Bispecific antibodies were associated with increased reporting of fatal cardiovascular adverse events (aROR 2.04) and hypotension (aROR 2.15) compared to all other drugs in the FAERS database.
Observational (n=246,490)
Are bispecific antibodies associated with increased cardiovascular adverse events compared to other drugs in the FAERS database?
Bispecific antibodies used for relapsed/refractory B-cell non-Hodgkin lymphomas are associated with significant cardiovascular toxicity signals, including hypotension and fatal events, highlighting the need for targeted cardiovascular assessment.
Effect estimate: aROR 2.04 (95% CI 1.60-2.60)
Abstract Bispecific antibodies (BsAb) approved for relapsed/refractory B-cell non-Hodgkin lymphomas (R/R NHL) redirect T-cells to malignant cells and have been associated with cardiovascular adverse events (CVAEs). We analyzed the FDA Adverse Event Reporting System (FAERS) data from December 2022 to September 2025 to characterize the safety of mosunetuzumab, glofitamab, and epcoritamab. Among 246,490 adverse event reports, 1,931 involved BsAbs. CVAEs occurred in 336 (17.4%) BsAb-associated reports of which 132 (39.3%) were fatal. The most frequent CVAEs were shock (3.2%), bleeding (3.0%), and hypotension (2.7%). As a class, BsAbs were associated with increased reporting of hypotension (aROR: 2.15, 95% CI = 1.48–3.13) and fatal CVAEs (aROR: 2.04, 95% CI = 1.60–2.60) compared to all other drugs in the FAERS database. Individual drugs showed distinct patterns: epcoritamab showed the strongest hypotension signal (aROR: 2.37, 95% CI = 1.55–3.62) and increased fatal CVAE reporting (aROR: 2.26, 95% CI = 1.72–2.98), while mosunetuzumab was associated with atrial fibrillation/flutter (aROR: 3.04, 95% CI = 1.53–6.03), supraventricular tachycardia (aROR: 2.72, 95% CI = 1.42–5.21), and tachyarrhythmias (aROR: 2.60, 95% CI = 1.44–4.72). CVAEs occurred earlier than non-CVAEs (median, 10 vs. 16 days, P < 0.001). Cytokine release syndrome occurred in 33.4% of BsAb-related adverse events, with hypotension most commonly overlapping (53.8%), while most arrhythmias occurred independently. These findings highlight cardiovascular toxicity signals associated with BsAbs and underscore the need for continued surveillance, risk stratification, and targeted cardiovascular assessment as these expand into broader clinical practice. However, consistent with the limitations of pharmacovigilance analyses, particularly the reliance on spontaneous adverse event reporting, these observations require confirmation in prospective studies.
Munir et al. (Tue,) conducted a observational in Relapsed or refractory B-cell non-Hodgkin lymphomas (n=246,490). Bispecific antibodies (mosunetuzumab, glofitamab, epcoritamab) vs. All other drugs in the FAERS database was evaluated on Fatal cardiovascular adverse events (aROR 2.04, 95% CI 1.60-2.60). Bispecific antibodies were associated with increased reporting of fatal cardiovascular adverse events (aROR 2.04) and hypotension (aROR 2.15) compared to all other drugs in the FAERS database.
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