About The Trial
Trial Name: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)
ClinicalTrials.gov ID: NCT04232553
Sponsor: Eli Lilly and Company
Completion Date (Estimated): December 2026
Mirikizumab Demonstrates Sustained Clinical, Endoscopic Outcomes for Crohn Disease
Patients who achieved clinical remission at 1 year in VIVID-1 maintain clinical remission at 92.9% at 2 years with the Crohn Disease Activity Index.
In the VIVID-2 (NCT04232553) open-label extension study, mirikizumab-mrkz (Omvoh) showed long-term clinical and endoscopic outcomes for Crohn disease, including for 43.8% of those with previous biologic failure.1
Patients who achieved clinical remission at 1 year in VIVID-1 maintained clinical remission at 92.9% at 2 years with the Crohn Disease Activity Index. | Image Credit: Jo Panuwat D | stock.adobe.com
"Many people living with Crohn disease have tried available therapies without success or have experienced a loss of efficacy with their treatment," Edward Barnes, MD, MPH, associate professor of medicine in the division of gastroenterology & hepatology, at the University of North Carolina at Chapel Hill, said in a news release.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."
In the extension study, investigators aimed to determine the long-term efficacy and safety of the drug for those with Crohn disease. Investigators included patients who completed the 16T-MC-AMAG (NCT02891226) or 16T-MC-AMAM (NCT03926130) studies. Investigators randomized treatment as either mirikizumab subcutaneous or mirikizumab intravenous or subcutaneous. The primary outcomes included the percentage of patients that achieved endoscopic response and those who achieved clinical remission, according to the clinical trial information. Further, the secondary end points included change from baseline in C-reactive protein, change from baseline in fecal calprotectin, and change from baseline on the Inflammatory Bowel Disease Questionnaire.2
In the VIVID-1 (NCT03926130) study, investigators found that 38% of the 579 patients receiving mirikizumab achieved endoscopic response compared with 9% receiving the placebo. Approximately 45.4% of 579 patients achieved clinical remission compared with 19.6%, respectively. They also found that the overall incidence rates of adverse events and discontinuations for patients treated with mirikizumab were lower compared to the placebo.3
In the VIVID-2 analysis, patients who achieved clinical remission at 1 year in VIVID-1 maintained clinical remission at 92.9% at 2 years with the Crohn Disease Activity Index. Additionally, 87.6% of patients in VIVID-2 maintained endoscopic response, and among those who achieved endoscopic remission at 1 year in VIVID-1, 78.6% maintained the response at 2 years.1
For patients who were not in clinical remission or endoscopic remission at year 1, 60.8% gained clinical remission and 35.4% gained endoscopic remission during year 2. Furthermore, the long-term safety profile remained consistent with the known safety profile of the drug. During the second year, 6.8% of patients with endoscopic response at 1 year reported serious adverse events (AEs) and 0.8% discontinued treatment due to an AE. In VIVID-1, the most common AE was COVID-19, and serious AEs were experienced in 10.3% of 630 patients receiving mirikizumab, 10.7% of 309 receiving ustekinumab, and 17.1% of 211 receiving the placebo.1,3
The FDA approved mirikizumab for the treatment of moderately to severely active Crohn disease in adults in January 2025. It is the first and only IL-23p19 antagonist that showed long-term, sustained efficacy and safety for patients with Crohn disease and ulcerative colitis. The data were presented at the Crohn’s and Colitis Congress from February 6 to February 8, 2025, in San Francisco, California.1
REFERENCES
1. Most patients on Lilly's Omvoh (mirikizumab-mrkz) for Crohn's disease achieved sustained clinical remission and endoscopic response at two years. News release. Eli Lilly. 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. A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2). ClinicalTrials.gov identification: NCT04232553. Updated January 1, 2025. Accessed February 7, 2025. https://clinicaltrials.gov/study/NCT04232553
3. Ferrante M, D'Haens G, Jairath V, et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. doi:10.1016/S0140-6736(24)01762-8
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