| アブストラクト | BACKGROUND: Disease-modifying therapies (DMTs) are the cornerstone of remission-phase management for multiple sclerosis (MS), a prevalent autoimmune neuroinflammatory disorder of the central nervous system. However, their immune-modulating mechanisms carry inherent risks of systemic and neurological adverse events (ADEs), which remain a major barrier to optimal long-term care. This study aimed to comprehensively characterize the real-world safety profiles of all major MS DMT classes and identify clinically actionable safety signals. METHODS: We analyzed 15-year (2009Q1-2023Q4) ADE reports for 8 classes of FDA-approved MS DMTs from the FDA Adverse Event Reporting System (FAERS) database. Four disproportionality algorithms (ROR, PRR, BCPNN, MGPS) were used for signal detection. Time-to-onset (TTO) analysis with Weibull distribution and multivariate logistic regression were performed to assess temporal risk patterns and patient-specific risk factors for important medical events (IMEs). RESULTS: A total of 498,847 ADE reports (1,048,575 events) were included, with nearly 50% involving IMEs. The most common ADEs were systemic symptoms, infections, liver injury and alopecia. Notably, progressive multifocal leukoencephalopathy (PML, ROR = 15.59) and spontaneous abortion (ROR = 2.54) were identified as high-risk severe events. Drug-specific analysis revealed distinct safety signatures: anti-CD20 antibodies carried the highest infection risk, natalizumab was strongly associated with PML (ROR = 45.62), and teriflunomide had the highest alopecia risk (ROR = 12.73). Approximately 70% of IMEs occurred within 2 years of treatment initiation. Multivariate analysis identified older age, male sex and longer treatment duration as independent risk factors for IMEs, while obesity was a protective factor. CONCLUSIONS: This long-term FAERS-based analysis identified potential safety signals associated with major MS DMTs, providing hypothesis-generating evidence to support clinical vigilance and prioritize further validation, but not to estimate incidence, comparative risk, or causality. |
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| ジャーナル名 | Frontiers in neurology |
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| Pubmed追加日 | 2026/10/28 |
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| 投稿者 | Lin, Sen; Zhang, Bei; Zhang, Yingzhao; Zhang, Xinyu; Li, Yijia; Zhang, Weiqing; He, Li |
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| 組織名 | The Fourth Clinical Medical College, Guangzhou University of Chinese Medicine,;Guangzhou, China.;The Chinese University of Hong Kong, Hong Kong, China.;Department of Oncology, Shenzhen Hospital (Futian) of Guangzhou University of;Chinese Medicine, Shenzhen, China.;Department of Traditional Chinese Medicine, Shenzhen Longhua District People's;Hospital, Shenzhen, China.;Department of Oncology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen,;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42947850/ |
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