| アブストラクト | BACKGROUND: T-cell engagers (TCEs) are transformative immunotherapies with significant potential in treating hematologic malignancies and solid tumors. However, their real-world safety profiles remain inadequately characterized. RESEARCH DESIGN AND METHODS: Using the FDA Adverse Event Reporting System (FAERS) database (October 2019 - September 2024, 8,747,158 reports), we analyzed adverse events (AEs) associated with nine TCEs. Disproportionality analysis identified overreported AEs, with 11,963 unique reports analyzed after deduplication. RESULTS: Blinatumomab was the most reported TCE (n = 4,950), and Tarlatamab the least (n = 185). Predominant AEs included immune system disorders, particularly cytokine release syndrome (IC(025) range: 6.08-7.47). Drug-specific signals included reproductive system and breast disorders (IC(025): 2.74) and vascular disorders (IC(025): 2.25) with Tebentafusp, renal and urinary disorders with Epcoritamab (IC(025): 1.84), and eye disorders with Elranatamab (IC(025): 1.81). Novel AEs were also uncovered, including second malignant neoplasms, vasogenic cerebral edema with Mosunetuzumab (IC(025): 5.77, ROR(025): 56.29), and hydronephrosis with Epcoritamab (IC(025): 7.50, ROR(025): 180.70). Early-onset events (0.5-9.5 days) were linked to four TCEs, while delayed-onset events (>20 days) were linked to five others. CONCLUSIONS: This study highlights diverse AE profiles of TCEs, providing insights for clinicians to optimize their safe use in practice. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/2/21 |
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| 投稿者 | Le, Xiangyang; Zhang, Yefu; Ma, Junlong |
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| 組織名 | Department of Pharmacy, Yiyang Central Hospital, Yiyang, Hunan, China.;Quality Control Department, Yiyang Central Hospital, Yiyang, Hunan, China.;Center of Clinical Pharmacology, Third Xiangya Hospital, Central South;University, Changsha, Hunan, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39982395/ |
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