Initiation of rheumatoid arthritis treatments and the risk of serious infections
Initiation of rheumatoid arthritis treatments and the risk of serious infections
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DOI：
10.1093/rheumatology/kep325
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发表时间：
2010-01-01
期刊：
影响因子：
5.5
通讯作者：
Griffin, Marie R.
中科院分区：
文献类型：
--
作者：
Grijalva, Carlos G.;Kaltenbach, Lisa;Griffin, Marie R.
Objective.在RA患者接受传统DMARD治疗的临床试验中，与安慰剂相比，TNF-α拮抗剂增加了感染。我们的目的是比较严重感染后开始不同的RA方案。先前的比较研究DMARD启动产生了相互矛盾的结果。我们估计了田纳西州医疗补助登记的RA患者（1995-2005年）开始使用TNF-α拮抗剂、其他DMARD和口服糖皮质激素后感染的住院率。使用药房信息测量暴露时间，并使用经验证的定义确定感染。采用考克斯回归模型，以MTX作为参考，比较RA方案的启动。敏感性分析排除了糖皮质激素使用者，采用首次暴露结转法，将观察限制在2002-05年和首次使用事件，并探讨了未测量的混杂因素的影响。我们确定了28906例新的药物使用事件，包括TNF-α拮抗剂（8%），MTX单独（15%）和糖皮质激素单独（57%）。与MTX治疗相比，TNF-α拮抗剂治疗未显著增加因肺炎住院的风险[校正风险比（aHR）1.61; 95% CI 0.85，3.03]或任何感染（aHR 1.31; 95% CI 0.78，2.19）。与MTX相比，LEF，SSZ或HCQ的启动并没有增加严重感染。开始和同时使用糖皮质激素与严重感染的剂量依赖性增加相关。敏感性分析结果一致。与开始单独使用MTX相比，开始使用TNF-α拮抗剂与严重感染风险的大幅增加无关。糖皮质激素的使用与这些感染风险的剂量依赖性增加相关。
Objective. In clinical trials of RA patients on traditional DMARDs, the addition of TNF-alpha antagonists increased infections compared with addition of placebo. Our objective was to compare serious infections following initiation of different RA regimens. Prior comparative studies of DMARD initiation have yielded conflicting results.Methods. We estimated hospitalization rates for infections following initiation of TNF-alpha antagonists, other DMARDs and oral glucocorticoids in Tennessee Medicaid-enrolled RA patients (1995-2005). Exposure time was measured using pharmacy information and infections were identified using validated definitions. Initiation of RA regimens was compared using Cox regression models with MTX as the reference. Sensitivity analyses excluded glucocorticoid users, applied a first exposure carried forward approach, restricted observations to 2002-05 and first episodes of use and explored effects of unmeasured confounders.Results. We identified 28 906 new episodes of medication use, including TNF-alpha antagonists (8%), MTX alone (15%) and glucocorticoids alone (57%). Compared with MTX initiation, TNF-alpha antagonist initiation did not significantly increase the risk of hospitalizations for pneumonia [adjusted hazard ratio (aHR) 1.61; 95% CI 0.85, 3.03] or any infection (aHR 1.31; 95% CI 0.78, 2.19). Initiation of LEF, SSZ or HCQ did not increase serious infections, compared with MTX. Both initiation and concurrent glucocorticoid use were associated with a dose-dependent increase in serious infections. Sensitivity analyses showed consistent results.Conclusions. Compared with initiation of MTX alone, initiation of TNF-alpha antagonists was not associated with a large increase in the risk of serious infections. Glucocorticoid use was associated with a dose-dependent increase in the risk of these infections.