Efficacy of mirikizumab induction therapy in inflammatory bowel disease: A systematic review and meta-analysis

Background: Mirikizumab, an IL-23p19 monoclonal antibody, has emerged as a promising therapy for inflammatory bowel disease (IBD). However, the efficacy of different induction doses has not been comprehensively summarized. This systematic review and meta-analysis evaluated the effectiveness of mirikizumab induction therapy across multiple dose regimens at 12 weeks. Methods: Studies assessing mirikizumab induction doses ranging from 50 to 1000 mg in IBD were systematically searched in PubMed, Embase, Scopus, Web of Science, and Cochrane Library from inception to October 2025. Outcomes included clinical remission, clinical response, endoscopic remission, and histologic remission. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a fixed-effect model. Results: Across included studies, clinical remission improved significantly with 200 (OR: 5.83, 95% CI: 1.58–21.48), 300 (OR: 2.09, 95% CI: 1.44–3.02), and 900 mg (OR: 3.23, 95% CI: 2.20–4.75), while 50 and 600 mg showed nonsignificant trends. Clinical response was significantly higher for 50-, 200-, 300-, and 600-mg doses, with the strongest effect observed at 200 mg (OR: 5.89, 95% CI: 2.57–12.59). Endoscopic remission was inconsistent at low doses but significantly improved at 300 (OR: 2.13, 95% CI: 1.56–2.91), 900 (OR: 6.16, 95% CI: 3.69–10.29), and 1000 mg (OR: 16.06, 95% CI: 2.03–126.91). Histologic remission improved significantly with 200, 300, and 600 mg, while the 50-mg dose showed no meaningful benefit. Overall, mid- to high-dose mirikizumab consistently demonstrated superior efficacy compared with placebo. Conclusion: Mirikizumab provides dose-dependent therapeutic benefits during induction therapy in IBD. Doses of 200 to 1000 mg, particularly 300 and 900 mg, offer the most consistent improvements across clinical, endoscopic, and histologic outcomes. These findings support the use of mid- to high-dose mirikizumab as an effective induction option in patients with IBD.