Evidera, Bethesda, Maryland, USA.
Department of Neurology, Albert Einstein College of Medicine, New York, New York, USA.
Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.
The purpose of this study was to examine changes in the functional impact of migraine following treatment with erenumab, as measured by the Migraine Functional Impact Questionnaire (MFIQ).
The MFIQ, a novel patient-reported outcome (PRO) measuring the impact of migraine on four domains (physical function, social function, and emotional function [PF, SF, and EF]; usual activities [UAs]) and a single item assessing overall impact on UA, was included in phase III trials evaluating erenumab 70 and 140 mg monthly for migraine prevention among people with episodic migraine (EM).
In the ARISE study, 577 patients with EM were randomized to erenumab 70 mg or placebo. In the STRIVE study, 955 patients with EM were randomized to erenumab, 70 mg or 140 mg or placebo. Pairwise comparisons of least-squares mean (LSM) change from baseline in MFIQ scores (with associated 95% confidence interval [CI]) were assessed for each active treatment versus placebo.
In ARISE, greater reductions from baseline to month 3 were observed for 70 mg versus placebo for PF (LSM [95% CI]: -3.2 [-6.4 to -0.1]; p = 0.046) and EF (-4.0 [-7.3 to -0.7]; p = 0.019) domain scores. In STRIVE, between-group differences also reflected reductions from baseline to the average of months 4-6 that favored erenumab on all four MFIQ domain scores. Reductions in impact for 70 mg compared to placebo were -4.3 (95% CI: -6.8 to -1.7; p < 0.001) for PF, -4.0 (-6.3 to -1.7; p < 0.001) for UA, -3.7 (-6.1 to -1.2; p = 0.003) for SF, and -5.3 (-7.9 to -2.6; p < 0.001) for EF domain scores. Improvements were also observed for 140 mg versus placebo with between-group differences of -5.7 (95% CI: -8.2 to -3.2; p < 0.001) in PF, -5.1 (-7.5 to -2.8; p < 0.001) in UA, -5.0 (-7.4 to -2.6; p < 0.001) in SF, and -7.2 (-9.9 to -4.5; p < 0.001) in EF domain scores. There were also greater improvements in the overall impact on UA score for 70 mg (LSM [95% CI]: -4.3 [-7.0 to -1.7]; p = 0.001) and 140 mg (-5.3 [-8.5 to -3.2]; p < 0.001) versus placebo.
The MFIQ measures the frequency of impacts and level of difficulty on multiple functional domains that provide a more complete picture of the effects of migraine. MFIQ scores showed that in comparison with placebo, patients treated with erenumab had greater reductions in the functional impact of migraine, providing insight into treatment benefits that extend beyond improvements in clinical status and health-related quality of life previously reported based on clinical end points and other PROs.
本研究旨在通过偏头痛功能影响问卷（MFIQ）来评估依瑞奈珠单抗治疗后偏头痛对功能影响的变化。
MFIQ 是一种新的患者报告结局（PRO）测量工具，用于评估偏头痛对四个功能领域（身体功能、社会功能和情绪功能[PF、SF 和 EF]；日常活动[UA]）以及对日常活动总体影响的单一项目的影响。该问卷已被纳入评估依瑞奈珠单抗预防偏头痛的 III 期临床试验，包括 70 和 140mg 每月治疗的发作性偏头痛（EM）患者。
在 ARISE 研究中，577 例 EM 患者被随机分配至依瑞奈珠单抗 70mg 或安慰剂组。在 STRIVE 研究中，955 例 EM 患者被随机分配至依瑞奈珠单抗 70mg、140mg 或安慰剂组。对各活性治疗组与安慰剂组之间的最小二乘均数（LSM）变化进行了比较（并附有 95%置信区间[CI]）。
在 ARISE 中，与安慰剂相比，70mg 组从基线到第 3 个月的 PF（LSM[95%CI]：-3.2[-6.4 至-0.1]；p=0.046）和 EF（-4.0[-7.3 至-0.7]；p=0.019）评分的降低更为显著。在 STRIVE 中，各 MFIQ 评分也反映了从基线到第 4-6 个月平均值的改善，依瑞奈珠单抗优于安慰剂。与安慰剂相比，70mg 组的 PF 评分降低了-4.3（95%CI：-6.8 至-1.7；p<0.001），UA 评分降低了-4.0（95%CI：-6.3 至-1.7；p<0.001），SF 评分降低了-3.7（95%CI：-6.1 至-1.2；p=0.003），EF 评分降低了-5.3（95%CI：-7.9 至-2.6；p<0.001）。与安慰剂相比，140mg 组也有改善，PF 评分的组间差异为-5.7（95%CI：-8.2 至-3.2；p<0.001），UA 评分的组间差异为-5.1（95%CI：-7.5 至-2.8；p<0.001），SF 评分的组间差异为-5.0（95%CI：-7.4 至-2.6；p<0.001），EF 评分的组间差异为-7.2（95%CI：-9.9 至-4.5；p<0.001）。与安慰剂相比，70mg 和 140mg 治疗组在 UA 评分的整体影响上也有更大的改善（LSM[95%CI]：-4.3[-7.0 至-1.7]；p=0.001）和 140mg（-5.3[-8.5 至-3.2]；p<0.001）。
MFIQ 测量了偏头痛在多个功能领域的影响频率和困难程度，提供了偏头痛影响的更完整的图景。MFIQ 评分表明，与安慰剂相比，接受依瑞奈珠单抗治疗的患者偏头痛对功能的影响更大，这为治疗益处提供了新的见解，除了先前基于临床终点和其他 PRO 报告的临床状况和健康相关生活质量改善之外，还延伸到其他方面。
