Efficacy and Safety of Calcitonin Gene-related Peptide Monoclonal Antibodies in the Preventive Treatment of Migraine：A Bayesian Network Meta-analysis / 中国药房

ABSTRACT

OBJECTIVE：To systematically evaluate th e efficacy and safety of 4 kinds of calcitonin gene-related peptide （CGRP）monoclonal antibodies in the preventive treatment of migraine ，and to provide evidence-based reference for the clinical treatment of migraine. METHODS ：Retrieved from the Cochrane Library ，PubMed，Embase，CJFD，VIP and Wanfang database ， RCTs about 4 kinds of CGRP monoclonal antibodies （trial Δ 基金项目 ：四川省科技厅重点研发 （重大科技专项 ）项目 group） versus placebo （control group ） in the preventive （No.2019YFS0180） ＊硕士研究生 。研究方向 ：临床药学 、循证药学 。电话：0830- treatment of migraine were collected. After literature screening 3165787。E-mail：lewxinn@outlook.com and data extraction ， the quality evaluation of included # 通信作者：教授，硕士生导师，硕士。研究方向：临床药学、循证 literature was performed by using the bias risk assessment tool 药学。电话：0830-3165787。E-mail：hyl3160131@163.com provided by the Cochrane system evaluator manual 5.1.0. 中国药房 2020年第31卷第18期 China Pharmacy 2020Vol. 31 No. 18 ·2275· Bayesian network Meta-analysis was performed by using GeMTC 0.14.3 software and Stata 16.0 software. RESULTS ：A total of 19 RCTs involving 11 392 patients were included ，involving 10 interventions，such as Erenumab 70，140 mg/month；Fremanezumab 675 mg/3 months，225 mg/month；Galcanezumab 120，240，300 mg/month；Eptinezumab 100 mg/3 months，300 mg/3 months and placebo. Results of Meta-analysis showed that compared with control group ，4 kinds of CGRP monoclonal antibodies significantly reduced the change of mean monthly migraine days （MMD）（P＜0.05）. Among trial groups ，compared with Galcanezumab 300 mg/month [MD ＝－1.30，95％CI（－2.59，－0.05），P＜0.05] and Eptinezumab 100 mg/3 months [MD ＝－1.18， 95％CI（－2.26，－0.03），P＜0.05]，Fremanezumab 225 mg/month could significantly reduce MMD. Network Meta-analysis ranking showed that Fremanezumab 225 mg/month＞Fremanezumab 675 mg/3 months＞Galcanezumab 120 mg/month＞Erenumab 140 mg/month＞Galcanezumab 240 mg/month＞Eptinezumab 300 mg/3 months＞Erenumab 70 mg/month＞Eptinezumab 100 mg/3 months＞Galcanezumab 300 mg/month＞placebo. Compared with control group ，4 kinds of CGRP monoclonal antibodies were significantly increased of the proportion of patients whose mean monthly migraine days reduction ≥50％ compared with baseline （MMD 50）（P＜0.05）. Among trial groups ，compared with Eptinezumab 100 mg/3 months group ，MMD 50 of Fremanezumab 675 mg/3 months group [OR ＝1.51，95％CI（1.02，2.31），P＜0.05]，Fremanezumab 225 mg/month group [OR ＝1.58，95％CI （1.05，2.44），P＜0.05] were increased significantly. Network Meta-analysis ranking showed that Fremanezumab 225 mg/month＞ Fremanezumab 675 mg/3 months＞Erenumab 140 mg/month＞Galcanezumab 120 mg/month＞Eptinezumab 300 mg/3 months＞ Galcanezumab 240 mg/month＞Erenumab 70 mg/month＞Galcanezumab 300 mg/month＞Eptinezumab 100 mg/3 months＞placebo. In terms of safety ，incidence of total adverse events （AE）of trial groups receiving Fremanezumab 675 mg/3 months [OR ＝1.31， 95％CI（1.05，1.64），P＜0.05]，Galcanezumab 240 mg/month [OR ＝1.39，95％CI（1.09，1.74），P＜0.05] were significantly higher than control group. Among trial groups ，compared with Galcanezumab 240 mg/month group ，AE of Erenumab 70 mg/month group [OR ＝0.67，95％CI（0.50，0.93），P＜0.05]，Erenumab 140 mg/month group [OR ＝0.70，95％CI（0.51，0.98），P＜0.05] were decreased significantly. Compared with Fremanezumab 675 mg/3 months group ，AE of Erenumab 70 mg/month group [OR ＝ 0.72，95％CI（0.52，0.98），P＜0.05] were decreased significantly. Network Meta-analysis ranking showed that Galcanezumab 240 mg/month＞ Fremanezumab 675 mg/3 months＞Galcanezumab 120 mg/month＞Galcanezumab 300 mg/month＞Eptinezumab 300 mg/3 months＞Fremanezumab 225 mg/month＞Eptinezumab 100 mg/3 months＞placebo＞Erenumab 140 mg/month＞Erenumab 70 mg/month. CONCLUSIONS ：Four kinds of CGRP monoclonal antibodies are effective in the preventive treatment of migraine ， among which Fremanezumab 225 mg/month is most likely to have the best efficacy and Erenumab 70 mg/month is most likely to have the highest safety.