Evidence map›Paper›PMID 39915776›Full record

ArticleBMC medicine2025

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

Wen Gao, Jingwei Yu, Yifei Sun, Zheng Song, Xia Liu, Xue Han, Lanfan Li, Lihua Qiu, Shiyong Zhou, Zhengzi Qian and 2 more

Abstract read
In one paragraph

Article in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Wen Gao *State Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Jingwei Yu *State Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Yifei SunState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Zheng SongState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Xia LiuState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Xue HanState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Lanfan LiState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Lihua QiuState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Shiyong ZhouState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Zhengzi QianState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China.
Xianhuo WangState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China. tjzlyy_xianhuow@163.com.
Huilai ZhangState Key Laboratory of Druggability Evaluation and Systematic Translational Medicine/Department of Lymphoma, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Sino-US Center for Lymphoma and Leukemia Research, Tianjin, 300060, China. huilai_zhang@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNervous system toxicity (NST) is a frequent and serious adverse event (AE) associated with blinatumomab, the first bispecific antibody drug targeting CD19 and CD3. Real-world data are needed to better understand the incidence and characteristics of NST in clinical practice.

methodsData were obtained from the FDA Adverse Event Reporting System (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 utilized for data mining.

resultsA total of 5,962 blinatumomab-related cases were analyzed. NSTs were more frequent in males (44.01%) and younger individuals (18-45 years, 28.39%), with a higher prevalence in the USA (77.99%). 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. The median time to onset (TTO) for neurological events was 3 days (range, 1 ~ 21). 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).

conclusionsAge 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.

Indexed as

Antibodies, BispecificAntineoplastic AgentsNeurotoxicity SyndromesAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedChildChild, PreschoolFemaleHumansMaleMiddle AgedUnited StatesYoung AdultAntibodies, BispecificAntineoplastic AgentsblinatumomabBlinatumomabFDA Adverse Event Reporting System (FAERS)Nervous system toxicityPharmacovigilance

Identifiers

PMID39915776
PMCPMC11804067

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.