Safety and efficacy of IL-23 inhibitors in patients with moderate to severe ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials
Amin, Hamza Muhammad Hasan, Sundas Abukhater, Reem Lilley, Rachel Atique, Arif Shoaib, Maheen Sattar Albustanji, Qutaiba Sadique, Humza Khalid, Saad Muhammad Hasan, Ali
Amin, Hamza Muhammad
Hasan, Sundas
Abukhater, Reem
Lilley, Rachel
Atique, Arif
Shoaib, Maheen Sattar
Albustanji, Qutaiba
Sadique, Humza
Khalid, Saad Muhammad
Hasan, Ali
Abstract
Background and objective
Targeting the interleukin-23 (IL-23) pathway is an emerging therapeutic strategy for moderate to severe ulcerative colitis (UC). This systematic review and meta-analysis evaluated the efficacy and safety of IL-23 inhibitors for induction and maintenance therapy in UC.
Methods
A systematic search of PubMed, Cochrane, and Google Scholar was conducted up to May 2025 to identify randomized controlled trials (RCTs) of IL-23 inhibitors (mirikizumab, risankizumab, guselkumab) in UC. Data were analyzed using Review Manager (RevMan 5.4) with a random-effects model.
Results
Seven RCTs (four induction, three maintenance) including 4203 patients were analyzed. IL-23 inhibitors significantly increased clinical remission during both induction (RR 1.52) and maintenance (RR 1.62). Rates of histo-endoscopic healing were also higher with IL-23 blockade in both induction (RR 2.53) and maintenance (RR 1.81). Importantly, IL-23 inhibitors were associated with a reduced risk of serious adverse events during induction (RR 0.39), with no significant difference observed during maintenance (RR 0.68). Other outcomes, including clinical response and corticosteroid-free remission, also consistently favored IL-23 blockade.
Conclusion
IL-23 inhibitors provide significant improvements in clinical remission and mucosal healing, with a favorable safety profile, particularly during induction therapy in moderate to severe UC.
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Date
2026-01
Type
Article
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Citation
Amin HM, Hasan S, Abukhater R, Lilley R, Atique A, Shoaib MS, Albustanji Q, Sadique H, Khalid SM, Hasan A, Majeed S, Shahzad MA, Shahzad M, Ahmed M, Ahmed R, Gardezi SA. Safety and efficacy of IL-23 inhibitors in patients with moderate to severe ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials. Int J Colorectal Dis. 2026;41(1):1. doi:10.1007/s00384-025-05014-5.