A real-world data claims-based review of CAR-T procedures, time to adverse events, patient characteristics and social factors.

Abstract

11163 Background: With the increasing utilization of Chimeric antigen receptors T-cell therapies (CAR-T), administrative claims can provide insights into approved CAR-T therapies, procedures, associated adverse events (AEs) and population characteristics. Methods: We used administrative open claims with medical and pharmacy encounters of 330 million US patients (PurpleLab). We identified patients with a coded AE as the principial diagnosis following the first initial claim with any CAR-T. CAR-T claims were identified with drug and procedure coding. The AEs included were Cytokine release syndrome (CRS), Immune effector-cell associated neurotoxicity (ICANS), complication of immune effector cellular therapy, tumor lysis, and cardiovascular events such as arrhythmias. The time to the AE and death were noted. In cases where social determinants of health (SDOH) are noted, race, gender, marital status, occupation, and education were analyzed. Results: The number of patients with CAR-T related claims within the database was 20,003. Of those patients, approximately 10% (2166) had at least one claim with an AE code as the principal diagnosis reported following the very first CAR-T claim. For those with an initial AE claim, 38% had a cardiovascular event, 36% had a complication of immune effector cellular therapy, 13% had a CRS event, 7% had an ICANS, 2% had a tumor lysis event, and 1.3% had a secondary lymphoma. Most AEs occurred within the first 30 to 90 days from the first documented CAR-T claim procedure. Cardiac and complication AEs were higher in patients aged greater than 65, while tumor lysis was higher in patients under 65. Death was reported in a quarter of the patients (532 patients) with 65% of those recorded deaths occurring within a year post first CAR-T related claim. Of those patients with a documented social demographic factor, patients with AEs were white males (41%), Asian males (2.6%), African American males (2.7%), and unspecified males (17%) making up the other races and gender. In terms of occupation and education, 34% were white collar, 5% blue collar, and 4% retired, and 29% had some level of high school, 23% college-level education, and 13% were postgraduate. More patients were identified as married (34%) than single (14%) and approximately 57% had an income below $100,000, while 11% were above $100,000, with the remaining incomes were not recorded. Conclusions: Real-world data can provide insights into CAR-T and AEs, patient social factors, and temporal trends. Age greater than 65 seemed the more prevalent SDOH with higher AE seen in this subgroup. Additional investigation on AEs within the different patient population subgroups are needed to provide deeper insights into treatment effects.