Akihiro Yamada1,2, Jingzhou Wang3, Yuga Komaki1,4, Fukiko Komaki1,4, Dejan Micic1, Atsushi Sakuraba1. 1. Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, The University of Chicago Medicine, Chicago, Illinois. 2. Section of Gastroenterology, Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan. 3. Department of Medicine, The University of Chicago Medicine, Chicago, Illinois. 4. Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Abstract
BACKGROUND: New onset IBD has been reported with the use of anti-IL-17 agents, but it remains unclear to what extent this is attributed to treatment or to underlying disease. AIM: To evaluate the risk of new onset IBD with the use of anti-IL-17 agents METHODS: Electronic databases were searched for randomised controlled trials (RCT) of anti-IL-17 agents (brodalumab, ixekizumab and secukinumab). Risk of new onset IBD was compared to placebo by Mantel-Haenszel (MH) risk difference (RD). Sensitivity analyses including meta-analysis using fixed-effect model, MH and Peto odds ratio and MH risk ratio were performed due to incidence of rare adverse events. The risk of diarrhoea was also assessed due to the possibility of underdiagnosis of IBD. RESULTS: Thirty-eight RCTs including 16 690 patients treated with anti-IL-17 agents were included. Twelve cases of new onset IBD were reported with anti-IL-17 agents in five studies, whereas no cases were reported with placebo. There was no difference in the risk of developing new onset IBD with anti-IL-17 agents compared to placebo (MH RD 0.00062, 95% CI -0.00072-0.0021, P = 0.35). Sensitivity analyses demonstrated no consistent risk with any method. There was no difference in the risk of diarrhoea (MH RD 0.0013, 95% CI -0.0014-0.0041, P = 0.34). CONCLUSIONS: New onset IBD with the use of anti-IL-17 agents was rare. Interpretation of the results needs caution due to the presence of many zero-event studies.
BACKGROUND: New onset IBD has been reported with the use of anti-IL-17 agents, but it remains unclear to what extent this is attributed to treatment or to underlying disease. AIM: To evaluate the risk of new onset IBD with the use of anti-IL-17 agents METHODS: Electronic databases were searched for randomised controlled trials (RCT) of anti-IL-17 agents (brodalumab, ixekizumab and secukinumab). Risk of new onset IBD was compared to placebo by Mantel-Haenszel (MH) risk difference (RD). Sensitivity analyses including meta-analysis using fixed-effect model, MH and Peto odds ratio and MH risk ratio were performed due to incidence of rare adverse events. The risk of diarrhoea was also assessed due to the possibility of underdiagnosis of IBD. RESULTS: Thirty-eight RCTs including 16 690 patients treated with anti-IL-17 agents were included. Twelve cases of new onset IBD were reported with anti-IL-17 agents in five studies, whereas no cases were reported with placebo. There was no difference in the risk of developing new onset IBD with anti-IL-17 agents compared to placebo (MH RD 0.00062, 95% CI -0.00072-0.0021, P = 0.35). Sensitivity analyses demonstrated no consistent risk with any method. There was no difference in the risk of diarrhoea (MH RD 0.0013, 95% CI -0.0014-0.0041, P = 0.34). CONCLUSIONS: New onset IBD with the use of anti-IL-17 agents was rare. Interpretation of the results needs caution due to the presence of many zero-event studies.
Authors: Igor Kremenevski; Oliver Sander; Michael Sticherling; Martin Raithel; FirstName MiddleName LastName Journal: Dtsch Arztebl Int Date: 2022-02-11 Impact factor: 8.251
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