Already Approved for UC, Mirikizumab Shows Promise for Moderate to Severe Crohn's Disease

Already approved for ulcerative colitis, the monoclonal antibody mirikizumab met study endpoints for Crohn's disease response and remission.

compared with placebo up to 52 weeks, according to results of the phase 3 randomized, double blind, treat-through VIVID-1 study.

Sands and a team of US and international collaborators studied 1065 adults with Crohn's disease or fistulizing Crohn's disease for 3 months or more, with a mean duration of more than 7 years. At baseline, participants had a Simple Endoscopic Score for Crohn's Disease of 7 or more and reported an inadequate response, lost response, or intolerance to other therapy.Mean age of study participants was 30 years, and men comprised 57%-59% of the groups.

Researchers also tracked 12 major secondary endpoints for mirikizumab vs placebo, including clinical response, endoscopic response, and clinical remission at week 12 and week 52. A higher percentage of participants in the mirikizumab group achieved 12-week secondary endpoints compared with placebo. In the treatment group, 32.5% reached endoscopic response vs 12.6% in the placebo group, a statistically significant difference . In addition, 17.

Treatment-emergent adverse events occurred in 78.6% of mirikizumab participants vs 73.0% of the placebo group. The most common were COVID-19,, and arthralgia. Serious adverse events were reported in 10.3% of the mirikizumab group vs 17.1% of the placebo group. There were seven opportunistic infections in the treatment group, includingPeople randomly assigned to placebo without a response at 12 weeks were switched over to mirikizumab.

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Crohn Disease Regional Enteritis Crohn Crohn’S Remission Biologic Therapy Biologics Colitis Monoclonal Antibody Cetuximab Rituximab New York Ulcerative Colitis Ulcerative Colitis (UC) UC - Ulcerative Colitis Inflammatory Bowel Disease IBD - Inflammatory Bowel Disease IBD Anemia Anaemia Arthralgia Painful Joint Joint Pain Candida Embolism

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