Introduction

Coagulopathy is an increasingly recognized and potentially life-threatening complication following chimeric antigen receptor (CAR) T-cell therapy. The spectrum of hemostatic abnormalities observed in this setting ranges from mild, asymptomatic laboratory findings, such as isolated prolongation of the activated partial thromboplastin time, to severe coagulopathies, including DIC [1,2]. These coagulation disorders frequently emerge in the context of cytokine release syndrome (CRS), a well-characterized and common toxicity associated with CAR T-cell therapy. This association suggests an underlying pathophysiological link mediated by systemic inflammation, endothelial activation, and consumption of coagulation factors [3,4].

Coagulopathy typically develops within a few days of CRS onset and can occur as early as 6 days postinfusion [5,6]. Among the coagulopathies observed, DIC, although relatively rare, represents 1 of the most clinically significant and potentially fatal complications. It has been reported in ∼14% to 50% of patients who develop severe CAR T-cell–associated coagulopathy [7]. The development of DIC appears to correlate strongly with the severity of CRS. In 1 study, DIC was observed in 7 patients (7%) who experienced grade ≥3 CRS. Of these, 2 patients had grade 3 CRS, 2 had grade 4 CRS, and 3 developed grade 5 CRS, highlighting a direct relationship between increasing CRS severity and DIC incidence. Importantly, this association was found to be independent of other clinical variables such as patient age, sex, underlying malignancy, tumor burden, or the type of lymphodepleting chemotherapy administered [5].

The clinical manifestations of DIC in CAR T-cell therapy recipients range from subclinical laboratory derangements to overt hemorrhage, multiorgan dysfunction, and death [5,8]. Data from the US Food and Drug Administration’s Adverse Event Reporting System, analyzing CAR T-cell therapy–related hematologic toxicities from 2017 to 2021, reported DIC-associated mortality rates as high as 59.6% [9].

Despite its potential severity, DIC remains undercharacterized in the context of CAR T-cell therapy, and given the expanding use of CAR T-cell therapies across hematologic malignancies, a deeper understanding of the epidemiology, clinical course, and health care burden of DIC is urgently needed. The present study aims to address this gap by evaluating the incidence, outcomes, and resource utilization associated with DIC in CAR T-cell therapy recipients using nationally representative US data. These findings are expected to inform clinical decision-making and contribute to ongoing efforts to optimize safety and outcomes in patients undergoing CAR T-cell therapy.