Photo Credit: Lars Neumann
Mirikizumab met its primary endpoints in the phase 3 VIVID-1 study, testing this agent among patients with moderate to severe Crohn’s disease.
Mirikizumab met its primary endpoints in a phase 3 trial, testing this agent among patients with moderate to severe Crohn’s disease (CD). The response rates were comparable between patients who had failed prior biologic therapy and those who had not.
The multicenter, double-blind, placebo- and active-controlled phase 3 VIVID-1 study randomized 1,150 adult patients with moderate to severe CD 6:3:2 to mirikizumab, ustekinumab, or a placebo. In the mirikizumab arm, participants received 900 mg of this agent every 4 weeks via intravenous administration during the induction phase and 300 mg every 4 weeks via subcutaneous administration during the maintenance phase. Furthermore, in the placebo arm, participants were rerandomized to mirikizumab or placebo after 12 weeks of therapy. Marc Ferrante, MD, PhD, presented the first results of the coprimary endpoints, including:
- clinical response at week 12 plus endoscopic response at week 52, and
- clinical response at week 12 plus clinical remission at week 52.1
The first coprimary endpoint was met by 38.0% of the participants in the mirikizumab arm and by 9.0% of the participants in the placebo arm (Δ28.7; 95% CI 20.6–36.8; P<0.001), with consistent results among bio-naïve and bio-experienced patients. Next, 45.4% of the mirikizumab receivers and 19.6% of the placebo receivers achieved the second co-primary endpoint (Δ25.8; 95% CI 15.9–35.6; P<0.001). These results were confirmed by more stringent secondary efficacy endpoints. Finally, the safety profile of mirikizumab was consistent with the known favorable safety profile of this agent among patients with ulcerative colitis.
“Mirikizumab demonstrated significant and clinically meaningful improvements in primary and secondary efficacy endpoints compared with placebo in this population of patients with CD, with an acceptable safety profile,” concluded Dr. Ferrante.
Medical writing support was provided by Robert van den Heuvel.
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