Effectiveness and Safety of Mirikizumab in Patients With Moderate-to-severe Ulcerative Colitis: a Real-life Retrospective Multicenter Study
This study reports real-world data on mirikizumab in adults with ulcerative colitis, focusing on clinical and endoscopic remission and inflammatory markers — outcomes patients and clinicians use to judge treatment benefit and safety in routine care.
Adults with ulcerative colitis, clinicians treating UC, researchers studying biologics and real-world effectiveness, and patients on or considering mirikizumab.
What To Know
This ClinicalTrials.gov record describes a completed, retrospective multicenter observational study of mirikizumab for adults with moderate-to-severe ulcerative colitis, tracking effectiveness and safety through 52 weeks. The study’s primary outcome is clinical remission at 12 weeks, with endoscopic remission assessed at weeks 24 and 52.
Secondary measures include changes in urgency (Urgency NRS), fecal calprotectin, CRP, and imaging/biochemical parameters. Planned enrollment was 282 and the study was conducted at participating centers including IRCCS San Raffaele, Milan.
This is a real-world, retrospective registry study—not a randomized trial—so it reflects how mirikizumab was used in routine clinical practice and collects outcomes over time. It can provide useful information about effectiveness and safety outside of controlled trials, but it does not by itself prove comparative efficacy.
The record lists adult patients (≥18) with established UC treated with mirikizumab per usual care and excludes Crohn’s disease or other inflammatory GI conditions. Outcomes include clinical remission at 12 weeks and endoscopic remission at 24 and 52 weeks, plus laboratory markers (fecal calprotectin, CRP) and patient-reported urgency.
If you’re considering mirikizumab or following real-world data on biologics, this study’s findings (when available in full publications or aggregated reports) may be relevant. Talk with your clinician about how real-world registry data compare to randomized trial results for treatment decisions.
This is a retrospective observational study (registry) rather than a randomized controlled trial; such studies can show how a drug performs in routine practice but are subject to selection bias and confounding.
The ClinicalTrials.gov entry provides protocol and outcome definitions but not detailed results; look for peer-reviewed publications or registry reports for full findings.
