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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.


Related in: MedlinePlus

Forest plot of the meta-analysis showed non-significant difference in main adverse events of CGRP-mAbs compared with placebo. upper (a), respiratory tract infection; (b), nasopharyngitis; (c), nausea; (d), dizziness; (e), injection-site pain; (f), back pain. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval. ★ The significant result was labeled with an asterisk
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Fig10: Forest plot of the meta-analysis showed non-significant difference in main adverse events of CGRP-mAbs compared with placebo. upper (a), respiratory tract infection; (b), nasopharyngitis; (c), nausea; (d), dizziness; (e), injection-site pain; (f), back pain. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval. ★ The significant result was labeled with an asterisk

Mentions: The most frequent adverse events in migraine with CGRP-mAbs were upper respiratory tract infection, nasopharyngitis, nausea, dizziness, injection-site pain and back pain [35–39]. As shown in Fig. 10, there was no obvious difference between CGRP-mAbs and placebo group in main adverse events (upper respiratory tract infection: OR 1.44, 95% CI 0.82 to 2.55 (Fig. 10a); nasopharyngitis: OR 0.59, 95% CI 0.30 to 1.16 (Fig. 10b); nausea: OR 0.61, 95% CI 0.29 to 1.32 (Fig. 10c); injection-site pain: OR 1.73, 95% CI 0.95 to 3.16 (Fig. 10e); back pain: OR 0.97, 95% CI 0.49 to 1.90 (Fig. 10f), but the significant increase of dizziness in CGRP-mAbs was found (OR 3.22, 95% CI 1.09 to 9.45) (Fig. 10d). All I2 value revealed a non-significant heterogeneity among the included studies. The funnel plot was not created for the main adverse events due to the small sample size.Fig. 10


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 non-significant difference in main adverse events of CGRP-mAbs compared with placebo. upper (a), respiratory tract infection; (b), nasopharyngitis; (c), nausea; (d), dizziness; (e), injection-site pain; (f), back pain. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval. ★ The significant result was labeled with an asterisk
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5383797&req=5

Fig10: Forest plot of the meta-analysis showed non-significant difference in main adverse events of CGRP-mAbs compared with placebo. upper (a), respiratory tract infection; (b), nasopharyngitis; (c), nausea; (d), dizziness; (e), injection-site pain; (f), back pain. CGRP-mAbs, monoclonal antibodies to CGRP and its receptor; M-H, Mantel-Haenszel; CI, confidence interval. ★ The significant result was labeled with an asterisk
Mentions: The most frequent adverse events in migraine with CGRP-mAbs were upper respiratory tract infection, nasopharyngitis, nausea, dizziness, injection-site pain and back pain [35–39]. As shown in Fig. 10, there was no obvious difference between CGRP-mAbs and placebo group in main adverse events (upper respiratory tract infection: OR 1.44, 95% CI 0.82 to 2.55 (Fig. 10a); nasopharyngitis: OR 0.59, 95% CI 0.30 to 1.16 (Fig. 10b); nausea: OR 0.61, 95% CI 0.29 to 1.32 (Fig. 10c); injection-site pain: OR 1.73, 95% CI 0.95 to 3.16 (Fig. 10e); back pain: OR 0.97, 95% CI 0.49 to 1.90 (Fig. 10f), but the significant increase of dizziness in CGRP-mAbs was found (OR 3.22, 95% CI 1.09 to 9.45) (Fig. 10d). All I2 value revealed a non-significant heterogeneity among the included studies. The funnel plot was not created for the main adverse events due to the small sample size.Fig. 10

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.


Related in: MedlinePlus