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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| _version_ | 1852022551668064256 |
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| author | Xiangyang Le (8769839) |
| author2 | Yefu Zhang (20765237) Junlong Ma (8769845) |
| author2_role | author author |
| author_facet | Xiangyang Le (8769839) Yefu Zhang (20765237) Junlong Ma (8769845) |
| author_role | author |
| dc.creator.none.fl_str_mv | Xiangyang Le (8769839) Yefu Zhang (20765237) Junlong Ma (8769845) |
| dc.date.none.fl_str_mv | 2025-02-21T15:40:04Z |
| dc.identifier.none.fl_str_mv | 10.6084/m9.figshare.28458680.v1 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/dataset/Comprehensive_analysis_of_adverse_events_associated_with_T-cell_engagers_using_the_FAERS_database/28458680 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Medicine Pharmacology Biotechnology Immunology Cancer Mental Health Biological Sciences not elsewhere classified T-cell engagers pharmacovigilance FAERS disproportionality analysis adverse events |
| dc.title.none.fl_str_mv | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| dc.type.none.fl_str_mv | Dataset info:eu-repo/semantics/publishedVersion dataset |
| description | <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> |
| eu_rights_str_mv | openAccess |
| id | Manara_0856bc5cebf70dab6dd7e2e1e498b430 |
| identifier_str_mv | 10.6084/m9.figshare.28458680.v1 |
| network_acronym_str | Manara |
| network_name_str | ManaraRepo |
| oai_identifier_str | oai:figshare.com:article/28458680 |
| publishDate | 2025 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS databaseXiangyang Le (8769839)Yefu Zhang (20765237)Junlong Ma (8769845)MedicinePharmacologyBiotechnologyImmunologyCancerMental HealthBiological Sciences not elsewhere classifiedT-cell engagerspharmacovigilanceFAERSdisproportionality analysisadverse events<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>2025-02-21T15:40:04ZDatasetinfo:eu-repo/semantics/publishedVersiondataset10.6084/m9.figshare.28458680.v1https://figshare.com/articles/dataset/Comprehensive_analysis_of_adverse_events_associated_with_T-cell_engagers_using_the_FAERS_database/28458680CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/284586802025-02-21T15:40:04Z |
| spellingShingle | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database Xiangyang Le (8769839) Medicine Pharmacology Biotechnology Immunology Cancer Mental Health Biological Sciences not elsewhere classified T-cell engagers pharmacovigilance FAERS disproportionality analysis adverse events |
| status_str | publishedVersion |
| title | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| title_full | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| title_fullStr | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| title_full_unstemmed | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| title_short | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| title_sort | Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database |
| topic | Medicine Pharmacology Biotechnology Immunology Cancer Mental Health Biological Sciences not elsewhere classified T-cell engagers pharmacovigilance FAERS disproportionality analysis adverse events |