抗 CGRP 单克隆抗体对伴有症状的偏头痛发作的影响：真实世界证据研究。

Impact of anti-CGRP monoclonal antibodies on migraine attack accompanying symptoms: A real-world evidence study.

机构信息

Headache Clinic, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain.

Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

Cephalalgia. 2023 Aug;43(8):3331024231177636. doi: 10.1177/03331024231177636.

DOI:10.1177/03331024231177636

PMID:37555331

Abstract

BACKGROUND

Clinical trials on anti-calcitonin gene-related peptide monoclonal antibodies poorly investigated their impact on migraine accompanying symptoms.

OBJECTIVE

To evaluate the impact of basal accompanying symptoms on anti-CGRP monoclonal antibodies treatment response and their evolution after six months of treatment in migraine patients.

METHODS

Patients with migraine diagnosis seen in the Headache Clinic and treated with erenumab, galcanezumab or fremanezumab were prospectively recruited. They completed a daily eDiary which provided data on headache frequency and the following accompanying symptoms of each day: photophobia, phonophobia, nausea, dizziness, and aura. Patients were classified as responders or non-responders based on 50% or greater reduction in headache days per month at month 6 (≥50% response rate). Accompanying symptoms ratios based on headache days per month were assessed per patient at baseline and after three and six months. Comparisons for basal characteristics, basal accompanying symptoms ratios and their evolution after six months between responders and non-responders were performed.

RESULTS

One hundred and fifty-eight patients were included, 44% (69/158) showed ≥50% response rate after six months. A significant reduction in headache days per month in both groups was found at month 6 (-9.4 days/month in ≥50% response rate group; p < 0.001, -2.2 days/month in <50% response rate group; p = 0.004). Additionally, significant decreases in photophobia (-19.5%, p < 0.001), phonophobia (-12.1%, p = 0.010) and aura ratios (-25.1%, p = 0.008) were found in ≥50% response rate group. No statistically significant reductions were found in nausea and dizziness in any group since their reduction was correlated with the decrease in headache days per month. Higher photophobia ratios at baseline were predictive of an increased response between months 3 and 6 (Incidence Risk Ratio = 0.928, p = 0.040).

CONCLUSIONS

The days per month with photophobia, phonophobia and aura decreased at a higher rate than headache days per month after six months in the ≥50% response group. Higher photophobia ratios were associated with higher response rates between three and six months. It could indicate an involvement of peripheral CGRP in photophobia as well as a central modulation of migraine through these treatments which mainly act on the periphery.

摘要

背景

针对降钙素基因相关肽单克隆抗体的临床试验对偏头痛伴随症状的影响研究甚少。

目的

评估基础伴随症状对偏头痛患者使用抗 CGRP 单克隆抗体治疗反应的影响，以及治疗 6 个月后这些伴随症状的变化。

方法

前瞻性招募在头痛诊所就诊并接受依那西普、加奈珠单抗或佛来美奈珠单抗治疗的偏头痛患者。他们每天填写电子日记，记录头痛频率以及每天的以下伴随症状：畏光、畏声、恶心、头晕和先兆。根据 6 个月时每月头痛天数减少 50%或以上（≥50%应答率）将患者分为应答者或无应答者。根据每位患者的每月头痛天数评估基线时和治疗 3 个月和 6 个月后的伴随症状比值。比较应答者和无应答者的基线特征、基础伴随症状比值以及治疗 6 个月后的变化。

结果

共纳入 158 例患者，其中 44%（69/158）在 6 个月时达到≥50%应答率。两组在 6 个月时每月头痛天数均显著减少（≥50%应答率组减少 9.4 天/月；p<0.001，<50%应答率组减少 2.2 天/月；p=0.004）。此外，在≥50%应答率组中还观察到畏光（-19.5%，p<0.001）、畏声（-12.1%，p=0.010）和先兆比值（-25.1%，p=0.008）的显著降低。由于恶心和头晕的减少与每月头痛天数的减少相关，因此在任何一组中均未发现其有统计学意义的减少。基线时更高的畏光比值预示着在 3 至 6 个月时的应答增加（发生率风险比=0.928，p=0.040）。