Wang Jingyu, Zhang Zhao, Liu Xingzi, Shi Sufang, Lv Jicheng, Zhang Yuemiao, Zhang Hong
Renal Division, Peking University First Hospital, Beijing, China.
Peking University Institute of Nephrology, Beijing, China.
Kidney Int Rep. 2024 Jul 6;9(9):2705-2717. doi: 10.1016/j.ekir.2024.07.006. eCollection 2024 Sep.
Nefecon, the first innovative drug approved by both the US Food and Drug Administration (FDA) and European Medicines Agency for IgA nephropathy (IgAN), lacked comprehensive real-world assessments of its adverse events (AEs).
We leveraged postmarketing data of Nefecon from the US FDA Adverse Event Reporting System (FAERS), employing disproportionate analysis (DPA) to detect positive signals at the system organ class (SOC) and preferred terms (PTs) levels. Duplicate AEs related to budesonide and those previously reported in studies were excluded through the use of the Medical Dictionary of Regulatory Activities (MedDRA). Our analysis encompassed time-to-onset (TTO), Weibull shape parameter (WSP) evaluation, cumulative incidence, clinical prioritization evaluation, and subgroup analysis based on gender and age.
A total of 1515 individuals with IgAN were included. Five positive SOC signals and 23 positive PT signals were identified, including 4 PTs (asthenia, malaise, product dose omission issue, and anxiety) representing novel AEs newly identified in this study. None of the positive PTs were classified as high clinical priority, with only acne, hypertension, swelling face, and weight increased considered as moderate clinical priority events. The median time to TTO was 31 days. All WSP test results indicated an early failure type profile. Lastly, subgroup analysis provided further insights into the relative risk of specific AEs.
Nefecon demonstrates a favorable safety profile, with no high-priority clinical events identified. The identification of novel AEs and subgroup-specific relative high-risk events fills a gap in existing studies and offers valuable insights for early clinical vigilance.
耐赋康（Nefecon）是首个获美国食品药品监督管理局（FDA）和欧洲药品管理局批准用于治疗IgA肾病（IgAN）的创新药物，缺乏对其不良事件（AE）的全面真实世界评估。
我们利用了美国FDA不良事件报告系统（FAERS）中耐赋康的上市后数据，采用不成比例分析（DPA）在系统器官分类（SOC）和首选术语（PT）层面检测阳性信号。通过使用《监管活动医学词典》（MedDRA）排除了与布地奈德相关的重复不良事件以及先前在研究中报告过的不良事件。我们的分析包括发病时间（TTO）、威布尔形状参数（WSP）评估、累积发病率、临床优先级评估以及基于性别和年龄进行的亚组分析。
共纳入1515例IgA肾病患者。识别出5个阳性SOC信号和23个阳性PT信号，包括4个PT（乏力、不适、漏服药物问题和焦虑）代表本研究新发现的新不良事件。没有阳性PT被归类为高临床优先级，只有痤疮、高血压、面部肿胀和体重增加被视为中度临床优先级事件。TTO的中位时间为31天。所有WSP测试结果均表明为早期失效类型。最后，亚组分析进一步深入了解了特定不良事件的相对风险。
耐赋康显示出良好的安全性，未发现高优先级临床事件。新不良事件和亚组特异性相对高风险事件的识别填补了现有研究的空白，并为早期临床监测提供了有价值的见解。
