Cardiovascular Toxicity Associated With Bispecific Antibodies in Hematological Malignancies: A Comprehensive Pharmacovigilance Analysis

Department

Internal Medicine

Document Type

Article

Publication Title

American Journal of Hematology

Abstract

Cardiovascular adverse events (CVAEs) associated with bispecific T-cell engaging antibodies (BsAbs) have not been systematically investigated across approved agents. In this disproportionality analysis of FAERS (December 2014-September 2025), reports listing BsAbs as the primary suspected drug (n = 7647) were compared with all other drugs in the database (N = 7 289 316) and appropriate active comparators. Adjusted reporting odds ratios (aRORs) were estimated using multivariable logistic regression, adjusting for age, sex, cardiovascular comorbidity, disease, and concomitant cardiotoxic medications. Among 7647 BsAb-associated reports (median age: 60 [36-71] years; 44.6% female), 1408 (18.4%) involved a CVAE and 447 (5.8%) were fatal. BsAbs showed increased reporting of DIC (aROR: 4.35 [3.18-5.96]; n = 49), hypotension (1.61 [1.38-1.89]; n = 181), and fatal CVAEs (1.63 [1.47-1.80]; n = 447). MM-directed BsAbs were associated with shock (2.09 [1.65-2.66]) and myocarditis (3.68 [1.49-9.10]). Blinatumomab was associated with DIC (4.41 [3.05-6.37]) and hypotension (1.46 [1.18-1.81]). Teclistamab showed the strongest myocarditis signal (5.95 [2.16-16.43]; n = 4). Mosunetuzumab showed increased reporting of atrial fibrillation (2.25 [1.15-4.38]) and supraventricular tachycardia (2.21 [1.17-4.15]). CVAEs occurred earlier than non-CVAEs (median 7 vs. 15 days; p <  0.001). The majority of hypotension (56.4%) and heart failure (44.2%) reports occurred independently of both CRS and infection. Case fatality proportions for shock (60.1%), DIC (51.0%), and heart failure (48.1%) exceeded those for CRS (24.3%). BsAb-associated cardiovascular signals, particularly DIC, hemodynamic events, and fatal CVAEs, varied by agent and target antigen. These findings support the need for cardiovascular-specific monitoring during therapy.

First Page

2546

Last Page

2556

DOI

10.1002/ajh.70449

Volume

101

Issue

10

Publication Date

10-1-2026

Publisher

Wiley-Liss

Medical Subject Headings

Humans; Antibodies, Bispecific; Female; Hematologic Neoplasms; Pharmacovigilance; Male; Middle Aged; Aged; Adult; Cardiovascular Diseases; Cardiotoxicity; Antineoplastic Agents, Immunological

PubMed ID

42499150

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