Headache and Pain Unit, IRCCS San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy.
San Raffaele University, Rome, Italy.
J Headache Pain. 2022 Dec 2;23(1):153. doi: 10.1186/s10194-022-01521-w.
The multinational phase 3b DELIVER trial was designed to evaluate the efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures across 17 countries. In the placebo-controlled portion, eptinezumab relative to placebo demonstrated greater reductions in migraine and headache frequency, migraine and headache severity, and acute medication use. The objective of this report is to describe the effects of eptinezumab on self-reported work productivity in the placebo-controlled portion of DELIVER.
Adults 18-75 years of age with migraine and documented evidence of 2 to 4 prior preventive treatment failures in the past 10 years were randomized to receive eptinezumab 100 mg, 300 mg, or placebo intravenously (IV) every 12 weeks. The Work Productivity and Activity Impairment questionnaire specific to migraine (WPAI:M), which comprises 6 items (4 of which are completed by currently employed patients only), was administered every 4 weeks. Changes from baseline in subscores (absenteeism, presenteeism, work productivity loss, and activity impairment) were calculated based on item responses. A mixed model for repeated measures was used to analyze changes from baseline in WPAI:M subscores.
A total of 890 adults (mean age, 43.8 years) were included in the full analysis set (eptinezumab 100 mg, n = 299; eptinezumab 300 mg, n = 293; placebo, n = 298). Mean WPAI:M subscores at baseline indicated a negative impact of migraine attacks on work productivity and ability to complete normal daily activities. Eptinezumab improved WPAI:M subscores more than placebo at all assessment points throughout the study. Mean changes from baseline in self-reported work productivity loss were -19.5, -24.0, and -9.7 at Week 12; and -22.6, -20.2, and -7.2 at Week 24 (all P < 0.001 vs placebo) for eptinezumab 100 mg, eptinezumab 300 mg, and placebo, respectively. Mean changes from baseline in activity impairment were -21.3, -23.8, and -11.2 at Week 12; and -24.7, -22.6, and -10.1 at Week 24 (all P < 0.0001 vs placebo). Similarly, mean improvements in absenteeism and presenteeism were greater in the eptinezumab groups than in the groups receiving placebo at all timepoints (P < 0.05).
In adults with migraine and prior preventive treatment failure, eptinezumab 100 mg and 300 mg IV every 12 weeks improved absenteeism, presenteeism, work productivity loss, and activity impairment more than placebo.
ClinicalTrials.gov (Identifier: NCT04418765 ); EudraCT (Identifier: 2019-004497-25) ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004497-25/PL ). Eptinezumab improves self-reported work productivity in patients with migraine and prior preventive treatment failures.
这项多中心 3b 期 DELIVER 试验旨在评估eptinezumab 对既往预防治疗失败的偏头痛患者的疗效和安全性，该试验在 17 个国家进行。在安慰剂对照部分，eptinezumab 相对于安慰剂显示偏头痛和头痛发作频率、偏头痛和头痛严重程度以及急性药物使用的更大降低。本报告的目的是描述eptinezumab 对 DELIVER 安慰剂对照部分患者自我报告的工作生产力的影响。
年龄在 18-75 岁之间、有偏头痛病史且在过去 10 年中有 2 至 4 次预防治疗失败记录的成年人，被随机分配接受每 12 周静脉注射（IV）100mg、300mg 的eptinezumab 或安慰剂。偏头痛特异性工作生产力和活动障碍问卷（WPAI：M），包含 6 个项目（其中 4 个仅由当前在职患者完成），每 4 周进行一次评估。根据项目应答，计算从基线到亚评分（旷工、在职工作效率降低、工作生产力损失和活动障碍）的变化。使用重复测量混合模型分析 WPAI：M 亚评分的变化。
共有 890 名成年人（平均年龄 43.8 岁）被纳入全分析集（eptinezumab 100mg，n=299；eptinezumab 300mg，n=293；安慰剂，n=298）。基线时 WPAI：M 亚评分表明偏头痛发作对工作生产力和完成正常日常活动的能力有负面影响。eptinezumab 在整个研究过程中的所有评估点均比安慰剂更能改善 WPAI：M 亚评分。从基线到第 12 周自我报告的工作生产力损失的平均变化为-19.5、-24.0 和-9.7；从基线到第 24 周的平均变化为-22.6、-20.2 和-7.2（均 P<0.001 与安慰剂相比），分别为 eptinezumab 100mg、eptinezumab 300mg 和安慰剂。从基线到第 12 周活动障碍的平均变化为-21.3、-23.8 和-11.2；从基线到第 24 周的平均变化为-24.7、-22.6 和-10.1（均 P<0.0001 与安慰剂相比）。同样，在所有时间点，与安慰剂组相比，eptinezumab 组的旷工和在职工作效率提高的平均值更大（P<0.05）。
在偏头痛和既往预防治疗失败的成年人中，每 12 周静脉注射 100mg 和 300mg eptinezumab 可改善旷工、在职工作效率、工作生产力损失和活动障碍，优于安慰剂。
ClinicalTrials.gov（标识符：NCT04418765）；EudraCT（标识符：2019-004497-25）（https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004497-25/PL）。eptinezumab 改善了既往预防治疗失败的偏头痛患者的自我报告工作生产力。
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