Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk -: A multicenter active-surveillance report
Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk -: A multicenter active-surveillance report
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DOI：
10.1002/art.11137
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发表时间：
2003-08-01
影响因子：
--
通讯作者：
Montero, MD
中科院分区：
文献类型：
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作者：
Gómez-Reino, JJ;Carmona, L;Montero, MD
Objective.中和肿瘤坏死因子（TNF）的治疗药物的长期安全性尚不确定。基于自发报告的最新证据显示与活动性结核病（TB）有关。我们进行了这项研究，以确定和描述的长期安全性的2这些药物，英夫利西单抗和依那西普，在风湿性疾病的基础上，国家积极监测系统后，商业化的药物。我们分析了在BIOBADASER（Base de Datos de Productos Biologicos de la Sociedad Espanola de Rehabilologia）数据库中积极收集的安全性数据，该数据库由西班牙流变学学会于2000年2月启动。对于结核病风险的估计，患者的年发病率。将这些药物治疗的患者与背景发生率和抗TNF治疗前类风湿关节炎（RA）患者队列的发生率进行比较。71个参与中心发送了1，540例患者的1，578次英夫利昔单抗（86%）或依那西普（14%）治疗的数据。合并英夫利西单抗和依那西普的药物生存率（报告为仍在接受药物治疗的患者的累积百分比）在1年和2年时分别为85%和81%。停药主要是由于不良事件。在接受英夫利西单抗治疗的患者中发现了17例结核病病例。RA患者中与英夫利西单抗相关的TR的估计发生率在2000年为1，893/100，000，在2001年为1，113/100，000。与背景率相比，这些发现表明风险显著增加。在2002年的前5个月，在制定了预防使用生物制剂患者结核病的官方指南后，仅登记了1例新的结核病病例（1月份）。英夫利西单抗治疗与活动性TB风险增加相关。需要采取适当措施预防和管理该不良事件。
Objective. The long-term safety of therapeutic agents that neutralize tumor necrosis factor (TNF), is uncertain. Recent evidence based on spontaneous reporting shows an association with active tuberculosis (TB). We undertook this study to determine and describe the long-term safety of 2 of these agents, infliximab and etanercept, in rheumatic diseases based on a national active-surveillance system following the commercialization of the drugs.Methods. We analyzed the safety data actively collected in the BIOBADASER (Base de Datos de Productos Biologicos de la Sociedad Espanola de Reumatologia) database, which was launched in February 2000 by the Spanish Society of Rheumatology. For the estimation of TB risk, the annual incidence rate in patients. treated with these agents was compared with the background rate and with the rate in a cohort of patients with rheumatoid arthritis (RA) assembled before the era of anti-TNF treatment.Results. Seventy-one participating centers sent data on 1,578 treatments with infliximab (86%) or etanercept (14%) in 1,540 patients. Drug survival rates (reported as the cumulative percentage of patients still receiving medication) for infliximab and etanercept pooled together were 85% and 81% at 1 year and 2 years, respectively. Instances of discontinuation were essentially due to adverse events. Seventeen cases of TB were found in patients treated with infliximab. The estimated incidence of TR associated with infliximab in RA patients was 1,893 per 100,000 in the year 2000 and 1,113 per 100,000 in the year 2001. These findings represent a significant increased risk compared with background rates. In the first 5 months of 2002, after official guidelines were established for TB prevention in patients treated with biologics, only 1 new TB case was registered (in January).Conclusion. Therapy with infliximab is associated with an increased risk of active TB. Proper measures are needed to prevent and manage this adverse event.