■Polatuzumabvedotin,第一个FDA批准的抗体-药物偶联物(ADC)靶向CD79b,用于治疗先前未治疗的弥漫性大B细胞淋巴瘤(DLBCL)或高级B细胞淋巴瘤(HGBL),以及复发或难治性(R/R)DLBCL。尽管得到了批准,关于polatuzumabvedotin的长期安全性的担忧仍然存在.这项研究旨在评估自2019年批准以来与polatuzumabvedotin相关的不良事件(AE),利用适用于FDA不良事件报告系统(FAERS)的数据挖掘策略。
■信号检测采用四种方法,包括报告赔率比(ROR),比例报告比率(PRR),贝叶斯置信传播神经网络(BCPNN),和多项目gammapoissonshrinker(MGPS),评估和量化polatuzumabvedotin相关AE的信号。此外,根据患者年龄进行亚组分析,性别,和致命病例进行调查,以调查特定亚群中的AE发生情况。
■从FAERS数据库中收集了总共1,521份报告,将polatuzumabvedotin列为“主要嫌疑人(PS)”药物。通过同时遵守四种算法,检测到19个显著的标准化MedDRA查询(SMQ)AE和92个显著的优选术语(PT)AE。亚组分析显示,男性患者的PT发生率高于女性患者,老年患者polatuzumabvedotin相关AE的可能性增加(>65岁),具有高致死性病例风险的不良事件包括:血乳酸脱氢酶升高,血细胞减少,和肾积水.polatuzumabvedotin开始后发生不良事件的中位时间为18.5(5~57.75)天,95%的AE发生在162天内。
■这项研究确定了与polatuzumabvedotin相关的各种不良事件,为接受polatuzumabvedotin治疗的患者的临床监测和风险识别提供重要见解。
UNASSIGNED: Polatuzumab vedotin, the first FDA-approved antibody-drug conjugate (ADC) targeting CD79b, is utilized in the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL), as well as relapsed or refractory (R/R) DLBCL. Despite its approval, concerns persist regarding the long-term safety profile of polatuzumab vedotin. This study aims to evaluate the adverse events (AEs) associated with polatuzumab vedotin since its approval in 2019, utilizing data mining strategies applied to the FDA Adverse Event Reporting System (FAERS).
UNASSIGNED: Signal detection employed four methodologies, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS), to evaluate and quantify the signals of polatuzumab vedotin-associated AEs. Additionally, subgroup analyses based on patients age, gender, and fatal cases were conducted to investigate AEs occurrences in specific subpopulations.
UNASSIGNED: A total of 1,521 reports listing polatuzumab vedotin as a \"principal suspect (PS)\" drug were collected from the FAERS database. Through concurrent compliance with four algorithms, 19 significant Standardized MedDRA Query (SMQ) AEs and 92 significant Preferred Term (PT) AEs were detected. Subgroup analyses revealed a higher incidence of PTs in male patients compared to female patients, increased likelihood of polatuzumab vedotin-associated AEs in elder patients (>65 years), and AEs with a high risk of fatal cases include: blood lactate dehydrogenase increased, cytopenia, and hydronephrosis. The median time to AEs occurrence following polatuzumab vedotin initiation was 18.5 (5∼57.75) days, with 95% of AEs occurred within 162 days.
UNASSIGNED: This study identified various AEs associated with polatuzumab vedotin, offering critical insights for clinical monitoring and risk identification in patients receiving polatuzumab vedotin therapy.