Objective: To evaluate the effectiveness and safety of mirikizumab in patients with ulcerative colitis in clinical practice. Methods: We conducted a retrospective, multicenter cohort study across five Italian inflammatory bowel disease centers. Patients initiating mirikizumab between November 2024 and May 2025 were included. The primary endpoint was steroid-free clinical remission (SFCR) at 12 weeks, defined as the absence of rectal bleeding and near-normal stool frequency without corticosteroids. Secondary outcomes included clinical response (≥30% improvement in stool frequency and rectal bleeding), biochemical response (normalisation of fecal calprotectin (FCP) and C-reactive protein (CRP)), and safety (any adverse events). Follow-up at 24 weeks was assessed when available. Subgroup analyses were performed according to prior exposure to biologics (including ustekinumab) and induction regimen. Results: A total of 95 patients were included (mean age 49.9±16.9 years; 50.5% male); 12.6% were biologic naïve and 17 (17.9%) received extended induction. At week 12, 43.2% of patients (41/95) achieved SFCR, 61.1% (58/95) clinical response, and 32/95 (33.7%) biochemical remission. SFCR rates were similar between biologic-naïve and biologic-experienced patients (42.6% vs 43.8%, p=0.906). SFCR rates were 36.2% and 88.2% in patients receiving extended and standard induction, respectively (p=0.002). At week 24, prior ustekinumab exposure was associated with numerically lower SFCR, although this difference was not statistically significant (38.5% vs 73.7%; OR=0.22, 95% CI 0.05 to 1.01, p=0.052). Changes in biomarkers were not statistically significant at week 12 (CRP Δ−0.08 mg/dL, p=0.464; FCP Δ−249 µg/g, p=0.127). Three patients discontinued treatment due to lack of efficacy. No adverse events were observed. Conclusion: Mirikizumab demonstrated meaningful clinical effectiveness and a favourable safety profile in a real-world setting, including in biologic-experienced patients.
Murgiano, M., Balestrieri, P., Calabrese, E., Fiorino, G., Festa, S., Pugliese, D., Di Vincenzo, F., Puca, P., Parello, S., Vespasiano, V., Colella, A., Marafini, I., Profeta, F., Foscarini, E., Papa, A., Lopetuso, L. R., Monteleone, G., Cicala, M., Gasbarrini, A., Laterza, L., Scaldaferri, F., Effectiveness and safety of mirikizumab in ulcerative colitis: real-world data from the Latium Net, <<BMJ OPEN GASTROENTEROLOGY>>, N/A; 13 (1): N/A-N/A. [doi:10.1136/bmjgast-2025-002232] [https://hdl.handle.net/10807/346081]
Effectiveness and safety of mirikizumab in ulcerative colitis: real-world data from the Latium Net
Murgiano, Marco;Festa, Stefano;Pugliese, Daniela;Di Vincenzo, Federica;Puca, Pierluigi;Parello, Simone;Papa, Alfredo;Lopetuso, Loris Riccardo;Monteleone, Giovanni;Gasbarrini, Antonio;Laterza, Lucrezia;Scaldaferri, Franco
2026
Abstract
Objective: To evaluate the effectiveness and safety of mirikizumab in patients with ulcerative colitis in clinical practice. Methods: We conducted a retrospective, multicenter cohort study across five Italian inflammatory bowel disease centers. Patients initiating mirikizumab between November 2024 and May 2025 were included. The primary endpoint was steroid-free clinical remission (SFCR) at 12 weeks, defined as the absence of rectal bleeding and near-normal stool frequency without corticosteroids. Secondary outcomes included clinical response (≥30% improvement in stool frequency and rectal bleeding), biochemical response (normalisation of fecal calprotectin (FCP) and C-reactive protein (CRP)), and safety (any adverse events). Follow-up at 24 weeks was assessed when available. Subgroup analyses were performed according to prior exposure to biologics (including ustekinumab) and induction regimen. Results: A total of 95 patients were included (mean age 49.9±16.9 years; 50.5% male); 12.6% were biologic naïve and 17 (17.9%) received extended induction. At week 12, 43.2% of patients (41/95) achieved SFCR, 61.1% (58/95) clinical response, and 32/95 (33.7%) biochemical remission. SFCR rates were similar between biologic-naïve and biologic-experienced patients (42.6% vs 43.8%, p=0.906). SFCR rates were 36.2% and 88.2% in patients receiving extended and standard induction, respectively (p=0.002). At week 24, prior ustekinumab exposure was associated with numerically lower SFCR, although this difference was not statistically significant (38.5% vs 73.7%; OR=0.22, 95% CI 0.05 to 1.01, p=0.052). Changes in biomarkers were not statistically significant at week 12 (CRP Δ−0.08 mg/dL, p=0.464; FCP Δ−249 µg/g, p=0.127). Three patients discontinued treatment due to lack of efficacy. No adverse events were observed. Conclusion: Mirikizumab demonstrated meaningful clinical effectiveness and a favourable safety profile in a real-world setting, including in biologic-experienced patients.
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