| Title: |
MIRACLE-UC: Mirikizumab Investigation of Real-world Assessment of Clinical and Long-term Effectiveness and Adverse Events in Patients with Ulcerative Colitis - A Multicenter Prospective Study from the Italian Group for the Study of Inflammatory Bowel Diseases (IG-IBD). |
| Authors: |
Barberio, B.1; Todeschini, A.2; Laterza, L.3; Viola, A.4; Bezzio, C.5; Mendolaro, M.6; Caprioli, F.7; Saibeni, S.8; Gerardi, V.9; Marafini, I.10; Ribaldone, D. G.11; M Onico, M. C.12; Viganò, C.13; Cappello, M.14; Dragoni, G.15; Gravina, A. G.16; Miranda, A.17; Mocci, G.18; Felice, C.19; Principi, M. B.20 |
| Source: |
Journal of Crohn's & Colitis. 2026 Supplement, Vol. 20, pi1625-i1628. 4p. |
| Abstract: |
Background: Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease. Mirikizumab has demonstrated efficacy in clinical trials, but real-world, long-term multicenter data remain limited. MIRACLE-UC, a prospective study promoted by the Italian Group for the Study of Inflammatory Bowel Diseases (IG-IBD), evaluated real-world effectiveness and safety of mirikizumab in clinical practice. Methods: This is a preliminary analysis from a prospective, multicenter observational study, enrolling adult patients with active UC treated with mirikizumab across several Italian referral centers. Consecutive patients were included with systematic collection of clinical and endoscopic data. Effectiveness endpoints were assessed at baseline, 3, and 6 months; 12-month follow-up data collection is still ongoing. The outcomes analyzed include clinical response (a reduction of at least 2 points in the partial Mayo score and improvement in rectal bleeding), clinical remission (partial Mayo ≤2, no subscore >1, no rectal bleeding), endoscopic improvement (MES ≤1) and remission (MES=0), steroid-free status, and changes in biomarkers (CRP and fecal calprotectin). Dropouts were counted as non-responders from discontinuation onward, and missing data excluded. Analyses were performed using R software. Results: A total of 407 patients were included. Previous biologic use was recorded in 83.8% (Table 1). Clinical response rates were 55.6% at 3 months and 69.4% at 6 months (p < 0.001). Clinical remission was achieved in 41.2% and 55.5% respectively (p < 0.001). Steroid-free clinical response occurred in 52.1% and 63.9%, and steroid-free clinical remission in 32.4% and 53.1% of patients at 3 and 6 months, respectively (all p < 0.001). Endoscopic improvement was achieved in 49.3% of patients at 6 months (p < 0.001); endoscopic remission was reached by 42.1% at 6 months (p < 0.001). Mean levels of fecal calprotectin decreased over time from 1731 (±3051) ug/g at baseline to 718 (±1649) ug/g at 6 months (p < 0.001), while CRP levels decreased from 69.5 (±162.0) at baseline to 42.7 (±91.1) mg/L at 6 months p < 0.001). Mirikizumab was discontinued in 4.9% by month 6 due to inefficacy or adverse events (n = 3/407). Conclusion: In this large multicenter real-world cohort, mirikizumab was associated with substantial rates of clinical, steroid-free, and endoscopic remission in patients with refractory UC. Improvements in fecal calprotectin levels supported clinical and endoscopic outcomes. These results confirm the effectiveness and safety of mirikizumab in clinical practice and support its use as part of a treat-to-target strategy for UC. [ABSTRACT FROM AUTHOR] |
| Database: |
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