作者
Edoardo Caronna,Víctor J. 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,S. Della Grazia,Sarah Broadhurst,Huy 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,M.A. Escudero,Arne May,A. López-Bravo,Isabel Pavāo 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 Rodríguez-Vico,J. Viguera Romero,Vı́ctor Obach,Sonia Santos‐Lasaosa,Mona Ghadiri–Sani,Roberto De Icco,Javier Díaz de Terán,S. Díaz-Insa,Carmen González Oria,Piero Barbanti,Patricia Pozo‐Rosich
摘要
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.