Efficacy, safety and outcome of selective IL-23 inhibitor risankizumab in induction and maintenance of CD and ulcerative colitis

Abstract

Background: Crohn disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases characterized by immune dysregulation. Despite biologic advancements, many patients experience treatment failure. Risankizumab (RZB), a selective interleukin-23 inhibitor, has emerged as a promising therapy for moderate-to-severe inflammatory bowel diseases. This systematic review evaluates its efficacy, safety, and therapeutic outcomes. Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic search of PubMed, Embase, Scopus, and ClinicalTrials.gov was conducted to identify studies published up to 2025. Eligible studies included randomized controlled trials, clinical trials, and retrospective observational studies evaluating RZB in adult patients with CD or UC. Primary outcomes included clinical remission, endoscopic response, hospitalization rates, and adverse events. Results: Seventeen studies involving 6602 patients (5627 with CD, 975 with UC) were analyzed. In CD, RZB demonstrated high clinical remission rates, endoscopic healing, and reduced hospitalizations, including in biologic-refractory patients. In UC, it showed significant remission rates and fewer UC-related hospitalizations. RZB was well tolerated, with mostly mild to moderate adverse events such as arthralgia, headache, and nasopharyngitis. Severe adverse events were rare. Conclusion: RZB is an effective and well-tolerated treatment for moderate-to-severe CD and UC, showing strong clinical and endoscopic outcomes. It offers a viable option for biologic-refractory patients, but further research is needed to assess long-term efficacy and safety.