Abstract
Background and Objective
Several studies on use of erenumab for migraine treatment have been published over recent years. However, its long-term safety and effectiveness have not been consistently established in the literature yet. We aimed to perform a qualitative and quantitative analysis of the long-term safety and effectiveness of erenumab for the treatment of migraine headaches.
Methods
Long-term follow-up was defined as ≥ 1 year. PubMed, Embase and Cochrane Library were systematically searched from inception to 14 June 2022 for studies meeting the inclusion criteria. Risk of bias was assessed using the Newcastle-Ottawa Scale.
Results
Fourteen studies, comprising 3574 patients, were included. The total follow-up period ranged from 48 to 268 weeks (i.e., 1 year to 5.6 years). Pooled estimate rates for all adverse events (AEs) were 63% (95% CI 46–78); for serious AEs, 3% (95% CI 1–7); and for AEs leading to discontinuation of erenumab, 3% (95% CI 2–5). Reduction in monthly migraine days (MMDs) was −6.98 (95% CI −8.90 to −5.05) and in migraine-specific medication days (MSMDs) was − 6.09 (95% CI − 9.43 to − 2.75). More than half (57%; 95% CI 51–63) and around one-third (35%; 95% CI 28–42) of patients presented with reductions of ≥ 50% and ≥ 75% in MMDs, respectively. Headache Impact Test-6 (HIT-6) score was decreased by −9.68 points (95% CI − 12.03 to − 7.34). Nine studies were considered of poor methodological quality and five of fair quality.
Conclusions
Erenumab has a favorable safety profile, with a low incidence of serious AEs, and sustained efficacy over ≥1 year of follow-up in the treatment of migraine.
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FFB: study conception and design, acquisition of data, analysis and interpretation of data, drafting of manuscript and critical revision. JPMT: analysis and interpretation of results and critical revision. RBR: acquisition of data and critical revision. GIC: draft manuscript preparation. GBN: draft manuscript preparation. All authors have read and agreed to the final version of the manuscript.
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Bomtempo, F.F., Rocha, R.B., Cenci, G.I. et al. Long-Term Safety and Effectiveness of Erenumab in Patients with Migraine: A Systematic Review and Single-Arm Meta-analysis. Clin Drug Investig 43, 45–59 (2023). https://doi.org/10.1007/s40261-022-01230-x
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DOI: https://doi.org/10.1007/s40261-022-01230-x