P1058 Trajectories of response in patients with moderately-to-severely active Crohn’s disease treated with mirikizumab based on biofailed status: Post hoc results from the VIVID-1 study

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Abstract Background Mirikizumab, an anti-IL-23p19 antibody, demonstrated robust efficacy in improving clinical and endoscopic endpoints with an acceptable safety profile1. We explored the trajectory of response to treatment in patients with moderate-to-severely active Crohn’s disease (CD), in patients treated with mirikizumab based on biofailed status at study baseline. Methods Biofailed was defined as patients with demonstrated intolerance, inadequate response, or loss of response to an approved biologic therapy for CD (BF, N=275) and Not Biofailed (NBF, N=297) patients described previously1 were assessed via Growth Mixture Model to identify distinct clusters based on individual patient response trajectories. Change from baseline in Crohn’s Disease Activity Index total score was used in the Growth Mixture Model to identify trajectories. Modified baseline observation carried forward imputation used. Results There were four clusters identified for both the BF and NBF groups. Mirikizumab trajectory groups by baseline biofailed status: Super Responder (BF/NBF: 18.9%/17.8%), Responder (BF/NBF: 19.3%/25.3%), Delayed Responder (BF/NBF, 29.8%/29.3%), and Non/Incomplete Responder (BF/NBF, 32.0%/27.6%) (Figure 1). The overall response rate across responder groups for BF patients was 68.0% and for NBF patients was 72.4%. Conclusion Mirikizumab clinical response groups (Super Responder, Responder, Delayed Responder, and Non/Incomplete Responder) were similar for BF and NBF patients suggesting mirikizumab works consistently for BF and NBF patients, and prior biofailed status is not associated with the speed or magnitude of a MIRI-triggered clinical response.