Dr. Nausheen Ahmed on the Need to Monitor Infection Risk After CAR-T Therapy

Nausheen Ahmed, MD, is an Associate Professor of Medicine at the University of Kansas Cancer Center. She spoke with Heme Today about her study evaluating the safety monitoring of patients who undergo chimeric antigen receptor (CAR) T-cell therapies, which was recently published in Blood Advances.

The study evaluated the US Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program for patients following CAR-T therapy. The program features management requirements, including that patients should relocate to within two hours of an authorized treatment center for four weeks of monitoring. These precautions are meant to prevent possible occurrences of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).

“If patients were to develop CRS [or] ICANS, it typically will happen within the first two weeks. If they don’t develop it by two weeks, then it’s unlikely that they will develop it beyond two weeks,” Dr. Ahmed noted.

However, she stressed that a key finding from her study is that CRS and ICANS are not the only potential severe side effects following CAR-T therapy, and that the current REMS may not account for this. Her study examined nonrelapse-related deaths among patients who underwent CAR-T therapy and found mortality risk persisted beyond the four-week monitoring period, primarily due to infections.

“There were infection-associated deaths within the first 28 days, but that continued to be so up to the 90-day mark, whereas deaths from other causes were not common,” Dr. Ahmed explained.

Given these findings, she argues that the FDA should reevaluate the REMS requirements regarding patients who have undergone CAR-T therapy. Moreover, clinicians who treat these patients will need to adjust their management accordingly, especially to address infection risk.

“We would have to really focus our efforts on involving and engaging the referring physician to understand how to manage [and] identify infections, and how to collaborate with the treatment center in order for the patient to get the care that they need if they do develop an infection,” Dr. Ahmed said.

She added that her study’s findings have implications for patients in socioeconomic groups that face barriers to CAR-T access.

“This is important because it can impact access to minority groups and disadvantaged groups. This has to be a priority to consider,” Dr. Ahmed emphasized.