Publications

Publications


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.
Discover our most recent publications here.

Battat R, Dulai PS, Ma C, Jairath V, Feagan BG, Sandborn WJ, et al. Current endpoints of clinical trials in ulcerative colitis: are they valid? Current Treatment Options in Gastroenterology. 2020; e-pub ahead of print.

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 of Systematic Reviews. 2020 Jan 27;1(1):CD012381. doi: 10.1002/14651858.CD012381.pub2.

Duijvestein M, Jeyarajah J, Guizzetti L, Zou G, Parker CE, van Viegen T, et al. Response to placebo, measured by endoscopic evaluation of Crohn’s disease activity, in a pooled analysis of data from 5 randomized controlled induction trials. Clinical Gastroenterology and Hepatology. 2020;18(5):1121-1132.e2.

Dulai PS, Jairath V, Khanna R, Ma C, McCarrier KP, Martin ML, et al. Development of the symptoms and impacts questionnaire for Crohn’s disease and ulcerative colitis. Alimentary Pharmacology & Therapeutics. 2020 Jun;51(11):1047-1066.

Dulai PS, Jairath V, Zou G, Stitt LW, Khanna R, Sandborn WJ, et al. Early combined immunosuppression may be more effective for reducing complications in isolated colonic- vs ileal-dominant Crohn disease. Inflammatory Bowel Diseases. 2020; e-pub ahead of print.

George J, Singh S, Dulai PS, Ma C, Nguyen T, Feagan BG, et al. Corticosteroid-free remission vs overall remission in clinical trials of moderate-severe ulcerative colitis and Crohn’s disease. Inflammatory Bowel Diseases. 2020 Mar 4;26(4):515-523.

Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, et al. Systematic review: Gastrointestinal ultrasound scoring indices for inflammatory bowel disease. Journal of’ Crohn’s and Colitis. 2020; e-pub ahead of print.

Gordon IO, Bettenworth D, Bokemeyer A, Srivastava A, Rosty C, de Hertogh G, et al.; 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.

Lu C, Baraty B, Lee Robertson H, Filyk A, Shen H, Fung T, et al.; Stenosis Therapy and Research (STAR) Consortium. Systematic review: medical therapy for fibrostenosing Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2020 Jun;51(12):1233-1246.

Ma C, Sandborn WJ, D’Haens GR, Zou G, Stitt LW, Singh S, et al. Discordance between patient-reported outcomes and mucosal inflammation in patients with mild to moderate ulcerative colitis. Clinical Gastroenterology and Hepatology. 2020 Jul;18(8):1760-1768.e1.

Ma C, Gecse KB, Duijvestein M, Sandborn WJ, Zou G, Shackelton LM, et al.  Discordance between patient-reported outcomes and mucosal inflammation in patients with mild to moderate ulcerative colitis. Clinical Gastroenterology and Hepatology. 2020 Aug;18(9):2139-2141.e2.

Townsend CM, Nguyen TM, Cepek J, Abbass M, Parker CE, MacDonald JK, et al. Adalimumab for maintenance of remission in Crohn’s disease. Cochrane Database of Systematic Reviews. 2020 May 16;5:CD012877. doi: 10.1002/14651858.CD012877.pub2.

Vande Casteele N, Jairath V, Jeyarajah J, Dulai P, Singh S, Shackelton LM, et al.  Discordance between patient-reported outcomes and mucosal inflammation in patients with mild to moderate ulcerative colitis. Clinical Gastroenterology and Hepatology. 2020; e-pub ahead of print.

Battat R, Duijvestein M, Guizzetti L, Choudhary D, Boland BS, Dulai PS, et al. Histologic healing rates of medical therapies for ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials. American Journal of Gastroenterology. 2019;114(5):733-745.

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 Safety. 2019;42(5):617-632.

Bettenworth D, Bokemeyer A, Baker M, Mao R, Parker CE, Nguyen T, et al. Assessment of Crohn’s disease-associated small bowel strictures and fibrosis on cross-sectional imaging: a systematic review. Gut. 2019;68(6):1115-1126.

de Rooij WE, Dellon ES, Parker CE, Feagan BG, Jairath V, Ma C, et al. Pharmacotherapies for the treatment of eosinophilic esophagitis: state of the art review. Drugs. 2019; 79(13):1419-1434.

Hindryckx P, Jairath V, Zou G, Feagan BG, Sandborn WJ, Stoker J, et al. Development and validation a magnetic resonance index for assessing fistulas in patients with Crohn’s disease. Gastroenterology; e-pub ahead of print.

Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, et al. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterology & Hepatology. 2019;4(1):63-70.

Jairath V, Peyrin-Biroulet L, Zou G, Mosli M, Vande Casteele N, Pai RK, et al. Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial. Gut. 2019;68(7):1162-1168.

Ma C, Athayde J, Davies SC, Parker CE, Nguyen TM, Khanna R, Identifying outcomes in clinical trials of pouchitis for the development of a core outcome set. Clinical Gastroenterology and Hepatology. 2019;17(8):1637-1640.

Ma C, Battat R, Dulai PS, Parker CE, Sandborn WJ, Feagan BG, et al. Innovations in oral therapies for inflammatory bowel disease. Drugs. 2019;79(12):1321-1335.

Ma C, Battat R, Khanna R, Parker CE, Feagan BG, Jairath V, et al. What is the role of C-reactive protein and fecal calprotectin in evaluating Crohn’s disease activity? Best Practice & Research: Clinical Gastroenterology. 2019;38-39:101602.

Ma C, Battat R, Jairath V, Vande Casteele N. Advances in therapeutic drug monitoring for small-molecule and biologic therapies in inflammatory bowel disease. Current Treatment Options in Gastroenterology. 2019; e-pub ahead of print.

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 Reviews in Gastroenterology and Hepatology. 2019;13(4):319-330.

Ma C, Guizzetti L, Cipriano LE, Parker CE, Nguyen TM, Gregor JC, et al. Systematic review with meta-analysis: high prevalence and cost of continued aminosalicylate use in patients with ulcerative colitis escalated to immunosuppressive and biological therapies. Alimentary Pharmacology & Therapeutics. 2019;49(4):364-374.

Ma C, Lee JK, Mitra AR, Teriaky A, Choudhary D, Nguyen TM, et al. Systematic review with meta-analysis: efficacy and safety of oral Janus kinase inhibitors for inflammatory bowel disease. Alimentary Pharmacology & Therapeutics. 2019;50(1):5-23.

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 Practice & Research: Clinical Gastroenterology. 2019;38-39:101604.

Ma C, Parker CE, Nguyen TM, Khanna R, Feagan BG, et al. Identifying outcomes in clinical trials of fistulizing Crohn’s disease for the development of a core outcome set. Clinical Gastroenterology and Hepatology. 2019;17(9):1904-1908.

Novak G, Stevens T, Van Viegen T, Bossuyt P, Štabuc B, Jeyarajah J, et al. Evaluation of optimal biopsy location for assessment of histological activity, transcriptomic and immunohistochemical analyses in patients with active Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2019;49(11):1401-1409.

Pai RK, Khanna R, D’Haens GR, Sandborn WJ, Jeyarajah J, Feagan BG, et al. Definitions of response and remission for the Robarts Histopathology Index. Gut. 2019;68(11):2102-2102.

Pai RK, Kleiner DE, Hart J, Adeyi OA, Clouston AD, Behling CA, et al. Standardising the interpretation of liver biopsies in non-alcoholic fatty liver disease clinical trials. Alimentary Pharmacology & Therapeutics. 2019; e-pub ahead of print.

Singh S, Stitt LW, Zou G, Khanna R, Dulai PS, Sandborn WJ, et al. Early combined immunosuppression may be effective and safe in older patients with Crohn’s disease: post hoc analysis of REACT. Alimentary Pharmacology & Therapeutics. 2019;49(9):1188-1194.

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. Clinical Gastroenterology and Hepatology. 2019;17(9):1814-1821.

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.

Athayde J, Davies SC, Parker CE, Guizzetti L, Ma C, Khanna R, et al. Placebo rates in randomized controlled trials of pouchitis therapy. Digestive Diseases and Sciences. 2018;63(10):2519-2528.

Duijvestein M, Battat R, Vande Casteele N, D’Haens GR, Sandborn WJ, Khanna R, et al. Novel therapies and treatment strategies for patients with inflammatory bowel disease. Current Treatment Options in Gastroenterology. 2018;16(1):129-46.

Guizzetti L, Zou G, Khanna R, Dulai PS, Sandborn WJ, Jairath V, et al. Development of clinical prediction models for surgery and complications in Crohn’s disease. Journal of Crohn’s & Colitis. 2018;12(2):167-77.

Hindryckx P, Levesque BG, Holvoet T, Durand S, Tang CM, Parker C, et al. Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials. Gut. 2018;67(1):61-9.

Hindryckx P, Vande Casteele N, Novak G, Khanna R, D’Haens G, Sandborn WJ, et al. The expanding therapeutic armamentarium for inflammatory bowel disease: how to choose the right drug[s] for our patients? Journal of Crohn’s & Colitis. 2018;12(1):105-19.

Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, et al. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterology & Hepatology. 2018;4(1):63-70.

Jairath V, Ordas I, Zou G, Panes J, Stoker J, Taylor SA, et al. Reliability of measuring ileo-colonic disease activity in Crohn’s disease by magnetic resonance enterography. Inflammatory Bowel Diseases. 2018;24(2):440-9.

Khanna R, Zou G, Feagan BG. Evolution of the randomized controlled trial in inflammatory bowel disease: current challenges and future solutions. Inflammatory Bowel Diseases. 2018;24(10):2155-2164.

Lee MJ, Parker CE, Taylor SR, Guizzetti L, Feagan BG, Lobo AJ, et al. Efficacy of medical therapies for fistulizing Crohn’s disease: systematic review and meta-analysis. Clinical Gastroenterology and Hepatology. 2018;16(12):1879-1892.

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. Digestive Diseases and Sciences. 2018; 63(10):2555-2563.

Ma C, Dutton SJ, Cipriano LE, Singh S, Parker CE, Nguyen TM, et al. Systematic review with meta-analysis: prevalence, risk factors and costs of aminosalicylate use in Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2018;48(2):114-26.

Ma C, Guizzetti L, Panaccione R, Fedorak RN, Pai RK, Parker CE, et al. Systematic review with meta-analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis. Alimentary Pharmacology & Therapeutics. 2018;47(12):1578-96.

Ma C, Hussein IM, Al-Abbar YJ, Panaccione R, Fedorak RN, Parker CE, et al. Heterogeneity in definitions of efficacy and safety endpoints for clinical trials of Crohn’s disease: a systematic review. Clinical Gastroenterology and Hepatology. 2018;16(9):1407-19.

Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, et al. Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: a systematic review for development of a core outcome set. Clinical Gastroenterology and Hepatology. 2018;16(5):637-47.e13.

Ma C, van Rhijn BD, Jairath V, Nguyen TM, Parker CE, Aceves SS, et al. Heterogeneity in clinical, endoscopic, and histologic outcome measures and placebo response rates in clinical trials of eosinophilic esophagitis: a systematic review. Clinical Gastroenterology and Hepatology. 2018;16(11):1714-1729.

Mohammed Vashist N, Samaan M, Mosli MH, Parker CE, MacDonald JK, Nelson SA, et al. Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis. The Cochrane Database of Systematic Reviews. 2018;1:Cd011450.

Rieder F, Bettenworth D, Ma C, Parker CE, Williamson LA, Nelson SA, et al. An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2018;48(3):347-57.

Samaan MA, Shen B, Mosli MH, Zou G, Sandborn WJ, Shackelton LM, et al. Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis. Gastrointestinal Endoscopy. 2018;88(2):360-9.e2.

Warners MJ, Ambarus CA, Bredenoord AJ, Verheij J, Lauwers GY, Walsh JC, et al. Reliability of histologic assessment in patients with eosinophilic oesophagitis. Alimentary Pharmacology & Therapeutics. 2018;47(7):940-50.

Wildenberg ME, Duijvestein M, Westera L, van Viegen T, Buskens CJ, van der Bilt JDW, et al. Evaluation of the effect of storage condition on cell extraction and flow cytometric analysis from intestinal biopsies. Journal of Immunological Methods. 2018;459:50-4.

D’Haens GR, Sandborn WJ, Zou G, Stitt LW, Rutgeerts PJ, Gilgen D, et al. Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis. Alimentary Pharmacology & Therapeutics. 2017;46(3):292-302.

Hindryckx P, Novak G, Vande Casteele N, Khanna R, Laukens D, Jairath V, et al. Incidence, prevention and management of anti-drug antibodies against therapeutic antibodies in inflammatory bowel disease: a practical overview. Drugs. 2017;77(4):363-77.

Hindryckx P, Novak G, Vande Casteele N, Laukens D, Parker C, Shackelton LM, et al. Review article: dose optimisation of infliximab for acute severe ulcerative colitis. Alimentary Pharmacology & Therapeutics. 2017;45(5):617-30.

Jairath V, Khanna R, Feagan BG. Alicaforsen for the treatment of inflammatory bowel disease. Expert Opinion on Investigational Drugs. 2017;26(8):991-7.

Jairath V, Levesque BG, Vande Casteele N, Khanna R, Mosli M, Hindryckx P, et al. Evolving concepts in phases I and II drug development for Crohn’s disease. Journal of Crohn’s & Colitis. 2017;11(2):246-55.

Jairath V, Zou GY, Parker CE, MacDonald JK, AlAmeel T, Al Beshir M, et al. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis. The Cochrane Database of Systematic Reviews. 2017;9:Cd011572.

Jairath V, Zou G, Parker CE, MacDonald JK, Mosli MH, AlAmeel T, et al. Systematic review with meta-analysis: placebo rates in induction and maintenance trials of Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2017;45(8):1021-42.

Kahan BC, Feagan B, Jairath V. A comparison of approaches for adjudicating outcomes in clinical trials. Trials. 2017;18(1):266.

Khanna R, Jairath V, Feagan BG. The evolution of treatment paradigms in Crohn’s disease: beyond better drugs. Gastroenterology Clinics of North America. 2017;46(3):661-77.

Khanna R, Zou G, Stitt L, Feagan BG, Sandborn WJ, Rutgeerts P, et al. Responsiveness of endoscopic indices of disease activity for Crohn’s disease. The American Journal of Gastroenterology. 2017;112(10):1584-92.

Kwapisz L, Jairath V, Khanna R, Feagan B. Pharmacokinetic drug evaluation of budesonide in the treatment of Crohn’s disease. Expert Opinion on Drug Metabolism & Toxicology. 2017;13(7):793-801.

Ma C, Panaccione R, Fedorak RN, Parker CE, Khanna R, Levesque BG, et al. 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;7(6):e016146.

Mosli MH, Feagan BG, Zou G, Sandborn WJ, D’Haens G, Khanna R, et al. Development and validation of a histological index for UC. Gut. 2017;66(1):50-8.

Mosli MH, Parker CE, Nelson SA, Baker KA, MacDonald JK, Zou GY, et al. Histologic scoring indices for evaluation of disease activity in ulcerative colitis. The Cochrane Database of Systematic Reviews. 2017;5:Cd011256.

Novak G, Hindryckx P, Khanna R, Jairath V, Feagan BG. The safety of vedolizumab for the treatment of ulcerative colitis. Expert Opinion on Drug Safety. 2017;16(4):501-7.

Novak G, Parker CE, Pai RK, MacDonald JK, Feagan BG, Sandborn WJ, et al. Histologic scoring indices for evaluation of disease activity in Crohn’s disease. The Cochrane Database of Systematic Reviews. 2017;7:Cd012351.

Samaan MA, Puylaert CAJ, Levesque BG, Zou GY, Stitt L, Taylor SA, et al. The development of a magnetic resonance imaging index for fistulising Crohn’s disease. Alimentary Pharmacology & Therapeutics. 2017;46(5):516-28.

Warners MJ, Hindryckx P, Levesque BG, Parker CE, Shackelton LM, Khanna R, et al. Systematic review: disease activity indices in eosinophilic esophagitis. The American Journal of Gastroenterology. 2017;112(11):1658-69.

Westera L, van Viegen T, Jeyarajah J, Azad A, Bilsborough J, van den Brink GR, et al. Centrally determined standardization of flow cytometry methods reduces interlaboratory variation in a prospective multicenter study. Clinical and Translational Gastroenterology. 2017;8(11):e126.

Yan B, Feagan B, Teriaky A, Mosli M, Mohamed R, Williams G, et al. Reliability of EUS indices to detect inflammation in ulcerative colitis. Gastrointestinal Endoscopy. 2017;86(6):1079-87.