Gao Bixi, Sun Nan, Yang Yanbo, Sun Yue, Chen Mingjia, Chen Zhouqing, Wang Zhong
Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.
Front Neurol. 2020 May 19;11:435. doi: 10.3389/fneur.2020.00435. eCollection 2020.
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. 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. 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 ( < 0.0001) and headache days ( < 0.0001) during 12 weeks compared with placebo. Moreover, after using fremanezumab, the risk of at least one adverse event (AE) ( = 0.001) and AE related to the trial regimen ( = 0.0005) significantly increased compared with the placebo. Fremanezumab showed good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but no serious adverse events.
夫瑞奈珠单抗（TEV - 48125）是一种完全人源化的免疫球蛋白G2a亚型选择性单克隆抗体，能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，偏头痛是全球最常见的神经系统疾病之一。已经进行了多项对照试验来研究夫瑞奈珠单抗的安全性和有效性，然而，尚未对现有文献进行系统综述。因此，在我们的研究中，我们进行了一项荟萃分析，以研究夫瑞奈珠单抗预防偏头痛的安全性和有效性。我们检索了2001年1月至2019年8月期间的PubMed（MEDLINE）、Embase和Cochrane图书馆，查找随机对照试验（RCT）。最终，我们的研究纳入了5项RCT，共3379例患者。我们汇总了5项RCT中的3379例患者；主要终点是从基线到第12周的平均每月偏头痛天数和头痛天数。我们发现，与安慰剂相比，夫瑞奈珠单抗在12周内可显著减少偏头痛天数（<0.0001）和头痛天数（<0.0001）。此外，使用夫瑞奈珠单抗后，与安慰剂相比，至少发生一次不良事件（AE）的风险（=0.001）和与试验方案相关的AE风险（=0.0005）显著增加。夫瑞奈珠单抗在预防偏头痛方面显示出良好的疗效。夫瑞奈珠单抗的给药可能会引起一些轻度不良事件，但不会引起严重不良事件。
