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Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab

机译:降钙素基因相关肽受体作为治疗发作性偏头痛的新靶点:艾瑞单抗的最新证据和安全性

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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 ( P <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).
机译:偏头痛是一种高度致残的神经系统疾病,由于大多数当前可用的预防药物的特异性,偏头痛的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中起着至关重要的作用。因此,近年来已经开发了旨在阻断其活性的药物,其中包括针对CGRP的单克隆抗体(mAb),以预防偏头痛。 Erenumab是唯一靶向CGRP受体而不是配体的mAb,具有高特异性和结合亲和力。这篇综述将报告关于埃仑单抗特征的最新数据以及其在预防发作性偏头痛方面的临床试验结果(4-14个月每月偏头痛天):一项II期和两项III期试验(已完成)和一项III期试验(进行中)。与安慰剂相比,每月皮下给药erenumab(70 mg或140 mg)持续3-6个月,显示出在减少平均每月偏头痛天数和使用偏头痛特异性药物以及减少身体损伤和偏头痛影响方面的显着更高的疗效。日常活动(P <0.001)。厄仑单抗治疗组与安慰剂治疗组的不良事件发生之间没有显着差异,证明了安全性良好。迄今为止获得的全球性结果表明,艾瑞单抗是预防发作性偏头痛的一种新的有希望的候选药物。 erenumab的许可申请最近已提交给美国食品和药物管理局和欧洲的欧洲药品管理局(2017年5月/ 6月)。

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