Real-world effectiveness and safety of galcanezumab for the treatment of migraine: A systematic review and meta-analysis

Abstract

OBJECTIVE: This study aimed to summarize and pool real-world evidence on the clinical effectiveness and safety of galcanezumab. BACKGROUND: Migraine is a disabling primary headache disorder. Several drugs that target calcitonin gene-related peptide, such as galcanezumab, have recently been developed. However, real-world effects have not been well studied. METHODS: A systematic search of PubMed, Scopus, and Web of Science was conducted from inception to February 2025. Studies that estimated the real-world effects of galcanezumab on monthly migraine days (MMDs), monthly headache days (MHDs), Headache Impact Test, Migraine Disability Assessment Scale, number of days in medication, acute monthly intake (AMI), pain intensity, and safety outcomes were included. Meta-analyses of proportions or mean differences were performed. RESULTS: Thirty-six studies were included, with an agreement of 0.93 [95% confidence interval (CI): 0.90, 0.96]. One month after the first injection, the reduction effects were -6.93 days (95% CI: -7.88, -5.99) for MMD, -8.55 days (95% CI: -11.32, -5.78) for MHD, and -7.96 points (95% CI: -8.93, -6.99) for Headache Impact Test. Over 60% of patients achieved a reduction in MMD/MHD of at least 50% within 3 months. The effect increased gradually and slightly up to 12 months. The adverse event rates were 0.25 (95% CI: 0.14, 0.38) and 0.35 (95% CI: 0.27, 0.45) at 6 and 12 months, respectively, with constipation being the most common. CONCLUSION: Galcanezumab appears to be associated with clinically meaningful improvements in migraine and favorable safety outcomes, although the evidence certainty is limited by heterogeneity.