Blinatumomab, as the first bispecific antibody targeting CD19, has shown significant efficacy in the treatment of acute lymphoblastic leukemia and has been widely used in clinical practice since its launch in 2014. However, the characteristics of adverse events, the differences in medication safety among different populations and the influencing factors of this drug in the real world are not very clear, requiring in-depth exploration.

To utilize the FDA Adverse Event Reporting System (FAERS) to obtain adverse drug event (ADE) reports for blinatumomab over the decade since its market launch and to analyze the influencing factors on the real-world safety of blinatumomab, thereby strengthening pharmacovigilance for high-risk populations.

Data in the FAERS database from the fourth quarter of 2014 to the third quarter of 2024 were searched. ADE positive signals were systematically classified. Conduct a statistical analysis on six types of adverse events with high incidence, strong characteristics and high relevance, including the nervous system disorders, cytokine release syndrome (CRS), immune system disorders, blood and lymphatic system disorders, infections and infestations, lineage switch leukaemia, categorized by various influencing factors such as age, gender, weight, interval time, and the continent where the patients were locate.

A total of 18 728 cases of ADE reports for blinatumomab were collected, along with 6 961 demographic data, identifying 371 valid signals involving 20 system organ classifications (SOC). Among these, the preferred term (PT) with the highest signal strength was lineage switch leukemia, which was not mentioned in the instructions, and the most frequent SOC was nervous system disorders. Statistical differences were observed in gender, body weight, interval time, and continent of residence among minors, young and middle-aged adults, and elderly individuals who experienced adverse events (P<0.05). Statistical differences were also found in interval time and continent of residence when comparing patients with nervous system disorders to other adverse events (P<0.05), as well as for cytokine release syndrome compared to other adverse events (P<0.05). For immune system adverse events, statistical differences were noted in age and continent of residence compared to other systemic adverse events (P<0.05). Additionally, statistical differences in interval time and continent of residence were found for blood and lymphatic system disorders compared to other adverse events (P<0.05), as well as for infections and infestations compared to other adverse events (P<0.05).

In clinical use of blinatumomab, there should be a high level of attention to the drug tolerance of the Asian population and vigilance against immediate and delayed adverse events. Blinatumomab has been on the market in China for a short time, and there is insufficient experience in medication use. In clinical applications, it is necessary to strengthen drug surveillance and risk protection for minors and the elderly in China.

贝林妥欧单抗作为首个靶向CD19的双特异性抗体，在急性淋巴细胞白血病治疗领域疗效显著，自2014年上市后在临床广泛应用。然而该药在真实世界中的各类型不良事件特征、不同人群用药安全性差异及影响因素尚不十分明确，需要深入探究。

利用美国食品药品管理局不良事件报告系统（FAERS）获取贝林妥欧单抗上市10年间的不良事件报告信息，对贝林妥欧单抗真实世界中使用的安全性进行影响因素分析，加强高危人群药学监护。

检索FAERS数据库中2014年第四季度至2024年第三季度的数据，对不良事件阳性信号进行系统分类，对发生率高、特征性强、相关度高的神经系统疾病、细胞因子释放综合征、免疫系统疾病、血液及淋巴系统疾病、感染及侵染类疾病、谱系转换等6类不良事件从年龄、性别、体质量、间隔时间和患者所在洲等不同影响因素分类进行统计分析。

共收集到18 728例次贝林妥欧单抗的不良事件报告，6 961例不良事件人口学数据，发现371个有效信号，涉及20个系统器官分类（SOC）。其中，信号强度最大的首选术语（PT）是白血病谱系转换，且该不良事件未在说明书中提及，发生频次最多的SOC是神经系统疾病。出现不良事件的未成年人、中青年人和老年人性别、体质量、间隔时间、所在洲比较，差异均有统计学意义（P<0.05）。神经系统不良事件与其他系统不良事件在间隔时间、所在洲比较，差异均有统计学意义（P<0.05）。细胞因子释放综合征与其他系统不良事件间隔时间、所在洲比较，差异均有统计学意义（P<0.05）。免疫系统不良事件与其他系统不良事件年龄、所在洲比较，差异均有统计学意义（P<0.05）。血液及淋巴系统不良事件与其他系统不良事件间隔时间、所在洲比较，差异均有统计学意义（P<0.05）。感染及侵染类不良事件与其他系统不良事件间隔时间、所在洲比较，差异均有统计学意义（P<0.05）。

临床在使用贝林妥欧单抗时，要高度关注亚洲人群的用药耐受性，警惕速发性和迟发性不良事件。贝林妥欧单抗在我国上市时间短，用药经验不足，在临床应用中要对我国未成年和老年人群加强用药监护和风险防护。