Eli Lilly and Company announced positive results from their phase 3 VIVID-1 study for mirikizumab in patients with moderately to severely active Crohn’s disease. The study showed statistically significant and clinically meaningful improvements across multiple clinical and endoscopic endpoints at one year compared with placebo, with 54.1% achieving clinical remission and 48.4% achieving endoscopic response. These results highlight mirikizumab’s potential impact on this challenging condition.
The VIVID-1 trial also found mirikizumab superior to ustekinumab in achieving clinical remission and decreasing key inflammation biomarkers, though not in endoscopic response. The safety profile of mirikizumab was consistent with its known profile in ulcerative colitis. Eli Lilly has submitted regulatory applications for mirikizumab in Crohn’s disease to the FDA and EMA, with further global submissions planned. The company remains committed to advancing treatments for inflammatory bowel diseases, with ongoing studies evaluating mirikizumab’s efficacy and safety in other Crohn’s disease populations and in ulcerative colitis.
Reference: Eli Lilly and Company. More than one-half of patients with Crohn’s disease treated with Lilly’s mirikizumab achieved clinical remission at one year, including patients with previous biologic failure. Lilly. Published May 21, 2024. Accessed July 31, 2024. https://investor.lilly.com/news-releases/news-release-details/more-one-half-patients-crohns-disease-treated-lillys-mirikizumab
