Clinical insights into IL-23 inhibition: risankizumab for Crohn's disease through a systematic review and meta-analysis of randomized controlled trials.
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Abstract
Background and aims: Crohn's disease is a chronic inflammatory disorder with rising global prevalence, marked by abdominal pain, diarrhea, and fatigue. Interleukin (IL)-23 plays a pivotal role in Crohn's disease pathogenesis, making it a therapeutic target. Risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit, has shown potential in clinical trials.
Objectives: This meta-analysis evaluates the efficacy and safety of Risankizumab in achieving clinical remission, clinical response, and endoscopic remission in patients with moderate-to-severe Crohn's disease.
Design: A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines.
Data sources and methods: A comprehensive search of PubMed, Embase, Cochrane CENTRAL, Web of Science, and ClinicalTrials.gov was performed to identify randomized controlled trials (RCTs) assessing Risankizumab in Crohn's disease. Primary outcomes were clinical remission, clinical response, and endoscopic remission, with secondary outcomes focusing on treatment-related adverse events. A random-effects model estimated odds ratios (ORs) with 95% confidence intervals. Meta-regression analyzed dose- and duration-dependent effects.
Results: Four RCTs involving 1774 participants showed that Risankizumab significantly improved clinical remission (OR = 2.223), clinical response (OR = 2.483), and endoscopic remission (OR = 4.112). Dose-dependent improvements were observed, with treatment duration affecting clinical remission (p = 0.0158) but not clinical response or endoscopic remission. Adverse event rates were comparable between Risankizumab and placebo groups (OR = 0.872, p = 0.592).
Conclusion: Risankizumab is effective in achieving clinical and endoscopic outcomes in moderate-to-severe Crohn's disease, demonstrating dose-dependent benefits and a favorable safety profile, supporting its use as a therapeutic option. However, the limited number of studies may affect the robustness of these findings. Further large-scale RCTs are needed to validate its long-term efficacy, safety in elderly populations, and effectiveness in biologic-naïve patients.
Trial registration: This systematic review and meta-analysis were registered with the INPLASY database under registration number INPLASY202530014. The full protocol is accessible at DOI: 10.37766/inplasy2025.3.0014.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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