Estimating treatment effects on health utility scores for patients living with migraine: a post hoc analysis of the DELIVER trial

Abstract

ABSTRACT Background This post hoc analysis aimed to estimate eptinezumab’s therapeutic effect on health utilities and determined to which extent monthly migraine days (MMDs) explain changes in health utilities. Research Design/Methods DELIVER, a randomized, double-blind, placebo-controlled phase 3b trial (NCT04418765), investigated eptinezumab efficacy and safety in patients with 2-4 prior migraine treatment failures. Regression analysis explored the relationship between utility scores and MMDs, with eptinezumab treatment as a covariate along with MMDs to identify any MMD-independent effect on utilities. Path analysis quantified eptinezumab’s impact as mediated through MMD reduction. Results The base case model showed that each reduction in MMD was associated with a mean utility score increase (0.0189; 95% CI: 0.0180, 0.0198; P < 0.001). Mean utility score was generally higher for eptinezumab versus placebo, justifying addition of treatment effect to the base case model. Patients administered eptinezumab had on average 0.0562 (95% CI: 0.0382, 0.0742; P < 0.001) higher utility versus placebo when controlling for number of MMDs. From path analysis, MMD reduction resulting from eptinezumab treatment accounted for 53% additional utility gain observed in patients. Conclusions Changes in MMDs alone inadequately captured migraine’s impact on patient utility, as there was also a positive eptinezumab-driven, treatment-specific impact on utility score. Trial Registration The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04418765).