug;58(3):268-282. doi: 10.1111/apt.17568. Epub 2023 May 29. PMID: 37246609. An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn’s Disease Maratt JK, Siegel CA, Barkun AN, Bouhnik Y, Bressler B, Calderwood AH, East JE, Fischer M, Grossmann J, Korzenik JR, Menees SB, Panes J, Rex DK, Sey MSL, Allio MK, Baker KA, Guizzetti L, Remillard J, Sedano R, Feagan BG, Ma C, Jairath V. An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease. Dig Dis Sci. 2023 May;68(5):1718-1727. doi: 10.1007/s10620-022-07775-3. Epub 2022 Nov 27. PMID: 36436154. Advanced Combination Treatment With Biologic Agents and Novel Small Molecule Drugs for Inflammatory Bowel Disease Solitano V., Ma C., Hanžel J., Panaccione R., Feagan B., Jairath V. Advanced Combination Treatment With Biologic Agents and Novel Small Molecule Drugs for Inflammatory Bowel Disease. Real-World Multicentre Observational Study With Pop-PK Modelling to Evaluate the Exposure-Response Relationship of Vedolizumab in IBD Vande Casteele N, Sandborn WJ, Feagan BG, Vermeire S, Dulai PS, Yarur A, Roblin X, Ben-Horin S, Dotan I, Osterman MT, Rosario M, Osborn TM, Panes J, Lindner D, Agboton C. Real-world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure-response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study. Aliment Pharmacol Ther. 2022 Aug;56(3):463-476. doi: 10.1111/apt.16937. Epub 2022 Apr 27. PMID: 35474325. Placebo Response Rates in Randomized Controlled Trials for Perianal Crohn’s Disease: A Systematic Review and Meta-Analysis Sharma T, Ma C, Sedano R, Hanzel J, McDonald C, Hogan M, Kochhar GS, Narula N, Peyrin-Biroulet L, Danese S, MacDonald JK, Jairath V. Placebo Response Rates in Randomized Controlled Trials for Perianal Crohn's Disease: A Systematic Review and Meta-Analysis. J Crohns Colitis. 2023 Apr 19;17(4):644-658. doi: 10.1093/ecco-jcc/jjac160. PMID: 36271904. ATRC Review: IL-12 and IL-23 pathway inhibition in inflammatory bowel disease Verstockt B, Salas A, Sands BE, Abraham C, Leibovitzh H, Neurath MF, Vande Casteele N; Alimentiv Translational Research Consortium (ATRC). IL-12 and IL-23 pathway inhibition in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2023 Jul;20(7):433-446. doi: 10.1038/s41575-023-00768-1. Epub 2023 Apr 17. PMID: 37069321. Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading Hanzel J, Sey M, Ma C, Zou G, East JE, Siegel CA, Mosli M, Reinisch W, McDonald JWD, Silverberg MS, Van Viegen T, Shackelton LM, Clayton LB, Enns R, Epstein I, Hilsden RJ, Hookey L, Moffatt DC, Ng Kwet Shing R, Telford JJ, von Renteln D, Feagan BG, Barkun A, Jairath V. Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading. Dig Dis Sci. 2023 Apr;68(4):1195-1207. doi: 10.1007/s10620-022-07729-9. Epub 2022 Oct 20. PMID: 36266592. Endoscopic and Histological Placebo Rates in Crohn’s Disease Clinical Trials: A Systematic Review and Meta-analysis Vuyyuru SK, Nguyen TM, Hogan M, Raine T, Noor NM, Narula N, Verstockt B, Feagan BG, Singh S, Ma C, Jairath V. Endoscopic and Histological Placebo Rates in Crohn's Disease Clinical Trials: A Systematic Review and Meta-analysis. Inflamm Bowel Dis. 2023 Apr 1:izad052. doi: 10.1093/ibd/izad052. Epub ahead of print. PMID: 37002875. Patients With Crohn’s Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review Vuyyuru SK, Rieder F, Solitano V, Nguyen TM, Crowley E, Narula N, Singh S, Ma C, Jairath V. Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review. Am J Gastroenterol. 2023 Jul 1;118(7):1285-1288. doi: 10.14309/ajg.0000000000002215. Epub 2023 Feb 8. PMID: 36757156. 2022 23 items CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease CORE-IBD Collaborators, Ma C, Hanzel J, Panaccione R, Sandborn WJ, D'Haens GR, Ahuja V, Atreya R, Bernstein CN, Bossuyt P, Bressler B, Bryant RV, Cohen B, Colombel JF, Danese S, Dignass A, Dubinsky MC, Fleshner PR, Gearry RB, Hanauer SB, Hart A, Kotze PG, Kucharzik T, Lakatos PL, Leong RW, Magro F, Panés J, Peyrin-Biroulet L, Ran Z, Regueiro M, Singh S, Spinelli A, Steinhart AH, Travis SP, van der Woude CJ, Yacyshyn B, Yamamoto T, Allez M, Bemelman WA, Lightner AL, Louis E, Rubin DT, Scherl EJ, Siegel CA, Silverberg MS, Vermeire S, Parker CE, McFarlane SC, Guizzetti L, Smith MI, Vande Casteele N, Feagan BG, Jairath V. CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease. Gastroenterology. 2022 Oct;163(4):950-964. doi: 10.1053/j.gastro.2022.06.068. Epub 2022 Jul 3. PMID: 35788348. Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn’s Disease Hanzel J, Jairath V, De Cruz P, Guizzetti L, Shackelton LM, Bossuyt P, Duijvestein M, Dulai PS, Grossmann J, Hirten RP, Khanna R, Panes J, Peyrin-Biroulet L, Regueiro M, Rubin DT, Singh S, Stidham RW, Sandborn WJ, Feagan BG, D'Haens GR, Ma C. Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease. Inflamm Bowel Dis. 2022 Sep 1;28(9):1321-1331. doi: 10.1093/ibd/izab259. PMID: 34791254; PMCID: PMC9756946. Heterogeneity in Efficacy and Safety Endpoints for Pediatric Clinical Trials in Inflammatory Bowel Disease: A Need for Harmonization Crowley E, Griffiths AM, Jairath V; pIBD CLINICAL TRIALS OUTCOME GROUP. Heterogeneity in Efficacy and Safety Endpoints for Pediatric Clinical Trials in Inflammatory Bowel Disease: A Need for Harmonization. Gastroenterology. 2022 Nov;163(5):1137-1144. doi: 10.1053/j.gastro.2022.07.006. Epub 2022 Jul 16. PMID: 35850191. Placebo Rates in Randomized Controlled Trials of Proctitis Therapy: A Systematic Review and Meta-Analysis De Silva TA, Alphonsus L, Ma C, Hogan M, Sedano R, Narula N, Danese S, Peyrin-Biroulet L, MacDonald JK, Singh S, Jairath V. Placebo rates in randomized controlled trials of proctitis therapy: A systematic review and meta-analysis. J Crohns Colitis. 2022 Aug 5:jjac109. doi: 10.1093/ecco-jcc/jjac109. Epub ahead of print. PMID: 35930405. Clinical, Endoscopic, and Safety Placebo Rates in Induction and Maintenance Trials of Crohn’s Disease: Meta-Analysis of Randomised Controlled Trials Almradi A, Sedano R, Hogan M, Zou GY, MacDonald JK, Parker CE, Hanzel J, Crowley E, Singh S, D'Haens G, Sandborn WJ, Feagan BG, Ma C, Jairath V. Clinical, Endoscopic, and Safety Placebo Rates in Induction and Maintenance Trials of Crohn's Disease: Meta-Analysis of Randomised Controlled Trials. J Crohns Colitis. 2022 Jun 24;16(5):717-736. doi: 10.1093/ecco-jcc/jjab194. PMID: 34758084. Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials Sedano R, Hogan M, Zou G, Narula N, Singh S, Ma C, Feagan BG, Jairath V. Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials. Inflamm Bowel Dis. 2022 Jun 24:izac128. doi: 10.1093/ibd/izac128. Epub ahead of print. PMID: 35749316. Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn’s Disease Biopsies Lefevre P, Guizzetti L, McKee TD, Zou G, van Viegen T, McFarlane SC, Shackelton L, Feagan BG, Jairath V, Pai RK, Casteele NV. Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn's Disease Biopsies. Appl Immunohistochem Mol Morphol. 2022 May 20. doi: 10.1097/PAI.0000000000001035. Epub ahead of print. PMID: 35587994. Disease Activity Indices for Pouchitis: A Systematic Review Sedano R, Nguyen TM, Almradi A, Rieder F, Parker CE, Shackelton LM, D'Haens G, Sandborn WJ, Feagan BG, Ma C, Jairath V. Disease Activity Indices for Pouchitis: A Systematic Review. Inflamm Bowel Dis. 2022 Mar 30;28(4):622-638. doi: 10.1093/ibd/izab124. PMID: 34180986; PMCID: PMC8972820. Reliability of Histologic Assessment for NAFLD and Development of an Expanded NAFLD Activity Score Rish K Pai, Vipul Jairath, Malcolm Hogan, Guangyong Zou, Oyedele A Adeyi, Quentin M Anstee, Bashar A Aqel, Cynthia Behling, Elizabeth J Carey, Andrew D Clouston, Kathleen Corey, Brian G Feagan, David E Kleiner, Christopher Ma, Stefanie C McFarlane, Mazen Noureddin, Vlad Ratziu, Mark A Valasek, Zobair M Younossi, Stephen A Harrison, Rohit Loomba. Reliability of histologic assessment for NAFLD and development of an expanded NAFLD activity score. Hepatology. 2022 Mar 25. DOI: 10.1002/hep.32475. Online ahead of print. PMID: 35332569 The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn’s Disease: A Systematic Review and Meta-analysis Ble A, Renzulli C, Cenci F, Grimaldi M, Barone M, Sedano R, Chang J, Nguyen TM, Hogan M, Zou G, MacDonald JK, Ma C, Sandborn WJ, Feagan BG, Merlo Pich E, Jairath V. The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn's Disease: A Systematic Review and Meta-analysis. J Crohns Colitis. 2022 Mar 14;16(3):490-499. doi: 10.1093/ecco-jcc/jjab163. PMID: 34508572; PMCID: PMC8919832. Recommendations for Standardizing Biopsy Acquisition and Histological Assessment of Immune Checkpoint Inhibitor-Associated Colitis Christopher Ma, Rish K Pai, David F Schaeffer, Jonathan Krell, Leonardo Guizzetti, Stefanie C McFarlane, John K MacDonald, Won-Tak Choi, Roger M Feakins, Richard Kirsch, Gregory Y Lauwers, Reetesh K Pai, Christophe Rosty, Amitabh Srivastava, Joanna C Walsh, Brian G Feagan, Vipul Jairath. Recommendations for standardizing biopsy acquisition and histological assessment of immune checkpoint inhibitor-associated colitis. J Immunother Cancer. 2022 Mar;10(3):e004560. DOI: 10.1136/jitc-2022-004560. PMID: 35296560 PMCID: PMC8928359 DOI: 10.1136/jitc-2022-004560. Design of Clinical Trials for Mild to Moderate Crohn’s Disease Jurij Hanzel, Christopher Ma, Vipul Jairath, IBD Trial Design Group. Design of Clinical Trials for Mild to Moderate Crohn's Disease. Gastroenterology. 2022 Jun;162(7):1800-1814.e1. DOI: 10.1053/j.gastro.2022.02.036. Epub 2022 Feb 28. PMID: 35240140 DOI: 10.1053/j.gastro.2022.02.036. A Nonparametric Approach to Confidence Intervals for Concordance Index and Difference Between Correlated Indices Guangyong Zou, Emma Smith, Vipul Jairath. A nonparametric approach to confidence intervals for concordance index and difference between correlated indices. J Biopharm Stat . 2022 Feb 25;1-28. doi: 10.1080/10543406.2022.2030747. Online ahead of print. PMID: 35216545 DOI: 10.1080/10543406.2022.2030747. Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease Crowley E, Ma C, Andic M, Feagan BG, Griffiths AM, Jairath V. Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease. J Crohns Colitis. 2022 Feb 23;16(2):331-335. doi: 10.1093/ecco-jcc/jjab140. PMID: 34379112. Sphingosine 1-Phosphate Modulation and Immune Cell Trafficking in Inflammatory Bowel Disease Bram Verstockt, Stefania Vetrano, Azucena Salas, Shadi Nayeri, Marjolijn Duijvestein, Niels Vande Casteele, Alimentiv Translational Research Consortium (ATRC). Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2022 Jun;19(6):351-366. DOI: 10.1038/s41575-021-00574-7. Epub 2022 Feb 14. PMID: 35165437 DOI: 10.1038/s41575-021-00574-7 Similar Clinical Improvement Rates Among Biologic Drug Classes in Crohn’s Disease: Systematic Review and Meta-Regression Jurij Hanžel, Rocio Sedano, Jenny Jeyarajah, Guangyong Zou, Stefanie C McFarlane, Christopher Ma, Vipul Jairath. Similar Clinical Improvement Rates Among Biologic Drug Classes in Crohn's Disease: Systematic Review and Meta-Regression. Inflamm Bowel Dis. 2022 Feb 15;izac018. DOI: 10.1093/ibd/izac018. Online ahead of print. PMID: 35166778 DOI: 10.1093/ibd/izac018. Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn’s Disease Jurij Hanžel, Vipul Jairath, Christopher Ma, Leonardo Guizzetti, Guangyong Zou, Cynthia S Santillan, Stuart A Taylor, Tanja van Viegen, Geert R D'Haens, Brian G Feagan, Julián Panés, Jordi Rimola. Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 Feb 9;S1542-3565(22)00128-8. DOI: 10.1016/j.cgh.2022.01.055. Online ahead of print. PMID: 35149220 DOI: 10.1016/j.cgh.2022.01.055 Reliability and Responsiveness of Endoscopic Disease Activity Assessment in Eosinophilic Esophagitis Ma C, Bredenoord AJ, Dellon ES, Alexander JA, Biedermann L, Hogan M, Guizzetti L, Zou G, Katzka DA, Chehade M, Falk GW, Furuta GT, Gupta SK, Kagalwalla AF, Schoepfer AM, Miehlke S, Moawad FJ, Peterson K, Gonsalves NP, Straumann A, Wechsler JB, Rémillard J, Shackelton LM, Almonte HS, Feagan BG, Jairath V, Hirano I. Reliability and responsiveness of endoscopic disease activity assessment in eosinophilic esophagitis. Gastrointest Endosc. 2022 Jun;95(6):1126-1137.e2. doi: 10.1016/j.gie.2022.01.014. Epub 2022 Feb 1. PMID: 35120883. Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis Ma C, Jairath V, Feagan BG, Guizzetti L, Zou G, McFarlane SC, Shackelton LM, Collins MH, Hirano I, de Rooij WE, Schaeffer DF, Pai RK, Bredenoord AJ, Dellon ES. Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis. Am J Gastroenterol. 2022 Feb 1;117(2):264-271. doi: 10.14309/ajg.0000000000001571. PMID: 34797816. Underrepresentation of Minorities and Lack of Race Reporting in Ulcerative Colitis Drug Development Clinical Trials Sedano R, Hogan M, McDonald C, Aswani-Omprakash T, Ma C, Jairath V. Underrepresentation of Minorities and Lack of Race Reporting in Ulcerative Colitis Drug Development Clinical Trials. Inflamm Bowel Dis. 2022 Jan 25:izab362. DOI: 10.1093/ibd/izab362. Epub ahead of print. PMID: 35078220. Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease Rocio Sedano, Christopher Ma, Vipul Jairath, Brian G Feagan. Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 2022 Jan;18(1):14-27. PMID: 35505771 PMCID: PMC9053496 Design of Clinical Trials for Mild to Moderate Ulcerative Colitis Sedano R, Jairath V, Ma C; IBD Trial Design Group. Design of Clinical Trials for Mild to Moderate Ulcerative Colitis. Gastroenterology. 2022 Apr;162(4):1005-1018. doi: 10.1053/j.gastro.2021.12.284. Epub 2022 Jan 6. PMID: 34998800. A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease Lefevre PLC, Dulai PS, Wang Z, Guizzetti L, Feagan BG, Pop A, Yassine M, Shackelton LM, Jairath V, Sandborn WJ, Vande Casteele N. A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn's Disease. BioDrugs. 2022 Jan;36(1):85-93. doi: 10.1007/s40259-021-00512-8. Epub 2021 Dec 24. PMID: 34951696. 2021 21 items Systematic Review: Disease Activity Indices for Immune Checkpoint Inhibitor-Associated Enterocolitis Ma C, MacDonald JK, Nguyen TM, Chang J, Vande Casteele N, Feagan BG, Jairath V. Systematic review: disease activity indices for immune checkpoint inhibitor-associated enterocolitis. Aliment Pharmacol Ther. 2022 Jan;55(2):178-190. DOI: 10.1111/apt.16718. Epub 2021 Nov 25. PMID: 34821404. Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis Bots SJ, Parker CE, Brandse JF, Löwenberg M, Feagan BG, Sandborn WJ, Jairath V, D'Haens G, Vande Casteele N. Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. BioDrugs. 2021 Nov;35(6):715-733. doi: 10.1007/s40259-021-00507-5. Epub 2021 Nov 19. PMID: 34797516; PMCID: PMC9826743. Underrepresentation of Minorities and Underreporting of Race and Ethnicity in Crohn’s Disease Clinical Trials Sedano R, Hogan M, Mcdonald C, Aswani-Omprakash T, Ma C, Jairath V. Underrepresentation of Minorities and Underreporting of Race and Ethnicity in Crohn's Disease Clinical Trials. Gastroenterology. 2022 Jan;162(1):338-340.e2. doi: 10.1053/j.gastro.2021.09.054. Epub 2021 Sep 27. PMID: 34592174. Meta-Analysis of Gene Expression Disease Signatures in Colonic Biopsy Tissue From Patients With Ulcerative Colitis Linggi B, Jairath V, Zou G, Shackelton LM, McGovern DPB, Salas A, Verstockt B, Silverberg MS, Nayeri S, Feagan BG, Vande Casteele N. Meta-analysis of gene expression disease signatures in colonic biopsy tissue from patients with ulcerative colitis. Sci Rep. 2021 Sep 14;11(1):18243. doi: 10.1038/s41598-021-97366-5. PMID: 34521888; PMCID: PMC8440637. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) COREOS Collaborators:, Ma C, Schoepfer AM, Dellon ES, Bredenoord AJ, Chehade M, Collins MH, Feagan BG, Furuta GT, Gupta SK, Hirano I, Jairath V, Katzka DA, Pai RK, Rothenberg ME, Straumann A, Aceves SS, Alexander JA, Arva NC, Atkins D, Biedermann L, Blanchard C, Cianferoni A, Ciriza de Los Rios C, Clayton F, Davis CM, de Bortoli N, Dias JA, Falk GW, Genta RM, Ghaffari G, Gonsalves N, Greuter T, Hopp R, Hsu Blatman KS, Jensen ET, Johnston D, Kagalwalla AF, Larsson HM, Leung J, Louis H, Masterson JC, Menard-Katcher C, Menard-Katcher PA, Moawad FJ, Muir AB, Mukkada VA, Penagini R, Pesek RD, Peterson K, Putnam PE, Ravelli A, Savarino EV, Schlag C, Schreiner P, Simon D, Smyrk TC, Spergel JM, Taft TH, Terreehorst I, Vanuytsel T, Venter C, Vieira MC, Vieth M, Vlieg-Boerstra B, von Arnim U, Walker MM, Wechsler JB, Woodland P, Woosley JT, Yang GY, Zevit N, Safroneeva E. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS). J Allergy Clin Immunol. 2022 Feb;149(2):659-670. doi: 10.1016/j.jaci.2021.07.001. Epub 2021 Jul 6. PMID: 34242635; PMCID: PMC8733049. An Expert Consensus to Standardise the Assessment of Histological Disease Activity in Crohn’s Disease Clinical Trials Almradi A, Ma C, D'Haens GR, Sandborn WJ, Parker CE, Guizzetti L, Borralho Nunes P, De Hertogh G, Feakins RM, Khanna R, Lauwers GY, Mookhoek A, Pai RK, Peyrin-Biroulet L, Riddell R, Rosty C, Schaeffer DF, Valasek MA, Singh S, Crowley E, Feagan BG, Jairath V, Pai RK. An expert consensus to standardise the assessment of histological disease activity in Crohn's disease clinical trials. Aliment Pharmacol Ther. 2021 Apr;53(7):784-793. doi: 10.1111/apt.16248. Epub 2021 Jan 7. PMID: 33410551. Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease Dulai PS, Jairath V, Zou G, Stitt LW, Khanna R, Sandborn WJ, Feagan BG, Singh S. Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease. Inflamm Bowel Dis. 2021 Apr 15;27(5):639-646. doi: 10.1093/ibd/izaa168. PMID: 32592481; PMCID: PMC8243599. Standardisation of Intestinal Ultrasound Scoring in Clinical Trials for Luminal Crohn’s Disease Goodsall TM, Jairath V, Feagan BG, Parker CE, Nguyen TM, Guizzetti L, Asthana AK, Begun J, Christensen B, Friedman AB, Kucharzik T, Lee A, Lewindon PJ, Maaser C, Novak KL, Rimola J, Taylor KM, Taylor SA, White LS, Wilkens R, Wilson SR, Wright EK, Bryant RV, Ma C. Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn's disease. Aliment Pharmacol Ther. 2021 Apr;53(8):873-886. doi: 10.1111/apt.16288. Epub 2021 Feb 28. PMID: 33641221. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129. PMID: 32614386. International Consensus to Standardise Histopathological Scoring for Small Bowel Strictures in Crohn’s Disease Gordon IO, Bettenworth D, Bokemeyer A, Srivastava A, Rosty C, de Hertogh G, Robert ME, Valasek MA, Mao R, Li J, Harpaz N, Borralho P, Pai RK, Odze R, Feakins R, Parker CE, Guizzetti L, Nguyen T, Shackelton LM, Sandborn WJ, Jairath V, Baker M, Bruining D, Fletcher JG, Feagan BG, Pai RK, Rieder F; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. International consensus to standardise histopathological scoring for small bowel strictures in Crohn's disease. Gut. 2022 Mar;71(3):479-486. doi: 10.1136/gutjnl-2021-324374. Epub 2021 May 5. PMID: 33952604; PMCID: PMC8903083. Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn’s Disease After Elective Surgery: Meta-Analysis Hanzel J, Almradi A, Istl AC, Yang ML, Fleshner KA, Parker CE, Guizzetti L, Ma C, Singh S, Jairath V. Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn's Disease After Elective Surgery: Meta-Analysis. Dig Dis Sci. 2022 Feb;67(2):646-660. doi: 10.1007/s10620-021-06895-6. Epub 2021 Feb 26. PMID: 33634430. Vedolizumab and Extraintestinal Manifestations in Inflammatory Bowel Disease Hanzel J, Ma C, Casteele NV, Khanna R, Jairath V, Feagan BG. Vedolizumab and Extraintestinal Manifestations in Inflammatory Bowel Disease. Drugs. 2021 Feb;81(3):333-347. doi: 10.1007/s40265-020-01460-3. Erratum in: Drugs. 2021 Sep;81(14):1697. PMID: 33400241. Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators Jairath V, Guizzetti L, Baker KA, Williamson LA, Sedano R, Thompson H, Ma C. Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators. Inflamm Bowel Dis. 2021 Jul 27;27(8):e98. doi: 10.1093/ibd/izab111. PMID: 33988238; PMCID: PMC8244581. Methods for Handling Missing Segments in Crohn’s Disease Clinical Trials: Analysis From the EXTEND Trial Ma C, Khanna R, Guizzetti L, Zou G, Feagan BG, Jairath V. Methods for handling missing segments in Crohn's disease clinical trials: analysis from the EXTEND trial. Gut. 2022 Feb;71(2):447-448. doi: 10.1136/gutjnl-2021-324658. Epub 2021 May 6. PMID: 33958434. An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials Ma C, Sedano R, Almradi A, Vande Casteele N, Parker CE, Guizzetti L, Schaeffer DF, Riddell RH, Pai RK, Battat R, Sands BE, Rosty C, Dubinsky MC, Rieder F, Harpaz N, Abreu MT, Bryant RV, Lauwers GY, Kirsch R, Valasek MA, Crowley E, Sandborn WJ, Feagan BG, Pai RK, Jairath V. An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials. Gastroenterology. 2021 Jun;160(7):2291-2302. doi: 10.1053/j.gastro.2021.02.035. Epub 2021 Feb 19. PMID: 33610533; PMCID: PMC8851891. Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis Sedano R, Hogan M, Nguyen TM, Chang J, Zou GY, Macdonald JK, Vande Casteele N, Hanzel J, Crowley E, Battat R, Dulai PS, Singh S, D'Haens G, Sandborn W, Feagan BG, Ma C, Jairath V. Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. J Crohns Colitis. 2022 Feb 23;16(2):224-243. doi: 10.1093/ecco-jcc/jjab135. PMID: 34309658. An Expert Consensus to Standardise Clinical, Endoscopic and Histologic Items and Inclusion and Outcome Criteria for Evaluation of Pouchitis Disease Activity in Clinical Trials Sedano R, Ma C, Pai RK, D' Haens G, Guizzetti L, Shackelton LM, Remillard J, Gionchetti P, Gordon IO, Holubar S, Kayal M, Lauwers GY, Pai RK, Pardi DS, Samaan MA, Schaeffer DF, Shen B, Silverberg MS, Feagan BG, Sandborn WJ, Jairath V. An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials. Aliment Pharmacol Ther. 2021 May;53(10):1108-1117. doi: 10.1111/apt.16328. Epub 2021 Mar 18. PMID: 33735522. Development and Validation of a Clinical Decision Support Tool That Incorporates Pharmacokinetic Data to Predict Endoscopic Healing in Patients Treated With Infliximab Vande Casteele N, Jairath V, Jeyarajah J, Dulai PS, Singh S, Shackelton LM, Feagan BG, Sandborn WJ. Development and Validation of a Clinical Decision Support Tool That Incorporates Pharmacokinetic Data to Predict Endoscopic Healing in Patients Treated With Infliximab. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1209-1217.e2. doi: 10.1016/j.cgh.2020.04.078. Epub 2020 May 4. PMID: 32376505. Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) Score for Assessment of Inflammation in Patients With Ulcerative Colitis Yan BM, Sey MSL, Belletrutti P, Brahm G, Guizzetti L, Jairath V. Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) score for assessment of inflammation in patients with ulcerative colitis. Endosc Int Open. 2021 Jul;9(7):E1116-E1122. doi: 10.1055/a-1481-8032. Epub 2021 Jun 21. PMID: 34327283; PMCID: PMC8312768. A Systematic Review On Immune Checkpoint Inhibitor-Associated Enterocolitis Ma C, MacDonald JK, Nguyen TM, Vande Casteele N, Linggi B, Lefevre P, Wang Y, Feagan BG, Jairath V. Pharmacological Interventions for the Prevention and Treatment of Immune Checkpoint Inhibitor-Associated Enterocolitis: A Systematic Review. Dig Dis Sci. 2022 Apr;67(4):1128-1155. doi: 10.1007/s10620-021-06948-w. Epub 2021 Mar 26. PMID: 33770330. Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy Akhtar HJ, Nguyen TM, Ma C, Jairath V. Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy. Clin Gastroenterol Hepatol. 2022 Mar;20(3):e614-e623. doi: 10.1016/j.cgh.2021.02.026. Epub 2021 Feb 19. PMID: 33618025. 2020 24 items Early Combined Immunosuppression Reduces Complications in Long-standing Crohn’s Disease: A Post Hoc Analysis of REACT Hanzel J, Ma C, Zou G, Singh S, Dulai PS, Feagan BG, D'Haens GR, Sandborn WJ, Jairath V. Early Combined Immunosuppression Reduces Complications in Long-standing Crohn's Disease: A Post Hoc Analysis of REACT. Clin Gastroenterol Hepatol. 2022 Jan;20(1):236-238. DOI: 10.1016/j.cgh.2020.12.019. Epub 2020 Dec 18. PMID: 33346141. Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials Khanna R, Ma C, Jairath V, Vande Casteele N, Zou G, Feagan BG. Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials. Clin Gastroenterol Hepatol. 2022 Apr;20(4):727-736.e2. doi: 10.1016/j.cgh.2020.12.017. Epub 2020 Dec 15. PMID: 33338657. Precision Medicine in IBD Clinical Research N/A Safety of Combination Biologic and Antirejection Therapy Post-Liver Transplantation in Patients With Inflammatory Bowel Disease Al Draiweesh S, Ma C, Alkhattabi M, McDonald C, Nguyen TM, Beaton M, Chande N, Colquhoun P, Feagan BG, Gregor JC, Khanna R, Marotta P, Ponich T, Quan D, Qumosani K, Sandhu A, Sey M, Skaro A, Teriaky A, Wilson A, Yan B, Brahmania M, Jairath V. Safety of Combination Biologic and Antirejection Therapy Post-Liver Transplantation in Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 May 12;26(6):949-959. doi: 10.1093/ibd/izz244. PMID: 31665288. Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease Almradi A, Hanzel J, Sedano R, Parker CE, Feagan BG, Ma C, Jairath V. Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease. BioDrugs. 2020 Dec;34(6):713-721. doi: 10.1007/s40259-020-00451-w. PMID: 33105016. Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid? Battat R, Dulai PS, Ma C, Jairath V, Feagan BG, Sandborn WJ, Khanna R. Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid? Curr Treat Options Gastroenterol. 2020 Jan 4. doi: 10.1007/s11938-019-00259-w. Epub ahead of print. PMID: 31902071. Evaluating the Optimum Number of Biopsies to Assess Histological Inflammation in Ulcerative Colitis: A Retrospective Cohort Study Battat R, Vande Casteele N, Pai RK, Wang Z, Zou G, McDonald JWD, Duijvestein M, Jeyarajah J, Parker CE, Van Viegen T, Nelson SA, Boland BS, Singh S, Dulai PS, Valasek MA, Feagan BG, Jairath V, Sandborn WJ. Evaluating the optimum number of biopsies to assess histological inflammation in ulcerative colitis: a retrospective cohort study. Aliment Pharmacol Ther. 2020 Nov;52(10):1574-1582. doi: 10.1111/apt.16083. Epub 2020 Sep 27. PMID: 32981088; PMCID: PMC8007067. Alternative and Complementary Approaches for the Treatment of Inflammatory Bowel Disease: Evidence From Cochrane Reviews Chande N, Costello SP, Limketkai BN, Parker CE, Nguyen TM, Macdonald JK, Feagan BG. Alternative and Complementary Approaches for the Treatment of Inflammatory Bowel Disease: Evidence From Cochrane Reviews. Inflamm Bowel Dis. 2020 May 12;26(6):843-851. doi: 10.1093/ibd/izz223. PMID: 31560744. Response to Placebo, Measured by Endoscopic Evaluation of Crohn’s Disease Activity, in a Pooled Analysis of Data From 5 Randomized Controlled Induction Trials Duijvestein M, Jeyarajah J, Guizzetti L, Zou G, Parker CE, van Viegen T, VandeCasteele N, Khanna R, Van Der Aa A, Sandborn WJ, Feagan BG, D'Haens GR, Jairath V. Response to Placebo, Measured by Endoscopic Evaluation of Crohn's Disease Activity, in a Pooled Analysis of Data From 5 Randomized Controlled Induction Trials. Clin Gastroenterol Hepatol. 2020 May;18(5):1121-1132.e2. doi: 10.1016/j.cgh.2019.08.025. Epub 2019 Aug 20. PMID: 31442599. Development of the Symptoms and Impacts Questionnaire for Crohn’s Disease and Ulcerative Colitis Dulai PS, Jairath V, Khanna R, Ma C, McCarrier KP, Martin ML, Parker CE, Morris J, Feagan BG, Sandborn WJ. Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther. 2020 Jun;51(11):1047-1066. doi: 10.1111/apt.15726. Epub 2020 Apr 21. PMID: 32319120; PMCID: PMC7317756. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis Dulai PS, Singh S, Vande Casteele N, Meserve J, Winters A, Chablaney S, Aniwan S, Shashi P, Kochhar G, Weiss A, Koliani-Pace JL, Gao Y, Boland BS, Chang JT, Faleck D, Hirten R, Ungaro R, Lukin D, Sultan K, Hudesman D, Chang S, Bohm M, Varma S, Fischer M, Shmidt E, Swaminath A, Gupta N, Rosario M, Jairath V, Guizzetti L, Feagan BG, Siegel CA, Shen B, Kane S, Loftus EV Jr, Sandborn WJ, Sands BE, Colombel JF, Lasch K, Cao C. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2952-2961.e8. doi: 10.1016/j.cgh.2020.02.010. Epub 2020 Feb 13. PMID: 32062041; PMCID: PMC7899124. Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn’s Disease George J, Singh S, Dulai PS, Ma C, Nguyen T, Feagan BG, Sandborn WJ, Jairath V. Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn's Disease. Inflamm Bowel Dis. 2020 Mar 4;26(4):515-523. doi: 10.1093/ibd/izz193. PMID: 31504528; PMCID: PMC8127062. Histopathology Scoring Systems of Stenosis Associated With Small Bowel Crohn’s Disease: A Systematic Review Gordon IO, Bettenworth D, Bokemeyer A, Srivastava A, Rosty C, de Hertogh G, Robert ME, Valasek MA, Mao R, Kurada S, Harpaz N, Borralho P, Pai RK, Pai RK, Odze R, Feakins R, Parker CE, Nguyen T, Jairath V, Baker ME, Bruining DH, Fletcher JG, Feagan BG, Rieder F; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. Histopathology Scoring Systems of Stenosis Associated With Small Bowel Crohn's Disease: A Systematic Review. Gastroenterology. 2020 Jan;158(1):137-150.e1. doi: 10.1053/j.gastro.2019.08.033. Epub 2019 Aug 30. PMID: 31476299; PMCID: PMC7649049. Clinical Pharmacology of Janus Kinase Inhibitors in Inflammatory Bowel Disease Lefevre PLC, Vande Casteele N. Clinical Pharmacology of Janus Kinase Inhibitors in Inflammatory Bowel Disease. J Crohns Colitis. 2020 Aug 1;14(Supplement_2):S725-S736. doi: 10.1093/ecco-jcc/jjaa014. PMID: 32160283; PMCID: PMC7395308. Systematic Review: Medical Therapy for Fibrostenosing Crohn’s Disease Lu C, Baraty B, Lee Robertson H, Filyk A, Shen H, Fung T, Novak K, Ma C, Panaccione R, Achkar JP, El Ouali S, Bruining D, Jairath V, Feagan B, Rieder F; Stenosis Therapy and Research (STAR) Consortium. Systematic review: medical therapy for fibrostenosing Crohn's disease. Aliment Pharmacol Ther. 2020 Jun;51(12):1233-1246. doi: 10.1111/apt.15750. Epub 2020 May 13. PMID: 32406116; PMCID: PMC7777136. Reliability of Endoscopic Evaluation of Postoperative Recurrent Crohn’s Disease Ma C, Gecse KB, Duijvestein M, Sandborn WJ, Zou G, Shackelton LM, Stitt LW, Parker CE, Bossuyt P, Löwenberg M, Khanna R, Vermeire S, Rutgeerts P, Feagan BG, Jairath V, D'Haens GR. Reliability of Endoscopic Evaluation of Postoperative Recurrent Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2139-2141.e2. doi: 10.1016/j.cgh.2019.08.046. Epub 2019 Aug 29. PMID: 31473359. Modeling Endoscopic Improvements Ma C, Jeyarajah J, Guizzetti L, Parker CE, Singh S, Dulai PS, D'Haens GR, Sandborn WJ, Feagan BG, Jairath V. Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Feb;20(2):447-454.e1. doi: 10.1016/j.cgh.2020.11.040. Epub 2020 Dec 3. PMID: 33279779; PMCID: PMC8588993. Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis Ma C, Sandborn WJ, D'Haens GR, Zou G, Stitt LW, Singh S, Ananthakrishnan AN, Dulai PS, Khanna R, Jairath V, Feagan BG. Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1760-1768.e1. doi: 10.1016/j.cgh.2019.09.021. Epub 2019 Sep 20. PMID: 31546056; PMCID: PMC7992966. Assessing National Trends and Disparities in Ambulatory, Emergency Department, and Inpatient Visits for Inflammatory Bowel Disease in the United States (2005-2016) Ma C, Smith MK, Guizzetti L, Panaccione R, Kaplan GG, Novak KL, Lu C, Khanna R, Feagan BG, Singh S, Jairath V, Ananthakrishnan AN. Assessing National Trends and Disparities in Ambulatory, Emergency Department, and Inpatient Visits for Inflammatory Bowel Disease in the United States (2005-2016). Clin Gastroenterol Hepatol. 2020 Oct;18(11):2500-2509.e1. doi: 10.1016/j.cgh.2020.01.023. Epub 2020 Jan 25. PMID: 31988046; PMCID: PMC8011653. Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions Porter AC, Aubrecht J, Birch C, Braun J, Cuff C, Dasgupta S, Gale JD, Hinton R, Hoffmann SC, Honig G, Linggi B, Schito M, Casteele NV, Sauer JM. Biomarkers of Crohn's Disease to Support the Development of New Therapeutic Interventions. Inflamm Bowel Dis. 2020 Sep 18;26(10):1498-1508. doi: 10.1093/ibd/izaa215. PMID: 32840322; PMCID: PMC7500523. Adalimumab for Maintenance of Remission in Crohn’s Disease Townsend CM, Nguyen TM, Cepek J, Abbass M, Parker CE, MacDonald JK, Khanna R, Jairath V, Feagan BG. Adalimumab for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev. 2020 May 16;5(5):CD012877. doi: 10.1002/14651858.CD012877.pub2. PMID: 32413933; PMCID: PMC7386457. JAK-STAT Pathway Targeting for the Treatment of Inflammatory Bowel Disease Salas A, Hernandez-Rocha C, Duijvestein M, Faubion W, McGovern D, Vermeire S, Vetrano S, Vande Casteele N. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Jun;17(6):323-337. doi: 10.1038/s41575-020-0273-0. Epub 2020 Mar 19. PMID: 32203403. ATRC Review: JAK-STAT Pathway Targeting for the Treatment of IBD Salas A, Hernandez-Rocha C, Duijvestein M, Faubion W, McGovern D, Vermeire S, Vetrano S, Vande Casteele N. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Jun;17(6):323-337. doi: 10.1038/s41575-020-0273-0. Epub 2020 Mar 19. PMID: 32203403. Oral Janus Kinase Inhibitors for Maintenance of Remission in Ulcerative Colitis Davies SC, Hussein IM, Nguyen TM, Parker CE, Khanna R, Jairath V. Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2020 Jan 27;1(1):CD012381. doi: 10.1002/14651858.CD012381.pub2. PMID: 31984480; PMCID: PMC6984444. 2019 20 items Factors Influencing Drug Disposition of Monoclonal Antibodies in Inflammatory Bowel Disease: Implications for Personalized Medicine Lefevre PLC, Shackelton LM, Vande Casteele N. Factors Influencing Drug Disposition of Monoclonal Antibodies in Inflammatory Bowel Disease: Implications for Personalized Medicine. BioDrugs. 2019 Oct;33(5):453-468. doi: 10.1007/s40259-019-00366-1. PMID: 31301024. Histologic Healing Rates of Medical Therapies for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Battat R, Duijvestein M, Guizzetti L, Choudhary D, Boland BS, Dulai PS, Parker CE, Nguyen TM, Singh S, Vande Casteele N, Pai RK, Feagan BG, Sandborn WJ, Jairath V. Histologic Healing Rates of Medical Therapies for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Gastroenterol. 2019 May;114(5):733-745. doi: 10.14309/ajg.0000000000000111. PMID: 30694863. Benefit-Risk Assessment of Vedolizumab in the Treatment of Crohn’s Disease and Ulcerative Colitis Battat R, Ma C, Jairath V, Khanna R, Feagan BG. Benefit-Risk Assessment of Vedolizumab in the Treatment of Crohn's Disease and Ulcerative Colitis. Drug Saf. 2019 May;42(5):617-632. doi: 10.1007/s40264-018-00783-1. PMID: 30830573. Assessment of Crohn’s Disease-Associated Small Bowel Strictures and Fibrosis on Cross-Sectional Imaging: A Systematic Review Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review de Rooij WE, Dellon ES, Parker CE, Feagan BG, Jairath V, Ma C, Bredenoord AJ. Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review. Drugs. 2019 Sep;79(13):1419-1434. doi: 10.1007/s40265-019-01173-2. PMID: 31352605. Development and Validation of a Magnetic Resonance Index for Assessing Fistulas in Patients With Crohn’s Disease Hindryckx P, Jairath V, Zou G, Feagan BG, Sandborn WJ, Stoker J, Khanna R, Stitt L, van Viegen T, Shackelton LM, Taylor SA, Santillan C, Mearadji B, D'Haens G, Richard MP, Panes J, Rimola J. Development and Validation of a Magnetic Resonance Index for Assessing Fistulas in Patients With Crohn's Disease. Gastroenterology. 2019 Nov;157(5):1233-1244.e5. doi: 10.1053/j.gastro.2019.07.027. Epub 2019 Jul 20. PMID: 31336124. Responsiveness of Histological Disease Activity Indices in Ulcerative Colitis: A Post Hoc Analysis Using Data From the TOUCHSTONE Randomised Controlled Trial Jairath V, Peyrin-Biroulet L, Zou G, Mosli M, Vande Casteele N, Pai RK, Valasek MA, Marchal-Bressenot A, Stitt LW, Shackelton LM, Khanna R, D'Haens GR, Sandborn WJ, Olson A, Feagan BG, Pai RK. Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial. Gut. 2019 Jul;68(7):1162-1168. doi: 10.1136/gutjnl-2018-316702. Epub 2018 Aug 3. PMID: 30076171. Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set Ma C, Athayde J, Davies SC, Parker CE, Nguyen TM, Khanna R, Feagan BG, Jairath V. Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1637-1640. doi: 10.1016/j.cgh.2018.09.042. Epub 2018 Sep 27. PMID: 30268563. Innovations in Oral Therapies for Inflammatory Bowel Disease Ma C, Battat R, Dulai PS, Parker CE, Sandborn WJ, Feagan BG, Jairath V. Innovations in Oral Therapies for Inflammatory Bowel Disease. Drugs. 2019 Aug;79(12):1321-1335. doi: 10.1007/s40265-019-01169-y. PMID: 31317509. What Is the Role of C-Reactive Protein and Fecal Calprotectin in Evaluating Crohn’s Disease Activity? Ma C, Battat R, Khanna R, Parker CE, Feagan BG, Jairath V. What is the role of C-reactive protein and fecal calprotectin in evaluating Crohn's disease activity? Best Pract Res Clin Gastroenterol. 2019 Feb-Apr;38-39:101602. doi: 10.1016/j.bpg.2019.02.004. Epub 2019 Feb 22. PMID: 31327404. Advances in Therapeutic Drug Monitoring for Small-Molecule and Biologic Therapies in Inflammatory Bowel Disease Ma C, Battat R, Jairath V, Vande Casteele N. Advances in Therapeutic Drug Monitoring for Small-Molecule and Biologic Therapies in Inflammatory Bowel Disease. Curr Treat Options Gastroenterol. 2019 Mar;17(1):127-145. doi: 10.1007/s11938-019-00222-9. PMID: 30680599. Update on C-Reactive Protein and Fecal Calprotectin: Are They Accurate Measures of Disease Activity in Crohn’s Disease? Ma C, Battat R, Parker CE, Khanna R, Jairath V, Feagan BG. Update on C-reactive protein and fecal calprotectin: are they accurate measures of disease activity in Crohn's disease? Expert Rev Gastroenterol Hepatol. 2019 Apr;13(4):319-330. doi: 10.1080/17474124.2019.1563481. Epub 2019 Jan 3. PMID: 30791776. Systematic Review With Meta-Analysis: Efficacy and Safety of Oral Janus Kinase Inhibitors for Inflammatory Bowel Disease Ma C, Lee JK, Mitra AR, Teriaky A, Choudhary D, Nguyen TM, Vande Casteele N, Khanna R, Panaccione R, Feagan BG, Jairath V. Systematic review with meta-analysis: efficacy and safety of oral Janus kinase inhibitors for inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Jul;50(1):5-23. doi: 10.1111/apt.15297. Epub 2019 May 23. PMID: 31119766. IL12/23 or Selective IL23 Inhibition for the Management of Moderate-To-Severe Crohn’s Disease? Ma C, Panaccione R, Khanna R, Feagan BG, Jairath V. IL12/23 or selective IL23 inhibition for the management of moderate-to-severe Crohn's disease? Best Pract Res Clin Gastroenterol. 2019 Feb-Apr;38-39:101604. doi: 10.1016/j.bpg.2019.02.006. Epub 2019 Feb 19. PMID: 31327402. Identifying Outcomes in Clinical Trials of Fistulizing Crohn’s Disease for the Development of a Core Outcome Set Ma C, Parker CE, Nguyen TM, Khanna R, Feagan BG, Jairath V. Identifying Outcomes in Clinical Trials of Fistulizing Crohn's Disease for the Development of a Core Outcome Set. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1904-1908. doi: 10.1016/j.cgh.2018.10.004. Epub 2018 Oct 4. PMID: 30292887. Evaluation of Optimal Biopsy Location for Assessment of Histological Activity, Transcriptomic and Immunohistochemical Analyses in Patients With Active Crohn’s Disease Novak G, Stevens T, Van Viegen T, Bossuyt P, Štabuc B, Jeyarajah J, Zou G, Gaemers IC, McKee TD, Fu F, Shackelton LM, Khanna R, van den Brink GR, Sandborn WJ, Feagan BG, Pai RK, Jairath V, Vande Casteele N, D'Haens G. Evaluation of optimal biopsy location for assessment of histological activity, transcriptomic and immunohistochemical analyses in patients with active Crohn's disease. Aliment Pharmacol Ther. 2019 Jun;49(11):1401-1409. doi: 10.1111/apt.15250. Epub 2019 Apr 15. PMID: 30983024. Definitions of Response and Remission for the Robarts Histopathology Index Pai RK, Khanna R, D'Haens GR, Sandborn WJ, Jeyarajah J, Feagan BG, Vande Casteele N, Jairath V. Definitions of response and remission for the Robarts Histopathology Index. Gut. 2019 Nov;68(11):2101-2102. doi: 10.1136/gutjnl-2018-317547. Epub 2018 Oct 26. PMID: 30366909. Standardising the Interpretation of Liver Biopsies in Non-alcoholic Fatty Liver Disease Clinical Trials Pai RK, Kleiner DE, Hart J, Adeyi OA, Clouston AD, Behling CA, Jain D, Kakar S, Brahmania M, Burgart L, Batts KP, Valasek MA, Torbenson MS, Guindi M, Wang HL, Ajmera V, Adams LA, Parker CE, Feagan BG, Loomba R, Jairath V. Standardising the interpretation of liver biopsies in non-alcoholic fatty liver disease clinical trials. Aliment Pharmacol Ther. 2019 Nov;50(10):1100-1111. doi: 10.1111/apt.15503. Epub 2019 Oct 3. PMID: 31583739; PMCID: PMC6817398. Early Combined Immunosuppression May Be Effective and Safe in Older Patients With Crohn’s Disease: Post Hoc Analysis of REACT Singh S, Stitt LW, Zou G, Khanna R, Dulai PS, Sandborn WJ, Feagan BG, Jairath V. Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT. Aliment Pharmacol Ther. 2019 May;49(9):1188-1194. doi: 10.1111/apt.15214. Epub 2019 Mar 19. PMID: 30891808; PMCID: PMC6461484. Infliximab Exposure-Response Relationship and Thresholds Associated With Endoscopic Healing in Patients With Ulcerative Colitis Vande Casteele N, Jeyarajah J, Jairath V, Feagan BG, Sandborn WJ. Infliximab Exposure-Response Relationship and Thresholds Associated With Endoscopic Healing in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1814-1821.e1. doi: 10.1016/j.cgh.2018.10.036. Epub 2018 Oct 26. PMID: 30613004. 2018 22 items A Composite Disease Activity Index for Early Drug Development in Ulcerative Colitis: Development and Validation of the UC-100 Score Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, D'Haens GR, Sandborn WJ, Feagan BG. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):63-70. doi: 10.1016/S2468-1253(18)30306-6. Epub 2018 Oct 18. PMID: 30343116. Evolution of the Randomized Controlled Trial in Inflammatory Bowel Disease: Current Challenges and Future Solutions Khanna R, Zou G, Feagan BG. Evolution of the Randomized Controlled Trial in Inflammatory Bowel Disease: Current Challenges and Future Solutions. Inflamm Bowel Dis. 2018 Sep 15;24(10):2155-2164. doi: 10.1093/ibd/izy117. PMID: 29788218. Additional Stability Testing of Cryopreserved Intestinal Biopsies for Downstream Flow Cytometric Analysis Vande Casteele N, Wildenberg ME. Additional Stability Testing of Cryopreserved Intestinal Biopsies for Downstream Flow Cytometric Analysis. J Immunol Methods. 2019 Nov;474:112517. doi: 10.1016/j.jim.2018.09.005. Epub 2018 Sep 8. PMID: 30201393. 2018 August Author Interview – Vipul Jairath Interview with Dr Vipul Jairath for his article, “Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis” from the August issue of Gastrointestinal Endoscopy. Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy Athayde J, Davies SC, Parker CE, Guizzetti L, Ma C, Khanna R, Feagan BG, Jairath V. Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy. Dig Dis Sci. 2018 Oct;63(10):2519-2528. doi: 10.1007/s10620-018-5199-9. Epub 2018 Jul 11. PMID: 29995184. Physicians’ Perspectives on Cost, Safety, and Perceived Efficacy Determine Aminosalicylate Use in Crohn’s Disease Ma C, Ascoytia C, McCarrier KP, Martin M, Feagan BG, Jairath V. Physicians' Perspectives on Cost, Safety, and Perceived Efficacy Determine Aminosalicylate Use in Crohn's Disease. Dig Dis Sci. 2018 Oct;63(10):2555-2563. doi: 10.1007/s10620-018-5181-6. Epub 2018 Jun 29. PMID: 29959726. An Expert Consensus to Standardise Definitions, Diagnosis and Treatment Targets for Anti-fibrotic Stricture Therapies in Crohn’s Disease Rieder F, Bettenworth D, Ma C, Parker CE, Williamson LA, Nelson SA, van Assche G, Di Sabatino A, Bouhnik Y, Stidham RW, Dignass A, Rogler G, Taylor SA, Stoker J, Rimola J, Baker ME, Fletcher JG, Panes J, Sandborn WJ, Feagan BG, Jairath V. An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease. Aliment Pharmacol Ther. 2018 Aug;48(3):347-357. doi: 10.1111/apt.14853. Epub 2018 Jun 19. PMID: 29920726; PMCID: PMC6043370. Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review Ma C, van Rhijn BD, Jairath V, Nguyen TM, Parker CE, Aceves SS, Furuta GT, Gupta SK, Katzka DA, Safroneeva E, Schoepfer AM, Straumann A, Spergel JM, Pai RK, Feagan BG, Hirano I, Dellon ES, Bredenoord AJ. Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1714-1729.e3. doi: 10.1016/j.cgh.2018.06.005. Epub 2018 Jun 14. PMID: 29908360. Evaluation of the Effect of Storage Condition on Cell Extraction and Flow Cytometric Analysis From Intestinal Biopsies Wildenberg ME, Duijvestein M, Westera L, van Viegen T, Buskens CJ, van der Bilt JDW, Stitt L, Jairath V, Feagan BG, Vande Casteele N. Evaluation of the effect of storage condition on cell extraction and flow cytometric analysis from intestinal biopsies. J Immunol Methods. 2018 Aug;459:50-54. doi: 10.1016/j.jim.2018.05.004. Epub 2018 Jun 1. PMID: 29772249. Systematic Review With Meta-Analysis: Prevalence, Risk Factors and Costs of Aminosalicylate Use in Crohn’s Disease Ma C, Dutton SJ, Cipriano LE, Singh S, Parker CE, Nguyen TM, Guizzetti L, Gregor JC, Chande N, Hindryckx P, Feagan BG, Jairath V. Systematic review with meta-analysis: prevalence, risk factors and costs of aminosalicylate use in Crohn's disease. Aliment Pharmacol Ther. 2018 Jul;48(2):114-126. doi: 10.1111/apt.14821. Epub 2018 May 30. PMID: 29851091. Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, Siegel CA, Peyrin-Biroulet L, D'Haens G, Sandborn WJ, Feagan BG, Jairath V. Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set. Clin Gastroenterol Hepatol. 2018 May;16(5):637-647.e13. doi: 10.1016/j.cgh.2017.08.025. Epub 2017 Aug 24. PMID: 28843356. Systematic Review With Meta-Analysis: Endoscopic and Histologic Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis Ma C, Guizzetti L, Panaccione R, Fedorak RN, Pai RK, Parker CE, Nguyen TM, Khanna R, Vande Casteele N, D'Haens G, Sandborn WJ, Feagan BG, Jairath V. Systematic review with meta-analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis. Aliment Pharmacol Ther. 2018 Jun;47(12):1578-1596. doi: 10.1111/apt.14672. Epub 2018 Apr 25. PMID: 29696670. Reliability Among Central Readers in the Evaluation of Endoscopic Disease Activity in Pouchitis Samaan MA, Shen B, Mosli MH, Zou G, Sandborn WJ, Shackelton LM, Nelson S, Stitt L, Bloom S, Pardi DS, Gionchetti P, Lindsay J, Travis S, Hart A, Silverberg MS, Feagan BG, D'Haens GR, Jairath V. Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis. Gastrointest Endosc. 2018 Aug;88(2):360-369.e2. doi: 10.1016/j.gie.2018.04.2330. Epub 2018 Apr 13. PMID: 29660321. Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn’s Disease: A Systematic Review Ma C, Hussein IM, Al-Abbar YJ, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, Siegel CA, Peyrin-Biroulet L, Pai RK, Vande Casteele N, D'Haens GR, Sandborn WJ, Feagan BG, Jairath V. Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn's Disease: A Systematic Review. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1407-1419.e22. doi: 10.1016/j.cgh.2018.02.051. Epub 2018 Mar 27. PMID: 29596987. Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease Duijvestein M, Battat R, Vande Casteele N, D'Haens GR, Sandborn WJ, Khanna R, Jairath V, Feagan BG. Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease. Curr Treat Options Gastroenterol. 2018 Mar;16(1):129-146. doi: 10.1007/s11938-018-0175-1. PMID: 29411220. Reliability of Histologic Assessment in Patients With Eosinophilic Oesophagitis Warners MJ, Ambarus CA, Bredenoord AJ, Verheij J, Lauwers GY, Walsh JC, Katzka DA, Nelson S, van Viegen T, Furuta GT, Gupta SK, Stitt L, Zou G, Parker CE, Shackelton LM, D Haens GR, Sandborn WJ, Dellon ES, Feagan BG, Collins MH, Jairath V, Pai RK. Reliability of histologic assessment in patients with eosinophilic oesophagitis. Aliment Pharmacol Ther. 2018 Apr;47(7):940-950. doi: 10.1111/apt.14559. Epub 2018 Feb 20. PMID: 29460418. Efficacy of Medical Therapies for Fistulizing Crohn’s Disease: Systematic Review and Meta-analysis Lee MJ, Parker CE, Taylor SR, Guizzetti L, Feagan BG, Lobo AJ, Jairath V. Efficacy of Medical Therapies for Fistulizing Crohn's Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1879-1892. doi: 10.1016/j.cgh.2018.01.030. Epub 2018 Jan 31. PMID: 29374617. Development of Clinical Prediction Models for Surgery and Complications in Crohn’s Disease Guizzetti L, Zou G, Khanna R, Dulai PS, Sandborn WJ, Jairath V, Feagan BG. Development of Clinical Prediction Models for Surgery and Complications in Crohn's Disease. J Crohns Colitis. 2018 Jan 24;12(2):167-177. doi: 10.1093/ecco-jcc/jjx130. PMID: 29028958; PMCID: PMC5881746. Endoscopic Scoring Indices for Evaluation of Disease Activity in Ulcerative Colitis Mohammed Vashist N, Samaan M, Mosli MH, Parker CE, MacDonald JK, Nelson SA, Zou GY, Feagan BG, Khanna R, Jairath V. Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis. Cochrane Database Syst Rev. 2018 Jan 16;1(1):CD011450. doi: 10.1002/14651858.CD011450.pub2. PMID: 29338066; PMCID: PMC6491285. Reliability of Measuring Ileo-Colonic Disease Activity in Crohn’s Disease by Magnetic Resonance Enterography Jairath V, Ordas I, Zou G, Panes J, Stoker J, Taylor SA, Santillan C, Horsthuis K, Samaan MA, Shackelton LM, Stitt LW, Hindryckx P, Khanna R, Sandborn WJ, D'Haens G, Feagan BG, Levesque BG, Rimola J. Reliability of Measuring Ileo-Colonic Disease Activity in Crohn's Disease by Magnetic Resonance Enterography. Inflamm Bowel Dis. 2018 Jan 18;24(2):440-449. doi: 10.1093/ibd/izx040. PMID: 29361096. Disease Activity Indices in Coeliac Disease: Systematic Review and Recommendations for Clinical Trials Hindryckx P, Levesque BG, Holvoet T, Durand S, Tang CM, Parker C, Khanna R, Shackelton LM, D'Haens G, Sandborn WJ, Feagan BG, Lebwohl B, Leffler DA, Jairath V. Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials. Gut. 2018 Jan;67(1):61-69. doi: 10.1136/gutjnl-2016-312762. Epub 2016 Oct 31. PMID: 27799282. The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients? Hindryckx P, Vande Casteele N, Novak G, Khanna R, D'Haens G, Sandborn WJ, Danese S, Jairath V, Feagan BG. The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients? J Crohns Colitis. 2018 Jan 5;12(1):105-119. doi: 10.1093/ecco-jcc/jjx117. PMID: 28961959. 2017 20 items Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study Westera L, van Viegen T, Jeyarajah J, Azad A, Bilsborough J, van den Brink GR, Cremer J, Danese S, D'Haens G, Eckmann L, Faubion W, Filice M, Korf H, McGovern D, Panes J, Salas A, Sandborn WJ, Silverberg MS, Smith MI, Vermeire S, Vetrano S, Shackelton LM, Stitt L, Jairath V, Levesque BG, Spencer DM, Feagan BG, Vande Casteele N. Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study. Clin Transl Gastroenterol. 2017 Nov 2;8(11):e126. doi: 10.1038/ctg.2017.52. PMID: 29095427; PMCID: PMC5717516. Systematic Review: Disease Activity Indices in Eosinophilic Esophagitis Warners MJ, Hindryckx P, Levesque BG, Parker CE, Shackelton LM, Khanna R, Sandborn WJ, D'Haens GR, Feagan BG, Bredenoord AJ, Jairath V. Systematic Review: Disease Activity Indices in Eosinophilic Esophagitis. Am J Gastroenterol. 2017 Nov;112(11):1658-1669. doi: 10.1038/ajg.2017.363. Epub 2017 Oct 17. PMID: 29039850. Placebo Response and Remission Rates in Randomised Trials of Induction and Maintenance Therapy for Ulcerative Colitis Jairath V, Zou GY, Parker CE, MacDonald JK, AlAmeel T, Al Beshir M, Almadi MA, Al-Taweel T, Atkinson NS, Biswas S, Chapman T, Dulai PS, Glaire MA, Hoekman DR, Koutsoumpas A, Minas E, Mosli MH, Samaan M, Khanna R, Travis S, D'Haens G, Sandborn WJ, Feagan BG. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis. Cochrane Database Syst Rev. 2017 Sep 8;9(9):CD011572. doi: 10.1002/14651858.CD011572.pub2. PMID: 28886205; PMCID: PMC6483671. Alicaforsen for the Treatment of Inflammatory Bowel Disease Jairath V, Khanna R, Feagan BG. Alicaforsen for the treatment of inflammatory bowel disease. Expert Opin Investig Drugs. 2017 Aug;26(8):991-997. doi: 10.1080/13543784.2017.1349753. Epub 2017 Jul 6. PMID: 28670932. Evolving Concepts in Phases I and II Drug Development for Crohn’s Disease Jairath V, Levesque BG, Vande Casteele N, Khanna R, Mosli M, Hindryckx P, Travis S, Duijvestein M, Rimola J, Panes J, D'Haens G, Sandborn WJ, Feagan BG. Evolving Concepts in Phases I and II Drug Development for Crohn's Disease. J Crohns Colitis. 2017 Feb;11(2):246-255. doi: 10.1093/ecco-jcc/jjw137. Epub 2016 Aug 3. Erratum in: J Crohns Colitis. 2018 Apr 27;12(5):631. PMID: 27487793. Reliability of EUS Indices to Detect Inflammation in Ulcerative Colitis Yan B, Feagan B, Teriaky A, Mosli M, Mohamed R, Williams G, Yeung E, Yong E, Haig A, Sey M, Stitt L, Zou GY, Jairath V. Reliability of EUS indices to detect inflammation in ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1079-1087. doi: 10.1016/j.gie.2017.07.035. Epub 2017 Jul 29. PMID: 28760533. Histologic Scoring Indices for Evaluation of Disease Activity in Crohn’s Disease Novak G, Parker CE, Pai RK, MacDonald JK, Feagan BG, Sandborn WJ, D'Haens G, Jairath V, Khanna R. Histologic scoring indices for evaluation of disease activity in Crohn's disease. Cochrane Database Syst Rev. 2017 Jul 21;7(7):CD012351. doi: 10.1002/14651858.CD012351.pub2. PMID: 28731502; PMCID: PMC6483549. The Development of a Magnetic Resonance Imaging Index for Fistulising Crohn’s Disease Samaan MA, Puylaert CAJ, Levesque BG, Zou GY, Stitt L, Taylor SA, Shackelton LM, Vandervoort MK, Khanna R, Santillan C, Rimola J, Hindryckx P, Nio CY, Sandborn WJ, D'Haens G, Feagan BG, Jairath V, Stoker J. The development of a magnetic resonance imaging index for fistulising Crohn's disease. Aliment Pharmacol Ther. 2017 Sep;46(5):516-528. doi: 10.1111/apt.14190. Epub 2017 Jun 27. PMID: 28653753. Pharmacokinetic Drug Evaluation of Budesonide in the Treatment of Crohn’s Disease Kwapisz L, Jairath V, Khanna R, Feagan B. Pharmacokinetic drug evaluation of budesonide in the treatment of Crohn's disease. Expert Opin Drug Metab Toxicol. 2017 Jul;13(7):793-801. doi: 10.1080/17425255.2017.1340454. Epub 2017 Jun 16. PMID: 28612627. Development of a Core Outcome Set for Clinical Trials in Inflammatory Bowel Disease: Study Protocol for a Systematic Review of the Literature and Identification of a Core Outcome Set Using a Delphi Survey Ma C, Panaccione R, Fedorak RN, Parker CE, Khanna R, Levesque BG, Sandborn WJ, Feagan BG, Jairath V. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. BMJ Open. 2017 Jun 9;7(6):e016146. doi: 10.1136/bmjopen-2017-016146. PMID: 28601837; PMCID: PMC5726090. A Comparison of Approaches for Adjudicating Outcomes in Clinical Trials Kahan BC, Feagan B, Jairath V. A comparison of approaches for adjudicating outcomes in clinical trials. Trials. 2017 Jun 8;18(1):266. doi: 10.1186/s13063-017-1995-3. PMID: 28595589; PMCID: PMC5465459. Randomised Non-inferiority Trial: 1600 MG Versus 400 MG Tablets of Mesalazine for the Treatment of Mild-To-Moderate Ulcerative Colitis D'Haens GR, Sandborn WJ, Zou G, Stitt LW, Rutgeerts PJ, Gilgen D, Jairath V, Hindryckx P, Shackelton LM, Vandervoort MK, Parker CE, Muller C, Pai RK, Levchenko O, Marakhouski Y, Horynski M, Mikhailova E, Kharchenko N, Pimanov S, Feagan BG. Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther. 2017 Aug;46(3):292-302. doi: 10.1111/apt.14164. Epub 2017 Jun 1. PMID: 28568974. Histologic Scoring Indices for Evaluation of Disease Activity in Ulcerative Colitis Mosli MH, Parker CE, Nelson SA, Baker KA, MacDonald JK, Zou GY, Feagan BG, Khanna R, Levesque BG, Jairath V. Histologic scoring indices for evaluation of disease activity in ulcerative colitis. Cochrane Database Syst Rev. 2017 May 25;5(5):CD011256. doi: 10.1002/14651858.CD011256.pub2. PMID: 28542712; PMCID: PMC6481362. The Evolution of Treatment Paradigms in Crohn’s Disease: Beyond Better Drugs Khanna R, Jairath V, Feagan BG. The Evolution of Treatment Paradigms in Crohn's Disease: Beyond Better Drugs. Gastroenterol Clin North Am. 2017 Sep;46(3):661-677. doi: 10.1016/j.gtc.2017.05.010. PMID: 28838421. Incidence, Prevention and Management of Anti-Drug Antibodies Against Therapeutic Antibodies in Inflammatory Bowel Disease: A Practical Overview Hindryckx P, Novak G, Vande Casteele N, Khanna R, Laukens D, Jairath V, Feagan BG. Incidence, Prevention and Management of Anti-Drug Antibodies Against Therapeutic Antibodies in Inflammatory Bowel Disease: A Practical Overview. Drugs. 2017 Mar;77(4):363-377. doi: 10.1007/s40265-017-0693-5. Erratum in: Drugs. 2017 Mar;77(4):379. Vipul, Jairath [corrected to Jairath, Vipul]. PMID: 28233275. The Safety of Vedolizumab for the Treatment of Ulcerative Colitis Novak G, Hindryckx P, Khanna R, Jairath V, Feagan BG. The safety of vedolizumab for the treatment of ulcerative colitis. Expert Opin Drug Saf. 2017 Apr;16(4):501-507. doi: 10.1080/14740338.2017.1300251. Epub 2017 Mar 5. PMID: 28276855. Systematic Review With Meta-Analysis: Placebo Rates in Induction and Maintenance Trials of Crohn’s Disease Jairath V, Zou G, Parker CE, MacDonald JK, Mosli MH, AlAmeel T, Al Beshir M, AlMadi M, Al-Taweel T, Atkinson NS, Biswas S, Chapman TP, Dulai PS, Glaire MA, Hoekman D, Kherad O, Koutsoumpas A, Minas E, Restellini S, Samaan MA, Khanna R, Levesque BG, D'Haens G, Sandborn WJ, Feagan BG. Systematic review with meta-analysis: placebo rates in induction and maintenance trials of Crohn's disease. Aliment Pharmacol Ther. 2017 Apr;45(8):1021-1042. doi: 10.1111/apt.13973. Epub 2017 Feb 5. PMID: 28164348. Development and Validation of a Histological Index for UC Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Shackelton LM, Walker CW, Nelson S, Vandervoort MK, Frisbie V, Samaan MA, Jairath V, Driman DK, Geboes K, Valasek MA, Pai RK, Lauwers GY, Riddell R, Stitt LW, Levesque BG. Development and validation of a histological index for UC. Gut. 2017 Jan;66(1):50-58. doi: 10.1136/gutjnl-2015-310393. Epub 2015 Oct 16. PMID: 26475633. Review Article: Dose Optimisation of Infliximab for Acute Severe Ulcerative Colitis Hindryckx P, Novak G, Vande Casteele N, Laukens D, Parker C, Shackelton LM, Narula N, Khanna R, Dulai P, Levesque BG, Sandborn WJ, D'Haens G, Feagan BG, Jairath V. Review article: dose optimisation of infliximab for acute severe ulcerative colitis. Aliment Pharmacol Ther. 2017 Mar;45(5):617-630. doi: 10.1111/apt.13913. Epub 2017 Jan 11. PMID: 28074618; PMCID: PMC6658182. Responsiveness of Endoscopic Indices of Disease Activity for Crohn’s Disease Khanna R, Zou G, Stitt L, Feagan BG, Sandborn WJ, Rutgeerts P, McDonald JWD, Dubcenco E, Fogel R, Panaccione R, Jairath V, Nelson S, Shackelton LM, Huang B, Zhou Q, Robinson AM, Levesque BG, D'Haens G. Responsiveness of Endoscopic Indices of Disease Activity for Crohn's Disease. Am J Gastroenterol. 2017 Oct;112(10):1584-1592. doi: 10.1038/ajg.2016.580. Epub 2017 Jan 10. Erratum in: Am J Gastroenterol. 2017 Jun;112(6):975. PMID: 28071654. 2016 2 items Effect of Standardised Scoring Conventions on Inter-rater Reliability in the Endoscopic Evaluation of Crohn’s Disease Dubcenco E, Zou G, Stitt L, Baker JP, Jeejeebhoy KN, Kandel G, Kim YI, Grover SC, McDonald JW, Shackelton LM, Khanna R, D'Haens G, Sandborn WJ, Feagan BG, Levesque BG. Effect of Standardised Scoring Conventions on Inter-rater Reliability in the Endoscopic Evaluation of Crohn's Disease. J Crohns Colitis. 2016 Sep;10(9):1006-14. doi: 10.1093/ecco-jcc/jjw120. Epub 2016 Jul 6. PMID: 27385400. Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis Jairath V, Zou G, Parker CE, Macdonald JK, Mosli MH, Khanna R, Shackelton LM, Vandervoort MK, AlAmeel T, Al Beshir M, AlMadi M, Al-Taweel T, Atkinson NS, Biswas S, Chapman TP, Dulai PS, Glaire MA, Hoekman D, Koutsoumpas A, Minas E, Samaan MA, Travis S, D'Haens G, Levesque BG, Sandborn WJ, Feagan BG. Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. J Crohns Colitis. 2016 May;10(5):607-18. doi: 10.1093/ecco-jcc/jjw004. Epub 2016 Jan 7. PMID: 26746169; PMCID: PMC4957452. 2014 4 items Assessment of Histologic Disease Activity in Crohn’s Disease: A Systematic Review Mojtahed A, Khanna R, Sandborn WJ, D'Haens GR, Feagan BG, Shackelton LM, Baker KA, Dubcenco E, Valasek MA, Geboes K, Levesque BG. Assessment of histologic disease activity in Crohn's disease: a systematic review. Inflamm Bowel Dis. 2014 Nov;20(11):2092-103. doi: 10.1097/MIB.0000000000000155. PMID: 25137418. Reproducibility of Histological Assessments of Disease Activity in UC Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Behling C, Kaplan K, Driman DK, Shackelton LM, Baker KA, MacDonald JK, Vandervoort MK, Samaan MA, Geboes K, Valasek MA, Pai R, Langner C, Riddell R, Harpaz N, Sewitch M, Peterson M, Stitt LW, Levesque BG. Reproducibility of histological assessments of disease activity in UC. Gut. 2015 Nov;64(11):1765-73. doi: 10.1136/gutjnl-2014-307536. Epub 2014 Oct 30. PMID: 25360036. A Prospective Cohort Study to Determine the Relationship Between Serum Infliximab Concentration and Efficacy in Patients With Luminal Crohn’s Disease Levesque BG, Greenberg GR, Zou G, Sandborn WJ, Singh S, Hauenstein S, Ohrmund L, Wong CJ, Stitt LW, Shackelton LM, King D, Lockton S, Ducharme J, Feagan BG. A prospective cohort study to determine the relationship between serum infliximab concentration and efficacy in patients with luminal Crohn's disease. Aliment Pharmacol Ther. 2014 May;39(10):1126-35. doi: 10.1111/apt.12733. Epub 2014 Apr 1. PMID: 24689499. Histologic Evaluation of Ulcerative Colitis: A Systematic Review of Disease Activity Indices Mosli MH, Feagan BG, Sandborn WJ, Dʼhaens G, Behling C, Kaplan K, Driman DK, Shackelton LM, Baker KA, Macdonald JK, Vandervoort MK, Geboes K, Levesque BG. Histologic evaluation of ulcerative colitis: a systematic review of disease activity indices. Inflamm Bowel Dis. 2014 Mar;20(3):564-75. doi: 10.1097/01.MIB.0000437986.00190.71. PMID: 24412993. 2013 1 items The Role of Centralized Reading of Endoscopy in a Randomized Controlled Trial of Mesalamine for Ulcerative Colitis Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JWD, Rutgeerts P, Munkholm P, Mittmann U, King D, Wong CJ, Zou G, Donner A, Shackelton LM, Gilgen D, Nelson S, Vandervoort MK, Fahmy M, Loftus EV Jr, Panaccione R, Travis SP, Van Assche GA, Vermeire S, Levesque BG. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013 Jul;145(1):149-157.e2. doi: 10.1053/j.gastro.2013.03.025. Epub 2013 Mar 22. PMID: 23528626.
Placebo Rates in Crohn’s Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis Solitano V, Hogan M, Singh S, Danese S, Peyrin-Biroulet L, Zou G, Yuan Y, Sands BE, Feagan BG, Dulai PS, Narula N, Ma C, Jairath V. Placebo Rates in Crohn's Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis. Gastroenterology. 2025 Feb;168(2):344-356. doi: 10.1053/j.gastro.2024.10.009. Epub 2024 Oct 15. PMID: 39414161.
Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials Rivas A, Ahmed NS, Yuan Y, Qasim A, O'Gorman DB, Feagan BG, Jairath V, Bredenoord AJ, Dellon ES, Ma C. Meta-Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials. Aliment Pharmacol Ther. 2024 Nov 14. doi: 10.1111/apt.18382. Epub ahead of print. PMID: 39543931.
Efficacy and Safety of Advanced Combination Treatment in Immune-Mediated Inflammatory Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Solitano V, Yuan Y, Singh S, Ma C, Nardone OM, Fiorino G, Acosta Felquer ML, Barra L, D'Agostino MA, Pope J, Peyrin-Biroulet L, Danese S, Jairath V. Efficacy and safety of Advanced Combination Treatment in immune-mediated inflammatory disease: A systematic review and meta-analysis of randomized controlled trials. J Autoimmun. 2024 Nov 6;149:103331. doi: 10.1016/j.jaut.2024.103331. Epub ahead of print. PMID: 39509741.
Responsiveness of Different Disease Activity Indices in Moderate-To-Severe Ulcerative Colitis Solitano V, Panaccione R, Sands BE, Wang Z, Hogan M, Zou G, Peyrin-Biroulet L, Danese S, Cornfield LJ, Feagan BG, Singh S, Jairath V, Ma C. Responsiveness of different disease activity indices in moderate-to-severe ulcerative colitis. Med. 2024 Sep 26:S2666-6340(24)00345-3. doi: 10.1016/j.medj.2024.09.001. Epub ahead of print. PMID: 39368474.
Management of Complications in Patients With an Ileostomy: An Umbrella Review of Systematic Reviews for the Endotrial Consortium Solitano V, Vuyyuru SK, Yuan Y, Singh S, Narula N, Ma C, Hanzel J, Hutton M, Van Koughnett JA, Rieder F, Jairath V. Management of complications in patients with an ileostomy: an umbrella review of systematic reviews for the EndOTrial Consortium. Int J Colorectal Dis. 2024 Sep 21;39(1):147. doi: 10.1007/s00384-024-04714-8. PMID: 39304546; PMCID: PMC11415412.
Reliability of CT Enterography for Describing Fibrostenosing Crohn Disease Rieder F, Ma C, Hanzel J, Fletcher JG, Baker ME, Wang Z, Guizzetti L, Shackelton LM, Rémillard J, Patel M, Niu J, Ottichilo R, Santillan CS, Capozzi N, Taylor SA, Bruining DH, Zou G, Feagan BG, Jairath V, Rimola J; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. Reliability of CT Enterography for Describing Fibrostenosing Crohn Disease. Radiology. 2024 Aug;312(2):e233038. doi: 10.1148/radiol.233038. PMID: 39105638; PMCID: PMC11366669.
Reliability of MR Enterography Features for Describing Fibrostenosing Crohn Disease Rieder F, Baker ME, Bruining DH, Fidler JL, Ehman EC, Sheedy SP, Heiken JP, Ream JM, Holmes DR 3rd, Inoue A, Mohammadinejad P, Lee YS, Taylor SA, Stoker J, Zou G, Wang Z, Rémillard J, Carter RE, Ottichilo R, Atkinson N, Siddiqui MT, Sunkesula VC, Ma C, Parker CE, Panés J, Rimola J, Jairath V, Feagan BG, Fletcher JG; Stenosis Therapy and Anti-Fibrosis Research (STAR) Consortium. Reliability of MR Enterography Features for Describing Fibrostenosing Crohn Disease. Radiology. 2024 Aug;312(2):e233039. doi: 10.1148/radiol.233039. PMID: 39105637; PMCID: PMC11366673.
Reliability of Intestinal Ultrasound for Evaluating Crohn’s Disease Activity Using Point-of-care and Central Reading Goodsall TM, An YK, Andrews JM, Begun J, Friedman AB, Lee A, Lewindon PJ, Spizzo P, Rodgers N, Taylor KM, White LS, Wilkens R, Wright EK, Zou L, Maguire BR, Parker CE, Rémillard J, Novak KL, Panaccione R, Feagan BG, Jairath V, Ma C, Bryant RV. Reliability of Intestinal Ultrasound for Evaluating Crohn's Disease Activity Using Point-of-care and Central Reading. Clin Gastroenterol Hepatol. 2024 Aug 28:S1542-3565(24)00773-0. doi: 10.1016/j.cgh.2024.08.007. Epub ahead of print. PMID: 39209200.
Performance of Bowel Preparation Quality Scales in Patients With Crohn’s Disease Solitano V, Siegel CA, Korzenik JR, Maratt JK, Rex DK, Maguire B, Bressler B, Grossmann J, Sedano R, McDonald JWD, Remillard J, Shackelton LM, Zou G, Feagan BG, Ma C, Jairath V. Performance of bowel preparation quality scales in patients with Crohn's disease. Aliment Pharmacol Ther. 2024 Oct;60(8):1042-1050. doi: 10.1111/apt.18210. Epub 2024 Aug 11. PMID: 39129393.
Re-Evaluating Methods for Assessing Differences in Response in Ileal vs. Colonic Crohn’s Disease: A Post-hoc Analysis of the FITZROY Trial Ma C, Feagan BG, Wang Z, Zou G, Smith MI, Shackelton LM, Sands BE, Panaccione R, D'Haens GR, Vermeire S, Jairath V. Re-evaluating Methods for Assessing Differences in Response in Ileal vs. Colonic Crohn's Disease: A Post-hoc Analysis of the FITZROY Trial. J Crohns Colitis. 2024 Jul 20:jjae113. doi: 10.1093/ecco-jcc/jjae113. Epub ahead of print. PMID: 39030919.
Endoscopic Scoring Indices for Assessing Disease Severity in Familial Adenomatous Polyposis: Systematic Review Silverman AL, Bouchiba H, Aelvoet A, MacDonald J, Dekker E, Zayadi A, Le J, Feagan B, Jairath V, Ma C, Samadder J. Endoscopic scoring indices for assessing disease severity in familial adenomatous polyposis: Systematic review. Endosc Int Open. 2024 Jun 18;12(6):E799-E809. doi: 10.1055/a-2330-8037. PMID: 38904059; PMCID: PMC11188755.
Scoring Indices for Perianal Fistulising Crohn’s Disease: A Systematic Review Vuyyuru SK, Solitano V, Singh S, Hanzel J, Macdonald JK, Danese S, Peyrin Biroulet L, Ma C, Jairath V. Scoring Indices for Perianal Fistulising Crohn's Disease: A Systematic Review. J Crohns Colitis. 2024 Jun 3;18(6):836-850. doi: 10.1093/ecco-jcc/jjad214. PMID: 38126903.
Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn’s Disease Khanna R, Feagan BG, Zou G, Stitt LW, McDonald JWD, Bressler B, Panaccione R, Shackelton LM, VanViegen T, Loftus EV Jr, Daperno M, Jairath V, D'Haens G, Sandborn WJ. Reliability and Responsiveness of Clinical and Endoscopic Outcome Measures in Crohn's Disease. Inflamm Bowel Dis. 2024 Apr 25:izae089. doi: 10.1093/ibd/izae089. Epub ahead of print. PMID: 38661492.
Pharmacological Therapies for the Management of Fistulizing Crohn’s Disease: A Systematic Review and Meta-Analysis Vuyyuru SK, Solitano V, Narula N, Lee MJ, MacDonald JK, McCurdy JD, Singh S, Ma C, Jairath V. Pharmacological Therapies for the Management of Fistulizing Crohn's Disease: A Systematic Review and Meta-Analysis. J Crohns Colitis. 2024 Apr 23;18(4):589-603. doi: 10.1093/ecco-jcc/jjad185. PMID: 37933849.
Operating Properties of Disease Activity Indices in Pediatric Inflammatory Bowel Disease: A Systematic Review Colman RJ, Solitano V, MacDonald JK, Ma C, Griffiths AM, Jairath V, Crowley E. Operating Properties of Disease Activity Indices in Pediatric Inflammatory Bowel Disease: A Systematic Review. Inflamm Bowel Dis. 2024 Mar 28:izae060. doi: 10.1093/ibd/izae060. Epub ahead of print. PMID: 38547511.
Systematic Review: Defining, Diagnosing and Monitoring Small Bowel Strictures in Crohn’s Disease on Intestinal Ultrasound Lu C, Rosentreter R, Delisle M, White M, Parker CE, Premji Z, Wilson SR, Baker ME, Bhatnagar G, Begun J, Bruining DH, Bryant R, Christensen B, Feagan BG, Fletcher JG, Jairath V, Knudsen J, Kucharzik T, Maaser C, Maconi G, Novak K, Rimola J, Taylor SA, Wilkens R, Rieder F; Stenosis Therapy and Anti‐Fibrotic Research (STAR) consortium. Systematic review: Defining, diagnosing and monitoring small bowel strictures in Crohn's disease on intestinal ultrasound. Aliment Pharmacol Ther. 2024 Apr;59(8):928-940. doi: 10.1111/apt.17918. Epub 2024 Mar 4. PMID: 38436124.
Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn’s Disease Clinical Trials Crowley E, Ma C, Guizzetti L, Zou G, Lewindon PJ, Gee MS, Hyams JS, Rosen MJ, von Allmen D, de Buck van Overstraeten A, Shackelton LM, Remillard J, Schleicher L, Dillman JR, Rimola J, Taylor SA, Fletcher JG, Church PC, Feagan BG, Griffiths AM, Jairath V, Greer MC. Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials. Inflamm Bowel Dis. 2024 Mar 1;30(3):357-369. doi: 10.1093/ibd/izad134. PMID: 37524088.
Identification of Immune Cell Markers Associated With Ulcerative Colitis Histological Disease Activity in Colonic Biopsies Lefevre PLC, Wang Z, Teft W, Zou G, Van Viegen T, Linggi B, Jairath V, Feagan BG, Pai RK, Vande Casteele N. Identification of immune cell markers associated with ulcerative colitis histological disease activity in colonic biopsies. J Clin Pathol. 2024 Feb 28:jcp-2023-209327. doi: 10.1136/jcp-2023-209327. Epub ahead of print. PMID: 38418201.
Determining the Optimal Treatment Target in Patients With Ulcerative Colitis: Rationale, Design, Protocol and Interim Analysis for the Randomised Controlled VERDICT Trial Jairath V, Zou G, Wang Z, Adsul S, Colombel JF, D'Haens GR, Freire M, Moran GW, Peyrin-Biroulet L, Sandborn WJ, Sebastian S, Travis S, Vermeire S, Radulescu G, Sigler J, Hanžel J, Ma C, Sedano R, McFarlane SC, Arya N, Beaton M, Bossuyt P, Danese S, Green D, Harlan W 3rd, Horynski M, Klopocka M, Petroniene R, Silverberg MS, Wolanski L, Feagan BG. Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterol. 2024 Feb 8;11(1):e001218. doi: 10.1136/bmjgast-2023-001218. PMID: 38336367; PMCID: PMC10870790.
Use of External Control Arms in Immune-Mediated Inflammatory Diseases: A Systematic Review Zayadi A, Edge R, Parker CE, Macdonald JK, Neustifter B, Chang J, Zhong G, Singh S, Feagan BG, Ma C, Jairath V. Use of external control arms in immune-mediated inflammatory diseases: a systematic review. BMJ Open. 2023 Dec 9;13(12):e076677. doi: 10.1136/bmjopen-2023-076677. PMID: 38070932; PMCID: PMC10729249.
Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn’s Disease Activity Solitano V, Schaeffer DF, Hogan M, Vande Casteele N, Pai RK, Zou G, Pai RK, Parker CE, Rémillard J, Christensen B, Danese S, Peyrin-Biroulet L, Panaccione R, Sands BE, D'Haens G, Feagan BG, Ma C, Jairath V. Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn's Disease Activity. Clin Gastroenterol Hepatol. 2023 Dec 4:S1542-3565(23)00969-2. doi: 10.1016/j.cgh.2023.11.032. Epub ahead of print. PMID: 38056798.
Efficacy and Safety of Advanced Oral Small Molecules for Inflammatory Bowel Disease: Systematic Review and Meta-Analysis Solitano V, Vuyyuru SK, MacDonald JK, Zayadi A, Parker CE, Narula N, Peyrin-Biroulet L, Danese S, Feagan BG, Singh S, Ma C, Jairath V. Efficacy and Safety of Advanced Oral Small Molecules for Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. J Crohns Colitis. 2023 Nov 24;17(11):1800-1816. doi: 10.1093/ecco-jcc/jjad100. PMID: 37317532.
Case Report: Medical Management of Acute Severe Ulcerative Colitis Sudheer Kumar Vuyyuru, DM,1,2 Vipul Jairath, MD, PhD,1,2,3 Jurij Hanžel, MD, PhD,2,4 Christopher Ma, MD, MPH,2,5 and Brian G. Feagan, MD1,2,3: Case Report: Medical Management of Acute Severe. Gastroenterology & Hepatology Volume 19, Issue 10 October 2023
Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study Lebwohl B, Ma C, Lagana SM, Pai RK, Baker KA, Zayadi A, Hogan M, Bouma G, Cellier C, Goldsmith JD, Lundin KEA, Pinto-Sanchez MI, Robert ME, Rubio-Tapia A, Sanders DS, Schaeffer DF, Semrad CE, Silvester JA, Verdú EF, Verma R, Wu TT, Feagan BG, Crowley E, Jairath V, Murray JA. Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study. Gastroenterology. 2024 Jan;166(1):88-102. doi: 10.1053/j.gastro.2023.08.051. Epub 2023 Sep 11. PMID: 37704112.
Systematic Review With Meta-Analysis: Medical Therapies for Treatment of Ulcerative Proctitis Aruljothy A, Singh S, Narula N, Moran GW, Vuyyuru SK, Hogan M, Zayadi A, MacDonald JK, Caron B, Danese S, Peyrin Biroulet L, Ma C, Jairath V. Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis. Aliment Pharmacol Ther. 2023 Oct;58(8):740-762. doi: 10.1111/apt.17666. Epub 2023 Aug 17. PMID: 37589498.
Efficacy and Safety of IL-12/23 and IL-23 Inhibitors for Crohn’s Disease: Systematic Review and Meta-Analysis Vuyyuru SK, Solitano V, Hogan M, MacDonald JK, Zayadi A, Parker CE, Sands BE, Panaccione R, Narula N, Feagan BG, Singh S, Jairath V, Ma C. Efficacy and Safety of IL-12/23 and IL-23 Inhibitors for Crohn's Disease: Systematic Review and Meta-Analysis. Dig Dis Sci. 2023 Sep;68(9):3702-3713. doi: 10.1007/s10620-023-08014-z. Epub 2023 Jun 28. PMID: 37378711; PMCID: PMC10981469.
Standardizing Scoring Conventions for Crohn’s Disease Endoscopy: An International RAND/UCLA Appropriateness Study Khanna R, Ma C, Hogan M, Zou G, Bessissow T, Bressler B, Colombel JF, Danese S, Daperno M, East JE, Hookey L, Loftus EV Jr, McDonald JWD, Panaccione R, Peyrin-Biroulet L, Rutter M, Sands BE, Vermeire S, Rémillard J, McFarlane SC, Sandborn WJ, D'Haens GR, Feagan BG, Jairath V. Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2938-2950.e6. doi: 10.1016/j.cgh.2023.05.029. Epub 2023 Jun 10. PMID: 37308036.
Targeting IL-23 for IBD: Rationale and Progress to Date Vuyyuru SK, Shackelton LM, Hanzel J, Ma C, Jairath V, Feagan BG. Targeting IL-23 for IBD: Rationale and Progress to Date. Drugs. 2023 Jul;83(10):873-891. doi: 10.1007/s40265-023-01882-9. Epub 2023 Jun 2. PMID: 37266801.
Effect of Storage Time on Peripheral Blood Mononuclear Cell Isolation From Blood Collected in Vacutainer CPT™ Tubes Linggi B, Cremer J, Wang Z, Van Viegen T, Vermeire S, Lefevre P, Shackelton LM, Jairath V, Teft W, Vande Casteele N, Verstockt B. Effect of storage time on peripheral blood mononuclear cell isolation from blood collected in vacutainer CPT™ tubes. J Immunol Methods. 2023 May 29;519:113504. doi: 10.1016/j.jim.2023.113504. Epub ahead of print. PMID: 37257687.
Systematic Review and Meta-Analysis of Randomised Controlled Trials: Medical Therapies for the Treatment and Prevention of Pouchitis Alphonsus L, De Silva TA, Ma C, MacDonald JK, Hanzel J, Beaton M, Bessissow T, Kayal M, Sedano R, Singh S, Jairath V. Systematic review and meta-analysis of randomised controlled trials: Medical therapies for the treatment and prevention of pouchitis. Aliment Pharmacol Ther. 2023 Aug;58(3):268-282. doi: 10.1111/apt.17568. Epub 2023 May 29. PMID: 37246609.
An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn’s Disease Maratt JK, Siegel CA, Barkun AN, Bouhnik Y, Bressler B, Calderwood AH, East JE, Fischer M, Grossmann J, Korzenik JR, Menees SB, Panes J, Rex DK, Sey MSL, Allio MK, Baker KA, Guizzetti L, Remillard J, Sedano R, Feagan BG, Ma C, Jairath V. An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease. Dig Dis Sci. 2023 May;68(5):1718-1727. doi: 10.1007/s10620-022-07775-3. Epub 2022 Nov 27. PMID: 36436154.
Advanced Combination Treatment With Biologic Agents and Novel Small Molecule Drugs for Inflammatory Bowel Disease Solitano V., Ma C., Hanžel J., Panaccione R., Feagan B., Jairath V. Advanced Combination Treatment With Biologic Agents and Novel Small Molecule Drugs for Inflammatory Bowel Disease.
Real-World Multicentre Observational Study With Pop-PK Modelling to Evaluate the Exposure-Response Relationship of Vedolizumab in IBD Vande Casteele N, Sandborn WJ, Feagan BG, Vermeire S, Dulai PS, Yarur A, Roblin X, Ben-Horin S, Dotan I, Osterman MT, Rosario M, Osborn TM, Panes J, Lindner D, Agboton C. Real-world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure-response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study. Aliment Pharmacol Ther. 2022 Aug;56(3):463-476. doi: 10.1111/apt.16937. Epub 2022 Apr 27. PMID: 35474325.
Placebo Response Rates in Randomized Controlled Trials for Perianal Crohn’s Disease: A Systematic Review and Meta-Analysis Sharma T, Ma C, Sedano R, Hanzel J, McDonald C, Hogan M, Kochhar GS, Narula N, Peyrin-Biroulet L, Danese S, MacDonald JK, Jairath V. Placebo Response Rates in Randomized Controlled Trials for Perianal Crohn's Disease: A Systematic Review and Meta-Analysis. J Crohns Colitis. 2023 Apr 19;17(4):644-658. doi: 10.1093/ecco-jcc/jjac160. PMID: 36271904.
ATRC Review: IL-12 and IL-23 pathway inhibition in inflammatory bowel disease Verstockt B, Salas A, Sands BE, Abraham C, Leibovitzh H, Neurath MF, Vande Casteele N; Alimentiv Translational Research Consortium (ATRC). IL-12 and IL-23 pathway inhibition in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2023 Jul;20(7):433-446. doi: 10.1038/s41575-023-00768-1. Epub 2023 Apr 17. PMID: 37069321.
Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading Hanzel J, Sey M, Ma C, Zou G, East JE, Siegel CA, Mosli M, Reinisch W, McDonald JWD, Silverberg MS, Van Viegen T, Shackelton LM, Clayton LB, Enns R, Epstein I, Hilsden RJ, Hookey L, Moffatt DC, Ng Kwet Shing R, Telford JJ, von Renteln D, Feagan BG, Barkun A, Jairath V. Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading. Dig Dis Sci. 2023 Apr;68(4):1195-1207. doi: 10.1007/s10620-022-07729-9. Epub 2022 Oct 20. PMID: 36266592.
Endoscopic and Histological Placebo Rates in Crohn’s Disease Clinical Trials: A Systematic Review and Meta-analysis Vuyyuru SK, Nguyen TM, Hogan M, Raine T, Noor NM, Narula N, Verstockt B, Feagan BG, Singh S, Ma C, Jairath V. Endoscopic and Histological Placebo Rates in Crohn's Disease Clinical Trials: A Systematic Review and Meta-analysis. Inflamm Bowel Dis. 2023 Apr 1:izad052. doi: 10.1093/ibd/izad052. Epub ahead of print. PMID: 37002875.
Patients With Crohn’s Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review Vuyyuru SK, Rieder F, Solitano V, Nguyen TM, Crowley E, Narula N, Singh S, Ma C, Jairath V. Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review. Am J Gastroenterol. 2023 Jul 1;118(7):1285-1288. doi: 10.14309/ajg.0000000000002215. Epub 2023 Feb 8. PMID: 36757156.
CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease CORE-IBD Collaborators, Ma C, Hanzel J, Panaccione R, Sandborn WJ, D'Haens GR, Ahuja V, Atreya R, Bernstein CN, Bossuyt P, Bressler B, Bryant RV, Cohen B, Colombel JF, Danese S, Dignass A, Dubinsky MC, Fleshner PR, Gearry RB, Hanauer SB, Hart A, Kotze PG, Kucharzik T, Lakatos PL, Leong RW, Magro F, Panés J, Peyrin-Biroulet L, Ran Z, Regueiro M, Singh S, Spinelli A, Steinhart AH, Travis SP, van der Woude CJ, Yacyshyn B, Yamamoto T, Allez M, Bemelman WA, Lightner AL, Louis E, Rubin DT, Scherl EJ, Siegel CA, Silverberg MS, Vermeire S, Parker CE, McFarlane SC, Guizzetti L, Smith MI, Vande Casteele N, Feagan BG, Jairath V. CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease. Gastroenterology. 2022 Oct;163(4):950-964. doi: 10.1053/j.gastro.2022.06.068. Epub 2022 Jul 3. PMID: 35788348.
Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn’s Disease Hanzel J, Jairath V, De Cruz P, Guizzetti L, Shackelton LM, Bossuyt P, Duijvestein M, Dulai PS, Grossmann J, Hirten RP, Khanna R, Panes J, Peyrin-Biroulet L, Regueiro M, Rubin DT, Singh S, Stidham RW, Sandborn WJ, Feagan BG, D'Haens GR, Ma C. Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease. Inflamm Bowel Dis. 2022 Sep 1;28(9):1321-1331. doi: 10.1093/ibd/izab259. PMID: 34791254; PMCID: PMC9756946.
Heterogeneity in Efficacy and Safety Endpoints for Pediatric Clinical Trials in Inflammatory Bowel Disease: A Need for Harmonization Crowley E, Griffiths AM, Jairath V; pIBD CLINICAL TRIALS OUTCOME GROUP. Heterogeneity in Efficacy and Safety Endpoints for Pediatric Clinical Trials in Inflammatory Bowel Disease: A Need for Harmonization. Gastroenterology. 2022 Nov;163(5):1137-1144. doi: 10.1053/j.gastro.2022.07.006. Epub 2022 Jul 16. PMID: 35850191.
Placebo Rates in Randomized Controlled Trials of Proctitis Therapy: A Systematic Review and Meta-Analysis De Silva TA, Alphonsus L, Ma C, Hogan M, Sedano R, Narula N, Danese S, Peyrin-Biroulet L, MacDonald JK, Singh S, Jairath V. Placebo rates in randomized controlled trials of proctitis therapy: A systematic review and meta-analysis. J Crohns Colitis. 2022 Aug 5:jjac109. doi: 10.1093/ecco-jcc/jjac109. Epub ahead of print. PMID: 35930405.
Clinical, Endoscopic, and Safety Placebo Rates in Induction and Maintenance Trials of Crohn’s Disease: Meta-Analysis of Randomised Controlled Trials Almradi A, Sedano R, Hogan M, Zou GY, MacDonald JK, Parker CE, Hanzel J, Crowley E, Singh S, D'Haens G, Sandborn WJ, Feagan BG, Ma C, Jairath V. Clinical, Endoscopic, and Safety Placebo Rates in Induction and Maintenance Trials of Crohn's Disease: Meta-Analysis of Randomised Controlled Trials. J Crohns Colitis. 2022 Jun 24;16(5):717-736. doi: 10.1093/ecco-jcc/jjab194. PMID: 34758084.
Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials Sedano R, Hogan M, Zou G, Narula N, Singh S, Ma C, Feagan BG, Jairath V. Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials. Inflamm Bowel Dis. 2022 Jun 24:izac128. doi: 10.1093/ibd/izac128. Epub ahead of print. PMID: 35749316.
Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn’s Disease Biopsies Lefevre P, Guizzetti L, McKee TD, Zou G, van Viegen T, McFarlane SC, Shackelton L, Feagan BG, Jairath V, Pai RK, Casteele NV. Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn's Disease Biopsies. Appl Immunohistochem Mol Morphol. 2022 May 20. doi: 10.1097/PAI.0000000000001035. Epub ahead of print. PMID: 35587994.
Disease Activity Indices for Pouchitis: A Systematic Review Sedano R, Nguyen TM, Almradi A, Rieder F, Parker CE, Shackelton LM, D'Haens G, Sandborn WJ, Feagan BG, Ma C, Jairath V. Disease Activity Indices for Pouchitis: A Systematic Review. Inflamm Bowel Dis. 2022 Mar 30;28(4):622-638. doi: 10.1093/ibd/izab124. PMID: 34180986; PMCID: PMC8972820.
Reliability of Histologic Assessment for NAFLD and Development of an Expanded NAFLD Activity Score Rish K Pai, Vipul Jairath, Malcolm Hogan, Guangyong Zou, Oyedele A Adeyi, Quentin M Anstee, Bashar A Aqel, Cynthia Behling, Elizabeth J Carey, Andrew D Clouston, Kathleen Corey, Brian G Feagan, David E Kleiner, Christopher Ma, Stefanie C McFarlane, Mazen Noureddin, Vlad Ratziu, Mark A Valasek, Zobair M Younossi, Stephen A Harrison, Rohit Loomba. Reliability of histologic assessment for NAFLD and development of an expanded NAFLD activity score. Hepatology. 2022 Mar 25. DOI: 10.1002/hep.32475. Online ahead of print. PMID: 35332569
The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn’s Disease: A Systematic Review and Meta-analysis Ble A, Renzulli C, Cenci F, Grimaldi M, Barone M, Sedano R, Chang J, Nguyen TM, Hogan M, Zou G, MacDonald JK, Ma C, Sandborn WJ, Feagan BG, Merlo Pich E, Jairath V. The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn's Disease: A Systematic Review and Meta-analysis. J Crohns Colitis. 2022 Mar 14;16(3):490-499. doi: 10.1093/ecco-jcc/jjab163. PMID: 34508572; PMCID: PMC8919832.
Recommendations for Standardizing Biopsy Acquisition and Histological Assessment of Immune Checkpoint Inhibitor-Associated Colitis Christopher Ma, Rish K Pai, David F Schaeffer, Jonathan Krell, Leonardo Guizzetti, Stefanie C McFarlane, John K MacDonald, Won-Tak Choi, Roger M Feakins, Richard Kirsch, Gregory Y Lauwers, Reetesh K Pai, Christophe Rosty, Amitabh Srivastava, Joanna C Walsh, Brian G Feagan, Vipul Jairath. Recommendations for standardizing biopsy acquisition and histological assessment of immune checkpoint inhibitor-associated colitis. J Immunother Cancer. 2022 Mar;10(3):e004560. DOI: 10.1136/jitc-2022-004560. PMID: 35296560 PMCID: PMC8928359 DOI: 10.1136/jitc-2022-004560.
Design of Clinical Trials for Mild to Moderate Crohn’s Disease Jurij Hanzel, Christopher Ma, Vipul Jairath, IBD Trial Design Group. Design of Clinical Trials for Mild to Moderate Crohn's Disease. Gastroenterology. 2022 Jun;162(7):1800-1814.e1. DOI: 10.1053/j.gastro.2022.02.036. Epub 2022 Feb 28. PMID: 35240140 DOI: 10.1053/j.gastro.2022.02.036.
A Nonparametric Approach to Confidence Intervals for Concordance Index and Difference Between Correlated Indices Guangyong Zou, Emma Smith, Vipul Jairath. A nonparametric approach to confidence intervals for concordance index and difference between correlated indices. J Biopharm Stat . 2022 Feb 25;1-28. doi: 10.1080/10543406.2022.2030747. Online ahead of print. PMID: 35216545 DOI: 10.1080/10543406.2022.2030747.
Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease Crowley E, Ma C, Andic M, Feagan BG, Griffiths AM, Jairath V. Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease. J Crohns Colitis. 2022 Feb 23;16(2):331-335. doi: 10.1093/ecco-jcc/jjab140. PMID: 34379112.
Sphingosine 1-Phosphate Modulation and Immune Cell Trafficking in Inflammatory Bowel Disease Bram Verstockt, Stefania Vetrano, Azucena Salas, Shadi Nayeri, Marjolijn Duijvestein, Niels Vande Casteele, Alimentiv Translational Research Consortium (ATRC). Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2022 Jun;19(6):351-366. DOI: 10.1038/s41575-021-00574-7. Epub 2022 Feb 14. PMID: 35165437 DOI: 10.1038/s41575-021-00574-7
Similar Clinical Improvement Rates Among Biologic Drug Classes in Crohn’s Disease: Systematic Review and Meta-Regression Jurij Hanžel, Rocio Sedano, Jenny Jeyarajah, Guangyong Zou, Stefanie C McFarlane, Christopher Ma, Vipul Jairath. Similar Clinical Improvement Rates Among Biologic Drug Classes in Crohn's Disease: Systematic Review and Meta-Regression. Inflamm Bowel Dis. 2022 Feb 15;izac018. DOI: 10.1093/ibd/izac018. Online ahead of print. PMID: 35166778 DOI: 10.1093/ibd/izac018.
Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn’s Disease Jurij Hanžel, Vipul Jairath, Christopher Ma, Leonardo Guizzetti, Guangyong Zou, Cynthia S Santillan, Stuart A Taylor, Tanja van Viegen, Geert R D'Haens, Brian G Feagan, Julián Panés, Jordi Rimola. Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 Feb 9;S1542-3565(22)00128-8. DOI: 10.1016/j.cgh.2022.01.055. Online ahead of print. PMID: 35149220 DOI: 10.1016/j.cgh.2022.01.055
Reliability and Responsiveness of Endoscopic Disease Activity Assessment in Eosinophilic Esophagitis Ma C, Bredenoord AJ, Dellon ES, Alexander JA, Biedermann L, Hogan M, Guizzetti L, Zou G, Katzka DA, Chehade M, Falk GW, Furuta GT, Gupta SK, Kagalwalla AF, Schoepfer AM, Miehlke S, Moawad FJ, Peterson K, Gonsalves NP, Straumann A, Wechsler JB, Rémillard J, Shackelton LM, Almonte HS, Feagan BG, Jairath V, Hirano I. Reliability and responsiveness of endoscopic disease activity assessment in eosinophilic esophagitis. Gastrointest Endosc. 2022 Jun;95(6):1126-1137.e2. doi: 10.1016/j.gie.2022.01.014. Epub 2022 Feb 1. PMID: 35120883.
Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis Ma C, Jairath V, Feagan BG, Guizzetti L, Zou G, McFarlane SC, Shackelton LM, Collins MH, Hirano I, de Rooij WE, Schaeffer DF, Pai RK, Bredenoord AJ, Dellon ES. Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis. Am J Gastroenterol. 2022 Feb 1;117(2):264-271. doi: 10.14309/ajg.0000000000001571. PMID: 34797816.
Underrepresentation of Minorities and Lack of Race Reporting in Ulcerative Colitis Drug Development Clinical Trials Sedano R, Hogan M, McDonald C, Aswani-Omprakash T, Ma C, Jairath V. Underrepresentation of Minorities and Lack of Race Reporting in Ulcerative Colitis Drug Development Clinical Trials. Inflamm Bowel Dis. 2022 Jan 25:izab362. DOI: 10.1093/ibd/izab362. Epub ahead of print. PMID: 35078220.
Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease Rocio Sedano, Christopher Ma, Vipul Jairath, Brian G Feagan. Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease. Gastroenterol Hepatol (N Y). 2022 Jan;18(1):14-27. PMID: 35505771 PMCID: PMC9053496
Design of Clinical Trials for Mild to Moderate Ulcerative Colitis Sedano R, Jairath V, Ma C; IBD Trial Design Group. Design of Clinical Trials for Mild to Moderate Ulcerative Colitis. Gastroenterology. 2022 Apr;162(4):1005-1018. doi: 10.1053/j.gastro.2021.12.284. Epub 2022 Jan 6. PMID: 34998800.
A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease Lefevre PLC, Dulai PS, Wang Z, Guizzetti L, Feagan BG, Pop A, Yassine M, Shackelton LM, Jairath V, Sandborn WJ, Vande Casteele N. A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn's Disease. BioDrugs. 2022 Jan;36(1):85-93. doi: 10.1007/s40259-021-00512-8. Epub 2021 Dec 24. PMID: 34951696.
Systematic Review: Disease Activity Indices for Immune Checkpoint Inhibitor-Associated Enterocolitis Ma C, MacDonald JK, Nguyen TM, Chang J, Vande Casteele N, Feagan BG, Jairath V. Systematic review: disease activity indices for immune checkpoint inhibitor-associated enterocolitis. Aliment Pharmacol Ther. 2022 Jan;55(2):178-190. DOI: 10.1111/apt.16718. Epub 2021 Nov 25. PMID: 34821404.
Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis Bots SJ, Parker CE, Brandse JF, Löwenberg M, Feagan BG, Sandborn WJ, Jairath V, D'Haens G, Vande Casteele N. Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. BioDrugs. 2021 Nov;35(6):715-733. doi: 10.1007/s40259-021-00507-5. Epub 2021 Nov 19. PMID: 34797516; PMCID: PMC9826743.
Underrepresentation of Minorities and Underreporting of Race and Ethnicity in Crohn’s Disease Clinical Trials Sedano R, Hogan M, Mcdonald C, Aswani-Omprakash T, Ma C, Jairath V. Underrepresentation of Minorities and Underreporting of Race and Ethnicity in Crohn's Disease Clinical Trials. Gastroenterology. 2022 Jan;162(1):338-340.e2. doi: 10.1053/j.gastro.2021.09.054. Epub 2021 Sep 27. PMID: 34592174.
Meta-Analysis of Gene Expression Disease Signatures in Colonic Biopsy Tissue From Patients With Ulcerative Colitis Linggi B, Jairath V, Zou G, Shackelton LM, McGovern DPB, Salas A, Verstockt B, Silverberg MS, Nayeri S, Feagan BG, Vande Casteele N. Meta-analysis of gene expression disease signatures in colonic biopsy tissue from patients with ulcerative colitis. Sci Rep. 2021 Sep 14;11(1):18243. doi: 10.1038/s41598-021-97366-5. PMID: 34521888; PMCID: PMC8440637.
Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) COREOS Collaborators:, Ma C, Schoepfer AM, Dellon ES, Bredenoord AJ, Chehade M, Collins MH, Feagan BG, Furuta GT, Gupta SK, Hirano I, Jairath V, Katzka DA, Pai RK, Rothenberg ME, Straumann A, Aceves SS, Alexander JA, Arva NC, Atkins D, Biedermann L, Blanchard C, Cianferoni A, Ciriza de Los Rios C, Clayton F, Davis CM, de Bortoli N, Dias JA, Falk GW, Genta RM, Ghaffari G, Gonsalves N, Greuter T, Hopp R, Hsu Blatman KS, Jensen ET, Johnston D, Kagalwalla AF, Larsson HM, Leung J, Louis H, Masterson JC, Menard-Katcher C, Menard-Katcher PA, Moawad FJ, Muir AB, Mukkada VA, Penagini R, Pesek RD, Peterson K, Putnam PE, Ravelli A, Savarino EV, Schlag C, Schreiner P, Simon D, Smyrk TC, Spergel JM, Taft TH, Terreehorst I, Vanuytsel T, Venter C, Vieira MC, Vieth M, Vlieg-Boerstra B, von Arnim U, Walker MM, Wechsler JB, Woodland P, Woosley JT, Yang GY, Zevit N, Safroneeva E. Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS). J Allergy Clin Immunol. 2022 Feb;149(2):659-670. doi: 10.1016/j.jaci.2021.07.001. Epub 2021 Jul 6. PMID: 34242635; PMCID: PMC8733049.
An Expert Consensus to Standardise the Assessment of Histological Disease Activity in Crohn’s Disease Clinical Trials Almradi A, Ma C, D'Haens GR, Sandborn WJ, Parker CE, Guizzetti L, Borralho Nunes P, De Hertogh G, Feakins RM, Khanna R, Lauwers GY, Mookhoek A, Pai RK, Peyrin-Biroulet L, Riddell R, Rosty C, Schaeffer DF, Valasek MA, Singh S, Crowley E, Feagan BG, Jairath V, Pai RK. An expert consensus to standardise the assessment of histological disease activity in Crohn's disease clinical trials. Aliment Pharmacol Ther. 2021 Apr;53(7):784-793. doi: 10.1111/apt.16248. Epub 2021 Jan 7. PMID: 33410551.
Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease Dulai PS, Jairath V, Zou G, Stitt LW, Khanna R, Sandborn WJ, Feagan BG, Singh S. Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease. Inflamm Bowel Dis. 2021 Apr 15;27(5):639-646. doi: 10.1093/ibd/izaa168. PMID: 32592481; PMCID: PMC8243599.
Standardisation of Intestinal Ultrasound Scoring in Clinical Trials for Luminal Crohn’s Disease Goodsall TM, Jairath V, Feagan BG, Parker CE, Nguyen TM, Guizzetti L, Asthana AK, Begun J, Christensen B, Friedman AB, Kucharzik T, Lee A, Lewindon PJ, Maaser C, Novak KL, Rimola J, Taylor KM, Taylor SA, White LS, Wilkens R, Wilson SR, Wright EK, Bryant RV, Ma C. Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn's disease. Aliment Pharmacol Ther. 2021 Apr;53(8):873-886. doi: 10.1111/apt.16288. Epub 2021 Feb 28. PMID: 33641221.
Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129. PMID: 32614386.
International Consensus to Standardise Histopathological Scoring for Small Bowel Strictures in Crohn’s Disease Gordon IO, Bettenworth D, Bokemeyer A, Srivastava A, Rosty C, de Hertogh G, Robert ME, Valasek MA, Mao R, Li J, Harpaz N, Borralho P, Pai RK, Odze R, Feakins R, Parker CE, Guizzetti L, Nguyen T, Shackelton LM, Sandborn WJ, Jairath V, Baker M, Bruining D, Fletcher JG, Feagan BG, Pai RK, Rieder F; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. International consensus to standardise histopathological scoring for small bowel strictures in Crohn's disease. Gut. 2022 Mar;71(3):479-486. doi: 10.1136/gutjnl-2021-324374. Epub 2021 May 5. PMID: 33952604; PMCID: PMC8903083.
Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn’s Disease After Elective Surgery: Meta-Analysis Hanzel J, Almradi A, Istl AC, Yang ML, Fleshner KA, Parker CE, Guizzetti L, Ma C, Singh S, Jairath V. Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn's Disease After Elective Surgery: Meta-Analysis. Dig Dis Sci. 2022 Feb;67(2):646-660. doi: 10.1007/s10620-021-06895-6. Epub 2021 Feb 26. PMID: 33634430.
Vedolizumab and Extraintestinal Manifestations in Inflammatory Bowel Disease Hanzel J, Ma C, Casteele NV, Khanna R, Jairath V, Feagan BG. Vedolizumab and Extraintestinal Manifestations in Inflammatory Bowel Disease. Drugs. 2021 Feb;81(3):333-347. doi: 10.1007/s40265-020-01460-3. Erratum in: Drugs. 2021 Sep;81(14):1697. PMID: 33400241.
Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators Jairath V, Guizzetti L, Baker KA, Williamson LA, Sedano R, Thompson H, Ma C. Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators. Inflamm Bowel Dis. 2021 Jul 27;27(8):e98. doi: 10.1093/ibd/izab111. PMID: 33988238; PMCID: PMC8244581.
Methods for Handling Missing Segments in Crohn’s Disease Clinical Trials: Analysis From the EXTEND Trial Ma C, Khanna R, Guizzetti L, Zou G, Feagan BG, Jairath V. Methods for handling missing segments in Crohn's disease clinical trials: analysis from the EXTEND trial. Gut. 2022 Feb;71(2):447-448. doi: 10.1136/gutjnl-2021-324658. Epub 2021 May 6. PMID: 33958434.
An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials Ma C, Sedano R, Almradi A, Vande Casteele N, Parker CE, Guizzetti L, Schaeffer DF, Riddell RH, Pai RK, Battat R, Sands BE, Rosty C, Dubinsky MC, Rieder F, Harpaz N, Abreu MT, Bryant RV, Lauwers GY, Kirsch R, Valasek MA, Crowley E, Sandborn WJ, Feagan BG, Pai RK, Jairath V. An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials. Gastroenterology. 2021 Jun;160(7):2291-2302. doi: 10.1053/j.gastro.2021.02.035. Epub 2021 Feb 19. PMID: 33610533; PMCID: PMC8851891.
Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis Sedano R, Hogan M, Nguyen TM, Chang J, Zou GY, Macdonald JK, Vande Casteele N, Hanzel J, Crowley E, Battat R, Dulai PS, Singh S, D'Haens G, Sandborn W, Feagan BG, Ma C, Jairath V. Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. J Crohns Colitis. 2022 Feb 23;16(2):224-243. doi: 10.1093/ecco-jcc/jjab135. PMID: 34309658.
An Expert Consensus to Standardise Clinical, Endoscopic and Histologic Items and Inclusion and Outcome Criteria for Evaluation of Pouchitis Disease Activity in Clinical Trials Sedano R, Ma C, Pai RK, D' Haens G, Guizzetti L, Shackelton LM, Remillard J, Gionchetti P, Gordon IO, Holubar S, Kayal M, Lauwers GY, Pai RK, Pardi DS, Samaan MA, Schaeffer DF, Shen B, Silverberg MS, Feagan BG, Sandborn WJ, Jairath V. An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials. Aliment Pharmacol Ther. 2021 May;53(10):1108-1117. doi: 10.1111/apt.16328. Epub 2021 Mar 18. PMID: 33735522.
Development and Validation of a Clinical Decision Support Tool That Incorporates Pharmacokinetic Data to Predict Endoscopic Healing in Patients Treated With Infliximab Vande Casteele N, Jairath V, Jeyarajah J, Dulai PS, Singh S, Shackelton LM, Feagan BG, Sandborn WJ. Development and Validation of a Clinical Decision Support Tool That Incorporates Pharmacokinetic Data to Predict Endoscopic Healing in Patients Treated With Infliximab. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1209-1217.e2. doi: 10.1016/j.cgh.2020.04.078. Epub 2020 May 4. PMID: 32376505.
Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) Score for Assessment of Inflammation in Patients With Ulcerative Colitis Yan BM, Sey MSL, Belletrutti P, Brahm G, Guizzetti L, Jairath V. Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) score for assessment of inflammation in patients with ulcerative colitis. Endosc Int Open. 2021 Jul;9(7):E1116-E1122. doi: 10.1055/a-1481-8032. Epub 2021 Jun 21. PMID: 34327283; PMCID: PMC8312768.
A Systematic Review On Immune Checkpoint Inhibitor-Associated Enterocolitis Ma C, MacDonald JK, Nguyen TM, Vande Casteele N, Linggi B, Lefevre P, Wang Y, Feagan BG, Jairath V. Pharmacological Interventions for the Prevention and Treatment of Immune Checkpoint Inhibitor-Associated Enterocolitis: A Systematic Review. Dig Dis Sci. 2022 Apr;67(4):1128-1155. doi: 10.1007/s10620-021-06948-w. Epub 2021 Mar 26. PMID: 33770330.
Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy Akhtar HJ, Nguyen TM, Ma C, Jairath V. Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy. Clin Gastroenterol Hepatol. 2022 Mar;20(3):e614-e623. doi: 10.1016/j.cgh.2021.02.026. Epub 2021 Feb 19. PMID: 33618025.
Early Combined Immunosuppression Reduces Complications in Long-standing Crohn’s Disease: A Post Hoc Analysis of REACT Hanzel J, Ma C, Zou G, Singh S, Dulai PS, Feagan BG, D'Haens GR, Sandborn WJ, Jairath V. Early Combined Immunosuppression Reduces Complications in Long-standing Crohn's Disease: A Post Hoc Analysis of REACT. Clin Gastroenterol Hepatol. 2022 Jan;20(1):236-238. DOI: 10.1016/j.cgh.2020.12.019. Epub 2020 Dec 18. PMID: 33346141.
Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials Khanna R, Ma C, Jairath V, Vande Casteele N, Zou G, Feagan BG. Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials. Clin Gastroenterol Hepatol. 2022 Apr;20(4):727-736.e2. doi: 10.1016/j.cgh.2020.12.017. Epub 2020 Dec 15. PMID: 33338657.
Safety of Combination Biologic and Antirejection Therapy Post-Liver Transplantation in Patients With Inflammatory Bowel Disease Al Draiweesh S, Ma C, Alkhattabi M, McDonald C, Nguyen TM, Beaton M, Chande N, Colquhoun P, Feagan BG, Gregor JC, Khanna R, Marotta P, Ponich T, Quan D, Qumosani K, Sandhu A, Sey M, Skaro A, Teriaky A, Wilson A, Yan B, Brahmania M, Jairath V. Safety of Combination Biologic and Antirejection Therapy Post-Liver Transplantation in Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 May 12;26(6):949-959. doi: 10.1093/ibd/izz244. PMID: 31665288.
Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease Almradi A, Hanzel J, Sedano R, Parker CE, Feagan BG, Ma C, Jairath V. Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease. BioDrugs. 2020 Dec;34(6):713-721. doi: 10.1007/s40259-020-00451-w. PMID: 33105016.
Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid? Battat R, Dulai PS, Ma C, Jairath V, Feagan BG, Sandborn WJ, Khanna R. Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid? Curr Treat Options Gastroenterol. 2020 Jan 4. doi: 10.1007/s11938-019-00259-w. Epub ahead of print. PMID: 31902071.
Evaluating the Optimum Number of Biopsies to Assess Histological Inflammation in Ulcerative Colitis: A Retrospective Cohort Study Battat R, Vande Casteele N, Pai RK, Wang Z, Zou G, McDonald JWD, Duijvestein M, Jeyarajah J, Parker CE, Van Viegen T, Nelson SA, Boland BS, Singh S, Dulai PS, Valasek MA, Feagan BG, Jairath V, Sandborn WJ. Evaluating the optimum number of biopsies to assess histological inflammation in ulcerative colitis: a retrospective cohort study. Aliment Pharmacol Ther. 2020 Nov;52(10):1574-1582. doi: 10.1111/apt.16083. Epub 2020 Sep 27. PMID: 32981088; PMCID: PMC8007067.
Alternative and Complementary Approaches for the Treatment of Inflammatory Bowel Disease: Evidence From Cochrane Reviews Chande N, Costello SP, Limketkai BN, Parker CE, Nguyen TM, Macdonald JK, Feagan BG. Alternative and Complementary Approaches for the Treatment of Inflammatory Bowel Disease: Evidence From Cochrane Reviews. Inflamm Bowel Dis. 2020 May 12;26(6):843-851. doi: 10.1093/ibd/izz223. PMID: 31560744.
Response to Placebo, Measured by Endoscopic Evaluation of Crohn’s Disease Activity, in a Pooled Analysis of Data From 5 Randomized Controlled Induction Trials Duijvestein M, Jeyarajah J, Guizzetti L, Zou G, Parker CE, van Viegen T, VandeCasteele N, Khanna R, Van Der Aa A, Sandborn WJ, Feagan BG, D'Haens GR, Jairath V. Response to Placebo, Measured by Endoscopic Evaluation of Crohn's Disease Activity, in a Pooled Analysis of Data From 5 Randomized Controlled Induction Trials. Clin Gastroenterol Hepatol. 2020 May;18(5):1121-1132.e2. doi: 10.1016/j.cgh.2019.08.025. Epub 2019 Aug 20. PMID: 31442599.
Development of the Symptoms and Impacts Questionnaire for Crohn’s Disease and Ulcerative Colitis Dulai PS, Jairath V, Khanna R, Ma C, McCarrier KP, Martin ML, Parker CE, Morris J, Feagan BG, Sandborn WJ. Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther. 2020 Jun;51(11):1047-1066. doi: 10.1111/apt.15726. Epub 2020 Apr 21. PMID: 32319120; PMCID: PMC7317756.
Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis Dulai PS, Singh S, Vande Casteele N, Meserve J, Winters A, Chablaney S, Aniwan S, Shashi P, Kochhar G, Weiss A, Koliani-Pace JL, Gao Y, Boland BS, Chang JT, Faleck D, Hirten R, Ungaro R, Lukin D, Sultan K, Hudesman D, Chang S, Bohm M, Varma S, Fischer M, Shmidt E, Swaminath A, Gupta N, Rosario M, Jairath V, Guizzetti L, Feagan BG, Siegel CA, Shen B, Kane S, Loftus EV Jr, Sandborn WJ, Sands BE, Colombel JF, Lasch K, Cao C. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2952-2961.e8. doi: 10.1016/j.cgh.2020.02.010. Epub 2020 Feb 13. PMID: 32062041; PMCID: PMC7899124.
Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn’s Disease George J, Singh S, Dulai PS, Ma C, Nguyen T, Feagan BG, Sandborn WJ, Jairath V. Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn's Disease. Inflamm Bowel Dis. 2020 Mar 4;26(4):515-523. doi: 10.1093/ibd/izz193. PMID: 31504528; PMCID: PMC8127062.
Histopathology Scoring Systems of Stenosis Associated With Small Bowel Crohn’s Disease: A Systematic Review Gordon IO, Bettenworth D, Bokemeyer A, Srivastava A, Rosty C, de Hertogh G, Robert ME, Valasek MA, Mao R, Kurada S, Harpaz N, Borralho P, Pai RK, Pai RK, Odze R, Feakins R, Parker CE, Nguyen T, Jairath V, Baker ME, Bruining DH, Fletcher JG, Feagan BG, Rieder F; Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium. Histopathology Scoring Systems of Stenosis Associated With Small Bowel Crohn's Disease: A Systematic Review. Gastroenterology. 2020 Jan;158(1):137-150.e1. doi: 10.1053/j.gastro.2019.08.033. Epub 2019 Aug 30. PMID: 31476299; PMCID: PMC7649049.
Clinical Pharmacology of Janus Kinase Inhibitors in Inflammatory Bowel Disease Lefevre PLC, Vande Casteele N. Clinical Pharmacology of Janus Kinase Inhibitors in Inflammatory Bowel Disease. J Crohns Colitis. 2020 Aug 1;14(Supplement_2):S725-S736. doi: 10.1093/ecco-jcc/jjaa014. PMID: 32160283; PMCID: PMC7395308.
Systematic Review: Medical Therapy for Fibrostenosing Crohn’s Disease Lu C, Baraty B, Lee Robertson H, Filyk A, Shen H, Fung T, Novak K, Ma C, Panaccione R, Achkar JP, El Ouali S, Bruining D, Jairath V, Feagan B, Rieder F; Stenosis Therapy and Research (STAR) Consortium. Systematic review: medical therapy for fibrostenosing Crohn's disease. Aliment Pharmacol Ther. 2020 Jun;51(12):1233-1246. doi: 10.1111/apt.15750. Epub 2020 May 13. PMID: 32406116; PMCID: PMC7777136.
Reliability of Endoscopic Evaluation of Postoperative Recurrent Crohn’s Disease Ma C, Gecse KB, Duijvestein M, Sandborn WJ, Zou G, Shackelton LM, Stitt LW, Parker CE, Bossuyt P, Löwenberg M, Khanna R, Vermeire S, Rutgeerts P, Feagan BG, Jairath V, D'Haens GR. Reliability of Endoscopic Evaluation of Postoperative Recurrent Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2139-2141.e2. doi: 10.1016/j.cgh.2019.08.046. Epub 2019 Aug 29. PMID: 31473359.
Modeling Endoscopic Improvements Ma C, Jeyarajah J, Guizzetti L, Parker CE, Singh S, Dulai PS, D'Haens GR, Sandborn WJ, Feagan BG, Jairath V. Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Feb;20(2):447-454.e1. doi: 10.1016/j.cgh.2020.11.040. Epub 2020 Dec 3. PMID: 33279779; PMCID: PMC8588993.
Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis Ma C, Sandborn WJ, D'Haens GR, Zou G, Stitt LW, Singh S, Ananthakrishnan AN, Dulai PS, Khanna R, Jairath V, Feagan BG. Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1760-1768.e1. doi: 10.1016/j.cgh.2019.09.021. Epub 2019 Sep 20. PMID: 31546056; PMCID: PMC7992966.
Assessing National Trends and Disparities in Ambulatory, Emergency Department, and Inpatient Visits for Inflammatory Bowel Disease in the United States (2005-2016) Ma C, Smith MK, Guizzetti L, Panaccione R, Kaplan GG, Novak KL, Lu C, Khanna R, Feagan BG, Singh S, Jairath V, Ananthakrishnan AN. Assessing National Trends and Disparities in Ambulatory, Emergency Department, and Inpatient Visits for Inflammatory Bowel Disease in the United States (2005-2016). Clin Gastroenterol Hepatol. 2020 Oct;18(11):2500-2509.e1. doi: 10.1016/j.cgh.2020.01.023. Epub 2020 Jan 25. PMID: 31988046; PMCID: PMC8011653.
Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions Porter AC, Aubrecht J, Birch C, Braun J, Cuff C, Dasgupta S, Gale JD, Hinton R, Hoffmann SC, Honig G, Linggi B, Schito M, Casteele NV, Sauer JM. Biomarkers of Crohn's Disease to Support the Development of New Therapeutic Interventions. Inflamm Bowel Dis. 2020 Sep 18;26(10):1498-1508. doi: 10.1093/ibd/izaa215. PMID: 32840322; PMCID: PMC7500523.
Adalimumab for Maintenance of Remission in Crohn’s Disease Townsend CM, Nguyen TM, Cepek J, Abbass M, Parker CE, MacDonald JK, Khanna R, Jairath V, Feagan BG. Adalimumab for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev. 2020 May 16;5(5):CD012877. doi: 10.1002/14651858.CD012877.pub2. PMID: 32413933; PMCID: PMC7386457.
JAK-STAT Pathway Targeting for the Treatment of Inflammatory Bowel Disease Salas A, Hernandez-Rocha C, Duijvestein M, Faubion W, McGovern D, Vermeire S, Vetrano S, Vande Casteele N. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Jun;17(6):323-337. doi: 10.1038/s41575-020-0273-0. Epub 2020 Mar 19. PMID: 32203403.
ATRC Review: JAK-STAT Pathway Targeting for the Treatment of IBD Salas A, Hernandez-Rocha C, Duijvestein M, Faubion W, McGovern D, Vermeire S, Vetrano S, Vande Casteele N. JAK-STAT pathway targeting for the treatment of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Jun;17(6):323-337. doi: 10.1038/s41575-020-0273-0. Epub 2020 Mar 19. PMID: 32203403.
Oral Janus Kinase Inhibitors for Maintenance of Remission in Ulcerative Colitis Davies SC, Hussein IM, Nguyen TM, Parker CE, Khanna R, Jairath V. Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2020 Jan 27;1(1):CD012381. doi: 10.1002/14651858.CD012381.pub2. PMID: 31984480; PMCID: PMC6984444.
Factors Influencing Drug Disposition of Monoclonal Antibodies in Inflammatory Bowel Disease: Implications for Personalized Medicine Lefevre PLC, Shackelton LM, Vande Casteele N. Factors Influencing Drug Disposition of Monoclonal Antibodies in Inflammatory Bowel Disease: Implications for Personalized Medicine. BioDrugs. 2019 Oct;33(5):453-468. doi: 10.1007/s40259-019-00366-1. PMID: 31301024.
Histologic Healing Rates of Medical Therapies for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Battat R, Duijvestein M, Guizzetti L, Choudhary D, Boland BS, Dulai PS, Parker CE, Nguyen TM, Singh S, Vande Casteele N, Pai RK, Feagan BG, Sandborn WJ, Jairath V. Histologic Healing Rates of Medical Therapies for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Gastroenterol. 2019 May;114(5):733-745. doi: 10.14309/ajg.0000000000000111. PMID: 30694863.
Benefit-Risk Assessment of Vedolizumab in the Treatment of Crohn’s Disease and Ulcerative Colitis Battat R, Ma C, Jairath V, Khanna R, Feagan BG. Benefit-Risk Assessment of Vedolizumab in the Treatment of Crohn's Disease and Ulcerative Colitis. Drug Saf. 2019 May;42(5):617-632. doi: 10.1007/s40264-018-00783-1. PMID: 30830573.
Assessment of Crohn’s Disease-Associated Small Bowel Strictures and Fibrosis on Cross-Sectional Imaging: A Systematic Review
Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review de Rooij WE, Dellon ES, Parker CE, Feagan BG, Jairath V, Ma C, Bredenoord AJ. Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review. Drugs. 2019 Sep;79(13):1419-1434. doi: 10.1007/s40265-019-01173-2. PMID: 31352605.
Development and Validation of a Magnetic Resonance Index for Assessing Fistulas in Patients With Crohn’s Disease Hindryckx P, Jairath V, Zou G, Feagan BG, Sandborn WJ, Stoker J, Khanna R, Stitt L, van Viegen T, Shackelton LM, Taylor SA, Santillan C, Mearadji B, D'Haens G, Richard MP, Panes J, Rimola J. Development and Validation of a Magnetic Resonance Index for Assessing Fistulas in Patients With Crohn's Disease. Gastroenterology. 2019 Nov;157(5):1233-1244.e5. doi: 10.1053/j.gastro.2019.07.027. Epub 2019 Jul 20. PMID: 31336124.
Responsiveness of Histological Disease Activity Indices in Ulcerative Colitis: A Post Hoc Analysis Using Data From the TOUCHSTONE Randomised Controlled Trial Jairath V, Peyrin-Biroulet L, Zou G, Mosli M, Vande Casteele N, Pai RK, Valasek MA, Marchal-Bressenot A, Stitt LW, Shackelton LM, Khanna R, D'Haens GR, Sandborn WJ, Olson A, Feagan BG, Pai RK. Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial. Gut. 2019 Jul;68(7):1162-1168. doi: 10.1136/gutjnl-2018-316702. Epub 2018 Aug 3. PMID: 30076171.
Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set Ma C, Athayde J, Davies SC, Parker CE, Nguyen TM, Khanna R, Feagan BG, Jairath V. Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1637-1640. doi: 10.1016/j.cgh.2018.09.042. Epub 2018 Sep 27. PMID: 30268563.
Innovations in Oral Therapies for Inflammatory Bowel Disease Ma C, Battat R, Dulai PS, Parker CE, Sandborn WJ, Feagan BG, Jairath V. Innovations in Oral Therapies for Inflammatory Bowel Disease. Drugs. 2019 Aug;79(12):1321-1335. doi: 10.1007/s40265-019-01169-y. PMID: 31317509.
What Is the Role of C-Reactive Protein and Fecal Calprotectin in Evaluating Crohn’s Disease Activity? Ma C, Battat R, Khanna R, Parker CE, Feagan BG, Jairath V. What is the role of C-reactive protein and fecal calprotectin in evaluating Crohn's disease activity? Best Pract Res Clin Gastroenterol. 2019 Feb-Apr;38-39:101602. doi: 10.1016/j.bpg.2019.02.004. Epub 2019 Feb 22. PMID: 31327404.
Advances in Therapeutic Drug Monitoring for Small-Molecule and Biologic Therapies in Inflammatory Bowel Disease Ma C, Battat R, Jairath V, Vande Casteele N. Advances in Therapeutic Drug Monitoring for Small-Molecule and Biologic Therapies in Inflammatory Bowel Disease. Curr Treat Options Gastroenterol. 2019 Mar;17(1):127-145. doi: 10.1007/s11938-019-00222-9. PMID: 30680599.
Update on C-Reactive Protein and Fecal Calprotectin: Are They Accurate Measures of Disease Activity in Crohn’s Disease? Ma C, Battat R, Parker CE, Khanna R, Jairath V, Feagan BG. Update on C-reactive protein and fecal calprotectin: are they accurate measures of disease activity in Crohn's disease? Expert Rev Gastroenterol Hepatol. 2019 Apr;13(4):319-330. doi: 10.1080/17474124.2019.1563481. Epub 2019 Jan 3. PMID: 30791776.
Systematic Review With Meta-Analysis: Efficacy and Safety of Oral Janus Kinase Inhibitors for Inflammatory Bowel Disease Ma C, Lee JK, Mitra AR, Teriaky A, Choudhary D, Nguyen TM, Vande Casteele N, Khanna R, Panaccione R, Feagan BG, Jairath V. Systematic review with meta-analysis: efficacy and safety of oral Janus kinase inhibitors for inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Jul;50(1):5-23. doi: 10.1111/apt.15297. Epub 2019 May 23. PMID: 31119766.
IL12/23 or Selective IL23 Inhibition for the Management of Moderate-To-Severe Crohn’s Disease? Ma C, Panaccione R, Khanna R, Feagan BG, Jairath V. IL12/23 or selective IL23 inhibition for the management of moderate-to-severe Crohn's disease? Best Pract Res Clin Gastroenterol. 2019 Feb-Apr;38-39:101604. doi: 10.1016/j.bpg.2019.02.006. Epub 2019 Feb 19. PMID: 31327402.
Identifying Outcomes in Clinical Trials of Fistulizing Crohn’s Disease for the Development of a Core Outcome Set Ma C, Parker CE, Nguyen TM, Khanna R, Feagan BG, Jairath V. Identifying Outcomes in Clinical Trials of Fistulizing Crohn's Disease for the Development of a Core Outcome Set. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1904-1908. doi: 10.1016/j.cgh.2018.10.004. Epub 2018 Oct 4. PMID: 30292887.
Evaluation of Optimal Biopsy Location for Assessment of Histological Activity, Transcriptomic and Immunohistochemical Analyses in Patients With Active Crohn’s Disease Novak G, Stevens T, Van Viegen T, Bossuyt P, Štabuc B, Jeyarajah J, Zou G, Gaemers IC, McKee TD, Fu F, Shackelton LM, Khanna R, van den Brink GR, Sandborn WJ, Feagan BG, Pai RK, Jairath V, Vande Casteele N, D'Haens G. Evaluation of optimal biopsy location for assessment of histological activity, transcriptomic and immunohistochemical analyses in patients with active Crohn's disease. Aliment Pharmacol Ther. 2019 Jun;49(11):1401-1409. doi: 10.1111/apt.15250. Epub 2019 Apr 15. PMID: 30983024.
Definitions of Response and Remission for the Robarts Histopathology Index Pai RK, Khanna R, D'Haens GR, Sandborn WJ, Jeyarajah J, Feagan BG, Vande Casteele N, Jairath V. Definitions of response and remission for the Robarts Histopathology Index. Gut. 2019 Nov;68(11):2101-2102. doi: 10.1136/gutjnl-2018-317547. Epub 2018 Oct 26. PMID: 30366909.
Standardising the Interpretation of Liver Biopsies in Non-alcoholic Fatty Liver Disease Clinical Trials Pai RK, Kleiner DE, Hart J, Adeyi OA, Clouston AD, Behling CA, Jain D, Kakar S, Brahmania M, Burgart L, Batts KP, Valasek MA, Torbenson MS, Guindi M, Wang HL, Ajmera V, Adams LA, Parker CE, Feagan BG, Loomba R, Jairath V. Standardising the interpretation of liver biopsies in non-alcoholic fatty liver disease clinical trials. Aliment Pharmacol Ther. 2019 Nov;50(10):1100-1111. doi: 10.1111/apt.15503. Epub 2019 Oct 3. PMID: 31583739; PMCID: PMC6817398.
Early Combined Immunosuppression May Be Effective and Safe in Older Patients With Crohn’s Disease: Post Hoc Analysis of REACT Singh S, Stitt LW, Zou G, Khanna R, Dulai PS, Sandborn WJ, Feagan BG, Jairath V. Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT. Aliment Pharmacol Ther. 2019 May;49(9):1188-1194. doi: 10.1111/apt.15214. Epub 2019 Mar 19. PMID: 30891808; PMCID: PMC6461484.
Infliximab Exposure-Response Relationship and Thresholds Associated With Endoscopic Healing in Patients With Ulcerative Colitis Vande Casteele N, Jeyarajah J, Jairath V, Feagan BG, Sandborn WJ. Infliximab Exposure-Response Relationship and Thresholds Associated With Endoscopic Healing in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1814-1821.e1. doi: 10.1016/j.cgh.2018.10.036. Epub 2018 Oct 26. PMID: 30613004.
A Composite Disease Activity Index for Early Drug Development in Ulcerative Colitis: Development and Validation of the UC-100 Score Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, D'Haens GR, Sandborn WJ, Feagan BG. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):63-70. doi: 10.1016/S2468-1253(18)30306-6. Epub 2018 Oct 18. PMID: 30343116.
Evolution of the Randomized Controlled Trial in Inflammatory Bowel Disease: Current Challenges and Future Solutions Khanna R, Zou G, Feagan BG. Evolution of the Randomized Controlled Trial in Inflammatory Bowel Disease: Current Challenges and Future Solutions. Inflamm Bowel Dis. 2018 Sep 15;24(10):2155-2164. doi: 10.1093/ibd/izy117. PMID: 29788218.
Additional Stability Testing of Cryopreserved Intestinal Biopsies for Downstream Flow Cytometric Analysis Vande Casteele N, Wildenberg ME. Additional Stability Testing of Cryopreserved Intestinal Biopsies for Downstream Flow Cytometric Analysis. J Immunol Methods. 2019 Nov;474:112517. doi: 10.1016/j.jim.2018.09.005. Epub 2018 Sep 8. PMID: 30201393.
2018 August Author Interview – Vipul Jairath Interview with Dr Vipul Jairath for his article, “Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis” from the August issue of Gastrointestinal Endoscopy.
Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy Athayde J, Davies SC, Parker CE, Guizzetti L, Ma C, Khanna R, Feagan BG, Jairath V. Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy. Dig Dis Sci. 2018 Oct;63(10):2519-2528. doi: 10.1007/s10620-018-5199-9. Epub 2018 Jul 11. PMID: 29995184.
Physicians’ Perspectives on Cost, Safety, and Perceived Efficacy Determine Aminosalicylate Use in Crohn’s Disease Ma C, Ascoytia C, McCarrier KP, Martin M, Feagan BG, Jairath V. Physicians' Perspectives on Cost, Safety, and Perceived Efficacy Determine Aminosalicylate Use in Crohn's Disease. Dig Dis Sci. 2018 Oct;63(10):2555-2563. doi: 10.1007/s10620-018-5181-6. Epub 2018 Jun 29. PMID: 29959726.
An Expert Consensus to Standardise Definitions, Diagnosis and Treatment Targets for Anti-fibrotic Stricture Therapies in Crohn’s Disease Rieder F, Bettenworth D, Ma C, Parker CE, Williamson LA, Nelson SA, van Assche G, Di Sabatino A, Bouhnik Y, Stidham RW, Dignass A, Rogler G, Taylor SA, Stoker J, Rimola J, Baker ME, Fletcher JG, Panes J, Sandborn WJ, Feagan BG, Jairath V. An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn's disease. Aliment Pharmacol Ther. 2018 Aug;48(3):347-357. doi: 10.1111/apt.14853. Epub 2018 Jun 19. PMID: 29920726; PMCID: PMC6043370.
Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review Ma C, van Rhijn BD, Jairath V, Nguyen TM, Parker CE, Aceves SS, Furuta GT, Gupta SK, Katzka DA, Safroneeva E, Schoepfer AM, Straumann A, Spergel JM, Pai RK, Feagan BG, Hirano I, Dellon ES, Bredenoord AJ. Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1714-1729.e3. doi: 10.1016/j.cgh.2018.06.005. Epub 2018 Jun 14. PMID: 29908360.
Evaluation of the Effect of Storage Condition on Cell Extraction and Flow Cytometric Analysis From Intestinal Biopsies Wildenberg ME, Duijvestein M, Westera L, van Viegen T, Buskens CJ, van der Bilt JDW, Stitt L, Jairath V, Feagan BG, Vande Casteele N. Evaluation of the effect of storage condition on cell extraction and flow cytometric analysis from intestinal biopsies. J Immunol Methods. 2018 Aug;459:50-54. doi: 10.1016/j.jim.2018.05.004. Epub 2018 Jun 1. PMID: 29772249.
Systematic Review With Meta-Analysis: Prevalence, Risk Factors and Costs of Aminosalicylate Use in Crohn’s Disease Ma C, Dutton SJ, Cipriano LE, Singh S, Parker CE, Nguyen TM, Guizzetti L, Gregor JC, Chande N, Hindryckx P, Feagan BG, Jairath V. Systematic review with meta-analysis: prevalence, risk factors and costs of aminosalicylate use in Crohn's disease. Aliment Pharmacol Ther. 2018 Jul;48(2):114-126. doi: 10.1111/apt.14821. Epub 2018 May 30. PMID: 29851091.
Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, Siegel CA, Peyrin-Biroulet L, D'Haens G, Sandborn WJ, Feagan BG, Jairath V. Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set. Clin Gastroenterol Hepatol. 2018 May;16(5):637-647.e13. doi: 10.1016/j.cgh.2017.08.025. Epub 2017 Aug 24. PMID: 28843356.
Systematic Review With Meta-Analysis: Endoscopic and Histologic Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis Ma C, Guizzetti L, Panaccione R, Fedorak RN, Pai RK, Parker CE, Nguyen TM, Khanna R, Vande Casteele N, D'Haens G, Sandborn WJ, Feagan BG, Jairath V. Systematic review with meta-analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis. Aliment Pharmacol Ther. 2018 Jun;47(12):1578-1596. doi: 10.1111/apt.14672. Epub 2018 Apr 25. PMID: 29696670.
Reliability Among Central Readers in the Evaluation of Endoscopic Disease Activity in Pouchitis Samaan MA, Shen B, Mosli MH, Zou G, Sandborn WJ, Shackelton LM, Nelson S, Stitt L, Bloom S, Pardi DS, Gionchetti P, Lindsay J, Travis S, Hart A, Silverberg MS, Feagan BG, D'Haens GR, Jairath V. Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis. Gastrointest Endosc. 2018 Aug;88(2):360-369.e2. doi: 10.1016/j.gie.2018.04.2330. Epub 2018 Apr 13. PMID: 29660321.
Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn’s Disease: A Systematic Review Ma C, Hussein IM, Al-Abbar YJ, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, Siegel CA, Peyrin-Biroulet L, Pai RK, Vande Casteele N, D'Haens GR, Sandborn WJ, Feagan BG, Jairath V. Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn's Disease: A Systematic Review. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1407-1419.e22. doi: 10.1016/j.cgh.2018.02.051. Epub 2018 Mar 27. PMID: 29596987.
Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease Duijvestein M, Battat R, Vande Casteele N, D'Haens GR, Sandborn WJ, Khanna R, Jairath V, Feagan BG. Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease. Curr Treat Options Gastroenterol. 2018 Mar;16(1):129-146. doi: 10.1007/s11938-018-0175-1. PMID: 29411220.
Reliability of Histologic Assessment in Patients With Eosinophilic Oesophagitis Warners MJ, Ambarus CA, Bredenoord AJ, Verheij J, Lauwers GY, Walsh JC, Katzka DA, Nelson S, van Viegen T, Furuta GT, Gupta SK, Stitt L, Zou G, Parker CE, Shackelton LM, D Haens GR, Sandborn WJ, Dellon ES, Feagan BG, Collins MH, Jairath V, Pai RK. Reliability of histologic assessment in patients with eosinophilic oesophagitis. Aliment Pharmacol Ther. 2018 Apr;47(7):940-950. doi: 10.1111/apt.14559. Epub 2018 Feb 20. PMID: 29460418.
Efficacy of Medical Therapies for Fistulizing Crohn’s Disease: Systematic Review and Meta-analysis Lee MJ, Parker CE, Taylor SR, Guizzetti L, Feagan BG, Lobo AJ, Jairath V. Efficacy of Medical Therapies for Fistulizing Crohn's Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1879-1892. doi: 10.1016/j.cgh.2018.01.030. Epub 2018 Jan 31. PMID: 29374617.
Development of Clinical Prediction Models for Surgery and Complications in Crohn’s Disease Guizzetti L, Zou G, Khanna R, Dulai PS, Sandborn WJ, Jairath V, Feagan BG. Development of Clinical Prediction Models for Surgery and Complications in Crohn's Disease. J Crohns Colitis. 2018 Jan 24;12(2):167-177. doi: 10.1093/ecco-jcc/jjx130. PMID: 29028958; PMCID: PMC5881746.
Endoscopic Scoring Indices for Evaluation of Disease Activity in Ulcerative Colitis Mohammed Vashist N, Samaan M, Mosli MH, Parker CE, MacDonald JK, Nelson SA, Zou GY, Feagan BG, Khanna R, Jairath V. Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis. Cochrane Database Syst Rev. 2018 Jan 16;1(1):CD011450. doi: 10.1002/14651858.CD011450.pub2. PMID: 29338066; PMCID: PMC6491285.
Reliability of Measuring Ileo-Colonic Disease Activity in Crohn’s Disease by Magnetic Resonance Enterography Jairath V, Ordas I, Zou G, Panes J, Stoker J, Taylor SA, Santillan C, Horsthuis K, Samaan MA, Shackelton LM, Stitt LW, Hindryckx P, Khanna R, Sandborn WJ, D'Haens G, Feagan BG, Levesque BG, Rimola J. Reliability of Measuring Ileo-Colonic Disease Activity in Crohn's Disease by Magnetic Resonance Enterography. Inflamm Bowel Dis. 2018 Jan 18;24(2):440-449. doi: 10.1093/ibd/izx040. PMID: 29361096.
Disease Activity Indices in Coeliac Disease: Systematic Review and Recommendations for Clinical Trials Hindryckx P, Levesque BG, Holvoet T, Durand S, Tang CM, Parker C, Khanna R, Shackelton LM, D'Haens G, Sandborn WJ, Feagan BG, Lebwohl B, Leffler DA, Jairath V. Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials. Gut. 2018 Jan;67(1):61-69. doi: 10.1136/gutjnl-2016-312762. Epub 2016 Oct 31. PMID: 27799282.
The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients? Hindryckx P, Vande Casteele N, Novak G, Khanna R, D'Haens G, Sandborn WJ, Danese S, Jairath V, Feagan BG. The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients? J Crohns Colitis. 2018 Jan 5;12(1):105-119. doi: 10.1093/ecco-jcc/jjx117. PMID: 28961959.
Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study Westera L, van Viegen T, Jeyarajah J, Azad A, Bilsborough J, van den Brink GR, Cremer J, Danese S, D'Haens G, Eckmann L, Faubion W, Filice M, Korf H, McGovern D, Panes J, Salas A, Sandborn WJ, Silverberg MS, Smith MI, Vermeire S, Vetrano S, Shackelton LM, Stitt L, Jairath V, Levesque BG, Spencer DM, Feagan BG, Vande Casteele N. Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study. Clin Transl Gastroenterol. 2017 Nov 2;8(11):e126. doi: 10.1038/ctg.2017.52. PMID: 29095427; PMCID: PMC5717516.
Systematic Review: Disease Activity Indices in Eosinophilic Esophagitis Warners MJ, Hindryckx P, Levesque BG, Parker CE, Shackelton LM, Khanna R, Sandborn WJ, D'Haens GR, Feagan BG, Bredenoord AJ, Jairath V. Systematic Review: Disease Activity Indices in Eosinophilic Esophagitis. Am J Gastroenterol. 2017 Nov;112(11):1658-1669. doi: 10.1038/ajg.2017.363. Epub 2017 Oct 17. PMID: 29039850.
Placebo Response and Remission Rates in Randomised Trials of Induction and Maintenance Therapy for Ulcerative Colitis Jairath V, Zou GY, Parker CE, MacDonald JK, AlAmeel T, Al Beshir M, Almadi MA, Al-Taweel T, Atkinson NS, Biswas S, Chapman T, Dulai PS, Glaire MA, Hoekman DR, Koutsoumpas A, Minas E, Mosli MH, Samaan M, Khanna R, Travis S, D'Haens G, Sandborn WJ, Feagan BG. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis. Cochrane Database Syst Rev. 2017 Sep 8;9(9):CD011572. doi: 10.1002/14651858.CD011572.pub2. PMID: 28886205; PMCID: PMC6483671.
Alicaforsen for the Treatment of Inflammatory Bowel Disease Jairath V, Khanna R, Feagan BG. Alicaforsen for the treatment of inflammatory bowel disease. Expert Opin Investig Drugs. 2017 Aug;26(8):991-997. doi: 10.1080/13543784.2017.1349753. Epub 2017 Jul 6. PMID: 28670932.
Evolving Concepts in Phases I and II Drug Development for Crohn’s Disease Jairath V, Levesque BG, Vande Casteele N, Khanna R, Mosli M, Hindryckx P, Travis S, Duijvestein M, Rimola J, Panes J, D'Haens G, Sandborn WJ, Feagan BG. Evolving Concepts in Phases I and II Drug Development for Crohn's Disease. J Crohns Colitis. 2017 Feb;11(2):246-255. doi: 10.1093/ecco-jcc/jjw137. Epub 2016 Aug 3. Erratum in: J Crohns Colitis. 2018 Apr 27;12(5):631. PMID: 27487793.
Reliability of EUS Indices to Detect Inflammation in Ulcerative Colitis Yan B, Feagan B, Teriaky A, Mosli M, Mohamed R, Williams G, Yeung E, Yong E, Haig A, Sey M, Stitt L, Zou GY, Jairath V. Reliability of EUS indices to detect inflammation in ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1079-1087. doi: 10.1016/j.gie.2017.07.035. Epub 2017 Jul 29. PMID: 28760533.
Histologic Scoring Indices for Evaluation of Disease Activity in Crohn’s Disease Novak G, Parker CE, Pai RK, MacDonald JK, Feagan BG, Sandborn WJ, D'Haens G, Jairath V, Khanna R. Histologic scoring indices for evaluation of disease activity in Crohn's disease. Cochrane Database Syst Rev. 2017 Jul 21;7(7):CD012351. doi: 10.1002/14651858.CD012351.pub2. PMID: 28731502; PMCID: PMC6483549.
The Development of a Magnetic Resonance Imaging Index for Fistulising Crohn’s Disease Samaan MA, Puylaert CAJ, Levesque BG, Zou GY, Stitt L, Taylor SA, Shackelton LM, Vandervoort MK, Khanna R, Santillan C, Rimola J, Hindryckx P, Nio CY, Sandborn WJ, D'Haens G, Feagan BG, Jairath V, Stoker J. The development of a magnetic resonance imaging index for fistulising Crohn's disease. Aliment Pharmacol Ther. 2017 Sep;46(5):516-528. doi: 10.1111/apt.14190. Epub 2017 Jun 27. PMID: 28653753.
Pharmacokinetic Drug Evaluation of Budesonide in the Treatment of Crohn’s Disease Kwapisz L, Jairath V, Khanna R, Feagan B. Pharmacokinetic drug evaluation of budesonide in the treatment of Crohn's disease. Expert Opin Drug Metab Toxicol. 2017 Jul;13(7):793-801. doi: 10.1080/17425255.2017.1340454. Epub 2017 Jun 16. PMID: 28612627.
Development of a Core Outcome Set for Clinical Trials in Inflammatory Bowel Disease: Study Protocol for a Systematic Review of the Literature and Identification of a Core Outcome Set Using a Delphi Survey Ma C, Panaccione R, Fedorak RN, Parker CE, Khanna R, Levesque BG, Sandborn WJ, Feagan BG, Jairath V. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. BMJ Open. 2017 Jun 9;7(6):e016146. doi: 10.1136/bmjopen-2017-016146. PMID: 28601837; PMCID: PMC5726090.
A Comparison of Approaches for Adjudicating Outcomes in Clinical Trials Kahan BC, Feagan B, Jairath V. A comparison of approaches for adjudicating outcomes in clinical trials. Trials. 2017 Jun 8;18(1):266. doi: 10.1186/s13063-017-1995-3. PMID: 28595589; PMCID: PMC5465459.
Randomised Non-inferiority Trial: 1600 MG Versus 400 MG Tablets of Mesalazine for the Treatment of Mild-To-Moderate Ulcerative Colitis D'Haens GR, Sandborn WJ, Zou G, Stitt LW, Rutgeerts PJ, Gilgen D, Jairath V, Hindryckx P, Shackelton LM, Vandervoort MK, Parker CE, Muller C, Pai RK, Levchenko O, Marakhouski Y, Horynski M, Mikhailova E, Kharchenko N, Pimanov S, Feagan BG. Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther. 2017 Aug;46(3):292-302. doi: 10.1111/apt.14164. Epub 2017 Jun 1. PMID: 28568974.
Histologic Scoring Indices for Evaluation of Disease Activity in Ulcerative Colitis Mosli MH, Parker CE, Nelson SA, Baker KA, MacDonald JK, Zou GY, Feagan BG, Khanna R, Levesque BG, Jairath V. Histologic scoring indices for evaluation of disease activity in ulcerative colitis. Cochrane Database Syst Rev. 2017 May 25;5(5):CD011256. doi: 10.1002/14651858.CD011256.pub2. PMID: 28542712; PMCID: PMC6481362.
The Evolution of Treatment Paradigms in Crohn’s Disease: Beyond Better Drugs Khanna R, Jairath V, Feagan BG. The Evolution of Treatment Paradigms in Crohn's Disease: Beyond Better Drugs. Gastroenterol Clin North Am. 2017 Sep;46(3):661-677. doi: 10.1016/j.gtc.2017.05.010. PMID: 28838421.
Incidence, Prevention and Management of Anti-Drug Antibodies Against Therapeutic Antibodies in Inflammatory Bowel Disease: A Practical Overview Hindryckx P, Novak G, Vande Casteele N, Khanna R, Laukens D, Jairath V, Feagan BG. Incidence, Prevention and Management of Anti-Drug Antibodies Against Therapeutic Antibodies in Inflammatory Bowel Disease: A Practical Overview. Drugs. 2017 Mar;77(4):363-377. doi: 10.1007/s40265-017-0693-5. Erratum in: Drugs. 2017 Mar;77(4):379. Vipul, Jairath [corrected to Jairath, Vipul]. PMID: 28233275.
The Safety of Vedolizumab for the Treatment of Ulcerative Colitis Novak G, Hindryckx P, Khanna R, Jairath V, Feagan BG. The safety of vedolizumab for the treatment of ulcerative colitis. Expert Opin Drug Saf. 2017 Apr;16(4):501-507. doi: 10.1080/14740338.2017.1300251. Epub 2017 Mar 5. PMID: 28276855.
Systematic Review With Meta-Analysis: Placebo Rates in Induction and Maintenance Trials of Crohn’s Disease Jairath V, Zou G, Parker CE, MacDonald JK, Mosli MH, AlAmeel T, Al Beshir M, AlMadi M, Al-Taweel T, Atkinson NS, Biswas S, Chapman TP, Dulai PS, Glaire MA, Hoekman D, Kherad O, Koutsoumpas A, Minas E, Restellini S, Samaan MA, Khanna R, Levesque BG, D'Haens G, Sandborn WJ, Feagan BG. Systematic review with meta-analysis: placebo rates in induction and maintenance trials of Crohn's disease. Aliment Pharmacol Ther. 2017 Apr;45(8):1021-1042. doi: 10.1111/apt.13973. Epub 2017 Feb 5. PMID: 28164348.
Development and Validation of a Histological Index for UC Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Shackelton LM, Walker CW, Nelson S, Vandervoort MK, Frisbie V, Samaan MA, Jairath V, Driman DK, Geboes K, Valasek MA, Pai RK, Lauwers GY, Riddell R, Stitt LW, Levesque BG. Development and validation of a histological index for UC. Gut. 2017 Jan;66(1):50-58. doi: 10.1136/gutjnl-2015-310393. Epub 2015 Oct 16. PMID: 26475633.
Review Article: Dose Optimisation of Infliximab for Acute Severe Ulcerative Colitis Hindryckx P, Novak G, Vande Casteele N, Laukens D, Parker C, Shackelton LM, Narula N, Khanna R, Dulai P, Levesque BG, Sandborn WJ, D'Haens G, Feagan BG, Jairath V. Review article: dose optimisation of infliximab for acute severe ulcerative colitis. Aliment Pharmacol Ther. 2017 Mar;45(5):617-630. doi: 10.1111/apt.13913. Epub 2017 Jan 11. PMID: 28074618; PMCID: PMC6658182.
Responsiveness of Endoscopic Indices of Disease Activity for Crohn’s Disease Khanna R, Zou G, Stitt L, Feagan BG, Sandborn WJ, Rutgeerts P, McDonald JWD, Dubcenco E, Fogel R, Panaccione R, Jairath V, Nelson S, Shackelton LM, Huang B, Zhou Q, Robinson AM, Levesque BG, D'Haens G. Responsiveness of Endoscopic Indices of Disease Activity for Crohn's Disease. Am J Gastroenterol. 2017 Oct;112(10):1584-1592. doi: 10.1038/ajg.2016.580. Epub 2017 Jan 10. Erratum in: Am J Gastroenterol. 2017 Jun;112(6):975. PMID: 28071654.
Effect of Standardised Scoring Conventions on Inter-rater Reliability in the Endoscopic Evaluation of Crohn’s Disease Dubcenco E, Zou G, Stitt L, Baker JP, Jeejeebhoy KN, Kandel G, Kim YI, Grover SC, McDonald JW, Shackelton LM, Khanna R, D'Haens G, Sandborn WJ, Feagan BG, Levesque BG. Effect of Standardised Scoring Conventions on Inter-rater Reliability in the Endoscopic Evaluation of Crohn's Disease. J Crohns Colitis. 2016 Sep;10(9):1006-14. doi: 10.1093/ecco-jcc/jjw120. Epub 2016 Jul 6. PMID: 27385400.
Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis Jairath V, Zou G, Parker CE, Macdonald JK, Mosli MH, Khanna R, Shackelton LM, Vandervoort MK, AlAmeel T, Al Beshir M, AlMadi M, Al-Taweel T, Atkinson NS, Biswas S, Chapman TP, Dulai PS, Glaire MA, Hoekman D, Koutsoumpas A, Minas E, Samaan MA, Travis S, D'Haens G, Levesque BG, Sandborn WJ, Feagan BG. Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis. J Crohns Colitis. 2016 May;10(5):607-18. doi: 10.1093/ecco-jcc/jjw004. Epub 2016 Jan 7. PMID: 26746169; PMCID: PMC4957452.
Assessment of Histologic Disease Activity in Crohn’s Disease: A Systematic Review Mojtahed A, Khanna R, Sandborn WJ, D'Haens GR, Feagan BG, Shackelton LM, Baker KA, Dubcenco E, Valasek MA, Geboes K, Levesque BG. Assessment of histologic disease activity in Crohn's disease: a systematic review. Inflamm Bowel Dis. 2014 Nov;20(11):2092-103. doi: 10.1097/MIB.0000000000000155. PMID: 25137418.
Reproducibility of Histological Assessments of Disease Activity in UC Mosli MH, Feagan BG, Zou G, Sandborn WJ, D'Haens G, Khanna R, Behling C, Kaplan K, Driman DK, Shackelton LM, Baker KA, MacDonald JK, Vandervoort MK, Samaan MA, Geboes K, Valasek MA, Pai R, Langner C, Riddell R, Harpaz N, Sewitch M, Peterson M, Stitt LW, Levesque BG. Reproducibility of histological assessments of disease activity in UC. Gut. 2015 Nov;64(11):1765-73. doi: 10.1136/gutjnl-2014-307536. Epub 2014 Oct 30. PMID: 25360036.
A Prospective Cohort Study to Determine the Relationship Between Serum Infliximab Concentration and Efficacy in Patients With Luminal Crohn’s Disease Levesque BG, Greenberg GR, Zou G, Sandborn WJ, Singh S, Hauenstein S, Ohrmund L, Wong CJ, Stitt LW, Shackelton LM, King D, Lockton S, Ducharme J, Feagan BG. A prospective cohort study to determine the relationship between serum infliximab concentration and efficacy in patients with luminal Crohn's disease. Aliment Pharmacol Ther. 2014 May;39(10):1126-35. doi: 10.1111/apt.12733. Epub 2014 Apr 1. PMID: 24689499.
Histologic Evaluation of Ulcerative Colitis: A Systematic Review of Disease Activity Indices Mosli MH, Feagan BG, Sandborn WJ, Dʼhaens G, Behling C, Kaplan K, Driman DK, Shackelton LM, Baker KA, Macdonald JK, Vandervoort MK, Geboes K, Levesque BG. Histologic evaluation of ulcerative colitis: a systematic review of disease activity indices. Inflamm Bowel Dis. 2014 Mar;20(3):564-75. doi: 10.1097/01.MIB.0000437986.00190.71. PMID: 24412993.
The Role of Centralized Reading of Endoscopy in a Randomized Controlled Trial of Mesalamine for Ulcerative Colitis Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JWD, Rutgeerts P, Munkholm P, Mittmann U, King D, Wong CJ, Zou G, Donner A, Shackelton LM, Gilgen D, Nelson S, Vandervoort MK, Fahmy M, Loftus EV Jr, Panaccione R, Travis SP, Van Assche GA, Vermeire S, Levesque BG. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013 Jul;145(1):149-157.e2. doi: 10.1053/j.gastro.2013.03.025. Epub 2013 Mar 22. PMID: 23528626.