Publications Placebo Response Rates in Randomized Controlled Trials for Perianal Crohn’s Disease: A Systematic Review and Meta-Analysis Citation 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. Abstract Background and aims: Perianal fistulizing disease is a common complication of Crohn’s disease [CD], for which new therapies are urgently needed. To assist the design of clinical trials for novel therapeutics, we conducted a systematic review and meta-analysis of randomised controlled trials [RCTs] to quantify placebo rates and identify factors influencing them in perianal CD [pCD]. Methods: We searched MEDLINE, Embase and CENTRAL from inception to June 2021. Eligible studies were placebo-controlled trials of pharmacological interventions for pCD. Placebo fistula response and remission rates for induction and maintenance trials were extracted and pooled using a random-effects model. Mixed-effects meta-regression was used to evaluate the impact of patient and study-level characteristics on point estimates. Results: In 17 RCTs [13 induction, five maintenance] the pooled placebo fistula response and remission rate for induction trials was 25% (95% confidence interval [CI] 17-36%) and 17% [95% CI 11-25%], respectively. For maintenance trials, the pooled placebo fistula response and remission rate was 23% [95% CI 17-32%] and 19% [95% CI 14-25%], respectively. Trials enrolling patients with less disease activity and a higher proportion with ileal predominant disease were associated with significantly higher placebo response rates. Trials originating in Europe [compared to North America], therapies requiring perianal injection and a longer timepoint to measure remission were associated with higher placebo remission rates. Conclusions: Placebo response and remission rates in pCD trials are influenced by patient and disease-related factors, as well as the type of intervention being studied. These contemporary rates will inform trial design for novel therapeutics. Keywords: Peri-anal Crohn’s disease; clinical trials; placebo. Tags Perianal Crohn's Disease Read More