Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database
<p>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.</p> <p>Using the FDA Adverse Event Reporting System (FAERS) da...
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2025
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| Summary: | <p>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.</p> <p>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.</p> <p>Blinatumomab was the most reported TCE (<i>n</i> = 4,950), and Tarlatamab the least (<i>n</i> = 185). Predominant AEs included immune system disorders, particularly cytokine release syndrome (IC<sub>025</sub> range: 6.08–7.47). Drug-specific signals included reproductive system and breast disorders (IC<sub>025</sub>: 2.74) and vascular disorders (IC<sub>025</sub>: 2.25) with Tebentafusp, renal and urinary disorders with Epcoritamab (IC<sub>025</sub>: 1.84), and eye disorders with Elranatamab (IC<sub>025</sub>: 1.81). Novel AEs were also uncovered, including second malignant neoplasms, vasogenic cerebral edema with Mosunetuzumab (IC<sub>025</sub>: 5.77, ROR<sub>025</sub>: 56.29), and hydronephrosis with Epcoritamab (IC<sub>025</sub>: 7.50, ROR<sub>025</sub>: 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.</p> <p>This study highlights diverse AE profiles of TCEs, providing insights for clinicians to optimize their safe use in practice.</p> |
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