Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy - Results from the British Society for Rheumatology Biologics Register
Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy - Results from the British Society for Rheumatology Biologics Register
复制标题
DOI：
10.1002/art.21978
复制
发表时间：
2006-08-01
影响因子：
--
通讯作者：
Symmons, D. P. M.
中科院分区：
文献类型：
--
作者：
Dixon, W. G.;Watson, K.;Symmons, D. P. M.
Objective.确定抗肿瘤坏死因子（anti-TNF）治疗类风湿关节炎（RA）患者的严重感染率是否高于传统疾病缓解抗风湿药物（DMARDs）治疗的RA患者。这是一项国家前瞻性观察性研究，纳入了来自英国风湿病学会生物制剂注册中心的7，664例抗TNF治疗和1，354例DMARD治疗的重度RA患者。所有严重感染，分层的网站和微生物，包括在分析中。在2001年12月至2005年9月期间，抗TNF治疗队列中有525例严重感染，对照队列中有56例严重感染（随访分别为9，868和1，352人-年）。经基线风险校正后，抗TNF治疗队列与对照队列的发生率比（IRR）为1.03（95%置信区间0.68-1.57）。然而，在抗TNF治疗的患者中，严重皮肤和软组织感染的频率增加，校正的IRR为4.28（95%置信区间1.06-17.17）。3种主要抗TNF药物之间的感染风险无差异。发生了19例严重的细菌性细胞内感染，仅发生在抗TNF治疗组的患者中。在活动性RA患者中，校正基线风险后，与DMARD治疗相比，抗TNF治疗与总体严重感染风险增加无关。与此相反，严重的皮肤和软组织感染的发生率增加，表明TNF在皮肤和软组织中的宿主防御中的重要生理作用超出了其他组织。
Objective. To determine whether the rate of serious infection is higher in anti-tumor necrosis factor (anti-TNF)-treated rheumatoid arthritis (RA) patients compared with RA patients treated with traditional disease-modifying antirheumatic drugs (DMARDs).Methods. This was a national prospective observational study of 7,664 anti-TNF-treated and 1,354 DMARD-treated patients with severe RA from the British Society for Rheumatology Biologics Register. All serious infections, stratified by site and organism, were included in the analysis.Results. Between December 2001 and September 2005, there were 525 serious infections in the anti-TNF-treated cohort and 56 in the comparison cohort (9,868 and 1,352 person-years of followup, respectively). The incidence rate ratio (IRR), adjusted for baseline risk, for the anti-TNF-treated cohort compared with the comparison cohort was 1.03 (95% confidence interval 0.68-1.57). However, the frequency of serious skin and soft tissue infections was increased in anti-TNF-treated patients, with an adjusted IRR of 4.28 (95% confidence interval 1.06-17.17). There was no difference in infection risk between the 3 main anti-TNF drugs. Nineteen serious bacterial intracellular infections occurred, exclusively in patients in the anti-TNF-treated cohort.Conclusion. In patients with active RA, anti-TNF therapy was not associated with increased risk of overall serious infection compared with DMARD treatment, after adjustment for baseline risk. In contrast, the rate of serious skin and soft tissue infections was increased, suggesting an important physiologic role of TNF in host defense in the skin and soft tissues beyond that in other tissues.