Eli Lilly’s Mirikizumab Shows Promise in Crohn’s Disease: Phase 3 Data Highlights Histologic Response
Eli Lilly and Company (LLY) has announced positive results from its VIVID-1 Phase 3 study evaluating the safety and efficacy of mirikizumab in treating adults with moderately to severely active Crohn’s disease. The study compared mirikizumab to both a placebo and the active control, Johnson & Johnson’s (JNJ) Stelara (ustekinumab).
The data revealed a significant advantage for mirikizumab in achieving histologic response at Week 52 across the study population. Notably, 58.2% of patients treated with mirikizumab reached this endpoint compared to 48.8% in the placebo group (p=0.0075). These findings were even more pronounced in patients with active histologic disease at baseline and at least one prior biologic failure. In this subgroup, mirikizumab demonstrated a 56.5% histologic response rate versus 41.3% for the placebo at Week 52 (p=0.0064). Furthermore, mirikizumab showed a superior endoscopic-histologic response at Week 52, with 39.6% of patients achieving this compared to 27.8% in the Stelara group (p=0.024).
The safety profile of mirikizumab in patients with Crohn’s disease aligned with its known safety profile in patients with ulcerative colitis (UC). While serious adverse events were more frequent in the placebo group, the most common adverse events across all treatment groups were COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis, and injection site reactions.
“As the first company to report rigorous histologic and endo-histologic outcomes in Crohn’s disease that align with a recent ECCO position statement, Lilly is setting a higher bar for the evaluation of long-term treatment response in inflammatory bowel disease,” stated Mark Genovese, senior vice president of Lilly Immunology development. “This includes more ambitious targets of mucosal healing, which we applied to compare mirikizumab’s histo-endoscopic effect to ustekinumab.”
Mirikizumab, marketed as Omvoh, is already approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Lilly is currently conducting additional trials with mirikizumab for UC, including a study involving pediatric patients and another evaluating the long-term efficacy and safety of the drug in adults.
These promising results suggest that mirikizumab could become a valuable new treatment option for patients with Crohn’s disease. With its demonstrated efficacy in achieving histologic response and a favorable safety profile, mirikizumab offers hope for improved long-term management of this debilitating disease.
