Bruce E. Sands, Edward L. Barnes, Geert D’Haens, Tadakazu Hisamatsu, Miguel Regueiro, Colleen R. Kelly, David Laharie, Rebecca R. Hozak, Guanglei Yu, Arul Gandhi R, Michelle U. Lopes, Frédérick Durand, Marijana Protić, Richard E. Moses, Severine Vermeire
BACKGROUND & AIMS: Mirikizumab, an anti-interleukin-23p19 monoclonal antibody, demonstrated efficacy and safety in patients with moderately to severely active Crohn's disease (CD) up to week (W)52 in VIVID-1. We present the first results from the VIVID-2 open-label extension study in patients who received mirikizumab for 2 years. METHODS: Of the patients randomized to mirikizumab in VIVID-1 who rolled over to VIVID-2, 465 were included in the safety population for this interim analysis, and 430 met the eligibility criteria for the efficacy population. Of those, 251 were endoscopic responders at W52 of VIVID-1 (300 mg subcutaneous dosing every 4 weeks) and 179 were endoscopic nonresponders at W52 of VIVID-1 (reinduced with 900 mg intravenously at W0, W4, and W8, followed by subcutaneous dosing). Missing data were handled using modified nonresponder imputation (mNRI) and observed case (OC) approaches. RESULTS: In the efficacy population, 60.5% (mNRI) and 67.1% (OC) achieved endoscopic response, 37.9% and 41.7% achieved endoscopic remission, and 73.4% and 80.9% achieved Crohn's Disease Activity Index (CDAI) remission at W104. Among W52 endoscopic responders who achieved the specified endpoint at W52, 81.8% and 87.6% maintained endoscopic response, 72.5% and 78.6% maintained endoscopic remission, and 86.9% and 92.9% maintained CDAI remission at W104. Among W52 endoscopic responders who did not achieve the specified endpoint at W52, 33.3% and 35.4% gained endoscopic remission, and 55.8% and 60.8% gained CDAI remission at W104. Among W52 endoscopic nonresponders, 30.9% and 36.1% achieved endoscopic response at W104. During the second year of mirikizumab treatment, 64.7% of patients experienced treatment-emergent adverse events (AEs), and 7.7% had serious AEs. CONCLUSIONS: Long-term treatment with mirikizumab for up to 104 weeks was associated with durable improvements in patients with CD. Over 30% of endoscopic nonresponders at 1 year achieved endoscopic response with mirikizumab reinduction. Safety was consistent with the known mirikizumab safety profile. CLINICALTRIALS: gov, Number: NCT04232553.