Digestion · 2026
Short- and Long-Term Outcomes of Mirikizumab for Ulcerative Colitis: A Real-World Multicenter Retrospective Cohort Study from the INSIGHT Study.
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Sawada Tsunaki, Yamamura Takeshi, Maeda Keiko, Ishikawa Eri, Murate Kentaro, Miyake Nobuyuki, Matsuura Rinzaburo, Fujiyoshi Toshihisa, Uchida Genta, Suzuki Hiroto, Nishikawa Takahiro, Kuno Takeshi, Hattori Shun, Urata Noboru, Ohashi Ayako, Hasegawa Issei, Nakamura Masanao, Kawashima Hiroki
Аннотация
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.
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.