Medical College of Wisconsin, Milwaukee.
University School of Milwaukee, River Hills, Wisconsin.
Arthritis Care Res (Hoboken). 2024 Aug;76(8):1203-1209. doi: 10.1002/acr.25340. Epub 2024 May 2.
Neuroinflammatory adverse events have been observed among new users of tumor necrosis factor (TNF) inhibitors. No studies to date have compared the real-world risk of TNFs with other new users of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). The objective of this study is to describe the risk of neuroinflammatory disease after initiation b/tsDMARDs.
This new user comparative effectiveness cohort study used a large US-based electronic health records database to describe the unadjusted incidence of neuroinflammatory adverse events over a 3-year period. The cohort included patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis initiating treatment with a TNF inhibitor (n = 93,661) or other b/tsDMARD (n = 38,354).
Among 132,015 patients included in the analysis, the most common first biologic agent was a TNF inhibitor; the unadjusted incidence of neuroinflammatory events was numerically lower among new users of TNF inhibitors (incidence 1.34 per 1,000 patient-years) as compared with the combined non-TNF group (1.69 per 1,000 patient-years). There was no significant association between TNF exposure and neuroinflammatory events as compared with the combined non-TNF b/tsDMARDs overall (hazard ratio 1.01; 95% confidence interval 0.75-1.36) and within each disease group.
The overall risk of neuroinflammatory events among new users of TNF inhibitors did not differ substantially as compared with new users of other b/tsDMARDs. Meta-analyses of randomized trials should be conducted to corroborate these findings, which may be affected by channeling bias.
肿瘤坏死因子（TNF）抑制剂新使用者出现神经炎症性不良事件。迄今为止，尚无研究比较 TNF 与其他生物制剂或靶向合成疾病修正抗风湿药物（b/tsDMARD）新使用者的真实世界风险。本研究旨在描述生物制剂/靶向合成疾病修正抗风湿药物新使用者发生神经炎症性疾病的风险。
本新使用者比较有效性队列研究使用了一个大型美国电子健康记录数据库，描述了 3 年内神经炎症性不良事件的未经调整发生率。队列纳入了开始使用 TNF 抑制剂（n=93661）或其他生物制剂/靶向合成疾病修正抗风湿药物（n=38354）的类风湿关节炎、银屑病、银屑病关节炎、强直性脊柱炎、克罗恩病或溃疡性结肠炎患者。
在纳入分析的 132015 例患者中，最常见的第一种生物制剂为 TNF 抑制剂；与联合非 TNF 组（1000 患者-年 1.69 例）相比，TNF 抑制剂新使用者神经炎症事件的未经调整发生率较低（1000 患者-年 1.34 例）。与联合非 TNF b/tsDMARD 相比，TNF 暴露与神经炎症事件之间无显著相关性（总体危险比 1.01；95%置信区间 0.75-1.36），且在每个疾病组中均如此。
与其他生物制剂/靶向合成疾病修正抗风湿药物新使用者相比，TNF 抑制剂新使用者的神经炎症事件总体风险无显著差异。应开展随机试验的荟萃分析来证实这些发现，这些发现可能受渠道偏倚的影响。
