Abstract：
UNASSIGNED: Tumor necrosis factor-α inhibitors (TNFis) are used for the treatment of inflammatory bowel disease (IBD). The aim of this study was to evaluate the association between neurological adverse events (AEs) and TNFi use.
UNASSIGNED: Data of TNFis indicated for IBD were collected from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the marketed date to the second quarter of 2023. The reporting odds ratio (ROR) and a Bayesian confidence propagation neural network were used to identify signals.
UNASSIGNED: A total of 4,964 neurological AEs were reported in the IBD population. Infliximab had 3 signals, including demyelination [ROR (95% CI): 1.69 (1.33,2.15)], meningitis listeria [ROR (95% CI): 5.05 (3.52,7.25)], and optic neuritis [ROR (95% CI): 1.72 (1.3,2.26)]. The signals for adalimumab were gait disturbance [ROR (95% CI): 1.43 (1.32,1.56)] and muscular weakness [ROR (95% CI): 1.4 (1.27,1.55)]. A peripheral neuropathy signal was found for adalimumab [ROR (95% CI): 1.34 (1.18,1.53)] and certolizumab pegol [ROR (95% CI): 1.49 (1.07,2.08)]. However, there were no signals among neurological AEs for golimumab.
UNASSIGNED: Neurological signals were detected for TNFi use, indicating that the risk of neurological AEs requires additional attention in clinical use of TNFis.
UNASSIGNED: Data of TNFis indicated for IBD were collected from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the marketed date to the second quarter of 2023. The reporting odds ratio (ROR) and a Bayesian confidence propagation neural network were used to identify signals.
UNASSIGNED: A total of 4,964 neurological AEs were reported in the IBD population. Infliximab had 3 signals, including demyelination [ROR (95% CI): 1.69 (1.33,2.15)], meningitis listeria [ROR (95% CI): 5.05 (3.52,7.25)], and optic neuritis [ROR (95% CI): 1.72 (1.3,2.26)]. The signals for adalimumab were gait disturbance [ROR (95% CI): 1.43 (1.32,1.56)] and muscular weakness [ROR (95% CI): 1.4 (1.27,1.55)]. A peripheral neuropathy signal was found for adalimumab [ROR (95% CI): 1.34 (1.18,1.53)] and certolizumab pegol [ROR (95% CI): 1.49 (1.07,2.08)]. However, there were no signals among neurological AEs for golimumab.
UNASSIGNED: Neurological signals were detected for TNFi use, indicating that the risk of neurological AEs requires additional attention in clinical use of TNFis.
摘要：
■肿瘤坏死因子-α抑制剂(TNFis)用于治疗炎性肠病(IBD)。这项研究的目的是评估神经系统不良事件（AE）与TNFi使用之间的关联。
■从上市日期到2023年第二季度，从食品和药物管理局不良事件报告系统（FAERS）收集了用于IBD的TNFis数据。使用报告比值比（ROR）和贝叶斯置信度传播神经网络来识别信号。
■在IBD人群中总共报告了4,964例神经系统不良事件。英夫利昔单抗有3个信号,包括脱髓鞘[ROR（95%CI）：1.69（1.33,2.15）]，脑膜炎李斯特菌[ROR（95%CI）：5.05（3.52,7.25）]，和视神经炎[ROR(95%CI)：1.72(1.3,2.26)]。阿达木单抗的信号为步态障碍[ROR(95%CI):1.43(1.32,1.56)]和肌无力[ROR(95%CI):1.4(1.27,1.55)]。发现阿达木单抗[ROR（95％CI）：1.34（1.18,1.53）]和赛托珠单抗pegol[ROR（95％CI）：1.49（1.07,2.08）]的周围神经病变信号。然而,戈利木单抗的神经系统AE中没有信号.
■检测到用于TNFi的神经信号，这表明在临床使用TNF-α时需要额外注意神经系统AE的风险。
■从上市日期到2023年第二季度，从食品和药物管理局不良事件报告系统（FAERS）收集了用于IBD的TNFis数据。使用报告比值比（ROR）和贝叶斯置信度传播神经网络来识别信号。
■在IBD人群中总共报告了4,964例神经系统不良事件。英夫利昔单抗有3个信号,包括脱髓鞘[ROR（95%CI）：1.69（1.33,2.15）]，脑膜炎李斯特菌[ROR（95%CI）：5.05（3.52,7.25）]，和视神经炎[ROR(95%CI)：1.72(1.3,2.26)]。阿达木单抗的信号为步态障碍[ROR(95%CI):1.43(1.32,1.56)]和肌无力[ROR(95%CI):1.4(1.27,1.55)]。发现阿达木单抗[ROR（95％CI）：1.34（1.18,1.53）]和赛托珠单抗pegol[ROR（95％CI）：1.49（1.07,2.08）]的周围神经病变信号。然而,戈利木单抗的神经系统AE中没有信号.
■检测到用于TNFi的神经信号，这表明在临床使用TNF-α时需要额外注意神经系统AE的风险。
