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

Objectives: Mirikizumab demonstrated significant efficacy compared to placebo in patients with Crohn's disease (CD) in the phase 3 VIVID-1 study. Here, we report the impact of mirikizumab versus placebo on health-related quality of life (HRQoL) and work productivity in VIVID-1.

Methods: 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 analogue scale (VAS), and Work Productivity and Activity Impairment:CD (WPAI:CD) measures. Cochran-Mantel-Haenszel test with non-responder imputation (binary endpoints) and analysis of covariance with modified baseline observation carried forward (continuous endpoints) were used for treatment comparisons.

Results: Greater improvements in mean change from baseline to Weeks 12 and 52 were observed with mirikizumab versus placebo in IBDQ total and domain scores, SF-36 summary and domain scores, and EQ-5D-5L VAS scores (all p<0.001). Significant improvements with mirikizumab versus placebo were observed in WPAI: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 versus placebo achieved IBDQ response, IBDQ remission, and clinically important improvement in physical and mental component summaries of SF-36 (all p<0.001).

Conclusions: Patients with moderately to severely active CD treated with mirikizumab reported clinically meaningful improvements in HRQoL and work productivity versus placebo at Week 12 which were maintained at Week 52.