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Introducción: A finales de 2018 fue autorizado en España el uso de los primeros anticuerpos monoclonales contra el péptido relacionado con el gen de la calcitonina (CGRP) o su receptor como tratamiento preventivo de la migraña. Su posología y mecanismo de acción los diferencian de los fármacos orales actuales. El acceso a estos tratamientos requiere el cumplimiento de unas condiciones especiales para su financiación en nuestro medio. En este documento se revisan los aspectos fundamentales de estos fármacos. Además, se han elaborado una serie de recomendaciones prácticas sobre su manejo basadas en los principales consensos internacionales y en nuestra experiencia actual en la práctica clínica. Desarrollo: Este documento de consenso ha sido elaborado por el Grupo de Estudio de Cefaleas de la Asociación Madrileña de Neurología. Las recomendaciones se centran en las principales indicaciones y contraindicaciones de estos nuevos fármacos, su posología, la evaluación de su eficacia y su utilización en situaciones especiales. Conclusiones: Este documento de consenso proporciona a los profesionales de la neurología una actualización sobre el uso de los anticuerpos anti-CGRP en el tratamiento de la migraña. Se pretende con ello estandarizar en lo posible el uso de anticuerpos monoclonales en las unidades de cefalea, así como aconsejar sobre aspectos prácticos tales como el uso de medicación preventiva concomitante o el manejo de los efectos secundarios en caso de que aparezcan.

Abstract Background Anti-CGRP monoclonal antibodies have shown notable effectiveness and tolerability in migraine patients; however, data on their use in elderly patients is still lacking, as clinical trials have implicit age restrictions and real-world evidence is scarce. In this study, we aimed to describe the safety and effectiveness of erenumab, galcanezumab and fremanezumab in migraine patients over 65 years old in real-life. Methods In this observational real-life study, a retrospective analysis of prospectively collected data from 18 different headache units in Spain was performed. Migraine patients who started treatment with any anti-CGRP monoclonal antibody after the age of 65 years were included. Primary endpoints were reduction in monthly migraine days after 6 months of treatment and the presence of adverse effects. Secondary endpoints were reductions in headache and medication intake frequencies by months 3 and 6, response rates, changes in patient-reported outcomes and reasons for discontinuation. As a subanalysis, reduction in monthly migraine days and proportion of adverse effects were also compared among the three monoclonal antibodies. Results A total of 162 patients were included, median age 68 years (range 65–87), 74.1% women. 42% had dyslipidaemia, 40.3% hypertension, 8% diabetes, and 6.2% previous cardiovascular ischaemic disease. The reduction in monthly migraine days at month 6 was 10.1 ± 7.3 days. A total of 25.3% of patients presented adverse effects, all of them mild, with only two cases of blood pressure increase. Headache and medication intake frequencies were significantly reduced, and patient-reported outcomes were improved. The proportions of responders were 68%, 57%, 33% and 9% for reductions in monthly migraine days ≥ 30%, ≥ 50%, ≥ 75% and 100%, respectively. A total of 72.8% of patients continued with the treatment after 6 months. The reduction in migraine days was similar for the different anti-CGRP treatments, but fewer adverse effects were detected with fremanezumab (7.7%). Conclusions Anti-CGRP mAbs are safe and effective treatments in migraine patients over 65 years old in real-life clinical practice. Graphical Abstract