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. (2025)

Type of publication:

Systematic Review

Author(s):

Amin, Hamza Muhammad; Hasan, Sundas; Abukhater, Reem; Lilley, Rachel; Atique, Arif; Shoaib, Maheen Sattar; Albustanji, Qutaiba; Sadique, Humza; *Khalid, Saad Muhammad; Hasan, Ali; Majeed, Salman; Shahzad, Muhammad Aamir; Shahzad, Maryam; Ahmed, Mushood; Ahmed, Raheel; Gardezi, Syed Anjum.

Citation:

International Journal of Colorectal Disease. 2025 Dec 30.

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.

DOI: 10.1007/s00384-025-05014-5

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