Mirikizumab Shows Superior Histologic Response in Crohn’s Disease Compared to Ustekinumab

Superior Histologic Response:
The VIVID-1 trial demonstrated that more patients with moderately to severely active Crohn's disease treated with mirikizumab achieved histologic response at Week 52 compared to those treated with ustekinumab, regardless of prior biologic treatment history.

First Phase 3 Study:
VIVID-1 is the first Phase 3 study in Crohn's disease to report both histologic and combined histologic-endoscopic outcomes, evaluated using a systematic assessment of five bowel segments in accordance with the European Crohn's and Colitis Organization (ECCO) position statement on mucosal histopathology.

Mechanism of Action:
Mirikizumab functions as an IL23p19 antagonist, specifically targeting the p19 subunit of IL-23 and blocking its interaction with the IL-23 receptor, which is a significant factor in the development of Crohn's disease.

Safety Profile:
The safety profile of mirikizumab in Crohn's disease was consistent with its known safety profile in patients with ulcerative colitis (UC), with a higher incidence of serious adverse events in the placebo group compared to those receiving mirikizumab.

Regulatory Submissions:
Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease in various regions, including the U.S., Europe, Japan, and China, with additional global regulatory submissions anticipated.

Current Approval:
Mirikizumab is already approved for treating moderately to severely active UC in adults, marketed as Omvoh, and ongoing trials include studies in pediatric patients and evaluations of long-term efficacy and safety in adults.