A Real‐World Study of CAR‐T Hematological Adverse Events Based on FAERS Database.
Chimeric antigen receptor T‐cell therapy (CAR‐T) is an emerging therapy for malignancies, including refractory B‐cell lymphoma, follicular lymphoma, multiple myeloma, and chronic lymphocytic leukemia. Postmarketing monitoring is essential to ensure the rational administration of CAR‐T because of its...
| Publicado en: | Journal of Clinical Pharmacy & Therapeutics Vol. 2025; pp. 1 - 12 |
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| Autores principales: | , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
11/23/2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=189524894&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 189524894 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 02694727 EV4 jtl: Journal of Clinical Pharmacy & Therapeutics issn: 02694727 maglogo: Y pubinfo: dt: 11/23/2025 vid: 2025 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 189524894 189524894 189524894 10.1155/jcpt/5538794 189524894 ppf: 1 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: A Real‐World Study of CAR‐T Hematological Adverse Events Based on FAERS Database. aug: au: Gao, Xiaoyue Hu, Fangyuan Zhai, Yinghong Yuan, Lei Li, He Ye, Xiaofei Wang, Zhuo Imran, Ali affil: Pharmacy Department,, The First Affiliated Hospital of Naval Medical University,, Shanghai, 200433,, China, smmu.edu.cn sug: subj: Cell Therapy Adverse Effects Receptors, Cell Surface Therapeutic Use Immunotherapy Adverse Effects Adverse Drug Event Evaluation Hematologic Diseases Chemically Induced Neoplasms Drug Therapy United States Food and Drug Administration Databases, Health Evaluation Pharmacovigilance Antineoplastic Agents Adverse Effects Human Male Female Middle Age Retrospective Design Record Review Funding Source Marketing Drug Monitoring Receptors, Cell Surface Administration and Dosage Hemophagocytic Lymphohistiocytosis Chemically Induced Odds Ratio Cytopenia Chemically Induced Myelodysplastic Syndromes Chemically Induced Immunotherapy Mortality Cell Therapy Mortality Cytokine Release Syndrome Chemically Induced Drug Toxicity Risk Factors Thrombocytopenia Chemically Induced Early Diagnosis Risk Assessment Sex Factors Age Factors Descriptive Statistics Data Analysis Software Models, Statistical Regression Antigens, Surface Adverse Effects Hospitalization Gene Therapy Adverse Effects Afibrinogenemia Chemically Induced Neutropenia Chemically Induced Drug Information Anemia Chemically Induced Bone Marrow Drug Effects Confidence Intervals Febrile Neutropenia Chemically Induced Middle Aged: 45-64 years Male Female ab: Chimeric antigen receptor T‐cell therapy (CAR‐T) is an emerging therapy for malignancies, including refractory B‐cell lymphoma, follicular lymphoma, multiple myeloma, and chronic lymphocytic leukemia. Postmarketing monitoring is essential to ensure the rational administration of CAR‐T because of its high occurrence rate of adverse events. Thus, we collected the adverse event reports from the FAERS database between the first quarter of 2017 and the second quarter of 2025. Disproportion analysis methods, including the reporting odds ratio and information component, were used to identify potential hematological AEs associated with CAR‐T therapy. A total of 47,118,226 reports were analyzed, and 99,497 adverse events associated with CAR‐T‐cell therapy were identified. We found 11,689 hematological adverse events accounted for 11.75% of the total adverse events, of which cytopenia (ROR025 = 33.87, IC025 = 4.95), hemophagocytic lymphohistiocytosis (HLH, ROR025 = 28.20, IC025 = 4.71), and myelodysplastic syndrome (MS, ROR025 = 34.41, IC025 = 4.98) were highly underrated in the real world. All six CAR‐T products were associated with hematological adverse events, and the typical hematological adverse events varied among different products. A high proportion and frequency of death outcomes were identified after CAR‐T‐related hematological adverse events, such as thrombocytopenia, HLH, and cytopenia. Cytokine release syndrome frequently overlapped with hematological adverse events, including cytopenia, HLH, and thrombocytopenia. Our results may help clinicians identify rare but potentially fatal hematological AEs at an early stage, effectively reducing the risk of lethal hematological toxicity of CAR‐T therapy. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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