title: The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis.
abstract: BACKGROUND
  Migraine has been recognized as one of the leading causes of disability in the 2013 Global Burden of Disease Study and seriously affects the quality of patients' life, current treatment options are not ideal. Monoclonal antibodies to calcitonin gene-related peptide and its receptor (CGRP-mAbs) appear more promising for migraine because of considerably better effect and safety profiles. The objective of this study is to systematically assess the clinical efficacy and safety of CGRP-mAbs for migraine therapy.
  
  
  METHODS
  A systematic literature search in PubMed, Cochrane Library and Baidu Scholar was performed to identify randomized controlled trials (RCTs), which compared the effect and safety of CGRP-mAbs with placebo on migraine. Regarding the efficacy, the reduction of monthly migraine days from baseline to weeks 1-4, 5-8, and 9-12; responder rates were extracted as the outcome measures of the effects of CGRP-mAbs. Regarding the safety, total adverse events, the main adverse events, and other adverse events were evaluated.
  
  
  RESULTS
  We found significant reduction of monthly migraine days in CGRP-mAbs vs. placebo (weeks 1-4: SMD -0.49, 95% CI -0.61 to -0.36; weeks 5-8: SMD -0.43, 95% CI -0.56 to -0.30; weeks 9-12: SMD -0.37, 95% CI -0.49 to -0.24). 50% and 75% responder rates (OR 2.59, 95% CI 1.99 to 3.37; and OR 2.91, 95% CI 2.06 to 4.10) were significantly increased compared with placebo. There was no significant difference in total adverse events (OR 1.17, 95% CI 0.91 to 1.51), and the main adverse events including upper respiratory tract infection (OR 1.44, 95% CI 0.82 to 2.55), nasopharyngitis (OR 0.59, 95% CI 0.30 to 1.16), nausea (OR 0.61, 95% CI 0.29 to 1.32), injection-site pain (OR 1.73, 95% CI 0.95 to 3.16) and back pain (OR 0.97, 95% CI 0.49 to 1.90) were not obviously changed compared with placebo control, but the results showed significant increase of dizziness in CGRP-mAbs vs. placebo (OR 3.22, 95% CI 1.09 to 9.45).
  
  
  CONCLUSIONS
  This meta-analysis suggests that CGRP-mAbs are effective in anti-migraine therapy with few adverse reactions, but more and larger sample-size RCTs are required to verify the current findings.
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China.
authors.forename: Min
authors.initials: M
authors.lastname: Hou
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China.
authors.forename: Haiyan
authors.initials: H
authors.lastname: Xing
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China.
authors.forename: Yongqing
authors.initials: Y
authors.lastname: Cai
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China.
authors.forename: Bin
authors.initials: B
authors.lastname: Li
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China.
authors.forename: Xianfeng
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China.
authors.forename: Pan
authors.initials: P
authors.lastname: Li
authors.affiliation: China Pharmacy Publishing House, Chongqing, 500000, People's Republic of China.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Hu
authors.affiliation: Department of Pharmacy, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, 400042, People's Republic of China. chenjh-110@263.net.
authors.forename: Jianhong
authors.initials: J
authors.lastname: Chen
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D015740:Calcitonin Gene-Related Peptide / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000379:methods; D004244:Dizziness / Q000139:chemically induced; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy* / Q000378:metabolism; D009325:Nausea / Q000139:chemically induced; D018015:Receptors, Calcitonin Gene-Related Peptide / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018015:Receptors, Calcitonin Gene-Related Peptide; D015740:Calcitonin Gene-Related Peptide
keywords: CGRP-mAb; Meta-analysis; Migraine; Monoclonal antibodies to calcitonin gene-related peptide