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The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Forest plot of the meta-analysis showed significant decrease in 50 and 75% responder rates of CGRP-mAbs compared with placebo. a 50% responder rates; b 75% responder rates. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval
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Fig6: Forest plot of the meta-analysis showed significant decrease in 50 and 75% responder rates of CGRP-mAbs compared with placebo. a 50% responder rates; b 75% responder rates. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval

Mentions: Fifty percent responder rate was counted in the five included studies with a total of 962 subjects [35–39], and 75% responder rate was counted in four included studies with a total of 719 subjects [35–38]. 100% responder rate was not analyzed due to the small sample size (only 2 trials), but the results with CGRP-mAbs were increased compared with placebo [37, 38]. Figure 6 showed significant decrease in 50 and 75% responder rates of CGRP-mAbs for migraine compared with placebo (OR 2.59, 95% CI 1.99 to 3.37; and OR 2.91, 95% CI 2.06 to 4.10). Furthermore, the meta-analysis results of the included tails found a low level of heterogeneity (χ2 = 1.31 and 1.44, P = 0.86 and 0.70, I2 = 0%). The funnel plot showed no obvious publication bias for the meta-analysis of responder rates (Fig. 7).Fig. 6


The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis
Forest plot of the meta-analysis showed significant decrease in 50 and 75% responder rates of CGRP-mAbs compared with placebo. a 50% responder rates; b 75% responder rates. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
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getmorefigures.php?uid=PMC5383797&req=5

Fig6: Forest plot of the meta-analysis showed significant decrease in 50 and 75% responder rates of CGRP-mAbs compared with placebo. a 50% responder rates; b 75% responder rates. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval
Mentions: Fifty percent responder rate was counted in the five included studies with a total of 962 subjects [35–39], and 75% responder rate was counted in four included studies with a total of 719 subjects [35–38]. 100% responder rate was not analyzed due to the small sample size (only 2 trials), but the results with CGRP-mAbs were increased compared with placebo [37, 38]. Figure 6 showed significant decrease in 50 and 75% responder rates of CGRP-mAbs for migraine compared with placebo (OR 2.59, 95% CI 1.99 to 3.37; and OR 2.91, 95% CI 2.06 to 4.10). Furthermore, the meta-analysis results of the included tails found a low level of heterogeneity (χ2 = 1.31 and 1.44, P = 0.86 and 0.70, I2 = 0%). The funnel plot showed no obvious publication bias for the meta-analysis of responder rates (Fig. 7).Fig. 6

View Article: PubMed Central - PubMed

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.

No MeSH data available.