Acaster Lloyd Consulting Ltd, 8th Floor, Lacon House, 84 Theobalds Road, London, WC1X 8NL, UK.
StudyMetrix LLC, 3862 Mexico Road, St. Peters, MO, 63303, USA.
J Headache Pain. 2022 Aug 8;23(1):97. doi: 10.1186/s10194-022-01467-z.
Previous research has extensively documented the impact of migraine episodes ('ictal') on patients' health-related quality of life. Few studies have looked at the impact of migraine on migraine-free days ('interictal'). This study was designed to describe interictal burden of migraine in a mixed group of people affected by migraine and to explore patient characteristics associated with interictal burden.
People with migraine in the United States (US) and Germany were recruited for a cross-sectional online survey, including a subgroup treated with calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb). The survey included the Migraine Interictal Burden Scale (MIBS-4), Headache Impact Test (HIT-6), and items measuring patient demographics, clinical and treatment background. Data were analyzed using descriptive statistics and linear regression.
Five hundred six people with migraine completed the survey (US: n = 257; Germany: n = 249), of whom 195 had taken a CGRP mAb for three or more months. Participants had a mean of 8.5 (SD = 6.4) Monthly Migraine Days (MMD) and 10.4 (SD = 7.1) Monthly Headache Days (MHD). The mean MIBS-4 score was 6.3 (SD = 3.4), with 67% reporting severe interictal burden (MIBS-4: ≥5). The mean HIT-6 score was 65.3 (SD = 6.0), with 86% reporting severe migraine impact (HIT-6: ≥60). MIBS-4 was correlated with the HIT-6 (r = 0.37), MMD and MHD (both r = 0.27). The HIT-6, MMD, MHD, CGRP mAb treatment, and depression all had an independent positive association with the MIBS-4.
Two-thirds of the study sample reported substantial interictal burden. Whilst interictal burden was associated with migraine frequency and impact of migraine attacks, study results also show it represented a distinct aspect of the overall disease burden. Study findings further indicate unique associations between interictal burden and depression. A unique positive association between interictal burden and CGRP mAb treatment suggests a remaining unmet need among people affected by migraine treated with CGRP mAb.
先前的研究广泛记录了偏头痛发作（“发作期”）对患者健康相关生活质量的影响。很少有研究关注偏头痛对无偏头痛日（“发作间期”）的影响。本研究旨在描述受偏头痛影响的混合人群中发作间期的偏头痛负担，并探讨与发作间期负担相关的患者特征。
在美国（美国）和德国招募了偏头痛患者参加横断面在线调查，其中包括接受降钙素基因相关肽（CGRP）单克隆抗体（mAb）治疗的亚组。该调查包括偏头痛发作间期负担量表（MIBS-4）、头痛影响测试（HIT-6）和衡量患者人口统计学、临床和治疗背景的项目。使用描述性统计和线性回归分析数据。
506 名偏头痛患者完成了调查（美国：n=257；德国：n=249），其中 195 名患者服用 CGRP mAb 治疗三个月或以上。参与者每月偏头痛发作日（MMD）平均为 8.5（SD=6.4），每月头痛发作日（MHD）平均为 10.4（SD=7.1）。MIBS-4 评分平均为 6.3（SD=3.4），67%的人报告有严重的发作间期负担（MIBS-4：≥5）。HIT-6 评分平均为 65.3（SD=6.0），86%的人报告偏头痛影响严重（HIT-6：≥60）。MIBS-4 与 HIT-6（r=0.37）、MMD 和 MHD（均 r=0.27）相关。HIT-6、MMD、MHD、CGRP mAb 治疗和抑郁均与 MIBS-4 呈独立正相关。
研究样本中有三分之二的人报告有严重的发作间期负担。尽管发作间期负担与偏头痛发作的频率和偏头痛发作的影响有关，但研究结果还表明，它代表了整体疾病负担的一个独特方面。研究结果还表明，发作间期负担与抑郁之间存在独特的正相关关系。发作间期负担与 CGRP mAb 治疗之间存在独特的正相关关系表明，接受 CGRP mAb 治疗的偏头痛患者存在未满足的需求。
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