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Early Steroid and Anakinra Use to Manage Axicabtagene Ciloleucel Toxicity Reduces the Total Duration of CRS and ICANS.

Early Steroid and Anakinra Use to Manage Axicabtagene Ciloleucel Toxicity Reduces the Total Duration of CRS and ICANS. Blood advances Wang, W. L., Lee, D., Cheung, E., Jensen, A., Rana, M. S., Goyal, A., Hamilton, M. P., Ghalehsari, N., Latchford, T., Scott, B. J., Mallampet, J., Heng, E., Khan, H., Zarak, M. S., Lohman, C., Sahaf, B., Sidana, S., Weng, W. K., Smith, M., Bharadwaj, S., Frank, M. J., Miklos, D. B., Dahiya, S. 2026

Abstract

Axicabtagene ciloleucel (axi-cel) is an effective CAR-T cell therapy for relapsed or refractory (R/R) large B-cell lymphoma (LBCL). Yet, controlling cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) without compromising therapeutic efficacy remains a difficult challenge. In July 2020, our center adopted a toxicity management protocol modified from Cohort 4 of the registrational ZUMA-1 trial, with earlier steroid use and incorporation of anakinra in toxicity management. To evaluate this change, we conducted a retrospective analysis of patients receiving axi-cel for R/R LBCL in the 3L+ setting from January 2018 through April 2023. The outcomes of interest were toxicity incidence/duration, treatment response, CAR-T expansion, and drug/healthcare utilization. Out of the 195 identified patients, the post-change cohort (N = 103) had higher anakinra (22% vs. 5%) and steroid (88% vs. 71%) usage rates than the comparator cohort (N = 92) without increases in cumulative steroid dose. Overall CRS and ICANS rates were similar, with directionally lower severe (grade 3+) ICANS rates in the post-change cohort. A significant reduction in CRS and ICANS duration was observed with the new protocol (adj. est: -0.93 [95% CI: -1.67, -0.19] days and -2.49 [95% CI: -4.96, -0.03] days, respectively). Day 7 CAR-T expansion was lower in the post-change cohort, possibly due to the earlier steroid use. However, efficacy outcomes, ICU admission rates, and hospitalization length were similar between the cohorts. This study supports earlier intervention for CAR-T toxicities and establishes anakinra as a safe and effective alternative toxicity management drug to tocilizumab.

View details for DOI 10.1182/bloodadvances.2025019031

View details for PubMedID 41855506