暴露于特定肿瘤坏死因子抑制剂与炎症性关节炎患者队列中脱髓鞘和炎症性神经病的风险：五个北欧风湿病登记处的协作观察性研究。
Exposure to specific tumour necrosis factor inhibitors and risk of demyelinating and inflammatory neuropathy in cohorts of patients with inflammatory arthritis: a collaborative observational study across five Nordic rheumatology registers.
机构信息
Department of Medicine Solna, Clinical Epidemiology Division, Karolinska Institutet, Stockholm, Sweden
Department of Neurology, Copenhagen University Hospital, Kobenhavn, Denmark.
出版信息
RMD Open. 2023 Feb;9(1). doi: 10.1136/rmdopen-2022-002924.
OBJECTIVE
To compare incidences of neuroinflammatory events, including demyelinating disease (DML), inflammatory polyneuropathies (IPN) and multiple sclerosis (MS), in patients with rheumatoid arthritis (RA) or spondyloarthritis (SpA; including psoriatic arthritis) starting a tumour necrosis factor inhibitor (TNFi), investigating whether monoclonal TNFi antibodies (other TNFis (oTNFis)) confer higher risk than etanercept.
METHODS
This is an observational cohort study including patients from the five Nordic countries starting a TNFi in 2001-2020. Time to first neuroinflammatory event was identified through register linkages. We calculated crude incidence rates (cIR) per 1000 person-years and used multivariable-adjusted Cox regression to compare incidences of neuroinflammatory events overall and for DML, IPN and MS with oTNFi versus etanercept. We further examined individual TNFis and indications.
RESULTS
33 883 patients with RA and 28 772 patients with SpA were included, initiating 52 704 and 46 572 treatment courses, respectively. In RA, we observed 135 neuroinflammatory events (65% DML) with cIR of 0.38 with oTNFi and 0.34 with etanercept. The HR of oTNFi versus etanercept was 1.07 (95% CI 0.74 to 1.54) for any neuroinflammatory event, 0.79 (95% CI 0.51 to 1.22) for DML, 2.20 (95% CI 1.05 to 4.63) for IPN and 0.73 (95% CI 0.34 to 1.56) for MS. In SpA, we observed 179 events (78% DML) with cIR of 0.68 with oTNFi and 0.65 with etanercept. The HR for any neuroinflammatory event, DML, IPN and MS was 1.06 (95% CI 0.75 to 1.50), 1.01 (95% CI 0.68 to 1.50), 1.28 (95% CI 0.61 to 2.69) and 0.94 (95% CI0.53 to 1.69), respectively.
CONCLUSION
The cIRs of neuroinflammatory events are higher in SpA than in RA, but the choice of specific TNFi does not seem to play an important role in the risk of neuroinflammatory events.
目的
比较类风湿关节炎（RA）或脊柱关节炎（SpA；包括银屑病关节炎）患者开始使用肿瘤坏死因子抑制剂（TNFi）后神经炎症事件（包括脱髓鞘疾病[DML]、炎性多发性神经病[IPN]和多发性硬化症[MS]）的发生率，探讨单克隆 TNFi 抗体（其他 TNFis（oTNFis））是否比依那西普的风险更高。
方法
这是一项观察性队列研究，纳入了 2001 年至 2020 年期间来自北欧五国开始使用 TNFi 的患者。通过登记链接确定首次神经炎症事件的时间。我们计算了每 1000 人年的粗发生率（cIR），并使用多变量调整的 Cox 回归比较了 oTNFis 与依那西普总体以及 DML、IPN 和 MS 的神经炎症事件发生率。我们进一步研究了单个 TNFis 和适应证。
结果
共纳入 33883 例 RA 患者和 28772 例 SpA 患者，分别起始 52704 例和 46572 例治疗疗程。在 RA 中，我们观察到 135 例神经炎症事件（65%为 DML），oTNFis 的 cIR 为 0.38，依那西普为 0.34。oTNFis 与依那西普相比，任何神经炎症事件的 HR 为 1.07（95%CI 0.74 至 1.54），DML 为 0.79（95%CI 0.51 至 1.22），IPN 为 2.20（95%CI 1.05 至 4.63），MS 为 0.73（95%CI 0.34 至 1.56）。在 SpA 中，我们观察到 179 例事件（78%为 DML），oTNFis 的 cIR 为 0.68，依那西普为 0.65。任何神经炎症事件、DML、IPN 和 MS 的 HR 分别为 1.06（95%CI 0.75 至 1.50）、1.01（95%CI 0.68 至 1.50）、1.28（95%CI 0.61 至 2.69）和 0.94（95%CI0.53 至 1.69）。
结论
SpA 中神经炎症事件的 cIR 高于 RA，但特定 TNFi 的选择似乎在神经炎症事件风险中并未起重要作用。
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