Dou Xiaoke, Dai Yan, Zhu Li, Lin Yun, Wu Yan
Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Institute of Anesthesia and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Arch Dermatol Res. 2024 Dec 30;317(1):161. doi: 10.1007/s00403-024-03626-5.
We analyzed adverse events (AEs) related to adalimumab and etanercept using the Food and Drug Administration Adverse Event Reporting System (FAERS) to detect unexpected AEs. Subsequently, we compared the discrepancy in serious outcomes involving the same injection site reactions (ISRs) between two different medications.
Four algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were used to identify AE signals. These signals were standardized to preferred terms (PTs), and categorized at the system organ classification (SOC) level using the MedDRA system for further analysis. Serious outcomes were defined as death, disability, hospitalization, or life-threatening. The term "multiple serious outcomes" refers to instances that involve two or more of these serious consequences.
Adalimumab had 186,697 AE reports (736 PTs and 28 SOCs), while etanercept had 289,989 AE reports (294 PTs and 21 SOCs). At the PT level, we identified new unexpected AEs in adalimumab that related to multiple serious outcomes like intestinal obstruction, osteoarthritis, hernia, paternal drugs affecting the fetus, intestinal fistula, anal fistula, and postoperative adhesion. At the PT level of etanercept, we discerned unanticipated AEs related to multiple serious outcomes such as knee arthroplasty, joint destruction, finger deformity, and Felty's syndrome. At the SOC level, we paid special attention to the gastrointestinal disorders in adalimumab, with many unexpected PTs, as well as the vascular disorders and cardiac disorders in etanercept. For both drugs, the most common SOC is general disorders and administration site conditions, with ISRs being the most prevalent AEs within this category. The results indicate that etanercept has a greater variety of serious outcomes involving shared ISRs than adalimumab (p < 0.01) and also exhibits higher reported rates for these serious consequences (p < 0.01).
Upon individual analysis, we identified unanticipated AEs in adalimumab and etanercept, respectively. Comparative analysis suggests that, despite similar ISRs, etanercept necessitates heightened vigilance due to its potential for more serious outcomes.
我们使用美国食品药品监督管理局不良事件报告系统（FAERS）分析了与阿达木单抗和依那西普相关的不良事件（AE），以检测意外不良事件。随后，我们比较了两种不同药物在涉及相同注射部位反应（ISR）的严重后果方面的差异。
使用四种算法，包括报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）来识别AE信号。这些信号被标准化为首选术语（PT），并使用MedDRA系统在系统器官分类（SOC）级别进行分类，以进行进一步分析。严重后果定义为死亡、残疾、住院或危及生命。术语“多种严重后果”是指涉及上述两种或更多严重后果的情况。
阿达木单抗有186,697份AE报告（736个PT和28个SOC），而依那西普有289,989份AE报告（294个PT和21个SOC）。在PT级别，我们在阿达木单抗中确定了与多种严重后果相关的新的意外AE，如肠梗阻、骨关节炎、疝气、父源性药物影响胎儿、肠瘘、肛瘘和术后粘连。在依那西普的PT级别，我们识别出与多种严重后果相关的意外AE，如膝关节置换术、关节破坏、手指畸形和费尔蒂综合征。在SOC级别，我们特别关注阿达木单抗中的胃肠道疾病，有许多意外的PT，以及依那西普中的血管疾病和心脏疾病。对于这两种药物，最常见的SOC是一般疾病和给药部位情况，ISR是该类别中最常见的AE。结果表明，依那西普在涉及共同ISR的严重后果方面比阿达木单抗有更多样化的情况（p < 0.01），并且这些严重后果的报告率也更高（p < 0.01）。
通过单独分析，我们分别在阿达木单抗和依那西普中确定了意外AE。比较分析表明，尽管ISR相似，但依那西普因其可能导致更严重的后果而需要提高警惕。
