Real-world effectiveness and safety of galcanezumab for the treatment of migraine: A systematic review and meta-analysis
Objetive: 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....
| Autores: | , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Universidad de Castilla-La Mancha |
| Repositorio: | RUIdeRA. Repositorio Institucional de la UCLM |
| OAI Identifier: | oai:ruidera.uclm.es:10578/45681 |
| Acceso en línea: | https://doi.org/10.1111/head.70003 https://hdl.handle.net/10578/45681 |
| Access Level: | acceso abierto |
| Palabra clave: | Headache Migraine Monoclonal antibodies Neurology Pharmacology Quality of life |
| Sumario: | Objetive: 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. Plain Language Summary: Galcanezumab is a calcitonin gene-related peptide-targeting agent that has shown high efficacy in the treatment of migraine under controlled conditions, such as in randomized clinical trials. In order to assess its usefulness in the real world, we reviewed a large number of published studies from real-world clinical settings to assess the effectiveness and safety of galcanezumab in these conditions. Our study showed statistically and clinically significant reductions in monthly migraine or headache days, rescue medication use and medication days, and pain scores, which support the evidence from randomized clinical trials and help guide physicians in the management of patients with migraine. |
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