Crohn's & colitis 360 · 2026
Mirikizumab is equally effective in ustekinumab-exposed and ustekinumab-naïve patients with UC: a multicenter real-world cohort.
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Sharip Mohmmed Tauseef, Durai Dharmaraj, Vayreda Eva, Noor Nurulamin M, Herath Anushka, Withanachchi Achini, Dart Robin, Subramanian Sreedhar, Parkes Miles, Samaan Mark A, Raine Tim, Irving Peter M
Аннотация
BACKGROUND: Mirikizumab, a selective IL-23p19 monoclonal antibody, has demonstrated efficacy in moderate-to-severe ulcerative colitis (UC) although real-world data are limited. In addition, registrational trials excluded patients previously treated with ustekinumab, which targets the IL-12/23 p40 subunit. We aimed to evaluate the real-world effectiveness and safety of mirikizumab in a multicenter UK cohort of patients with UC, including those with prior ustekinumab exposure.
METHODS: A retrospective observational study was conducted across 3 tertiary UK centers. Adults with confirmed UC who received mirikizumab and had ≥12 weeks of follow-up were included. Data on demographics, disease activity (SCCAI, UCEIS), biomarkers (CRP, fecal calprotectin), and treatment persistence were analyzed at 3 and 6 months. Outcomes were compared between ustekinumab-exposed and ustekinumab-naïve patients.
RESULTS: Among 100 patients (36 ustekinumab-exposed), treatment persistence at 3 months was 72% with no significant difference between groups. SCCAI scores decreased from 5.8 to 3.3 at 3 months (P < .00001), and fecal calprotectin decreased from 1094 µg/g to 586 µg/g (p = 0.006). UCEIS scores (n = 36) improved significantly post-induction (mean 4.4 to 2.7, P < .000001). Multivariable logistic regression did not reveal any factors associated with treatment persistence, including prior ustekinumab exposure. Adverse events were infrequent and mild.
CONCLUSION: Mirikizumab is effective and well tolerated in a real-world UC population, including patients with prior ustekinumab exposure. These findings support the use of IL-23p19 inhibition regardless of previous IL-12/23 blockade.
METHODS: A retrospective observational study was conducted across 3 tertiary UK centers. Adults with confirmed UC who received mirikizumab and had ≥12 weeks of follow-up were included. Data on demographics, disease activity (SCCAI, UCEIS), biomarkers (CRP, fecal calprotectin), and treatment persistence were analyzed at 3 and 6 months. Outcomes were compared between ustekinumab-exposed and ustekinumab-naïve patients.
RESULTS: Among 100 patients (36 ustekinumab-exposed), treatment persistence at 3 months was 72% with no significant difference between groups. SCCAI scores decreased from 5.8 to 3.3 at 3 months (P < .00001), and fecal calprotectin decreased from 1094 µg/g to 586 µg/g (p = 0.006). UCEIS scores (n = 36) improved significantly post-induction (mean 4.4 to 2.7, P < .000001). Multivariable logistic regression did not reveal any factors associated with treatment persistence, including prior ustekinumab exposure. Adverse events were infrequent and mild.
CONCLUSION: Mirikizumab is effective and well tolerated in a real-world UC population, including patients with prior ustekinumab exposure. These findings support the use of IL-23p19 inhibition regardless of previous IL-12/23 blockade.