Sequencing Therapy for Optimal Response in Mirikizumab (STORM)-study: A tertiary referral center study on patients
Alica Kubesch1, Raul Lande1, Anna Leutgöb1
1Goethe University Frankfurt, University Hospital, Medical Clinic 1, Frankfurt, Germany.
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.
Insights
Mirikizumab shows good short- and long-term efficacy in ulcerative colitis (UC) patients previously treated with biologics. Prior anti-tumor necrosis factor (TNF) therapy was linked to better biochemical remission outcomes.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Optimized drug sequencing is crucial for ulcerative colitis (UC) management.
- Real-world data on mirikizumab response in patients with prior biologic exposure, especially anti-tumor necrosis factor (TNF) agents, is limited.
- This study assesses mirikizumab efficacy in UC patients refractory to prior biologic therapies.
Purpose of the Study:
- To evaluate the therapeutic response to mirikizumab in biologic-refractory ulcerative colitis (UC) patients.
- To compare treatment outcomes based on prior biologic exposure, including anti-TNF and Janus kinase inhibitor (JAKi) treatments.
- To assess both short-term (12-week) and long-term (up to 80 weeks) clinical and biochemical remission rates.
Main Methods:
- Retrospective analysis of 52 consecutive UC patients treated with mirikizumab from July 2023 to May 2025.
- Primary endpoint: 12-week clinical remission.
- Secondary endpoints: Clinical and biochemical remission at weeks 24-50 and 60-80.
Main Results:
- A 12-week clinical remission rate of 67.3% (35/52) was observed.
- Treatment duration significantly correlated with clinical and biochemical remission.
- Prior anti-TNF therapy positively impacted biochemical remission (OR=3.489, p=0.021), while prior JAKi therapy negatively impacted clinical remission (OR=0.19, p=0.019).
Conclusions:
- Mirikizumab demonstrates favorable short- and long-term efficacy in UC patients with prior biologic treatment history.
- Patients with previous anti-TNF therapy experienced better biochemical remission outcomes.
- These findings support mirikizumab as an effective option in heavily pretreated UC populations.
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