Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• In the induction trial at Week 12, mirikizumab demonstrated a clinical remission rate of 24.2% compared to 13.3% for placebo, with statistical significance (P<0.001) indicating a significant advantage for mirikizumab.
• In the maintenance trial at Week 40, mirikizumab achieved a clinical remission rate of 49.9%, significantly higher than the 25.1% observed in the placebo group (P<0.001), confirming its effectiveness over a longer duration.
• Mirikizumab met major secondary endpoints, including clinical response, endoscopic remission, and improvement in bowel-movement urgency, highlighting its comprehensive effectiveness in treating moderately to severely active ulcerative colitis.
• Common adverse events associated with mirikizumab included nasopharyngitis and arthralgia, both reported more frequently than in the placebo group.
• Serious adverse events included 15 cases of opportunistic infections (6 being herpes zoster) and 8 cases of cancer (including 3 colorectal cancers) in the mirikizumab group, while no serious infections or cancers were reported in the placebo group.
• The studies focused on adults with moderately to severely active ulcerative colitis, but did not provide further breakdown by age, gender, or other comorbid conditions, nor did they highlight specific findings for subgroups within this population.