ArticleTherapeutic advances in gastroenterology2026
Long-term real-world effectiveness and safety of mirikizumab in ulcerative colitis: 52-Week results from an expanded international two-center retrospective cohort study.
Article in Therapeutic advances in gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Mirikizumab, a selective interleukin-23p19 inhibitor, has demonstrated efficacy in randomized controlled trials for moderate-to-severe ulcerative colitis (UC). However, long-term real-world data remain limited, particularly in treatment-experienced populations. Objectives: To evaluate the 52-week real-world effectiveness and safety of mirikizumab in a treatment-experienced UC cohort. Design: Two-center international retrospective observational cohort study of adults with active UC initiating mirikizumab. Methods: This study expands a previously published 12-week real-world cohort from the same centers, adding patients and extending follow-up to 52 weeks. The primary outcome was clinical remission (SCCAI ≤2) at week 52 using non-responder imputation. Secondary outcomes included clinical response, corticosteroid-free remission, and drug persistence at weeks 12, 26, and 52, as well as safety. Results: The cohort included 120 patients with prior anti-TNF, vedolizumab, and JAK inhibitor exposure in 75.8%, 75.0%, and 42.5%, respectively. Clinical response rates were 67.5%, 52.3%, and 41.3% at weeks 12, 26, and 52, with corresponding remission rates of 14.2%, 19.8%, and 28.3% (modified NRI: 35.6%). Corticosteroid-free remission at 52 weeks was 26.1%. Drug persistence at 52 weeks was 64.6% (95% CI 54.9-72.7%), without significant differences by prior biologic exposure class. Among 60 patients (50.0%) receiving extended induction, week-26 remission was lower than in standard induction recipients (10.7% vs. 29.1%; p=0.018). Adverse events occurred in 13 patients (10.8%), leading to discontinuation in 5 (4.2%). Conclusion: In this large treatment-experienced real-world UC cohort, mirikizumab achieved 52-week clinical remission in 28.3% and drug persistence of 64.6%, with no new safety signals identified, supporting its role across lines of therapy in UC.
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