在 FOCUS 三期研究中，接受为期 6 个月的 fremanezumab 治疗后，患者的生活质量和工作效率得到改善，这些患者在接受 2 至 4 种偏头痛预防药物治疗后反应不足，为发作性和慢性偏头痛。

Improvements in quality of life and work productivity with up to 6 months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine-preventive medications in the phase 3b FOCUS study.

机构信息

Boston Headache Institute & MedVadis Research Corporation, Waltham, MA, USA.

Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.

出版信息

Headache. 2021 Oct;61(9):1376-1386. doi: 10.1111/head.14196. Epub 2021 Aug 10.

BACKGROUND

Migraine is associated with depression as well as negative impact on quality of life and work productivity. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa), selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine.

OBJECTIVE

In this open-label extension (OLE) of the phase 3b FOCUS study, we assessed patient-reported outcomes (PROs) over time.

METHODS

Patients with episodic migraine (EM) and chronic migraine (CM) completing the 12-week, double-blind (DB) period of the FOCUS trial entered the 12-week OLE and received three monthly doses of fremanezumab (225 mg). PROs included the Migraine-Specific Quality of Life (MSQoL) questionnaire (role function-restrictive [RFR], role function-preventive [RFP], and emotional function [EF] domains), EuroQol-5-Dimension-5-Level (EQ-5D-5L) questionnaire, Patient Global Impression of Change (PGIC) assessment, Work Productivity and Activity Impairment (WPAI) questionnaire, and 9-Item Patient Health Questionnaire (PHQ-9).

RESULTS

A total of 838 patients were randomized in the DB period, 807 entered the OLE at 3 months, and 772 were still enrolled at 6 months. At 6 months, patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups, respectively, reported improvements in RFR (mean [standard deviation] change from baseline: 24.6 [21.9]; 22.9 [21.3]; 20.8 [26.5]), RFP (19.6 [20.0]; 18.3 [19.7]; 16.0 [19.9]), and EF (22.5 [24.2]; 19.1 [23.6]; 17.2 [24.7]) domains of the MSQoL questionnaire, the EQ-5D-5L questionnaire (8.0 [19.6]; 7.3 [21.1]; 6.6 [21.0]), all four domains of the WPAI questionnaire, and the PHQ-9 (-2.4 [5.3]; -1.6 [5.5]; -2.0 [4.9]); 77.1% (209/271), 75.4% (205/272), and 68.8% (181/263) of patients were identified as PGIC responders.

CONCLUSION

Among patients with EM or CM and prior inadequate response to multiple migraine-preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6 months of fremanezumab treatment.

背景

偏头痛与抑郁有关，也会对生活质量和工作生产力产生负面影响。依洛尤单抗是一种完全人源化的单克隆抗体（IgG2Δa），选择性靶向降钙素基因相关肽，已被证明对偏头痛的预防性治疗有效。

目的

在这项 3b 期 FOCUS 研究的开放标签扩展（OLE）中，我们评估了随时间推移的患者报告结局（PROs）。

方法

完成 FOCUS 试验 12 周双盲（DB）期的阵发性偏头痛（EM）和慢性偏头痛（CM）患者进入 12 周 OLE，并接受三次每月 225mg 的依洛尤单抗剂量。PROs 包括偏头痛特异性生活质量（MSQoL）问卷（角色功能受限[RFR]、角色功能预防[RFP]和情感功能[EF]领域）、欧洲五维健康量表-5 维度问卷（EQ-5D-5L）、患者整体印象变化（PGIC）评估、工作生产力和活动障碍（WPAI）问卷和 9 项患者健康问卷（PHQ-9）。

结果

共有 838 名患者在 DB 期随机分组，807 名患者在 3 个月时进入 OLE，772 名患者在 6 个月时仍在入组。在 6 个月时，每季度依洛尤单抗、每月依洛尤单抗和安慰剂 DB 随机分组的患者分别报告 RFR（自基线的平均[标准偏差]变化：24.6 [21.9]；22.9 [21.3]；20.8 [26.5]）、RFP（19.6 [20.0]；18.3 [19.7]；16.0 [19.9]）和 EF（22.5 [24.2]；19.1 [23.6]；17.2 [24.7]）MSQoL 问卷领域、EQ-5D-5L 问卷（8.0 [19.6]；7.3 [21.1]；6.6 [21.0]）、WPAI 问卷的所有四个领域和 PHQ-9（-2.4 [5.3]；-1.6 [5.5]；-2.0 [4.9]）；77.1%（209/271）、75.4%（205/272）和 68.8%（181/263）的患者被认定为 PGIC 应答者。