S1733 Role of Mirikizumab in Inducing and Maintaining Remission in Crohn’s Disease: A Meta-Analysis of Randomized Controlled Trials

Introduction: Crohn disease (CD) often leads to steroid dependence or treatment resistance without timely biologic intervention. Mirikizumab, a humanized monoclonal antibody targeting IL-23p19, has demonstrated efficacy in ulcerative colitis. This meta-analysis assesses its therapeutic potential in patients with moderate to severe Crohn disease. Methods: We systematically searched PubMed, MEDLINE, SCOPUS, Google Scholar, and Cochrane CENTRAL through May 2025 for randomized controlled trials (RCTs) evaluating Mirikizumab 1000 mg in Crohn disease. Primary outcomes included endoscopic response (≥50% reduction in Simple Endoscopic Score for Crohn Disease [SES-CD]) or histologic response (>50% reduction in Robarts Histopathology Index [RHI] or Global Histologic Activity Score [GHAS]) at weeks 12 and 52, along with endoscopic or histologic remission (based on SES-CD and absence of mucosal neutrophils and epithelial damage). Secondary outcomes were patient-reported (PRO) clinical response at week 12 (≥30% decrease in abdominal pain and/or stool frequency) and Crohn’s Disease Activity Index [CDAI] remission (CDAI <150) at week 52. A random-effects meta-analysis was conducted, reporting pooled risk ratios (RR) with 95% confidence intervals (CI). Results: Three RCTs involving 1,511 participants were included. Mirikizumab significantly outperformed placebo in achieving endoscopic/histologic response at both 12 weeks (RR 2.91, 95% CI: 1.86–4.54; P < 0.00001; I² = 9%) and 52 weeks (RR 2.80, 95% CI: 1.15–6.80; P = 0.02; I² = 83%). It also showed superior rates of remission at 12 weeks (RR 7.41, 95% CI: 2.43–22.65; P = 0.0004; I² = 0%). However, remission rates at 52 weeks were comparable to placebo (RR 1.40, 95% CI: 0.76–2.58; P = 0.27; I² = 0%). For secondary outcomes, Mirikizumab was more effective in achieving PRO clinical response at 12 weeks (RR 6.16, 95% CI: 4.02–9.43; P < 0.00001; I² = 0%) but did not significantly improve CDAI remission at 52 weeks (RR 1.74, 95% CI: 0.44–6.86; P = 0.43; I² = 92%). Conclusion: Mirikizumab demonstrates promising efficacy in both short- and long-term management of moderate-to-severe Crohn disease. However, further comparative studies are needed to evaluate its effectiveness and safety against other available biologic therapies.