Phase 3 findings from the VIVID-1 study on mirikizumab, a selective IL-23p19 monoclonal antibody, demonstrate its capability to induce clinical remission and endoscopic response in patients with moderately to severely active Crohn's disease, regardless of previous biologic failure. Presented at Digestive Disease Week (DDW) 2024 in Washington, DC, these results mark the first phase 3 treat-through data for an IL-23p19 antibody.
At 52 weeks, nearly half of the patients on mirikizumab achieved endoscopic response, with a significant portion also reaching clinical remission. Eli Lilly and Company reported that mirikizumab met both co-primary endpoints and all major secondary endpoints compared to placebo, with consistent response rates across different patient groups, including those with no prior biologic failure and those who had experienced previous biologic failure.
Clinical remission and endoscopic response rates at one year were 54.1% and 48.4%, respectively, for patients on mirikizumab. Notably, 56.7% of bio-naïve and 51.2% of bio-failed patients achieved clinical remission at week 52. When compared to ustekinumab, mirikizumab showed statistically significant greater rates in achieving combined week 52 clinical remission and endoscopic response (34.4% vs 27.9%).
The safety profile of mirikizumab was consistent with its known profile in ulcerative colitis patients, with the most common adverse events being COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis, and injection site reaction. Serious adverse events were more frequent in the placebo group than in the mirikizumab group.
Bruce Sands, MD, discussed the significance of these findings, emphasizing mirikizumab's effectiveness in both bio-naive and advanced therapy-experienced patients compared to placebo and its comparable efficacy to ustekinumab. Sands highlighted the drug's potential advantages in more refractory patients who had failed advanced therapies, suggesting its value in treating sicker, more experienced patients.
This study underscores mirikizumab's potential as a treatment option for Crohn's disease, reinforcing the effectiveness of anti-IL 23 therapies in managing this condition.
