Mirikizumab Long-Term Efficacy and Safety in Patients With Crohn's Disease: Results From the VIVID-2 Open-Label Extension Trial.

In 30 seconds

This interim analysis of the VIVID-2 open-label extension followed patients with moderately to severely active Crohn’s disease who had received mirikizumab in the VIVID-1 randomized trial and continued treatment for up to 104 weeks. Among 430 patients in the efficacy population, 60.5% achieved endoscopic response at week 104 using modified nonresponder imputation; among week-52 endoscopic nonresponders who underwent reinduction, 30.9% achieved endoscopic response at week 104. During the second treatment year, 7.7% experienced serious adverse events. The findings indicate sustained clinical and endoscopic improvements, with safety consistent with the known profile.

Key findings

• At week 104, endoscopic response was achieved by 60.5% (mNRI) and 67.1% (observed case); endoscopic remission by 37.9% and 41.7%.
• Among week-52 endoscopic responders who had achieved the endpoint, 81.8% (mNRI) and 87.6% (observed case) maintained endoscopic response at week 104.
• Among week-52 endoscopic nonresponders, 30.9% (mNRI) and 36.1% (observed case) achieved endoscopic response at week 104 after reinduction.
• During the second treatment year, 64.7% experienced treatment-emergent adverse events and 7.7% had serious adverse events.

Why it matters

Crohn’s disease may require sustained therapy, and these extension results provide evidence about outcomes beyond the first year of mirikizumab treatment. The reported maintenance of response among prior responders and improvement in a subset of initial endoscopic nonresponders are clinically informative, while the adverse-event findings help characterize longer-term treatment experience.

What to keep in mind

This was an interim analysis of an open-label extension, not a controlled comparison of treatment over the second year. The efficacy population included patients who rolled over from VIVID-1 and met extension eligibility criteria.