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Risk of Significant Infection in Rheumatoid Arthritis Patients Switching Anti-Tumor Necrosis Factor-α Drugs

机译:类风湿关节炎患者转用抗肿瘤坏死因子-α药物引起重大感染的风险

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Objectives: To describe rates of first significant infection of rheumatoid arthritis patients who switch between anti-tumor necrosis factor (aTNF) drugs. Methods: Subjects with rheumatoid arthritis who received only aTNF drugs were observed in an insurance claims database from January 2001 to December 2007. Nonswitchers (NS) remained on one aTNF throughout the study period (date of the first aTNF claim was the index date); switchers (S) received at least one other aTNF (claim date for the 2nd agent was the index date). Significant infections included those that required intravenous antibiotics or hospitalization. Two attributable risk periods were used: (1) an infection occurring ≤90 days following a claim for an aTNF (90-day) and (2) an infection occurring after the index date (ever-treated). Follow-up was censored at the first occurrence of a significant infection event, end of eligibility, or end of study period. Data were analyzed using Cox regression. Results: In 13,752 NS and 2293 S patients, time-stratified rates declined 2- to 3-fold between the first year versus ≥2 years. Risk of significant infection was not different for either attribution model [90-day hazard ratio (HR)=0.93, 95CI: 0.74 to 1.17, P=0.55; ever treated HR=0.94, 95CI: 0.78 to 1.15, P = 0.57]. First and second year rates were similar. Predictors included age ≥50 years; history of significant or opportunistic infection, diabetes, respiratory disease; Charlson score ≥2; or prior hospitalizations. Conclusions: The risk of a significant infection was not different between NS and S patients. Regardless of switching status, the rate of infection was greater in the first year. This study was limited by the lack of clinical data to determine the reason for switching.
机译:目的:描述在抗肿瘤坏死因子(aTNF)药物之间切换的类风湿关节炎患者的首次重大感染率。方法:从2001年1月至2007年12月,在保险索赔数据库中观察到仅接受aTNF药物治疗的类风湿关节炎患者。在整个研究期间,非切换者(NS)仍在一个aTNF药物上(第一次aTNF药物索赔的日期为索引日期);交换者(S)至少接受了另一种aTNF(第二种药物的申领日期为索引日期)。重大感染包括需要静脉注射抗生素或住院的感染。使用了两个可归因的风险期:(1)要求aTNF感染后90天之内发生感染(90天),以及(2)在指标日期后发生的感染(曾经治疗)。在首次发生重大感染事件,资格终止或研究期结束时对随访进行检查。使用Cox回归分析数据。结果:在13752名NS和2293 S患者中,时间分层率在第一年和≥2年之间下降了2到3倍。两种归因模型[90天危险比(HR)= 0.93,95CI:0.74至1.17,P = 0.55; 90天危险比(HR)= 0.93,95CI:0.74至1.17,P = 0.55; HR = 0.94,95CI:0.78至1.15,P = 0.57]。第一和第二年的比率相似。预测因素包括年龄≥50岁;有重大或机会感染,糖尿病,呼吸系统疾病的病史;查尔森得分≥2;或先前的住院治疗。结论:NS和S患者之间发生重大感染的风险没有差异。无论切换状态如何,第一年的感染率都更高。这项研究由于缺乏确定转换原因的临床数据而受到限制。

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