Liu Yanxin, Dong Changjiang, He Xucheng, Shu Yamin, Wu Pan, Zou Jian
Pengzhou People's Hospital.
J Pharm Pharm Sci. 2022;25:377-390. doi: 10.18433/jpps33020.
Vemurafenib received approval for treatment of BRAF V600 variation metastatic melanoma in August 2011. This study analyzed Vemurafenib-related adverse events (AEs) to detect and characterize relevant safety signals using the real-word-data through the Food and Drug Administration Adverse Event Reporting System (FAERS).
Disproportionality analyses, including the reporting odds ratio (ROR), the healthcare products regulatory agency (MHRA), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) algorithms, were applied to quantify the signals of vemurafenib-related AEs.
Out of 8,042,244 reports gathered from the FAERS, 9554 reports of vemurafenib as the 'primary suspected (PS)' AEs were recognized. Vemurafenib-induced AEs occurrence targeted 23 system organ class (SOC). A total of 138 significant disproportionality PTs was simultaneously reserved according to the four algorithms. Unexpected significant AEs such as sarcoidosis and kidney fibrosis might also occur. The median onset time of vemurafenib-related AEs was 26 days (interquartile range [IQR] 8-97 days), and most of the cases occurred within the first one and two months after vemurafenib initiation.
Our study detected potential new AEs signals and might provide powerful support for clinical monitoring and risk identification of vemurafenib.
维莫非尼于2011年8月获批用于治疗BRAF V600变异的转移性黑色素瘤。本研究通过美国食品药品监督管理局不良事件报告系统（FAERS），利用真实世界数据对维莫非尼相关不良事件（AE）进行分析，以检测并描述相关安全信号。
采用不成比例分析，包括报告比值比（ROR）、医疗产品监管机构（MHRA）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）算法，对维莫非尼相关AE的信号进行量化。
从FAERS收集的8,042,244份报告中，识别出9554份将维莫非尼列为“主要怀疑（PS）”AE的报告。维莫非尼引起的AE发生涉及23个系统器官类别（SOC）。根据四种算法，共同时保留了138个显著不成比例的首选术语（PT）。还可能发生结节病和肾纤维化等意外的显著AE。维莫非尼相关AE的中位发病时间为26天（四分位间距[IQR]8 - 97天），大多数病例发生在开始使用维莫非尼后的前一两个月内。
我们的研究检测到潜在的新AE信号，可能为维莫非尼的临床监测和风险识别提供有力支持。
