Efficacy and safety of galcanezumab for migraine: evidences from direct and indirect comparisons

Abstract

Background

The optimal dose of galcanezumab for patients with migraine remains uncertain. Therefore, we conducted a network meta-analysis to assess the comparative effectiveness of various doses of galcanezumab for this group of patients.

Methods

A systematically search was implemented in several databases including the PubMed, Ovid MEDILNE, Ovid EMBASE and Cochrane Library from inception of the databases until 31 August 2020. Only randomized clinical trials of adults with migraine that assessed galcanezumab therapy and reported clinical outcomes were included. The primary efficacy outcome was monthly change in migraine headache days (MHDs). The primary safety outcome was treatment-emergent adverse events (TEAEs).

Results

Overall, eight randomized clinical trials included 4,720 patients, were assessed in our systematic review. In terms of efficacy, galcanezumab 120 and 240 mg significantly reduced monthly MHDs (MD −2.02, 95% CrI −2.62 to −1.42; MD −2.06, 95% CrI −2.74 to −1.36, respectively) compared to the placebo. In terms of safety, galcanezumab 120, 150 mg and 240 mg significantly increased incidences of adverse events (RR 1.11, 95% CrI 1.03–1.20; RR 1.85, 95% CrI 1.27–2.81; RR 1.15, 95% CrI 1.06–1.24, respectively).

Conclusions

Galcanezumab 240 mg offers the first level in terms of efficacy outcomes and galcanezumab 150 mg ranks the first level in terms of increasing treatment-emergent adverse events among adult patients with migraine. Attention should be devoted to the potential risk of adverse events, especially for injection site pain when the drug is administered subcutaneously.

Keywords:

• Galcanezumab
• migraine
• calcitonin gene-related peptide
• meta-analysis
• headache

Acknowledgements

None.

Authors’ contributions

XW and CY designed the meta-analysis, XW and YC searched for relevant studies, XW and YC selected the studies, extracted the relevant information, XW and JS synthesized the data, XW wrote the first draft of the paper. All authors revised the manuscript and approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Disclosure statement

The authors report no conflict of interest.

Additional information

Funding

This work was supported by the 1·3·5 project for disciplines of excellence–Clinical Research Incubation Project, West China Hospital, Sichuan University (2018HXFH010).