Neurological adverse events of blinatumomab in children with B-cell acute lymphoblastic leukemia: a retrospective...

This study aims to conduct a real-world analysis of blinatumomab-associated neurological adverse events (NAEs) in pediatric patients with B-cell acute lymphoblastic leukemia (B-ALL) to comprehensively elucidate its safety profile.

A retrospective analysis was conducted in children with B-ALL who were treated at hematology medical ward of our institution from January 2024 to December 2025. Document the occurrence of all NAEs during the dosing cycle of blinatumomab, including the time of occurrence, cycle of appearance, severity, management, and outcome.

There were 13 individuals with an average age of 10.08 ± 4.23 years experienced a total of 18 NAEs among all the 60 B-ALL patients. These NAEs primarily manifest as headache, dizziness, tremor, delirium, status epilepticus, and cerebral herniation. Most NAEs occur during the first cycle of medication (77.78%). The median onset time of the NAEs was approximately 9.5 days, with a duration of approximately 2.78 ± 2.21 days. The majority of NAEs associated with blinatumomab are mild to moderate in severity (grade 1 or 2) (88.89%). Two patients experienced severe adverse events (AEs) (grade 4), manifesting as status epilepticus and cerebral herniation. There were statistically significant differences in age (10.08 ± 4.23 vs. 5.40 ± 3.57; P < 0.01), and the proportion of males (84.62% vs. 55.32%; P = 0.03) between the group with NAEs and without. Additionally, we found age was identified as an independent predictor of blinatumomab-associated NAEs.

This study reveals real-world data on the neurological safety profile of blinatumomab, characterizes the features of it, and identifies age as an independent predictor of blinatumomab-associated NAEs in pediatric patients.