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重新定义偏头痛预防:抗 CGRP 单克隆抗体的早期治疗可增强真实世界中的反应。

Redefining migraine prevention: early treatment with anti-CGRP monoclonal antibodies enhances response in the real world.

机构信息

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

Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.

出版信息

J Neurol Neurosurg Psychiatry. 2024 Sep 17;95(10):927-937. doi: 10.1136/jnnp-2023-333295.

Abstract

BACKGROUND

Anti-CGRP monoclonal antibodies (anti-CGRP MAbs) are approved and available treatments for migraine prevention. Patients do not respond alike and many countries have reimbursement policies, which hinder treatments to those who might respond. This study aimed to investigate clinical factors associated with good and excellent response to anti-CGRP MAbs at 6 months.

METHODS

European multicentre, prospective, real-world study, including high-frequency episodic or chronic migraine (CM) patients treated since March 2018 with anti-CGRP MAbs. We defined good and excellent responses as ≥50% and ≥75% reduction in monthly headache days (MHD) at 6 months, respectively. Generalised mixed-effect regression models (GLMMs) were used to identify variables independently associated with treatment response.

RESULTS

Of the 5818 included patients, 82.3% were females and the median age was 48.0 (40.0-55.0) years. At baseline, the median of MHD was 20.0 (14.0-28.0) days/months and 72.2% had a diagnosis of CM. At 6 months (n=4963), 56.5% (2804/4963) were good responders and 26.7% (1324/4963) were excellent responders. In the GLMM model, older age (1.08 (95% CI 1.02 to 1.15), p=0.016), the presence of unilateral pain (1.39 (95% CI 1.21 to 1.60), p<0.001), the absence of depression (0.840 (95% CI 0.731 to 0.966), p=0.014), less monthly migraine days (0.923 (95% CI 0.862 to 0.989), p=0.023) and lower Migraine Disability Assessment at baseline (0.874 (95% CI 0.819 to 0.932), p<0.001) were predictors of good response (AUC of 0.648 (95% CI 0.616 to 0.680)). These variables were also significant predictors of excellent response (AUC of 0.691 (95% CI 0.651 to 0.731)). Sex was not significant in the GLMM models.

CONCLUSIONS

This is the largest real-world study of migraine patients treated with anti-CGRP MAbs. It provides evidence that higher migraine frequency and greater disability at baseline reduce the likelihood of responding to anti-CGRP MAbs, informing physicians and policy-makers on the need for an earlier treatment in order to offer the best chance of treatment success.

摘要

背景

抗降钙素基因相关肽单克隆抗体(抗 CGRP MAbs)是预防偏头痛的已获批上市的治疗药物。患者的反应不尽相同,许多国家都有报销政策,这阻碍了那些可能有反应的患者的治疗。本研究旨在探讨与抗 CGRP MAbs 治疗 6 个月时的良好和优异反应相关的临床因素。

方法

这是一项欧洲多中心、前瞻性、真实世界研究,纳入了自 2018 年 3 月以来接受抗 CGRP MAbs 治疗的高频发作性或慢性偏头痛(CM)患者。我们将≥50%和≥75%的每月头痛天数(MHD)减少定义为良好和优异反应,分别在 6 个月时。使用广义混合效应回归模型(GLMM)来确定与治疗反应相关的独立变量。

结果

在纳入的 5818 例患者中,82.3%为女性,中位年龄为 48.0(40.0-55.0)岁。基线时,MHD 的中位数为 20.0(14.0-28.0)天/月,72.2%的患者诊断为 CM。在 6 个月(n=4963)时,56.5%(2804/4963)为良好反应者,26.7%(1324/4963)为优异反应者。在 GLMM 模型中,年龄较大(1.08(95%CI 1.02 至 1.15),p=0.016)、单侧疼痛(1.39(95%CI 1.21 至 1.60),p<0.001)、无抑郁(0.840(95%CI 0.731 至 0.966),p=0.014)、每月偏头痛天数较少(0.923(95%CI 0.862 至 0.989),p=0.023)和基线时偏头痛残疾评估较低(0.874(95%CI 0.819 至 0.932),p<0.001)是良好反应的预测因素(AUC 为 0.648(95%CI 0.616 至 0.680))。这些变量也是优异反应的显著预测因素(AUC 为 0.691(95%CI 0.651 至 0.731))。在 GLMM 模型中,性别不显著。

结论

这是一项关于接受抗 CGRP MAbs 治疗的偏头痛患者的最大规模真实世界研究。它提供了证据表明,较高的偏头痛频率和基线时更大的残疾程度降低了对抗 CGRP MAbs 反应的可能性,这为医生和决策者提供了有关早期治疗的信息,以便为治疗成功提供最佳机会。

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