Mirikizumab Tops Placebo for Moderately-to-Severely Active Ulcerative Colitis
Medically reviewed by Drugs.com.
By Elana Gotkine HealthDay Reporter
FRIDAY, July 7, 2023 -- For patients with moderately-to-severely active ulcerative colitis, mirikizumab is more effective than placebo for inducing and maintaining clinical remission, according to a study published in the June 29 issue of the New England Journal of Medicine.
Geert D'Haens, M.D., Ph.D., from Amsterdam University Medical Centers, and colleagues conducted two phase 3 randomized, placebo-controlled trials involving adults with moderately-to-severely active ulcerative colitis. A total of 1,281 patients were randomly assigned in a 3:1 ratio to receive mirikizumab (300 mg) or placebo every four weeks for 12 weeks in the induction trial. In the maintenance trial, 544 patients with a response to mirikizumab induction were randomly assigned to receive mirikizumab (200 mg) or placebo in a 2:1 ratio every four weeks for 40 weeks.
The researchers found that at week 12 of the induction trial, a significantly higher percentage of patients in the mirikizumab versus placebo group had clinical remission (24.2 versus 13.3 percent); similar findings were seen at week 40 of the maintenance trial (49.9 versus 25.1 percent). In both trials, the criteria for all major secondary end points were met. Adverse events of nasopharyngitis and arthralgia occurred more often with mirikizumab than placebo. Fifteen of the 1,217 patients treated with mirikizumab during the controlled and uncontrolled periods in the two trials had an opportunistic infection.
"In these two phase 3 trials, we found that, over periods of 12 weeks and 24 weeks, mirikizumab therapy had efficacy in both induction and maintenance phases across clinical, symptomatic, endoscopic, and histologic measures of disease," the authors write.
The study was funded by Eli Lilly, which manufactures mirikizumab.
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Posted July 2023
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