Adverse events in the nervous system associated with blinatumomab: A real-world study

Background Nervous system toxicity (NST) is frequent and dangerous adverse events of blinatumomab, which is the first bispecific antibody drug targeting CD19 and CD3. Current data from clinical trials do not fully reflect the real-world situation. This study aimed to evaluate the NST of blinatumomab in real-word. Methods Data were retrieved from the FAERS. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence interval progressive neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms were used for data mining. Results A total of 5,962 cases involving blinatumomab were extracted. NST occurred more frequently in male (40.19%) and was prevalent among young (18–45 years, 20.21%) and the United States patients (58.60%). Forty-three signals of NST were identified, of which neurotoxicity, neurological symptoms, agnosia, intention tremor, and immune effector cell-associated neurotoxicity syndrome had the highest ROR values. Concomitant use of medication for age, musculoskeletal system, genitourinary system and sexual hormones were independent risk factors for NST, and age was an independent protective factor for fatal NST. For neurological events, the median time to onset (TTO) was 3 days (range, 1 ~ 17). The highest fatality rate for neurological events was observed for increased intracranial pressure disorders, which also had the highest co-occurrence rate with cytokine release syndrome (CRS). Conclusions Age is an independent protective factor for fatal NST and CRS leads to a higher fatality rate for NST patients treated with blinatumomab. Thorough medication evaluation should be conducted before administering blinatumomab, especially for high-risk patients with preexisting neurological conditions.