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

Int J Neurosci. 2023 Dec;133(8):925-933. doi: 10.1080/00207454.2022.2098732. Epub 2022 Jul 19.


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; calcitonin gene-related peptide; headache; meta-analysis; migraine.

Publication types

  • Systematic Review
  • Meta-Analysis

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Double-Blind Method
  • Humans
  • Migraine Disorders* / drug therapy
  • Treatment Outcome


  • galcanezumab
  • Antibodies, Monoclonal, Humanized