Short- and Long-Term Outcomes of Mirikizumab for Ulcerative Colitis: A Real-World Multicenter Retrospective Cohort Study from the INSIGHT Study.

Abstract

Introduction: Mirikizumab (MIR), a selective IL-23p19 inhibitor, has shown efficacy in clinical trials for ulcerative colitis (UC). However, real-world data, especially on long-term outcomes and in treatment-experienced populations, remain limited.

Methods: We conducted a multicenter retrospective cohort study involving 85 patients with moderate-to-severe UC who initiated MIR between July 2023 and December 2024 across 12 Japanese centers. Co-primary endpoints were clinical remission (Simple Clinical Colitis Activity Index [SCCAI] ≤2 and with no rectal bleeding) at weeks 12 and 52. Secondary outcomes included corticosteroid (CS)-free remission, C-reactive protein normalization, treatment persistence, and safety.

Results: Clinical remission was achieved in 62.4% at week 12 and 55.3% at week 52. CS-free remission rates were identical to overall remission at both time points. MIR maintained effectiveness regardless of prior exposure to biologics or JAK inhibitors. Early clinical response at week 4 independently predicted week 52 remission, while steroid dependence was a predictor at week 12. Among patients receiving extended induction, 27.3% of initial nonresponders achieved remission by week 24. Treatment was generally well tolerated, with 17.6% experiencing adverse events and 9.4% discontinuing due to these events. No serious infections or hospitalizations occurred.

Conclusion: MIR demonstrated durable effectiveness and a favorable safety profile over 52 weeks in a real-world UC population, including those with prior treatment failures. These findings support MIR as a viable long-term therapeutic option in routine clinical practice.