eptinezumab对工作生产力的影响——超越每月偏头痛天数的减少：DELIVER试验的事后分析

Impact of eptinezumab on work productivity beyond reductions in monthly migraine days: post hoc analysis of the DELIVER trial.

作者信息

Barbanti Piero, Awad Susanne F, Rae-Espinoza Heather, Regnier Stephane A, Lee Xin Ying, Goadsby Peter J

机构信息

Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy.

San Raffaele University, Rome, Italy.

出版信息

J Patient Rep Outcomes. 2024 Dec 18;8(1):146. doi: 10.1186/s41687-024-00813-w.

DOI:10.1186/s41687-024-00813-w

PMID:39692817

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11655748/

Abstract

BACKGROUND

Eptinezumab's impact on self-reported work productivity in adults with migraine and 2‒4 prior preventive migraine treatment failures is not fully understood.

METHODOLOGY

Electronic diaries captured monthly migraine days (MMDs) reported by patients enrolled in the randomized, double-blind, placebo-controlled DELIVER trial (NCT04418765). The migraine-specific Work Productivity and Activity Impairment questionnaire, administered at baseline and each monthly visit, was a secondary outcome of DELIVER and used to model changes from baseline in self-reported monthly hours of absenteeism (decreased work attendance) and presenteeism (reduced work efficiency while at work with a migraine) in Canada, as the base case. Path analysis illustrated eptinezumab's impact on work productivity beyond MMDs.

RESULTS

As MMDs increased, monthly hours of absenteeism increased linearly while those of presenteeism increased quadratically. Best-fit models were improved after including an eptinezumab treatment effect, showing benefit over placebo after controlling for MMD frequency. Compared to placebo, patients treated with eptinezumab (pooled) had a modeled reduction from baseline of 7.2 h/month (absenteeism) (95% CI: -9.9, -4.5; P < 0.001) and 21.4 h/month (presenteeism) (95% CI: -26.3, -16.5; P < 0.001) over weeks 1‒24. Beyond MMD reductions, improvements in patient-identified most bothersome symptom (PI-MBS) and reductions in percent of severe migraine attacks contributed to eptinezumab's effect.

CONCLUSIONS

Eptinezumab decreased absenteeism and presenteeism based on patient reports, with data highlighting the importance of considering the PI-MBS. The greater change from baseline than placebo in self-reported absenteeism and presenteeism was only partly explained by changes in MMDs, presenting a potential opportunity to decrease the cost of migraine in the workplace.

TRIAL REGISTRATION

ClinicalTrials.gov (Identifier: NCT04418765); EudraCT (Identifier: 2019-004497-25).

摘要

背景

对于患有偏头痛且之前进行过2 - 4次预防性偏头痛治疗失败的成年人，依替奈珠单抗对自我报告的工作效率的影响尚未完全明确。

方法

电子日记记录了参与随机、双盲、安慰剂对照的DELIVER试验（NCT04418765）的患者每月报告的偏头痛天数（MMD）。在基线和每次月度访视时进行的偏头痛特异性工作效率和活动障碍问卷，是DELIVER试验的次要结果，并用于模拟加拿大自我报告的每月旷工小时数（工作出勤减少）和出勤主义（偏头痛发作时工作效率降低）相对于基线的变化，作为基础情况。路径分析说明了依替奈珠单抗对工作效率的影响超过MMD。

结果

随着MMD增加，每月旷工小时数呈线性增加，而出勤主义小时数呈二次方增加。纳入依替奈珠单抗治疗效果后，最佳拟合模型得到改善，在控制MMD频率后显示出优于安慰剂的效果。与安慰剂相比，接受依替奈珠单抗（汇总）治疗的患者在第1 - 24周相对于基线的模拟减少量为：每月旷工7.2小时（95%置信区间：-9.9，-4.5；P < 0.001）和每月出勤主义21.4小时（95%置信区间：-26.3，-16.5；P < 0.001）。除了MMD减少外，患者确定的最困扰症状（PI - MBS）的改善和严重偏头痛发作百分比的降低也促成了依替奈珠单抗的效果。