Listing Joachim, Strangfeld Anja, Kary Sonja, Rau Rolf, von Hinueber Ulrich, Stoyanova-Scholz Maria, Gromnica-Ihle Erika, Antoni Christian, Herzer Peter, Kekow Jörn, Schneider Matthias, Zink Angela
German Rheumatism Research Centre, Schumannstrasse 21/22, D-10117 Berlin, Germany.
Arthritis Rheum. 2005 Nov;52(11):3403-12. doi: 10.1002/art.21386.
To estimate the incidence rates of serious and nonserious infections in patients with rheumatoid arthritis (RA) who start treatment with a biologic agent, and to compare these rates with those in patients with RA who receive conventional treatment.
Patients enrolled in the German biologics register between May 2001 and September 2003 were included. Treating rheumatologists assessed adverse events and serious adverse events. All adverse events and serious adverse events experienced within 12 months after study entry were analyzed. Propensity score methods were applied to estimate which part of a rate increase was likely to be attributable to differences in patient characteristics.
Data were available for 512 patients receiving etanercept, 346 patients receiving infliximab, 70 patients receiving anakinra, and 601 control patients treated with disease-modifying antirheumatic drugs. The total number of adverse events per 100 patient-years was 22.6 (95% confidence interval [95% CI] 18.7-27.2) among patients receiving etanercept, 28.3 (95% CI 23.1-34.7) among patients receiving infliximab, and 6.8 (95% CI 5.0-9.4) among controls (P < 0.0001). Significant differences in the rate of serious adverse events were also observed. For patients receiving etanercept, those receiving infliximab, and controls, the total numbers of serious adverse events per 100 patient-years were 6.4 (95% CI 4.5-9.1), 6.2 (95% CI 4.0-9.5), and 2.3 (95% CI 1.3-3.9), respectively (P = 0.0016). After adjusting for differences in the case patient mix, the relative risks of serious adverse events were 2.2 (95% CI 0.9-5.4) for patients receiving etanercept and 2.1 (95% CI 0.8-5.5) for patients receiving infliximab, compared with controls.
Patients treated with biologic agents have a higher a priori risk of infection. However, our data suggest that this risk is increased by treatment with tumor necrosis factor inhibitors.
评估开始使用生物制剂治疗的类风湿关节炎（RA）患者中严重感染和非严重感染的发病率，并将这些发病率与接受传统治疗的RA患者的发病率进行比较。
纳入2001年5月至2003年9月在德国生物制剂登记处登记的患者。治疗的风湿病学家评估不良事件和严重不良事件。分析研究入组后12个月内发生的所有不良事件和严重不良事件。应用倾向评分方法来估计发病率增加的哪一部分可能归因于患者特征的差异。
有512例接受依那西普治疗的患者、346例接受英夫利昔单抗治疗的患者、70例接受阿那白滞素治疗的患者以及601例接受改善病情抗风湿药物治疗的对照患者的数据。每100患者年的不良事件总数在接受依那西普治疗的患者中为22.6（95%置信区间[95%CI]18.7 - 27.2）；在接受英夫利昔单抗治疗的患者中为28.3（95%CI 23.1 - 34.7）；在对照患者中为6.8（95%CI 5.0 - 9.4）（P < 0.0001）。在严重不良事件发生率方面也观察到显著差异。对于接受依那西普治疗的患者、接受英夫利昔单抗治疗的患者和对照患者，每100患者年的严重不良事件总数分别为6.4（95%CI 4.5 - 9.1）、6.2（95%CI 4.0 - 9.5）和2.3（95%CI 1.3 - 3.9）（P = 0.0016）。在对病例患者构成的差异进行调整后,与对照相比，接受依那西普治疗的患者严重不良事件的相对风险为2.2（95%CI 0.9 - 5.4），接受英夫利昔单抗治疗的患者为2.1（95%CI 0.8 - 5.5）。
接受生物制剂治疗的患者感染的先验风险较高。然而，我们的数据表明，肿瘤坏死因子抑制剂治疗会增加这种风险.
