Mirikizumab Long-Term Efficacy and Safety in Patients with Crohn’s disease: Results from the VIVID-2 Open-Label Extension Trial

BACKGROUND AND AIMS Mirikizumab, an anti-IL-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 two 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 (300mg subcutaneous dosing every 4 weeks) and 179 were endoscopic non-responders at W52 of VIVID-1 (reinduced with 900mg intravenously at W0, W4, W8, followed by subcutaneous dosing). Missing data were handled using modified non-responder imputation (mNRI) and observed case (OC) approaches. RESULTS In the efficacy population, 60.5%(mNRI)/67.1%(OC) achieved endoscopic response, 37.9%/41.7% achieved endoscopic remission, and 73.4%/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%/87.6% maintained endoscopic response, 72.5%/78.6% maintained endoscopic remission, and 86.9%/92.9% maintained CDAI remission at W104. Among W52 endoscopic responders who did not achieve the specified endpoint at W52,33.3%/35.4% gained endoscopic remission, and 55.8%/60.8% gained CDAI remission at W104. Among W52 endoscopic non-responders, 30.9%/36.1% achieved endoscopic response at W104. During the second year of mirikizumab treatment, 64.7% of patients experienced treatment-emergent 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 non-responders at 1 year achieved endoscopic response with mirikizumab reinduction. Safety was consistent with the known mirikizumab safety profile. CLINICALTRIALS gov ID no: NCT04232553.