Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) Study
Non-viral opportunistic infections in new users of tumour necrosis factor inhibitor therapy: results of the SAfety Assessment of Biologic ThERapy (SABER) Study
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DOI：
10.1136/annrheumdis-2013-203407
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发表时间：
2014-11-01
影响因子：
27.4
通讯作者：
Curtis, Jeffrey R.
中科院分区：
文献类型：
--
作者：
Baddley, John W.;Winthrop, Kevin L.;Curtis, Jeffrey R.
目的 确定在美国患有自身免疫性疾病的患者中，与用于治疗活动性疾病的非生物制剂的使用者相比，肿瘤坏死因子 a 抑制剂 (TNFI) 新使用者的非病毒机会性感染 (OI) 风险是否增加。 1998 年至 2007 年期间的银屑病-银屑病关节炎-强直性脊柱炎患者使用北加州 Kaiser Permanente、两个针对老年人的药物援助计划、田纳西州医疗补助计划和美国医疗补助/医疗保险计划的综合数据。我们比较了新 TNFI 使用者和开始使用非生物疾病缓解抗风湿药物 (DMARD) 的患者和每个疾病队列中的非病毒性成骨不全的发生率。 Cox 回归模型用于比较新 TNFI 使用者和非生物 DMARD 使用者之间的倾向评分和类固醇调整的 OI 发生率。结果 在 33 324 名新 TNFI 用户的队列中，我们发现了 80 例非病毒性 OI，其中最常见的是肺囊肿病 (n=16)。在合并队列中，与开始使用非生物 DMARD 的新使用者相比，新使用 TNFI 的非病毒性 OI 粗率分别为每 1000 人年 2.7 例和 1.7 例（aHR 1.6，95% CI 1.0 至 2.6）。基线皮质类固醇的使用与非病毒性成骨不全相关（aHR 2.5，95% CI 1.5 至 4.0）。在 RA 队列中，与新开始使用非生物 DMARD 的患者（aHR 2.6，95% CI 1.2 至 5.6）或新依那西普使用者（aHR 2.9，95% CI 1.5 至 5.4）相比，英夫利昔单抗新使用者中非病毒性 OI 发生率更高。 结论 在美国，TNFI 新使用者中非病毒性 OI 发生率更高具有自身免疫性 与非生物 DMARD 使用者相比。
Objectives To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor a inhibitors (TNFI), when compared to users of non-biological agents used for active disease.Methods We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating nonbiological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid-adjusted OI incidence between new TNFI and non-biological DMARD users.Results Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95% CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95% CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95% CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95% CI 1.5 to 5.4).Conclusions In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.