Therapeutic Safety and Efficacy of Erenumab for Treatment in Migraine Patients:A Systematic Review and Meta-analysis

• 作者: Benhong Zhou Fuchao Chen Jiexin Lei Peng Chen
• 来源期刊: 亚洲毒理学研究
• 学科: 医学
• 关键词: MIGRAINE Erenumab CGRP-m Ab EFFICACY SAFETY META-ANALYSIS
• 年，卷（期）: 2019,（1）
• 页码范围: 2-17
• 页数: 16页
• 分类号: R24

摘要

Background:Calcitonin gene-related peptide(CGRP)plays an important role in migraine pathophysiology.Erenumab,a human monoclonal antibody(mAb)that inhibits the CGRP appear more promising for migraine because of effective and well tolerated profiles.The purpose of this study is to perform a meta-analysis to evaluate the therapeutic safety and efficacy of erenumab for treatment in migraine patients.Methods:We searched multiple sources included PubMed,Embase,Cochrane library,and CNKI data based on collected the double-blinded randomized clinical trials comparing erenumab to placebo.After data extraction and quality assessment of the included RCTs,the RevMan 5.3 software was applied for meta-analysis of reduction of monthly migraine days(MMD),the proportion of patients reaching 50%reduction in MMD,the reduction of monthly acute migraine-speci?c medication treatment days(MSMD),and 50%responder rate.As for the safety,total adverse events and the main adverse events were assessed.Results:We included data from 5 randomized clinical trials,with a total of 3349 participants.We found significant reduction of MMD and MSMD in erenumab vs.placebo(WMD=-1.31,95%CI-1.78 to-0.83,P<0.00001;WMD=-1.24,95%CI-1.63 to-0.83,P<0.00001).The proportion of patients reaching 50%reduction in MMD(OR=2.01,95%CI 1.78 to 2.49,P<0.00001)and 50%responder rate(OR=1.70,95%CI:1.23 to 2.35,P=0.001)were significantly increased compared with placebo.There was no significant difference in total adverse events(OR=1.02,95%CI:0.84-1.24),and the main adverse events including upper respiratory tract infection(OR=1.14,95%CI 0.84-1.56),nasopharyngitis(OR=0.85,95%CI 0.66-1.10),migraine(OR=0.82,95%CI 0.51-1.33),and nausea(OR=0.98,95%CI 0.63-1.53),were not obviously changed compared with placebo control,but the results showed significant increase of injection-site pain in erenumab vs placebo(OR=2.48,95%CI 1.45-2.46).Conclusion:This meta-analysis suggests that erenumab is effective in anti-migraine therapy with few adverse,and further high-quality studies should be co