重新定义偏头痛的预防:使用抗 CGRP 单克隆抗体进行早期治疗可增强真实世界中的反应。

IF 8.7 1区 医学 Q1 CLINICAL NEUROLOGY
Edoardo Caronna, Victor José Gallardo, Gabriella Egeo, Manuel Millán Vázquez, Candela Nieves Castellanos, Javier A Membrilla, Gloria Vaghi, Joana Rodríguez-Montolio, Neus Fabregat Fabra, Francisco Sánchez-Caballero, Alex Jaimes Sánchez, Albert Muñoz-Vendrell, Renato Oliveira, Gabriel Gárate, Yésica González-Osorio, Daniel Guisado-Alonso, Raffaele Ornello, Cem Thunstedt, Iris Fernández-Lázaro, Marta Torres-Ferrús, Alicia Alpuente, Paola Torelli, Cinzia Aurilia, Raquel Lamas Pére, Maria José Ruiz Castrillo, Roberto De Icco, Grazia Sances, Sarah Broadhurst, Hui Ching Ong, Andrea Gómez García, Sergio Campoy, Jordi Sanahuja, Gonçalo Cabral, Isabel Beltrán Blasco, Marta Waliszewska-Prosół, Liliana Pereira, Almudena Layos-Romero, Isabel Luzeiro, Laura Dorado, María Rocio Álvarez Escudero, Arne May, Alba López-Bravo, Isabel Pavão Martins, Christina Sundal, Pablo Irimia, Alberto Lozano Ros, Ana Beatriz Gago-Veiga, Fernando Velasco Juanes, Ruth Ruscheweyh, Simona Sacco, Elisa Cuadrado-Godia, David García-Azorín, Julio Pascual, Raquel Gil-Gouveia, Mariano Huerta-Villanueva, Jaime Rodriguez-Vico, Javier Viguera Romero, Victor Obach, Sonia Santos-Lasaosa, Mona Ghadiri-Sani, Cristina Tassorelli, Javier Díaz-de-Terán, Samuel Díaz Insa, Carmen González Oria, Piero Barbanti, Patricia Pozo-Rosich
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引用次数: 0

摘要

背景:抗 CGRP 单克隆抗体(anti-CGRP MAbs)是已获批准且可用来预防偏头痛的治疗方法。患者的反应不尽相同,许多国家的报销政策阻碍了对可能有反应的患者的治疗。本研究旨在调查与抗CGRP MAbs 6个月后良好和卓越反应相关的临床因素:欧洲多中心、前瞻性、真实世界研究,包括自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。我们将良好和卓越反应分别定义为6个月时每月头痛天数(MHD)减少≥50%和≥75%。采用广义混合效应回归模型(GLMM)确定与治疗反应独立相关的变量:在纳入的 5818 名患者中,82.3% 为女性,年龄中位数为 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%的患者被诊断为CM。6 个月时(n=4963),56.5% 的患者(2804/4963)反应良好,26.7% 的患者(1324/4963)反应极佳。在 GLMM 模型中,年龄较大(1.08(95% CI 1.02 至 1.15),p=0.016)、存在单侧疼痛(1.39(95% CI 1.21 至 1.60),p结论:这是针对接受抗CGRP MAbs治疗的偏头痛患者进行的最大规模的真实世界研究。它提供的证据表明,基线偏头痛频率越高、残疾程度越严重,对抗CGRP MAbs产生反应的可能性就越小,这让医生和政策制定者了解到需要尽早治疗,以提供最佳的治疗成功机会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Redefining migraine prevention: early treatment with anti-CGRP monoclonal antibodies enhances response in the real world.

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.

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来源期刊
CiteScore
15.70
自引率
1.80%
发文量
888
审稿时长
6 months
期刊介绍: The Journal of Neurology, Neurosurgery & Psychiatry (JNNP) aspires to publish groundbreaking and cutting-edge research worldwide. Covering the entire spectrum of neurological sciences, the journal focuses on common disorders like stroke, multiple sclerosis, Parkinson’s disease, epilepsy, peripheral neuropathy, subarachnoid haemorrhage, and neuropsychiatry, while also addressing complex challenges such as ALS. With early online publication, regular podcasts, and an extensive archive collection boasting the longest half-life in clinical neuroscience journals, JNNP aims to be a trailblazer in the field.
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