Adverse drug event signal detection and risk factor analysis of blinatumomab in ten years of post-marketing use

Abstract

Objective: To analyze factors influencing the safety of blinatumomab based on real-world adverse drug event (ADE) reports collected from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) over the last decade since its market approval, thereby strengthening pharmacovigilance for high-risk populations.

Methods: Data from the FAERS database from the fourth quarter of 2014 to the third quarter of 2024 were retrieved. ADE positive signals were systematically classified, and six types of adverse events with high incidence, strong specificity, and high correlation were analyzed, including neurological disorders, cytokine release syndrome (CRS), immune system disorders, hematologic and lymphatic system disorders, infections and infestations, and lineage switch. For each type, statistical analyses were performed according to potential influencing factors, including age, sex, body weight, interval time, and continent of patient origin.

Results: A total of 18,728 ADE reports associated with blinatumomab were collected, from which 371 positive signals were identified, involving 20 system organ classifications (SOCs). The preferred term (PT) with the strongest signal was lineage switch leukemia, an adverse event not mentioned in the prescribing information. The SOC with the highest frequency was neurological disorders. Except for lineage switch leukemia, significant differences in influencing factors were observed across the other five adverse event categories. Analysis of the overall population of ADE suggested that Asian juvenile and elderly patients showed lower drug tolerability, and juvenile patients were more prone to delayed adverse events.

Conclusion: In clinical use of blinatumomab, particular attention should be paid to drug tolerability in Asian populations, with vigilance for early-onset and delayed adverse events. Given the short duration of blinatumomab's availability in China and limited local experience, enhanced drug monitoring and risk prevention are warranted for juvenile and elderly patients in clinical practice.

Keywords

Blinatumomab / FAERS database / Signal identification / Adverse drug events / Influencing factor analysis

Declarations

Not applicable.

Authors' contributions

Jinglin Liu: Data curation, Formal analysis, Investigation, Visualization, Writing-original draft. Xiaokun Song: Writing-review & editing. Jie Zhang: Writing-review & editing. Bole Li: Project administration, Supervision, Writing-review & editing. All authors contributed to the article and approved the submitted version.

Ethics approval and consent to participate

As the study utilized publicly accessible databases, there was no requirement for ethics committee approval or informed consent from participants. All methods were performed in accordance with the relevant guidelines and regulations.

Consent for publication

Not applicable.

Funding

This study was supported by the Tianjin Key Medical Discipline Construction Project (Grant No. TJYXZDXK-3-003A), the Joint Funds of the Natural Science Foundation of Tianjin (Grant No. 25JCLMJC00440), the Tianjin Medical University Cancer Hospital “14th Five-Year Plan” Summit Discipline Support Project-Outstanding Potential Discipline (Grant No. 7-2-11), and the Tianjin Medical University Cancer Institute and Hospital Special Fund for Pharmacy, Laboratory Medicine and Medical Imaging Research (Grant No. Y2205).

Declarations of Competing Interests

The authors declare that they have no competing interests.

Acknowledgements

Not applicable.

Authors' other information

Not applicable.

Appendix A. Supporting information

Supplementary data associated with this article can be found in the online version at doi:10.1016/j.prmedi.2025.100065.

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