Efficacy And Safety Of CGRP Monoclonal Antibody For The Prevention Of Migraine

Objective: In this study we used meta-analysis to compare the efficacy and safety of calcitonin gene-related peptide(CGRP)monoclonal antibody and placebo in preventing migraine and provided evidence for the role of CGRP in the prevention of migraine.Methods: Cochrane Central Register of Controlled Trials(CENTRAL),PubMed,Embase and ClinicalTrials.gov was searched to collect any studies about comparing CGRP monoclonal antibody with placebo to prevent migraine from the database establishment time to July 5,2019.Two reviewers independently screened the literature to include relevant clinical studies according to the inclusion and exclusion criteria.The reviewers extracted data and assessed risk of bias using the Cochrane Collaboration's tool for assessing risk of bias in the included literature.Finally,we used RevMan 5.3 software for data analysis.This review has been accepted by PROSPERO(CRD42019125928).Results: A total of 17 studies Contained four CGRP monoclonal antibodies: Eptinezumab,Erenumab,Fremanezumab,and Galcanezumab,involving 10,260 participants(1,529 males and 8,731 females),and the average age of the participants was 37 to 42.The meta-analysis results were as follows:1.Migraine days per month: the improvement of migraine days per month with CGRP monoclonal antibody was better than placebo(SMD=-0.36,95%CI-0.42~-0.30;P<0.00001);2.50% response rate: the 50% response rate of CGRP monoclonal antibody was better than placebo(RR=1.56,95%CI 1.44 ~1.70).P<0.00001);3.Headache days per month: the improvement of headache days per month with CGRP monoclonal antibody was better than placebo(SMD=-0.28,95%CI-0.34~-0.22;P<0.00001);4.Migraine attack frequency per month: the improvement of migraine attack frequency by CGRP monoclonal antibody was better than placebo(SMD=-0.18,95%CI-0.31~-0.06;P= 0.004,);5.Monthly headache hours: the improvement of monthly headache hours with CGRP monoclonal antibody was better than placebo(SMD=-0.27,95%CI-0.33~0.21;P<0.00001);6.Acute medication use days: the improvement of acute medication use days with CGRP monoclonal antibody was better than placebo(SMD=-0.44,95%CI-0.51~-0.37;P< 0.00001).7.Adverse events: There was no significant difference between CGRP monoclonal antibody and placebo in the rate of withdrawal due to adverse events(RR=1.44,95%CI 0.88~2.37,P=0.15).Fremanezumab had a higher incidence of any adverse events than placebo(RR=1.12,95%CI 1.04 ~ 1.20,P=0.002),and Galcanezumab had a higher incidence of treatment-induced adverse events than placebo(RR=1.11,95%CI 1.04~1.17,P=0.0006).In terms of common adverse events,constipation and injection site pain were significantly higher in the Erenumab group than in the placebo group.Erythema and indentation at the injection site were significantly higher in Fremanezumab group than in placebo group.The upper respiratory tract infection,erythema at the injection site and pruritus of Galcanezumab group were significantly higher than those of placebo group.Conclusion: CGRP monoclonal antibody is effective in preventing migraine.However,adverse events at the injection site were associated with Erenumab,Fremanezumab,and Galcanezumab.Constipation is more common in Erenumab.There is a higher risk of upper respiratory tract infection with Galcanezumab.