Department for Neurobiology, Care Sciences and Society, Division of Neurogeriatrics, Karolinska Institutet, Solna, Sweden.
H. Lundbeck A/S, Copenhagen, Denmark.
Expert Rev Pharmacoecon Outcomes Res. 2023 Jul-Dec;23(7):797-803. doi: 10.1080/14737167.2023.2219898. Epub 2023 Jun 2.
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.
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; < 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; < 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.
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.
The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04418765).
本事后分析旨在评估eptinezumab 对健康效用的治疗效果，并确定每月偏头痛天数（MMD）在多大程度上解释了健康效用的变化。
研究设计/方法：DELIVER 是一项随机、双盲、安慰剂对照的 3b 期试验（NCT04418765），调查了 2-4 次偏头痛治疗失败的患者中eptinezumab 的疗效和安全性。回归分析探讨了效用评分与 MMD 之间的关系，eptinezumab 治疗作为协变量与 MMD 一起纳入，以确定对效用的任何 MMD 无关影响。路径分析量化了 eptinezumab 通过 MMD 减少的影响。
基础病例模型表明，MMD 的每次减少都与效用评分的平均增加相关（0.0189；95%CI：0.0180，0.0198； < 0.001）。与安慰剂相比，eptinezumab 的平均效用评分通常更高，证明了在基础病例模型中加入治疗效果是合理的。在控制 MMD 数量的情况下，接受eptinezumab 治疗的患者平均比安慰剂高 0.0562（95%CI：0.0382，0.0742； < 0.001）的效用。从路径分析来看，eptinezumab 治疗导致的 MMD 减少解释了患者观察到的额外 53%的效用获益。
仅 MMD 的变化不能充分捕捉偏头痛对患者效用的影响，因为 eptinezumab 还对效用评分产生了积极的、特定于治疗的影响。
该试验在 ClinicalTrials.gov（CT.gov 标识符：NCT04418765）注册。
