Efectividad de anticuerpos monoclonales anti-PRGC en el tratamiento preventivo de la migraña: estudio prospectivo de 63 pacientes / Effectiveness of anti-CGRP monoclonal antibodies in the preventive treatment of migraine: A prospective study of 63 patients

Introducción: El péptido relacionado con el gen de la calcitonina (PRGC) ha supuesto una revolución en el conocimiento de la fisiopatología de la migraña y ha llevado al desarrollo de nuevos fármacos específicos contra esta nueva diana.MétodosPresentamos un estudio prospectivo de 63 pacientes con migraña episódica (ME) y crónica (MC) tratados con anticuerpos monoclonales anti-PRGC y describimos su eficacia, seguridad y recaídas tras su suspensión. Se analizan predictores de respuesta que puedan ayudar a planificar mejor los tratamientos.ResultadosLa edad media fue de 48,3 ± 11,81 años, siendo 84,1% mujeres. La media de días de migraña al mes (DMM) fue de 15,59 días; 63,5% tenían MC. En todos se comenzó con erenumab 70 mg subcutáneo. Se aumentó la dosis a 140 mg en 47,6% de los pacientes. Se obtuvo una reducción entre 49,85 y 59,53% de DMM entre los tres primeros meses y el año de tratamiento; 17,5% presentó estreñimiento y 4,8% reacción en el lugar de la inyección. En cinco pacientes (17,9%) se cambió el tratamiento a galcanezumab. Tras suspender el tratamiento 23 pacientes sufrieron recaídas, con buena respuesta al reintroducirlo. No hemos podido establecer predictores de respuesta, pero sí observamos de forma estadísticamente significativa mayor número de días de mejora cuantos más DMM hubiera al inicio (p = 0,002).ConclusionesLos anticuerpos monoclonales anti-PRGC son fármacos eficaces, seguros y bien tolerados. Observamos que su interrupción, en algunos casos, puede conllevar recaídas frecuentes y precoces, por lo que recomendamos prolongar el tratamiento en aquellos pacientes con mayor DMM. (AU)

Introduction: Calcitonine Gen-Related Peptide (CGRP) established a revolution in migraine pathophysiology knowledge and has led to the development of new drugs specifically targeting this disease.MethodsWe present a prospective study in which 63 episodic and chronic migraine patients have been treated with anti-CGRP monoclonal antibodies describing their efficacy, security and relapses after their interruption. Response predictors have been analyzed such they can help us to create a better treatment plan.ResultsAverage age was 48.3 ± 11.81 years old, 84.1% of them being women. The average was of 15.59 migraine days per month (MDM). 63.5% of all patients suffered chronic migraine. The initial dose of Erenumab in all patient was 70 mg subcutaneous. This was increased to 140 mg in 47.6% of the patients. An MDM reduction between 49.85% and 59.53% was obtained within three to twelve months from the start of treatment. Constipation was present in 17.5% of the patients and 4.8% suffered injection site reaction. The treatment was changed to Galcanezumab in 17.9% of the patients. After interrupting the treatment, 23 patients relapsed with a good response on reintroduction of the treatment. It was not possible to establish a clear response predictor, however a statistically significant increase in the number of days of improvement was observed with more MDM at baseline level (p = 0.002).ConclusionsAnti-CGRP monoclonal antibodies are effective, safe, and well tolerated drugs. We have observed that their discontinuation, in some cases can lead to frequent and early relapses so we strongly recommend to extend the treatment in those patients with a higher MDM. (AU)

[Effectiveness of anti-CGRP monoclonal antibodies in the preventive treatment of migraine: A prospective study of 63 patients]. / Efectividad de anticuerpos monoclonales anti-PRGC en el tratamiento preventivo de la migraña: estudio prospectivo de 63 pacientes.

INTRODUCTION: Calcitonine Gen-Related Peptide (CGRP) established a revolution in migraine pathophysiology knowledge and has led to the development of new drugs specifically targeting this disease. METHODS: We present a prospective study in which 63 episodic and chronic migraine patients have been treated with anti-CGRP monoclonal antibodies describing their efficacy, security and relapses after their interruption. Response predictors have been analyzed such they can help us to create a better treatment plan. RESULTS: Average age was 48.3 ± 11.81 years old, 84.1% of them being women. The average was of 15.59 migraine days per month (MDM). 63.5% of all patients suffered chronic migraine. The initial dose of Erenumab in all patient was 70 mg subcutaneous. This was increased to 140 mg in 47.6% of the patients. An MDM reduction between 49.85% and 59.53% was obtained within three to twelve months from the start of treatment. Constipation was present in 17.5% of the patients and 4.8% suffered injection site reaction. The treatment was changed to Galcanezumab in 17.9% of the patients. After interrupting the treatment, 23 patients relapsed with a good response on reintroduction of the treatment. It was not possible to establish a clear response predictor, however a statistically significant increase in the number of days of improvement was observed with more MDM at baseline level (p = 0.002). CONCLUSIONS: Anti-CGRP monoclonal antibodies are effective, safe, and well tolerated drugs. We have observed that their discontinuation, in some cases can lead to frequent and early relapses so we strongly recommend to extend the treatment in those patients with a higher MDM.