Long-Term VIVID-2 Data for Mirikizumab in Crohn’s Disease, with Edward Barnes, MD, MPH

Findings from the VIVID-2 open-label extension study of mirikizumab-mrkz (Omvoh) in patients with moderately to severely active Crohn's disease (CD) are highlighting the IL-23p19 antagonist’s impact on long-term clinical and endoscopic outcomes.1

The data come just weeks after the US Food and Drug Administration (FDA) approved mirikizumab for the treatment of CD, building upon its previous indication for ulcerative colitis (UC). The decision for its use in CD is 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.1,2

Historically, patients with CD have had limited treatment options, starting with the 1998 FDA approval of the first anti-tumor necrosis factor (TNF) therapy, infliximab.

“We had sort of a revolutionary era in 1998 when we saw the introduction of an anti-TNF therapy, but then we had this large period of time between 1998 and 2014 where we only had anti-TNF therapies,” Edward Barnes, MD, MPH, an 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, told HCPLive. “In the past couple of years, we’ve seen this explosion of different mechanisms of action.”

However, Barnes called attention to the “therapeutic ceiling” that still exists for CD and the ongoing need to treat patients earlier, more effectively, and with the right mechanism of action. He noted having mirikizumab as an option for patients “changes the landscape” by providing clinicians with another potential first-line treatment option beyond anti-TNFs, allowing them to stratify patients based on which therapy may be a better fit for them.

New data from the VIVID-2 open-label extension study build upon findings from VIVID-1 used to support mirikizumab’s approval in CD. In the trial, 92.9% of patients who were in clinical remission at 1 year in VIVID-1 maintained clinical remission at 2 years.1

Among patients treated in VIVID-2, 87.6% maintained endoscopic response. Among patients who were in endoscopic remission at 1 year of treatment in VIVID-1, 78.6% maintained endoscopic remission at 2 years.1

Results also 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

“For any decision that we make [for patients], it's going to be really important to know that drug is effective, safe, and it's going to work to treat their disease,” Barnes said. “That's why I think having mirikizumab approved and having some of the results that we're here talking about at Crohn’s and Colitis Congress is really exciting.”

Editors’ note: Barnes has relevant disclosures with AbbVie, Bristol-Meyers Squibb, Lilly, and Target RWE.

References

1. Brooks A. VIVID-2: Mirikizumab (Omvoh) Shows Long-Term Efficacy for Crohn’s Disease. HCPLive. February 7, 2025. Accessed February 10, 2025. https://www.hcplive.com/view/vivid-2-mirikizumab-omvoh-shows-long-term-efficacy-crohn-disease

2. Brooks A. FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease. HCPLive. January 15, 2025. Accessed February 10, 2025. https://www.hcplive.com/view/fda-approves-mirikizumab-omvoh-for-crohn-disease