Risk of Infections Among Patients With AML, CLL Treated With Venetoclax

A low probability of an increased risk of infectious adverse events (IAEs) and neutropenia were observed for patients with chronic lymphocytic leukemia (CLL) who were treated with venetoclax. However, patients with acute myelogenous leukemia (AML) who were treated with venetoclax may have an increased risk of high-grade neutropenia and febrile neutropenia.

This systematic review of seven randomized controlled trials follows the results of recent literature suggesting that another small molecule inhibitor, ibrutinib, increased the risk of opportunistic infections in patients with hematologic malignancies.

A total of 2067 patients were included in the review, of which 1032 were patients with CLL. The patients with CLL had a low probability of an increased risk of high-grade (P[risk ratio (RR)] = 71.2%) and fatal (P[RR] = 64.5%) IAEs. Further, these patients had a low probability of an increased risk of high-grade neutropenia (P[RR] = 63.4%).

A meta-analysis of IAEs in AML was not completed due to insufficient data, but one trial suggested an increased risk with venetoclax treatment. However, treatment of AML with venetoclax was associated with a high probability of an increased risk of both high-grade (P[RR] = 94.6%) and febrile (P[RR] = 90.6%) neutropenia.

“The risk of opportunistic infections was low overall,” the researchers concluded. “Our analyses did not identify any specific IAEs that would necessitate additional antimicrobial prophylaxis or pre-emptive testing. Nevertheless, we recommend that post-marketing studies continue surveillance off the IAEs associated with venetoclax treatment.”

Reference:
Prosty C, Katergi K, Nguyen A, et al. Risk of infectious adverse events of venetoclax therapy for hematologic malignancies: a systematic review and meta-analysis of RCTs. Blood Adv. 2024;8(4):857-866. doi:10.1182/bloodadvances.2023011964