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...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-07-01
|
| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-025-09490-1 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849333312369197056 |
|---|---|
| author | Junchen Chen Shunqiu Huang Yashi Chen Cheng Luo Yong Li |
| author_facet | Junchen Chen Shunqiu Huang Yashi Chen Cheng Luo Yong Li |
| author_sort | Junchen Chen |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e8b77f1fd3434d169ca4498bfe1f28b0 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-e8b77f1fd3434d169ca4498bfe1f28b02025-08-20T03:45:55ZengNature PortfolioScientific Reports2045-23222025-07-0115111510.1038/s41598-025-09490-1Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatmentJunchen Chen0Shunqiu Huang1Yashi Chen2Cheng Luo3Yong Li4Department of Neurosurgery, The First Affiliated Hospital of Shantou University Medical CollegeDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical CollegeDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical CollegeDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical CollegeDepartment of Neurosurgery, The First Affiliated Hospital of Shantou University Medical CollegeAbstract 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.https://doi.org/10.1038/s41598-025-09490-1EptinezumabMigrainePharmacovigilanceFAERSAdverse eventsCGRP |
| spellingShingle | Junchen Chen Shunqiu Huang Yashi Chen Cheng Luo Yong Li Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment Scientific Reports Eptinezumab Migraine Pharmacovigilance FAERS Adverse events CGRP |
| title | Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment |
| title_full | Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment |
| title_fullStr | Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment |
| title_full_unstemmed | Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment |
| title_short | Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment |
| title_sort | comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment |
| topic | Eptinezumab Migraine Pharmacovigilance FAERS Adverse events CGRP |
| url | https://doi.org/10.1038/s41598-025-09490-1 |
| work_keys_str_mv | AT junchenchen comprehensivesafetyanalysisofadverseeventsassociatedwitheptinezumabinmigrainetreatment AT shunqiuhuang comprehensivesafetyanalysisofadverseeventsassociatedwitheptinezumabinmigrainetreatment AT yashichen comprehensivesafetyanalysisofadverseeventsassociatedwitheptinezumabinmigrainetreatment AT chengluo comprehensivesafetyanalysisofadverseeventsassociatedwitheptinezumabinmigrainetreatment AT yongli comprehensivesafetyanalysisofadverseeventsassociatedwitheptinezumabinmigrainetreatment |