Infection-related adverse events associated with T-cell-engaging bispecific agents: A real-world pharmacovigilance study using FAERS/AEMS
Abstract
Background T-cell-engaging bispecific agents and related T-cell-engaging therapies are increasingly used across hematologic malignancies and selected solid tumors. Infection is a clinically important safety concern, but infection-focused post-marketing comparisons across the current product set remain limited. We evaluated infection-related adverse event reporting for T-cell-engaging agents using the FDA Adverse Event Reporting System/Adverse Event Monitoring System (FAERS/AEMS). Methods Public FAERS/AEMS quarterly ASCII files from 2022Q1 to 2026Q1 were analyzed. Reports were deduplicated by retaining the latest case version for each CASEID, and exposure was defined as a target T-cell-engaging agent recorded as the primary suspect drug. Infection-related events were identified with a prespecified MedDRA preferred-term dictionary and were summarized using a structured dominant-category framework. Disproportionality was assessed using reporting odds ratio (ROR) with 95% confidence interval (CI), with proportional reporting ratio (PRR) and information component (IC) as supportive metrics. Reporting followed the READUS-PV guideline for disproportionality analyses of individual case safety reports. Results Among 6,102,203 deduplicated primary-suspect reports, 15,108 involved a target T-cell-engaging agent, of which 3,114 were infection-related (20.6%). The class-level infection-related reporting signal was significant (ROR 2.03 (1.95-2.11); IC025 0.80). The largest number of infection-related reports was observed for Teclistamab (Tecvayli) (829 reports), whereas the highest drug-level ROR was observed for Elranatamab (Elrexfio) (ROR 4.38 (3.94-4.87)). Prominent preferred-term signals included pneumonia (ROR 2.01 (1.84-2.21)), sepsis (ROR 3.76 (3.32-4.24)), septic shock (ROR 4.39 (3.71-5.19)), cytomegalovirus infection reactivation (ROR 27.19 (23.39-31.60)), and cytomegalovirus infection (ROR 12.60 (10.71-14.82)). The class-level signal persisted under the narrower infection definition (2,545 reports; ROR 1.95, 95% CI 1.87-2.03). Concordant DailyMed infection terms and FAERS/AEMS infection signals were found for 7 agents. Conclusions FAERS/AEMS data showed a class-level reporting signal for infection-related adverse events with T-cell-engaging agents, particularly among BCMA x CD3 and CD20 x CD3 therapies. Cytomegalovirus-related events, pneumonia, and sepsis were prominent signal patterns. These findings are hypothesis-generating reporting patterns and should not be interpreted as incidence estimates, relative risks, or proof of causality.
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BibTeX
@article{liu2026infectionrelated,
title = {{Infection-related adverse events associated with T-cell-engaging bispecific agents: A real-world pharmacovigilance study using FAERS/AEMS}},
author = {Shui Liu and Ye Tan and Aidong Chen and Qian Liu},
journal = {International Journal of Immunopathology and Pharmacology},
year = {2026},
month = oct,
doi = {10.1177/03946320261499210},
url = {https://doi.org/10.1177/03946320261499210},
note = {CC BY},
}
RIS
TY - JOUR
TI - Infection-related adverse events associated with T-cell-engaging bispecific agents: A real-world pharmacovigilance study using FAERS/AEMS
AU - Shui Liu
AU - Ye Tan
AU - Aidong Chen
AU - Qian Liu
PY - 2026
DA - 2026/10/28
JO - International Journal of Immunopathology and Pharmacology
DO - 10.1177/03946320261499210
UR - https://doi.org/10.1177/03946320261499210
AB - Background T-cell-engaging bispecific agents and related T-cell-engaging therapies are increasingly used across hematologic malignancies and selected solid tumors. Infection is a clinically important safety concern, but infection-focused post-marketing comparisons across the current product set remain limited. We evaluated infection-related adverse event reporting for T-cell-engaging agents using the FDA Adverse Event Reporting System/Adverse Event Monitoring System (FAERS/AEMS). Methods Public FAERS/AEMS quarterly ASCII files from 2022Q1 to 2026Q1 were analyzed. Reports were deduplicated by retaining the latest case version for each CASEID, and exposure was defined as a target T-cell-engaging agent recorded as the primary suspect drug. Infection-related events were identified with a prespecified MedDRA preferred-term dictionary and were summarized using a structured dominant-category framework. Disproportionality was assessed using reporting odds ratio (ROR) with 95% confidence interval (CI), with proportional reporting ratio (PRR) and information component (IC) as supportive metrics. Reporting followed the READUS-PV guideline for disproportionality analyses of individual case safety reports. Results Among 6,102,203 deduplicated primary-suspect reports, 15,108 involved a target T-cell-engaging agent, of which 3,114 were infection-related (20.6%). The class-level infection-related reporting signal was significant (ROR 2.03 (1.95-2.11); IC025 0.80). The largest number of infection-related reports was observed for Teclistamab (Tecvayli) (829 reports), whereas the highest drug-level ROR was observed for Elranatamab (Elrexfio) (ROR 4.38 (3.94-4.87)). Prominent preferred-term signals included pneumonia (ROR 2.01 (1.84-2.21)), sepsis (ROR 3.76 (3.32-4.24)), septic shock (ROR 4.39 (3.71-5.19)), cytomegalovirus infection reactivation (ROR 27.19 (23.39-31.60)), and cytomegalovirus infection (ROR 12.60 (10.71-14.82)). The class-level signal persisted under the narrower infection definition (2,545 reports; ROR 1.95, 95% CI 1.87-2.03). Concordant DailyMed infection terms and FAERS/AEMS infection signals were found for 7 agents. Conclusions FAERS/AEMS data showed a class-level reporting signal for infection-related adverse events with T-cell-engaging agents, particularly among BCMA x CD3 and CD20 x CD3 therapies. Cytomegalovirus-related events, pneumonia, and sepsis were prominent signal patterns. These findings are hypothesis-generating reporting patterns and should not be interpreted as incidence estimates, relative risks, or proof of causality.
SN - 2058-7384
SN - 0394-6320
ER -