Post-marketing safety of panitumumab: a real-world pharmacovigilance study

Panitumumab has been extensively applied in antitumor therapy, and the regulation of its adverse drug reactions (ADRs) has become extremely important. This study utilized the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to extract real-world panitumumab ADR signals and provide relevant information for drug safety.
ROR, PRR, BCPNN, and MGPS were used to identify real-world ADR signals associated with panitumumab.
Analysis of 9,033 patients identified 263 ADR signals across 20 MedDRA System Organ Classifications. New signals including peripheral sensory neuropathy, gene mutation, decreased neutrophil count, polyneuropathy, ileus, neutropenia, and febrile neutropenia. Age and sex subgroup analyses revealed specific risks, such as polyneuropathy and gene mutation in those under 65 years of age, decreased neutrophil count and peripheral sensory neuropathy in those over 65 years of age, and febrile neutropenia in men. Ileus was highlighted as a novel ADR in gastrointestinal disorders, with no significant age or sex differences.
This study identified new signals of ADR associated with panitumumab, providing valuable information for the clinical use of panitumumab.

帕尼单抗（Panitumumab）已被广泛应用于抗肿瘤治疗领域，其药品不良反应（ADRs）的管控已成为药物安全领域的核心议题。本研究依托美国食品药品监督管理局不良事件报告系统（FAERS）数据库，提取帕尼单抗相关不良事件的真实世界信号，为药物安全监管及临床合理用药提供参考依据。
本研究采用报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信神经网络（BCPNN）及多重伽马泊松收缩法（MGPS）四种方法，识别与帕尼单抗相关的真实世界不良事件信号。
通过对9033例患者的数据分析，本研究在20个医学术语词典（MedDRA）系统器官分类中，共识别出263个药品不良反应信号，涵盖外周感觉神经病、基因突变、中性粒细胞计数降低、多发性神经病、肠梗阻、中性粒细胞减少症及发热性中性粒细胞减少症等全新信号。年龄与性别亚组分析揭示了特定人群的专属用药风险：65岁以下群体存在多发性神经病与基因突变的风险，65岁以上群体则表现出中性粒细胞计数降低与外周感觉神经病的风险，男性群体更易出现发热性中性粒细胞减少症。肠梗阻作为消化系统疾病类别的新型不良事件被重点提及，其发生风险未表现出显著的年龄或性别差异。
本研究成功识别出与帕尼单抗相关的药品不良反应全新信号，可为帕尼单抗的临床合理应用提供极具价值的参考信息。