Opportunistic infections in rheumatoid arthritis patients exposed to biologic therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis
Opportunistic infections in rheumatoid arthritis patients exposed to biologic therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis
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DOI：
10.1093/rheumatology/key023
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发表时间：
2018-06-01
期刊：
影响因子：
5.5
通讯作者：
Galloway, James B.
中科院分区：
文献类型：
--
作者：
Rutherford, Andrew I.;Patarata, Eunice;Galloway, James B.
目标。这项分析旨在通过生物学分类来评估RA患者机会性感染(OI)的风险。英国风湿病学会类风湿性关节炎生物制品登记是一项前瞻性观察队列研究，旨在评估生物疗法的安全性。该人群包括开始接受类风湿关节炎生物治疗的成年人。主要结果是除结核病(TB)外的任何严重OI。使用COX比例风险比较不同生物类别的事件发生率，并对确定的潜在混杂因素进行先验调整。分别对结核病发病情况进行分析。总共对19282例患者进行了106347年的随访，共发现142例非结核OI，平均为134例/10万病人年(PYRS)。不同药物类别的OI总发生率无显著差异，但利妥昔单抗的肺孢子虫感染率显著高于抗肿瘤坏死因子治疗(调整风险比=3.2，95%CI：1.4，7.5)。在研究期间，结核病发病率大幅下降(2002年为783例/10万人/10万人/年，2015年为38例/10万人/年)。利妥昔单抗使用者的结核病发病率明显低于抗肿瘤坏死因子使用者，分别为12例/10万和65例/10万。OI的总体发生率在不同药物类别之间没有显著差异；然而，在队列之间发现了OI模式的细微差异。年龄、性别和合并症等患者因素是OI最重要的预测因素。
Objectives. This analysis set out to estimate the risk of opportunistic infection (OI) among patients with RA by biologic class.Methods. The British Society for Rheumatology Biologics Register for Rheumatoid Arthritis is a prospective observational cohort study established to evaluate safety of biologic therapies. The population included adults commencing biologic therapy for RA. The primary outcome was any serious OI excluding tuberculosis (TB). Event rates were compared across biologic classes using Cox proportional hazards with adjustment for potential confounders identified a priori. Analysis of the incidence of TB was performed separately.Results. In total, 19 282 patients with 106 347 years of follow-up were studied; 142 non-TB OI were identified at a rate of 134 cases/100 000 patient years (pyrs). The overall incidence of OI was not significantly different between the different drug classes; however, the rate of Pneumocystis infection was significantly higher with rituximab than with anti-TNF therapy (adjusted hazard ratio = 3.2, 95% CI: 1.4, 7.5). The rate of TB fell dramatically over the study period (783 cases/100 000 pyrs in 2002 to 38 cases/100 000 pyrs in 2015). The incidence of TB was significantly lower among rituximab users than anti-TNF users, with 12 cases/100 000 pyrs compared with 65 cases/100 000 pyrs.Conclusions. The overall rate of OI was not significantly different between drug classes; however, a subtle difference in the pattern of OI was seen between the cohorts. Patient factors such as age, gender and comorbidity were the most important predictors of OI.