Expert review of pharmacoeconomics & outcomes research · 2023
Estimating treatment effects on health utility scores for patients living with migraine: a post hoc analysis of the DELIVER trial.
Рандомизированное исследованиеКлиническое исследование III фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Jönsson Linus, Regnier Stephane A, Kymes Steven, Awad Susanne F, Talon Brian, Lee Xin Ying, Goadsby Peter J
Аннотация
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).
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).