S1674 Patient-Level Dynamics of Clinical Response to Mirikizumab and Its Impact on Quality of Life: Analysis From the Vivid-1 Trial in Crohn’s Disease

Introduction: The efficacy of mirikizumab (MIRI), an anti-IL-23p19 monoclonal antibody, has been demonstrated in patients with moderately-to-severely active Crohn’s disease (CD) in the phase 3 VIVID-1 study (NCT03926130). Previously published patient-level data identified distinct responder populations with varying response dynamics. The Super Responder group with a fast robust response was generally linked to a higher proportion of patients achieving Week (W)52 clinical and endoscopic outcomes improvement. We evaluated improvements in patient-reported outcomes (PROs) and quality of life (QoL) among patients with CD with different patterns of response to MIRI. Methods: The VIVID-1 study design was previously reported. This post-hoc analysis used a Growth Mixture Model to identify distinct MIRI patient clusters based on change from baseline in Crohn’s Disease Activity Index (CDAI). Outcomes evaluated across trajectory groups included clinical remission by PRO, clinically meaningful improvement in fatigue, change from baseline in abdominal pain and stool frequency, and Inflammatory Bowel Disease Questionnaire (IBDQ) response and remission. These outcomes were assessed using descriptive statistics at W12 and W52. Missing data were imputed using non-responder imputation and a modified baseline observation carried forward approach. Results: Four response trajectory groups for MIRI were differentiated by early response and robustness of symptom resolution: Super Responder, Responder, Delayed Responder, and Non/Incomplete Responder. Achievement of clinical remission by PRO, fatigue improvement, and IBDQ response and remission at W12 and W52 was highest in Super Responders, followed by Responders, however high rates were also achieved among Delayed Responders. In the Delayed Responder group, there was a large increase in proportion achieving clinical remission by PRO over time (W12, 31%; W52, 60%). Conclusion: In all 3 MIRI responder trajectory groups (70.3% of patients), QoL improvement was observed at W12 that was maintained at W52. The highest efficacy was seen among Super Responders, suggesting an early robust response to MIRI may be linked to greater long-term benefits. Efficacy gain between W12 and W52 in Delayed Responders reinforces the need to keep patients with response on MIRI.