Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study.

Abstract

Mirikizumab demonstrated significant efficacy compared with placebo in patients with Crohn's disease (CD) in the phase 3 VIVID-1 study. In this study, we report the impact of mirikizumab vs placebo on health-related quality of life (HRQoL) and work productivity in VIVID-1. VIVID-1 patients randomized to receive mirikizumab (N = 579), or placebo (N = 199) were included. The effect of mirikizumab on HRQoL was assessed at weeks 12 and 52 using the Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 Health Survey (SF-36), EQ-5D-5L visual analog scale, and Work Productivity and Activity Impairment: CD measures. The Cochran-Mantel-Haenszel test with nonresponder imputation (binary end points) and analysis of covariance with modified baseline observation carried forward (continuous end points) were used for treatment comparisons. Greater improvements in the mean change from baseline to weeks 12 and 52 were observed with mirikizumab vs placebo in IBDQ total and domain scores, SF-36 summary and domain scores, and EQ-5D-5L visual analog scale scores (all P < 0.001). Significant improvements with mirikizumab vs placebo were observed in Work Productivity and Activity Impairment:CD scores at week 12: absenteeism ( P = 0.001), presenteeism ( P = 0.005), activity impairment ( P < 0.001), and overall work impairment ( P = 0.002); these improvements were maintained at week 52 (all P < 0.001, except absenteeism). At weeks 12 and 52, a greater proportion of mirikizumab-treated patients vs placebo achieved IBDQ response, IBDQ remission, and clinically important improvement in physical and mental component summaries of SF-36 (all P < 0.001). Patients with moderately to severely active CD treated with mirikizumab reported clinically meaningful improvements in HRQoL and work productivity vs placebo at week 12, which were maintained at week 52.