Askling Johan, Fored C Michael, Brandt Lena, Baecklund Eva, Bertilsson Lennart, Cöster Lars, Geborek Pierre, Jacobsson Lennart T, Lindblad Staffan, Lysholm Jörgen, Rantapää-Dahlqvist Solbritt, Saxne Tore, Romanus Victoria, Klareskog Lars, Feltelius Nils
Clinical Epidemiology Unit, Department of Medicine, Karolinska University Hospital Solna, Karolinska Institute, Stockholm, Sweden.
Arthritis Rheum. 2005 Jul;52(7):1986-92. doi: 10.1002/art.21137.
Because treatment with tumor necrosis factor (TNF) antagonists may increase the risk of tuberculosis (TB), and because knowledge of the risk of TB in rheumatoid arthritis (RA) not treated with biologics is scarce and of uncertain generalizability to low-risk populations, this study sought to determine the risk of TB among Swedish patients with RA.
Using data from Swedish nationwide and population-based registers and data from an ongoing monitoring program of TNF antagonists, the relative risks of TB in patients with RA (versus the general population) and of TB associated with TNF antagonists (versus RA patients not treated with biologics) were determined by comparing the incidence of hospitalization for TB in 3 RA cohorts and 2 general population cohorts from 1999 to 2001. We also reviewed the characteristics of all reported cases of TB in RA patients treated with TNF antagonists in Sweden and calculated the incidence of TB per type of TNF antagonist between 1999 and 2004.
During 1999-2001, RA patients who were not treated with TNF antagonists were at increased risk of TB versus the general population (relative risk 2.0, 95% confidence interval [95% CI] 1.2-3.4). RA patients treated with TNF antagonists had a 4-fold increased risk of TB (relative risk 4.0, 95% CI 1.3-12) versus RA patients not treated with TNF antagonists. The reported TB cases during 1999-2004 in RA patients exposed to TNF antagonists (9 infliximab, 4 etanercept, 2 both) were predominantly pulmonary. TB occurred up to 3 years following the start of treatment.
Irrespective of whether TNF antagonists are administered, Swedish patients with RA are at increased risk of TB. During 1999-2001, TNF antagonists were associated with an increased risk of TB, up to 4-fold in magnitude. This increased risk may persist over time during treatment and is related to both infliximab and etanercept.
由于使用肿瘤坏死因子（TNF）拮抗剂进行治疗可能会增加患结核病（TB）的风险，并且由于在未使用生物制剂治疗的类风湿关节炎（RA）患者中，关于结核病风险的了解甚少，且对低风险人群的普遍适用性不确定，因此本研究旨在确定瑞典RA患者患结核病的风险。
利用瑞典全国性和基于人群的登记数据以及一项正在进行的TNF拮抗剂监测计划的数据，通过比较1999年至2001年3个RA队列和2个普通人群队列中结核病住院发病率，确定RA患者（相对于普通人群）患结核病的相对风险以及与TNF拮抗剂相关的结核病（相对于未使用生物制剂治疗的RA患者）的相对风险。我们还回顾了瑞典接受TNF拮抗剂治疗的RA患者中所有报告的结核病病例的特征，并计算了1999年至2004年每种TNF拮抗剂的结核病发病率。
在1999 - 2001年期间，未使用TNF拮抗剂治疗的RA患者患结核病的风险高于普通人群（相对风险2.0，95%置信区间[95%CI]1.2 - 3.4）。与未使用TNF拮抗剂治疗的RA患者相比，使用TNF拮抗剂治疗的RA患者患结核病的风险增加了4倍（相对风险4.0，95%CI 1.3 - 12）。1999年至2004年期间，暴露于TNF拮抗剂的RA患者中报告的结核病病例（9例英夫利昔单抗、4例依那西普、2例两者皆有）主要为肺部感染。结核病在开始治疗后长达3年发生。
无论是否使用TNF拮抗剂，瑞典RA患者患结核病的风险都会增加。在1999 - 2001年期间，TNF拮抗剂与患结核病风险增加相关，幅度高达4倍。这种增加的风险在治疗期间可能会持续存在，并且与英夫利昔单抗和依那西普都有关。
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