‘Compelling data’ from VIVID-1 study support use of mirikizumab in Crohn’s disease

June 04, 2024

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Key takeaways:

  • Mirikizumab demonstrated noninferiority to ustekinumab in clinical remission at week 52.
  • Mirikizumab also showed a “numerically greater” rate of endoscopic response, especially in patients with biologic failure.

WASHINGTON — In this video, Mark Genovese, MD, discusses results of the VIVID-1 study, in which mirikizumab demonstrated noninferiority to ustekinumab for week 52 clinical remission among patients with moderate to severe Crohn’s disease.

“This study enabled us to demonstrate that, after 1 year of treatment, more than half of patients with moderately to severely active Crohn’s disease treated with mirikizumab achieved clinical remission and nearly one-half achieved an endoscopic response,” Genovese, senior vice president of immunology and clinical development at Lilly, said. “The majority of those patients achieved either one or more of these endpoints.”

Mark Genovese

In the phase 3, double-blind, double-dummy treat-through study, in which mirikizumab outperformed placebo, researchers investigated the efficacy of mirikizumab (Omvoh, Lilly) vs. ustekinumab (Stelara, Janssen) for the secondary endpoints of Crohn’s Disease Activity Index (CDAI) clinical remission and endoscopic response, among others, at week 52.

Researchers randomly assigned patients aged 18 to 80 years with moderately to severely active CD to mirikizumab (n = 579), ustekinumab (n = 287) or placebo (n = 199), and all participants underwent blinded induction and maintenance dosing. Baseline characteristics were generally balanced between groups, and all participants could have experienced inadequate response, loss of response or intolerance to treatment with corticosteroids, immunomodulators or approved biologics.

According to results, mirikizumab demonstrated noninferiority to ustekinumab in CDAI clinical remission at week 52 (54.1% vs. 48.4%; P < .0001).

Although the difference in endoscopic response at week 52 was not statistically different between mirikizumab and ustekinumab (48.4% vs. 46.3%; P = .51), Genovese noted that mirikizumab showed a “numerically greater” rate for this endpoint, particularly among patients with previous biologic failure.

Mirikizumab also showed “nominally statistically greater rates” compared with ustekinumab in combined CDAI clinical remission and endoscopic response at week 52, he added.

The safety profile was consistent with prior findings, researchers reported.

“Overall, this provides us with what we believe is compelling data to support the use of mirikizumab’s registration for the treatment of Crohn’s disease,” Genovese said.

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