Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Ann Rheum Dis. 2011 Aug;70(8):1401-6. doi: 10.1136/ard.2010.146365. Epub 2011 May 17.
It is unclear whether anti-tumour necrosis factor alpha and biological agents with different mechanisms of action have similar safety. This study evaluated the incidence of hospitalised infections among rheumatoid arthritis (RA) patients starting or switching various biological agents.
Using a database from a large US healthcare organisation from January 2005 to August 2009, the authors identified enrollees with RA and their treatment episodes entailing the new use of a biological agent, stratified by no biological use in the previous year ('biological-free') or switching from a different biological agent ('switchers'). Outcomes were hospitalised infections identified using previously validated algorithms. Proportional hazards models estimated the hazard ratio of hospitalised infections, comparing each biological agent with infliximab.
Among 7847 biological treatment episodes, 63% were for biological-free patients and 37% for switchers. There were 364 hospitalised infections. Rates of hospitalised infection among biological-free patients and switchers were 4.6 and 7.0 per 100 person-years, respectively (p<0.0001). After multivariable adjustment controlling for biological-free/switcher status and other infection-related factors and compared with infliximab, users of abatacept (HR 0.68, 95% CI 0.48 to 0.96), adalimumab (HR 0.52, 0.39 to 0.71), etanercept (HR 0.64, 0.49 to 0.84) and rituximab (HR 0.81, 0.55 to 1.20) had lower rates of hospitalised infection. Patient risk factors contributed more to the risk of infection than did the risk associated with specific biological therapies.
The rate of hospitalised infections among RA patients was highest for infliximab. Most of the variability in patients' risk of infection was driven by factors other than biological agent exposure.
目前尚不清楚作用机制不同的抗肿瘤坏死因子 α 药物和生物制剂是否具有相似的安全性。本研究评估了开始使用或转换各种生物制剂的类风湿关节炎（RA）患者发生住院感染的发生率。
研究人员使用来自美国一家大型医疗保健组织的数据库，该数据库的时间范围为 2005 年 1 月至 2009 年 8 月，确定了患有 RA 的患者及其接受新的生物制剂治疗的治疗期，这些患者分为前一年未使用生物制剂（“无生物制剂”）或从不同的生物制剂转换而来（“转换者”）。使用先前验证的算法确定住院感染的结果。比例风险模型估计了与 infliximab 相比，每种生物制剂发生住院感染的风险比。
在 7847 次生物治疗期内，63%为无生物制剂患者，37%为转换者。共有 364 例住院感染。无生物制剂患者和转换者的住院感染发生率分别为每 100 人年 4.6 和 7.0 例（p<0.0001）。在校正了无生物制剂/转换者状态和其他感染相关因素后，与 infliximab 相比，使用 abatacept（HR 0.68，95%CI 0.48 至 0.96）、阿达木单抗（HR 0.52，0.39 至 0.71）、依那西普（HR 0.64，0.49 至 0.84）和利妥昔单抗（HR 0.81，0.55 至 1.20）的患者住院感染率较低。患者的风险因素比特定生物治疗相关的风险因素对感染风险的贡献更大。
RA 患者的住院感染率以 infliximab 最高。患者感染风险的可变性主要归因于生物制剂暴露以外的因素。
