S1673 Mirikizumab Improves Quality of Life in Patients With Crohn’s Disease Up to 2 Years of Treatment: Results From the VIVID-2 Study

Introduction: Mirikizumab is a humanized IgG4 monoclonal, anti-interleukin-23p19 antibody. VIVID-2 (NCT04232553), an ongoing open-label study, has demonstrated sustained clinical and endoscopic efficacy at 2 years of treatment of mirikizumab for Crohn’s disease (CD). Here we present the long-term quality of life (QoL) up to 2 years from VIVID-2. Methods: Patients enrolled in the phase 3 VIVID-1 study who achieved an endoscopic response to mirikizumab continued maintenance treatment in VIVID-2, while endoscopic non-responders received mirikizumab induction therapy followed by maintenance treatment. Quality of life was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The proportion of patients who achieved IBDQ response/remission, as well as mean changes from VIVID-1 baseline in IBDQ total scores at W64 and 104 were reported. EQ-5D-5L Visual Analog Scale (VAS) scores (range 0-100, with 100 being best imaginable health state) were assessed at W64. Work productivity was assessed at W64 using Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI:CD) (4 scores including absenteeism, presenteeism, work productivity loss and activity impairment are derived as percentages with higher values indicating greater impairment). Modified non-responder imputation (mNRI) was used for binary missing data imputation, and modified baseline observation carried forward (mBOCF) was used for continuous missing data imputation. Estimates of mean changes from baseline were calculated with analysis of covariance (ANCOVA). Results: Analysis of endoscopic responders showed IBDQ response and IBDQ remission were maintained through W104 (85.0% and 71.3%, respectively) while endoscopic non-responders also maintained IBDQ response and remission through the same time (72.6% and 60.8%, respectively). Mean change from baseline in IBDQ total score was maintained through W104 for endoscopic responders and non-responders (least squares mean (standard error); 57.2 (2.1) and 46.8 (2.4), respectively). Similarly, EQ-5D-5L VAS improvement was observed for both groups at W64 (27.0 (1.0) and 22.3 (1.2), respectively). WPAI:CD improvements in both groups ranged from −13.9 (1.8) to −34.3 (1.5) for the different scores collected at W64. Conclusion: Patients continuing mirikizumab maintenance and those receiving reinduction achieved meaningful long-term QoL improvement that was maintained at 2 years of treatment.