Background: Fremanezumab (TEV-48125) is a fully-humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of the novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several controlled trials have been conducted to investigate the safety and efficacy of fremanezumab, however, there is no systematic review of the existing literature has been performed. Hence, in our study, we performed a meta-analysis to investigate the safety and efficacy of fremanezumab for the prevention of migraine. Method: Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3,379 patients were finally included in our study. Result: We pooled 3,379 patients from 5 RCTs; the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. Moreover, after using fremanezumab, the risk of at least one adverse event (AE) (P = 0.001) and AE related to the trial regimen (P = 0.0005) significantly increased compared with the placebo. Conclusions: Fremanezumab showed good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but no serious adverse events.

中文翻译：

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Fremanezumab 预防偏头痛的安全性和有效性：随机对照试验的荟萃分析。


背景：Fremanezumab (TEV-48125) 是一种全人源化免疫球蛋白 G 同种型 2a 选择性单克隆抗体，可有效结合降钙素基因相关肽 (CGRP)。它是预防偏头痛的新型治疗药物之一，偏头痛是全世界最常见的神经系统疾病之一。已经进行了几项对照试验来研究 fremanezumab 的安全性和有效性，但是，尚未对现有文献进行系统评价。因此，在我们的研究中，我们进行了一项荟萃分析，以调查 fremanezumab 预防偏头痛的安全性和有效性。方法：检索了 2001 年 1 月至 2019 年 8 月期间 Pubmed (MEDLINE)、Embase 和 Cochrane 图书馆的随机对照试验 (RCT)。我们的研究最终纳入了 5 项随机对照试验，涉及 3,379 名患者。结果：我们汇集了 5 项 RCT 中的 3,379 名患者；主要终点是从基线到第 12 周的平均每月偏头痛和头痛天数。我们发现，与安慰剂相比，fremanezumab 导致 12 周期间偏头痛天数 (P < 0.0001) 和头痛天数 (P < 0.0001) 显着减少。此外，使用fremanezumab后，与安慰剂相比，至少一种不良事件（AE）（P = 0.001）和与试验方案相关的AE（P = 0.0005）的风险显着增加。结论：Fremanezumab 对预防偏头痛具有良好的疗效。服用fremanezumab可引起一些轻微的不良事件，但不会引起严重的不良事件。