Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly
Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly
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DOI：
10.1093/rheumatology/keq242
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发表时间：
2011-01-01
期刊：
影响因子：
5.5
通讯作者：
Symmons, Deborah P. M.
中科院分区：
文献类型：
--
作者：
Galloway, James B.;Hyrich, Kimme L.;Symmons, Deborah P. M.
方法.我们使用来自英国风湿病学会生物制剂登记处的数据，一项前瞻性观察性研究，比较了11798例抗TNF治疗患者和3598例非生物制剂DMARD（nbDMARD）治疗患者的SI风险。共有1808例患者至少发生1次SI（抗TNF：1512例; nbDMARD：296例）。发生率为：抗TNF 42/1000随访患者年（95% CI 40，44）和nbDMARD 32/1000随访患者年（95% CI 28，36）。抗TNF队列中SI的校正风险比（adjHR）为1.2（95% CI 1.1，1.5）。阿达木单抗、依那西普和英夫利西单抗三种药物之间的风险无显著差异。在治疗的前6个月内风险最高[adjHR 1.8（95% CI 1.3，2.6）]。尽管在两个队列中，年龄增加是SI的独立危险因素，但在老年人群中接受抗TNF治疗的患者中，感染的相对风险没有差异。两个队列之间SI的住院时间无差异。抗TNF组SI后30天内的死亡率降低50%[比值比0.5（95%CI 0.3，0.8）]。这些数据增加了目前可用的证据，表明抗TNF治疗与SI的总体风险小但显著相关。这必须与疾病控制或替代治疗不良相关的风险相平衡。
Methods. Using data from the British Society for Rheumatology Biologics Register, a prospective observational study, we compared the risk of SI between 11 798 anti-TNF-treated patients and 3598 non-biologic DMARD (nbDMARD)-treated patients.Results. A total of 1808 patients had at least one SI (anti-TNF: 1512; nbDMARD: 296). Incidence rates were: anti-TNF 42/1000 patient-years of follow-up (95% CI 40, 44) and nbDMARD 32/1000 patient-years of follow-up (95% CI 28, 36). The adjusted hazard ratio (adjHR) for SI in the anti-TNF cohort was 1.2 (95% CI 1.1, 1.5). The risk did not differ significantly between the three agents adalimumab, etanercept and infliximab. The risk was highest during the first 6 months of therapy [adjHR 1.8 (95% CI 1.3, 2.6)]. Although increasing age was an independent risk factor for SI in both cohorts, there was no difference in relative risk of infection in patients on anti-TNF therapy in the older population. There was no difference in hospital stay for SI between cohorts. Mortality within 30 days of SI was 50% lower in the anti-TNF cohort [odds ratio 0.5 (95% CI 0.3, 0.8)].Conclusions. These data add to currently available evidence suggesting that anti-TNF therapy is associated with a small but significant overall risk of SI. This must be balanced against the risks associated with poor disease control or alternative treatments.