Sequencing Therapy for Optimal Response in Mirikizumab (STORM)-study: A tertiary referral center study on patients with therapy-refractory ulcerative colitis

Background: Optimized drug sequencing is an emerging area of interest in the treatment of ulcerative colitis (UC). Comparative real-world data on treatment response to mirikizumab in a cohort with exposure to multiple biologic agents, particularly tumor necrosis factor (TNF)-naïve versus TNF-treated patients, remain limited. This study evaluated the therapeutic response to mirikizumab treatment in a cohort of patients with UC who were refractory to biologic therapy. Methods: Consecutive patients with UC treated with mirikizumab between July 01, 2023, and May 31, 2025, at a tertiary university referral center were retrospectively analyzed. The primary endpoint was 12-week clinical remission. The secondary endpoints included clinical remission and biochemical remission between weeks 24 and 50 and between weeks 60 and 80. Results: This study included 52 patients. Among them, 17 (32.7%) had previous exposure to ≥3 biologic agents/small molecules. The 12-week clinical remission rate was 35 of 52 patients (67.3%). There was a significant association between the treatment duration and clinical and biochemical remission. The likelihood of achieving clinical remission was 5.583 times higher after 12 weeks of intravenous mirikizumab treatment (odds ratio [OR] = 5.583, p = 0.002). Anti-TNF pretreatment had a positive effect on biochemical remission (OR = 3.489, p = 0.021). Janus kinase inhibitor pretreatment had a negative effect on clinical remission (OR = 0.19, p = 0.019). Conclusion: Mirikizumab treatment had good short- and long-term efficacy in patients with UC who previously received biologic therapy. In particular, patients with prior anti-TNF therapies had favorable biochemical remission outcomes.