Effectiveness and Safety of Selective IL-23 Receptor Antagonists in Moderate to Severe Ulcerative Colitis: A Systematic Review, Meta-Analysis and Trial Sequential Analysis
Wellgner Fernandes Oliveira Amador, Isabelle Castro Vitor, Milena Ramos Tome, Diogo Delgado Dotta, Rodrigo V Motta
Published: 2025/9/29
Abstract
Selective interleukin-23 receptor antagonists (IL-23RA) show promise for treating moderate to severe ulcerative colitis (UC) but their efficacy and safety are not fully understood. We performed a systematic review and meta-analysis of randomized controlled trials comparing IL-23RA with placebo in moderate to severe UC. Outcomes included clinical and endoscopic remission, response rates, and adverse events. Nine trials including 3808 patients in the induction phase and 1734 in the maintenance phase were analyzed. IL-23RA improved clinical remission (induction risk ratio 2.63, 95 percent confidence interval 2.05-3.36; maintenance 1.99, 95 percent confidence interval 1.63-2.44) and endoscopic remission (induction 2.36, 95 percent confidence interval 1.70-2.20; maintenance 1.96, 95 percent confidence interval 1.63-2.37). IL-23RA reduced serious adverse events in the induction phase (0.40, 95 percent confidence interval 0.27-0.69) with no difference during maintenance (0.75, 95 percent confidence interval 0.31-1.84). No significant differences were observed in overall adverse events or specific events such as headache or nasopharyngitis. Trial sequential analysis confirmed sufficient sample size for clinical endpoints. IL-23RA showed superior effectiveness and similar safety compared with placebo in moderate to severe UC.