Outcomes Research, Truven Health Analytics, 7700 Old Georgetown Road, Bethesda, MD 20814, USA.
Semin Arthritis Rheum. 2013 Aug;43(1):39-47. doi: 10.1016/j.semarthrit.2012.12.024. Epub 2013 Feb 27.
This study compared the incidence and hazard of ICD-9-CM-coded infections and severe infections in rheumatoid arthritis (RA) patients treated with subsequent-line (SL) BIOs (BIO) after switching from first-line (FL) anti-TNF therapy (anti-TNF).
Retrospective analysis of a large U.S. claims database. RA patients initiating an FL anti-TNF between 1/1/2004 and 3/31/2010 were identified and followed forward in time to capture all SL BIO episodes through 3/31/2010. SL BIO episodes were classified into: abatacept, adalimumab, etanercept, infliximab, or rituximab. Multivariate mixed-effects survival models compared the hazard of infections and severe infections across the SL BIO episodes with adjustment for demographic and clinical confounders.
In total, 4332 SL BIO episodes were identified: mean age 55 years; 80% female. In adjusted analyses: when compared to rituximab, the hazard of all infections was significantly higher for adalimumab (hazard ratio [HR] = 1.31, 95% confidence interval [CI] = 1.09-1.55), etanercept (HR = 1.44, 95% CI = 1.20-1.72), and infliximab (HR = 1.30, 95% CI = 1.07-1.57), and insignificantly different for abatacept (HR = 1.18, 95% CI = 0.98-1.41); when compared to rituximab, the hazard of severe infection was significantly higher for infliximab (HR = 1.62, 95% CI = 1.03-2.55), and insignificantly different for abatacept (HR = 1.21, 95% CI = 0.78-1.88), adalimumab (HR = 1.10, 95% CI = 0.72-1.68), and etanercept (HR = 1.27, 95% CI = 0.83-1.95).
In RA patients treated with SL BIO, a 30-44% higher hazard of all infection was observed in anti-TNFs versus rituximab with a 62% higher hazard of severe infection observed in infliximab versus rituximab. This study used a non-randomized, observational design and is therefore subject to confounding from unmeasured factors that influence both treatment choice and infection risk.
本研究比较了类风湿关节炎(RA)患者在一线(FL)抗 TNF 治疗(抗 TNF)转换后接受后续线(SL)生物制剂(BIO)治疗时,ICD-9-CM 编码感染和严重感染的发生率和危害。
这是一项对美国大型索赔数据库进行的回顾性分析。2004 年 1 月 1 日至 2010 年 3 月 31 日期间,确定了开始 FL 抗 TNF 的 RA 患者,并进行前瞻性随访,以通过 2010 年 3 月 31 日之前捕获所有 SL BIO 发作。将 SL BIO 发作分为:阿巴西普、阿达木单抗、依那西普、英夫利昔单抗或利妥昔单抗。多变量混合效应生存模型比较了 SL BIO 发作期间感染和严重感染的危害,并调整了人口统计学和临床混杂因素。
共确定了 4332 例 SL BIO 发作:平均年龄 55 岁;80%为女性。在调整分析中:与利妥昔单抗相比,阿达木单抗(危害比 [HR] = 1.31,95%置信区间 [CI] = 1.09-1.55)、依那西普(HR = 1.44,95% CI = 1.20-1.72)和英夫利昔单抗(HR = 1.30,95% CI = 1.07-1.57)的所有感染风险显著更高,而阿巴西普(HR = 1.18,95% CI = 0.98-1.41)的风险则无显著差异;与利妥昔单抗相比,英夫利昔单抗(HR = 1.62,95% CI = 1.03-2.55)严重感染的风险显著更高,阿巴西普(HR = 1.21,95% CI = 0.78-1.88)、阿达木单抗(HR = 1.10,95% CI = 0.72-1.68)和依那西普(HR = 1.27,95% CI = 0.83-1.95)的风险则无显著差异。
在接受 SL BIO 治疗的 RA 患者中,与利妥昔单抗相比,抗 TNF 药物的所有感染风险增加了 30-44%,而与利妥昔单抗相比,英夫利昔单抗严重感染的风险增加了 62%。本研究使用了非随机、观察性设计,因此易受到影响治疗选择和感染风险的未测量因素的混杂。