TUESDAY, July 30, 2024 (HealthDay News) — New-onset cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are rare beyond two weeks following infusion of CD19-directed chimeric antigen receptor T (CAR T)-cell therapies, according to a study published online July 23 in Blood Advances.
Noting that the U.S. Food and Drug Administration has mandated that patients should remain close to treatment centers for four weeks to monitor and manage toxicity risks associated with CD19-directed CAR T-cell therapies, including CRS and ICANS, Nausheen Ahmed, M.D., from the University of Kansas Medical Center in Westwood, and colleagues conducted a retrospective cohort study involving 475 patients infused with axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel from 2018 to 2023 to assess onset and duration of CRS and ICANS.
The researchers found that although there were differences in the incidence and duration of CRS and ICANS between CAR T-cell products, new-onset CRS and ICANS were extremely rare after two weeks following infusion, occurring in 0 and 0.7 percent, respectively. After two weeks, there were no new cases of CRS, while a single case of new-onset ICANS occurred in the third week following infusion. In the early follow-up period, nonrelapse mortality was driven by ICANS (1.1 percent until day 28), followed by infection through three months postinfusion (1.2 percent).
“These data support further investigation into individualized monitoring strategies for stable patients,” the authors write. “A flexible monitoring period may help to decrease financial and geographic limitations for patients and make CAR T more accessible and feasible.”
Several authors disclosed ties to the biopharmaceutical industry.
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