Department of Gastroenterology, Research Institute, NorthShore University Health System, Evanston, IL 60201, USA.
Aliment Pharmacol Ther. 2013 Aug;38(4):388-96. doi: 10.1111/apt.12385. Epub 2013 Jun 26.
The association between inhibition of tumour necrosis factor alpha (TNF-α) and new onset of neurological adverse events (AEs) is unclear.
To evaluate neurological AEs with TNF-α inhibitors reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) utilising a standardised scoring tool for drug-induced AEs.
A search of FAERS for neurological AEs (January 1, 2000 to December 31, 2009) reported with infliximab, adalimumab, certolizumab and etanercept was performed. Full-text reports were accessed using the Freedom of Information Act and scored using Naranjo score, while accounting for temporal association, previous conclusive reports of the neurological AE with any TNF-α inhibitor, and alternate explanations including underlying disease, concomitant medications and comorbidities, such as diabetes mellitus.
There were 772 reports. Most were in patients who had rheumatoid arthritis (393, 50.9%) followed by inflammatory bowel disease (140, 18.1%). No significant differences in age or gender were seen between IBD patients compared with rheumatological diseases (P = 0.584 and P = 0.055 respectively). Etanercept was reported most (327, 42.4%) followed by infliximab (276, 35.8%) (P = 0.008). Peripheral neuropathy was the most common neurological AE (296 reports, 38.3%) followed by central nervous system and/or spinal cord demyelination (153 reports, 19.8%). Majority (551, 71.4%) of the reports were of 'possible' AE with the remaining 'probable' AE and none identified as 'definite' AE.
While several neurological AEs have been described, definite association between de novo development of these AEs and exposure to TNF-α inhibitors was not established using the Naranjo score.
肿瘤坏死因子-α（TNF-α）抑制剂与新发神经不良事件（AE）之间的关系尚不清楚。
利用药物诱发 AE 的标准化评分工具，通过食品和药物管理局不良事件报告系统（FAERS）评估报告的 TNF-α抑制剂相关的神经 AE。
对 FAERS 中 2000 年 1 月 1 日至 2009 年 12 月 31 日报告的与英夫利昔单抗、阿达木单抗、依那西普和 certolizumab 相关的神经 AE 进行了检索。利用信息自由法获取全文报告，并采用 Naranjo 评分进行评分，同时考虑到时间关联、任何 TNF-α抑制剂相关神经 AE 的先前明确报告以及其他解释，包括基础疾病、伴随药物和合并症，如糖尿病。
共报告了 772 例。大多数患者患有类风湿关节炎（393 例，50.9%），其次是炎症性肠病（140 例，18.1%）。与风湿性疾病相比，IBD 患者的年龄或性别无显著差异（P=0.584 和 P=0.055）。依那西普报告最多（327 例，42.4%），其次是英夫利昔单抗（276 例，35.8%）（P=0.008）。最常见的神经 AE 是周围神经病（296 例报告，38.3%），其次是中枢神经系统和/或脊髓脱髓鞘（153 例报告，19.8%）。大多数报告（551 例，71.4%）为“可能”AE，其余为“很可能”AE，无“确定”AE。
虽然已经描述了几种神经 AE，但使用 Naranjo 评分并未确定这些 AE 的新发与 TNF-α 抑制剂暴露之间存在明确的关联。
