VIVID-2: Omvoh demonstrates ‘continued durability,’ safety in Crohn’s disease at 2 years
Key takeaways:
- More than 80% of Omvoh responders from the VIVID-1 study maintained endoscopic response at week 104 in VIVID-2.
- Endoscopic and clinical remission were maintained by 72.5% and 86.9%, respectively.
SAN FRANCISCO — Most patients with moderately to severely active Crohn’s disease who achieved endoscopic response and remission after 52 weeks of Omvoh therapy maintained those results through 104 weeks, according to VIVID-2 study results.
“The durability of response and remission among patients who were in endoscopic response at week 52 of the initial study is a critical result in my opinion,” Edward L. Barnes, MD, MPH, associate professor of medicine in the division of gastroenterology and hepatology and co-director of the Multidisciplinary IBD Center at UNC School of Medicine, told Healio. “To see endoscopic response maintained at over 80% for another 52 weeks, and clinical remission maintained at over 85% of patients in clinical remission at week 104, is key in understanding the durability of this therapy.”
In the phase 3 VIVID-1 study, patients with moderately to severely active CD who were randomly assigned to Omvoh (mirikizumab-mrkz, Lilly) received 900 mg IV induction at 0, 4 and 8 weeks, then 300 mg subcutaneously every 4 weeks. Patients who achieved endoscopic response by week 52, defined as at least a 50% reduction from baseline in Simple Endoscopic Score for CD (SES-CD), continued subcutaneous mirikizumab 300 mg in the ongoing, open-label VIVID-2 extension study.
VIVID-2 outcomes at 104 weeks included endoscopic response; endoscopic remission, defined as an SES-CD of 4 or less with a reduction of at least two points from baseline; and clinical remission, defined as a CD Activity Index score of less than 150. The researchers also assessed safety from the first dose in VIVID-2 through Aug. 2, 2024.
Using a modified nonresponder imputation approach, the researchers found that 81.8% of patients who had achieved endoscopic response at week 52 maintained it through week 104, with 54.9% achieving endoscopic remission and 79% achieving clinical remission. Of those who were in endoscopic remission at week 52, 72.5% maintained remission.
“Another key takeaway is that among patients who were not in endoscopic remission at week 52, one-third went on to achieve endoscopic remission by week 104,” Barnes, who presented the results at Crohn’s & Colitis Congress, said.
In addition, clinical remission was maintained by 86.9% of patients at week 104, and among those not in clinical remission at week 52, 55.8% achieved clinical remission at week 104.
Similar results were observed between patients with and without prior biologic failure, the researchers noted.
Overall, 3.4% of patients experienced severe treatment-emergent adverse events, and 6.8% experienced serious adverse events. Due to adverse events, 0.8% of patients discontinued treatment.
“The combination of durability of therapy without any new safety signals indicates the overall balance of efficacy and safety that we hope to achieve with our therapies for Crohn’s disease in the current era,” Barnes told Healio. “Especially when considering the breakdown of results among biologic naive and patients with prior biologic failure, this indicates the potential efficacy of mirikizumab in multiple settings among patients with Crohn’s disease and should also give those patients who have achieved initial response/remission with mirikizumab the confidence of continued durability of therapy.”
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Barnes EL, et al. Long-term efficacy and safety of mirikizumab following 104 weeks of continuous treatment for Crohn’s disease: Results from the VIVID-2 open-label extension study. Presented at: Crohn’s & Colitis Congress; Feb. 6-8, 2025; San Francisco.
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