Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment
Abstract Migraine significantly impacts quality of life, with eptinezumab emerging as a promising calcitonin gene-related peptide-targeting therapy. Real-world data and clinical trials are crucial for evaluating its safety and effectiveness comprehensively. This study evaluated its safety using a du...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-07-01
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| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-025-09490-1 |
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| Summary: | Abstract Migraine significantly impacts quality of life, with eptinezumab emerging as a promising calcitonin gene-related peptide-targeting therapy. Real-world data and clinical trials are crucial for evaluating its safety and effectiveness comprehensively. This study evaluated its safety using a dual approach: pharmacovigilance analysis of the FDA’s Adverse Event Reporting System (FAERS) database (2020–2024) and a systematic review with meta-analysis of clinical trials. FAERS data identified 5,306 adverse event (AE) reports, with “drug ineffective” (ROR = 6.71) and “migraine” (ROR = 67.45) as the strongest signals. Serious adverse events (SAEs) included anaphylactic reactions (ROR = 4.19) and rare events like increased intracranial pressure. Most AEs occurred within the first treatment month. A meta-analysis of six trials (n = 3,148) found no increased overall AE risk versus placebo (RR = 1.02, 95% CI 0.95–1.10) but a higher SAE incidence (RR = 2.87, 95% CI 1.27–6.48). Upper respiratory infections were more frequent (RR = 1.49, P = 0.04), while dizziness, nausea, and fatigue showed no significant differences. Eptinezumab shows promise but warrants further research on safety in vulnerable populations and real-world settings. |
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| ISSN: | 2045-2322 |