VIVID-2: Mirikizumab (Omvoh) Shows Long-Term Efficacy for Crohn’s Disease

Eli Lilly and Company has announced results from the VIVID-2 open-label extension study of mirikizumab-mrkz (Omvoh) in patients with moderately to severely active Crohn's disease (CD).1

According to a February 7, 2025, press release from the company, the majority of patients receiving 2 years of continuous treatment with mirikizumab achieved long-term clinical and endoscopic outcomes, including those with previous biologic failure. Data from the study will be presented at the Crohn's and Colitis Congress, being held from February 6-8, 2025, in San Francisco, CA.1

"Many people living with Crohn's disease have tried available therapies without success or have experienced a loss of efficacy with their treatment," said Edward Barnes, MD, MPH, associate professor of medicine in the division of gastroenterology and hepatology and co-director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of North Carolina at Chapel Hill.1 "These positive, multi-year data can give health care providers confidence that Omvoh may help their patients achieve and maintain long-term outcomes, including intestinal healing."

Building upon its previous US Food and Drug Administration approval for ulcerative colitis (UC), the interleukin-23p19 antagonist recently earned an additional indication for the treatment of CD based on positive results from the phase 3 VIVID-1 study in adults who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologics. Of note, mirikizumab is the first and only IL-23p19 antagonist to demonstrate long-term, multi-year, sustained efficacy and safety for both CD and ulcerative colitis.1,2

In the randomized, double-blind, placebo-controlled 52-week study, patients received mirikizumab 900 mg by intravenous infusion at weeks 0, 4, and 8 followed by a maintenance dose of 300 mg by subcutaneous injection at week 12 and then every 4 weeks for 40 weeks. Patients randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks were subsequently switched to mirikizumab treatment.2

Participants who were randomized to mirikizumab in VIVID-1 and who achieved endoscopic response after 1 year of treatment continued mirikizumab maintenance treatment in VIVID-2.1

VIVID-2 findings announced by Lilly showed 92.9% of patients who were in clinical remission at 1 year in VIVID-1 maintained clinical remission at 2 years as measured by Crohn's Disease Activity Index (CDAI). Additionally, among patients treated in VIVID-2, 87.6% maintained endoscopic response, defined by visible healing of the intestinal lining and measured by a ≥50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score.1

Among patients who were in endoscopic remission at 1 year of treatment in VIVID-1, 78.6% maintained endoscopic remission at 2 years as measured by SES-CD ≤4 and ≥2-point reduction from baseline, with no subscore >1 in any individual variable.1

Additionally, results showed 60.8% of patients who were not in clinical remission by CDAI at 1 year gained clinical remission during the second year of treatment. For those who were not in endoscopic remission at 1 year, 35.4% gained endoscopic remission during the second year of treatment.1

According to the release, the long-term safety profile of mirikizumab in patients with CD was generally consistent with mirikizumab’s known safety profile. During the second year of continuous treatment, 6.8% of patients with endoscopic response at 1 year reported a serious adverse event and 0.8% discontinued treatment due to an adverse event.

"Lilly is setting a high bar for sustained and durable treatment response for patients living with the profound impact of inflammatory bowel disease," said Mark Genovese, MD, senior vice president of Lilly Immunology development.1 "These results build on the body of evidence that demonstrates Omvoh's ability to provide early meaningful improvement and long-term disease control with strong clinical, endoscopic and histologic outcomes."

References

1. Lilly. Most patients on Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease achieved sustained clinical remission and endoscopic response at two years. February 7, 2025. Accessed February 7, 2025. https://investor.lilly.com/news-releases/news-release-details/most-patients-lillys-omvohr-mirikizumab-mrkz-crohns-disease
2. Brooks A. FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease. HCPLive. January 15, 2025. Accessed February 7, 2025. https://www.hcplive.com/view/fda-approves-mirikizumab-omvoh-for-crohn-disease