VIVID-1 trial: More than half of mirikizumab users achieve clinical remission in Crohn’s
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Key takeaways:
- Of patients treated with mirikizumab, 54.1% achieved clinical remission at 52 weeks.
- Common adverse events were COVID-19, anemia, arthralgia, headache and upper respiratory tract infection.
Topline findings from the phase 3 VIVID-1 trial showed Eli Lilly’s mirikizumab, an interleukin-23p19 antagonist, demonstrated clinical remission and endoscopic response through 52 weeks in adults with moderate to severe Crohn’s disease.
According to a company press release, this was the first double-blind placebo and active controlled trial assessing an IL-23p19 antibody.
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“I’m excited by these results, which showed more than half of patients on mirikizumab achieved clinical remission as measured by [Crohn’s Disease Activity Index] at one year,” Lotus Mallbris, MD, PhD, senior vice president of immunology development at Lilly, said in the release. “Furthermore, mirikizumab demonstrated robust efficacy across subgroups and particularly in patients for whom prior biologic therapy had failed.”
The trial evaluated the safety and efficacy of mirikizumab in adults with moderately to severely active CD, who were randomly assigned to mirikizumab, placebo or the active control, ustekinumab. Following the 12-week induction period, patients in the active treatment arms continued therapy into the study’s maintenance phase up to 52 weeks.
The primary endpoints were the proportion of patients achieving clinical response at week 12 by patient reported outcomes (PRO) and clinical remission, defined as Crohn’s Disease Activity Index score less than 150, at week 52; and the proportion of patients who achieved clinical response by PRO at week 12 and endoscopic response, defined as greater than 50% reduction in Simple Endoscopic Score-Crohn’s disease, at week 52.
According to the release, a statistically higher proportion of patients treated with mirikizumab achieved clinical response at week 12 and clinical remission at week 52 compared with placebo (45.4% vs. 19.6%, P < .000001), as well as clinical response at week 12 and endoscopic response at week 52 (38% vs. 9%, P < .000001).
Further, 54.1% of participants in the mirikizumab arm achieved clinical remission at week 52 compared with 19.6% on placebo.
Lilly also reported that mirikizumab showed non-inferiority compared with ustekinumab in achieving clinical remission, but it was not superior in achieving endoscopic response at week 52.
The overall safety of mirikizumab was consistent with its known safety profile, the release stated, with the most common treatment-emergent adverse events including COVID-19, anemia, arthralgia, headache and upper respiratory tract infection. Other adverse events included infections, injection-site reactions, hypersensitivity, liver enzyme elevations, depression and suicidal thoughts. No major adverse cardiac events were reported in those treated with mirikizumab.
Based on these results, the company in 2024 plans to submit a marketing application to the FDA, as well as submissions to other global regulatory agencies, for mirikizumab in Crohn’s disease.
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