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依瑞奈尤单抗治疗发作性偏头痛预防。

Erenumab for episodic migraine prophylaxis.

机构信息

a Department of Neurology and Experimental Neurology , Charite - Universitatsmedizin , Berlin , Germany.

出版信息

Expert Rev Neurother. 2019 Aug;19(8):751-757. doi: 10.1080/14737175.2019.1565996. Epub 2019 Jan 29.

Abstract

: This paper reviews placebo-controlled randomized double-blind studies with erenumab for the prevention of migraine. Erenumab is a fully human monoclonal antibody (mAb), which specifically blocks the calcitonin gene-related peptide (GGRP) receptor. : This manuscript was based on articles written in English located on PubMed using the following search terms: episodic and chronic migraine, migraine prophylaxis and prevention, CGRP, CGRP receptor, CGRP receptor antagonist, erenumab, treatment failures, and trigeminal nerve. : The primary endpoints in Phase II and III preventive episodic migraine trials have been reached successfully, and so have multiple secondary endpoints. Monthly subcutaneous injections of either erenumab 70 mg or 140 mg reduced mean monthly migraine days (MMDs) after 3 and 6 months significantly greater than placebo when compared to baseline values with an onset of action within the first week. About 50% of subjects have at least a 50% reduction of MMDs. Several patient-reported outcome measures demonstrate improved quality of life with erenumab. This antibody also shows efficacy in a prior preventive treatment failure population. The tolerability of erenumab is good, which is reflected by low dropout rates in all erenumab clinical trials. Within the first year of treatment, no specific group or type of adverse events were observed.

摘要

本文回顾了依瑞奈umab 用于预防偏头痛的安慰剂对照随机双盲研究。依瑞奈umab 是一种全人源单克隆抗体(mAb),特异性阻断降钙素基因相关肽(GGRP)受体。本文基于在 PubMed 上发表的英文文章,使用以下搜索词:发作性和慢性偏头痛、偏头痛预防和预防、CGRP、CGRP 受体、CGRP 受体拮抗剂、依瑞奈umab、治疗失败和三叉神经。在 II 期和 III 期预防发作性偏头痛试验中,主要终点已成功达到,并且还达到了多个次要终点。每月皮下注射依瑞奈umab70mg 或 140mg,与基线相比,在第 3 个月和第 6 个月显著降低了每月偏头痛天数(MMD),与安慰剂相比,起效时间在第一周内。约 50%的受试者 MMD 减少至少 50%。几项患者报告的结局指标表明依瑞奈umab 改善了生活质量。这种抗体在先前的预防性治疗失败人群中也显示出疗效。依瑞奈umab 的耐受性良好,这反映在所有依瑞奈umab 临床试验中低的脱落率。在治疗的第一年,没有观察到特定的不良事件类型或类型。

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