Abstract

Inflammatory bowel diseases (IBD) involve two persistent inflammatory conditions, Crohn’s disease (CD), and ulcerative colitis (UC), which require effective and safe therapeutic strategies. Mirikizumab, an interleukin- 23 (IL-23) inhibitor, has been evaluated in trials for IBD treatment. To identify the safety and efficacy of Mirikizumab in managing IBD, with subgroup analyses for CD and UC. A meta-analysis was conducted on four randomized controlled trials, including 2,259 patients who received mirikizumab or placebo for UC or CD from inception to December 2024. Outcomes evaluated included clinical response, endoscopic response, and clinical remission at weeks 12 and 52. Safety was assessed through serious adverse effects (SAEs). Heterogeneity was evaluated using the I² statistic. Mirikizumab showed trends of improved clinical and endoscopic outcomes for IBD overall, but without statistical significance. Subgroup analysis revealed significant efficacy in Crohn’s disease at week 12, with minimal heterogeneity. However, no significant efficacy was observed in ulcerative colitis at any time point, with substantial heterogeneity noted. Safety outcomes showed no significant differences in SAEs between mirikizumab and placebo overall, although a lower incidence of SAEs was observed in Crohn’s disease. Mirikizumab showed potential as an effective treatment for Crohn’s disease, particularly at week 12, with minimal safety concerns. Its efficacy in ulcerative colitis remains inconclusive, warranting further investigation. High heterogeneity limits the generalizability of findings, emphasizing the need for future investigation to explore long-term outcomes and subgroup-specific responses.

Key words: Inflammatory bowel disease, Crohn's disease, ulcerative colitis, mirikizumab, systematic review