Redefining migraine prevention: early treatment with anti-CGRP monoclonal
antibodies enhances response in the real world
Authors: Caronna Edoardo , Gallardo Victor José , Egeo Gabriella , Vázquez Manuel Millán , Castellanos Candela Nieves , Membrilla Javier A , Vaghi Gloria , Rodríguez-Montolio Joana , Fabregat Fabra Neus , Sánchez-Caballero Francisco , Jaimes Sánchez Alex , Muñoz-Vendrell Albert , Oliveira Renato , Gárate Gabriel , González-Osorio Yésica , Guisado-Alonso Daniel , Ornello Raffaele , Thunstedt Cem , Fernández-Lázaro Iris , Torres-Ferrús Marta , Alpuente Alicia , Torelli Paola , Aurilia Cinzia , Pére Raquel Lamas , Castrillo Maria José Ruiz , Icco Roberto De , Sances Grazia , Broadhurst Sarah , Ong Hui Ching , García Andrea Gómez , Campoy Sergio , Sanahuja Jordi , Cabral Gonçalo , Beltrán Blasco Isabel , Waliszewska-Prosół Marta , Pereira Liliana , Layos-Romero Almudena , Luzeiro Isabel , Dorado Laura , Álvarez Escudero María Rocio , May Arne , López-Bravo Alba , Martins Isabel Pavão , Sundal Christina , Irimia Pablo , Lozano Ros Alberto , Gago-Veiga Ana Beatriz , Juanes Fernando Velasco , Ruscheweyh Ruth , Sacco Simona , Cuadrado-Godia Elisa , García-Azorín David , Pascual Julio , Gil-Gouveia Raquel , Huerta-Villanueva Mariano , Rodriguez-Vico Jaime , Viguera Romero Javier , Obach Victor , Santos-Lasaosa Sonia , Ghadiri-Sani Mona , Tassorelli Cristina , Díaz-de-Terán Javier , Díaz Insa Samuel , Oria Carmen González , Barbanti Piero , Pozo-Rosich Patricia 
Published: June 2024

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.