Eli Lilly and Company has reported new three-year data showing that Omvoh (mirikizumab-mrkz) maintained durable efficacy in adults with moderately to severely active Crohn's disease in a Phase 3 open-label extension study. The VIVID-2 extension included patients who had achieved an endoscopic response after one year of treatment with Omvoh in the VIVID-1 trial and continued on therapy.
At 152 weeks, more than 90% of these patients remained in clinical remission and corticosteroid-free clinical remission, based on the Crohn's Disease Activity Index (CDAI). Specifically, 92.4% were in clinical remission and 91.2% were in corticosteroid-free clinical remission among those who had achieved these outcomes at Week 52 and continued treatment. In addition, 82.1% achieved at least a three‑point reduction on the 0–10 Urgency Numeric Rating Scale, and 71.7% had bowel urgency scores of 2 or less among those with higher baseline urgency.
Lilly reported that inflammatory biomarkers, including C‑reactive protein and fecal calprotectin, continued to improve through three years, and the long-term safety profile was consistent with the known safety of Omvoh. Common adverse events (≥5%) between years one and three included COVID‑19, nasopharyngitis and upper respiratory tract infection. Across the VIVID-1 and LUCENT-3 programs, Omvoh-treated patients showed low rates of disease-related hospitalizations and surgeries in both Crohn’s disease and ulcerative colitis. Omvoh is an interleukin-23p19 antagonist approved for moderately to severely active ulcerative colitis and Crohn’s disease in adults in 47 countries
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