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Abstract Introduction The efficacy of galcanezumab has been demonstrated in randomized controlled trials, but evidence about its use under clinical practice conditions is still limited. This study aimed to describe the characteristics of the patients treated with galcanezumab in routine clinical practice in Spain as well as treatment patterns, persistence, and effectiveness. Methods A retrospective chart review study was carried out in six hospitals. Information of adults with migraine, who started treatment with galcanezumab between November 2019 and September 2021, was analyzed until end or loss of follow-up. Continuous variables were described as mean (standard deviation, SD) and median (interquartile range, IQR), and categorical variables as frequency and percentages. Persistence to treatment was estimated using Kaplan–Meier analysis. Results A total of 314 patients were analyzed over median follow-up period of 17.5 months (13.8–20.7), with a mean age of 46.3 (12.6), 85% women, 80.6% chronic migraine, and reporting a mean of monthly migraine days of 16.7 (7.8). Overall, 72.9% had comorbid conditions, with anxiety and depression disorders being the most frequent. More than 60% had received ≥ 6 previous preventive drugs, the most common being antiepileptics, antidepressants, and botulinum toxin (95.2%, 89.8% and 84.1%, respectively). Overall, 60.3% of the patients with other preventive treatments maintained them after galcanezumab initiation. The median time on galcanezumab was 14.6 months (9.4–22.8); 95.7%, 82.0%, 76.2% and 59.8% of patients were persistent to treatment at 3, 6, 9 and 12 months, respectively. Of the patients who discontinued (151: 48.1%), 57.6% were due to lack of effectiveness and 31.1% were due to improvement in migraine. The average reduction of monthly migraine days at 3, 6, 9 and 12 months was 7.9 (7.2), 9.1 (7.5), 8.8 (6.6) and 9.0 (6.9) days, respectively. Conclusions In real clinical practice, galcanezumab is an effective treatment and has a high persistence in patients with migraine, mostly chronic and with multiple use of previous preventive treatments.

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.