Safety and efficacy of mirikizumab as induction and maintenance for inflammatory bowel disease in adult patients: a systematic review and meta-analysis

Abstract Background Mirikizumab, a monoclonal antibody targeting interleukin-23 (IL-23), was studied for adult patients with moderate-to-severe inflammatory bowel disease (IBD). However, conflicting evidence exists on its safety, efficacy and optimal dosing strategy. Aim To evaluate the safety and efficacy of mirikizumab in treating IBD and understand a dose–response relationship based on clinical, endoscopic, and histological outcomes. Methodology A systematic search of six electronic databases, i.e. PubMed, ClinicalTrials.gov, Cochrane CENTRAL, ScienceDirect, ProQuest, and EBSCO, was conducted (PROSPERO: CRD42024570804). Relevant data were extracted from selected studies. Primary endpoints included safety, efficacy, adverse events (AEs), serious adverse events (SAEs), and mortality. Dose–response relationship was assessed as a secondary endpoint. Results Six trials were eligible from 415 screened records, pooling 3,990 participants (3,073 of whom received mirikizumab). Mirikizumab significantly improved clinical remission (relative risk [RR] [95% CI] = 1.87 [1.57–2.22]) and histological outcomes (RR [95% CI] = 1.63 [1.35–1.97]) with minimal heterogeneity across subgroups, i.e. intravenous (IV) and subcutaneous (SC) routes. The drug significantly improved endoscopic remission (RR [95% CI] = 1.66 [1.28–2.16]), particularly with IV route (RR = 2.09). The risk for AEs was similar between groups, with low heterogeneity (I 2 = 2.0%). Conclusion Mirikizumab improves clinical, histological, and endoscopic outcomes in IBD with a favorable safety profile. There was no significant difference with different injection routes and with incrementing dose beyond 200 mg.