Giamberardino Maria Adele, Affaitati Giannapia, Costantini Raffaele, Cipollone Francesco, Martelletti Paolo
Department of Medicine and Science of Aging, Headache Center, Geriatrics Clinic and Ce.S.I.-Met, "G. D'Annunzio" University of Chieti, Chieti, Italy.
Department of Medical, Oral and Biotechnological Sciences, Institute of Surgical Pathology, "G. D'Annunzio" University of Chieti, Chieti, Italy.
J Pain Res. 2017 Dec 8;10:2751-2760. doi: 10.2147/JPR.S128143. eCollection 2017.
Migraine is a highly disabling neurological condition, and preventative treatment still remains problematic, due to aspecificity of the majority of the currently available prophylactic drugs. Calcitonin-gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology; agents aimed at blocking its activity have, therefore, been developed in recent years, among which are monoclonal antibodies (mAbs) against CGRP, to prevent migraine. Erenumab is the only mAb that targets the CGRP receptor instead of the ligand, with high specificity and affinity of binding. This review will report on the most recent data on erenumab characteristics and on the results of clinical trials on its employment in the prevention of episodic migraine (4-14 monthly migraine days): one Phase II and two Phase III trials (completed) and one Phase III trial (ongoing). Monthly subcutaneous administration (70 mg or 140 mg) of erenumab vs placebo for 3-6 months showed significantly higher efficacy in reducing the mean monthly number of migraine days and the use of migraine-specific medication, and in decreasing physical impairment and impact of migraine on everyday activities (<0.001). A favorable safety profile was demonstrated by the lack of significant differences in the occurrence of adverse events in erenumab-treated vs placebo-treated patients. Global results so far obtained point to erenumab as a new promising candidate for the preventative treatment of episodic migraine. Licence applications for erenumab were recently submitted to the Food and Drug Administration in the USA and European Medicines Agency in Europe (May/June 2017).
偏头痛是一种导致严重功能障碍的神经系统疾病,由于目前大多数预防性药物缺乏特异性,预防性治疗仍然存在问题。降钙素基因相关肽(CGRP)在偏头痛的病理生理学中起关键作用;因此,近年来已开发出旨在阻断其活性的药物,其中包括抗CGRP单克隆抗体(mAb),用于预防偏头痛。erenumab是唯一一种靶向CGRP受体而非配体的单克隆抗体,具有高特异性和结合亲和力。本综述将报告erenumab特性的最新数据以及其用于预防发作性偏头痛(每月偏头痛发作4 - 14天)的临床试验结果:一项II期试验和两项III期试验(已完成)以及一项III期试验(正在进行)。每月皮下注射erenumab(70mg或140mg)与安慰剂,持续3 - 6个月,结果显示在减少每月偏头痛发作天数的平均值、使用偏头痛特异性药物以及降低身体损伤和偏头痛对日常活动的影响方面,erenumab的疗效显著更高(<0.001)。在erenumab治疗组和安慰剂治疗组患者中,不良事件发生率无显著差异,表明erenumab具有良好的安全性。目前获得的总体结果表明,erenumab是发作性偏头痛预防性治疗的一个有前景的新候选药物。erenumab的上市许可申请最近已提交给美国食品药品监督管理局和欧洲药品管理局(2017年5月/6月)。