ARC Epidemiology Unit, University of Manchester, Manchester M13 9PT, UK.
Ann Rheum Dis. 2010 Mar;69(3):522-8. doi: 10.1136/ard.2009.118935. Epub 2009 Oct 22.
The risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA) is thought to be increased following anti-tumour necrosis factor (anti-TNF) therapy, with a proposed differential risk between the anti-TNF drugs etanercept (ETA), infliximab (INF) and adalimumab (ADA).
To compare directly the risk between drugs, to explore time to event, site of infection and the role of ethnicity.
Data from the British Society for Rheumatology Biologics Register (BSRBR), a national prospective observational study, were used to compare TB rates in 10 712 anti-TNF treated patients (3913 ETA, 3295 INF, 3504 ADA) and 3232 patients with active RA treated with traditional disease-modifying antirheumatic drugs.
To April 2008, 40 cases of TB were reported, all in the anti-TNF cohort. The rate of TB was higher for the monoclonal antibodies ADA (144 events/100,000 person-years) and INF (136/100,000 person-years) than for ETA (39/100,000 person-years). After adjustment, the incidence rate ratio compared with ETA-treated patients was 3.1 (95% CI 1.0 to 9.5) for INF and 4.2 (1.4 to 12.4) for ADA. The median time to event was lowest for INF (5.5 months) compared with ETA (13.4 months) and ADA (18.5 months). 13/40 cases occurred after stopping treatment. 25/40 (62%) cases were extrapulmonary, of which 11 were disseminated. Patients of non-white ethnicity had a sixfold increased risk of TB compared with white patients treated with anti-TNF therapy.
The rate of TB in patients with RA treated with anti-TNF therapy was three- to fourfold higher in patients receiving INF and ADA than in those receiving ETA.
据认为，肿瘤坏死因子（TNF）拮抗剂治疗后，类风湿关节炎（RA）患者的结核病（TB）风险增加，etanercept（ETA）、infliximab（INF）和 adalimumab（ADA）这三种 TNF 拮抗剂药物之间的风险可能存在差异。
直接比较药物之间的风险，探索事件时间、感染部位以及种族的作用。
利用英国风湿病学会生物制剂登记处（BSRBR）的数据，该数据来自一项全国性前瞻性观察性研究，对 10712 例接受 TNF 拮抗剂治疗的患者（3913 例接受 ETA、3295 例接受 INF、3504 例接受 ADA）和 3232 例接受传统疾病修饰抗风湿药物治疗的活动性 RA 患者的 TB 发生率进行了比较。
截至 2008 年 4 月，共报告了 40 例 TB 病例，均发生在 TNF 拮抗剂组。单克隆抗体 ADA（144 例/10 万人年）和 INF（136 例/10 万人年）的 TB 发生率高于 ETA（39 例/10 万人年）。校正后，与 ETA 治疗组相比，INF 和 ADA 的发病率比值比分别为 3.1（95%CI1.0 至 9.5）和 4.2（1.4 至 12.4）。INF 的中位发病时间最短（5.5 个月），其次是 ETA（13.4 个月）和 ADA（18.5 个月）。40 例中的 13 例在停药后发生。25/40（62%）例为肺外，其中 11 例为播散性。与接受 TNF 拮抗剂治疗的白人患者相比，非白人患者的 TB 风险增加了 6 倍。
接受 RA 治疗的 TNF 拮抗剂治疗患者的 TB 发生率，接受 INF 和 ADA 的患者比接受 ETA 的患者高 3 至 4 倍。
