University of Alabama at Birmingham.
University of Pennsylvania, Philadelphia.
Arthritis Rheumatol. 2016 Jan;68(1):56-66. doi: 10.1002/art.39399.
The risks of hospitalized infection associated with biologic agents used to treat rheumatoid arthritis (RA) are unclear. The aim of this study was to determine whether the associated risk of hospitalized infections differed between specific biologic agents used to treat RA.
In a retrospective cohort study using Medicare data from 2006-2011 for all enrolled patients with RA, new episodes of treatment with etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, rituximab, and tocilizumab were identified. Patients were required to have received another biologic agent previously and to have been continuously enrolled in Medicare medical and pharmacy plans during the baseline period and throughout followup. Followup started on the date of initiation of treatment with the new biologic agent (after previous treatment with a different biologic agent) and ended on the date of the earliest hospitalized infection, at 12 months, after an exposure gap of >30 days, or at the time of death or loss of Medicare coverage. Cox regression analysis was used to calculate the adjusted hazard ratio (HR) for hospitalized infection, adjusting for an infection risk score and other confounders.
Of 31,801 new biologic treatment episodes in patients who had previously received another biologic agent, 12.0% were with etanercept, 15.2% with adalimumab, 5.9% with certolizumab, 4.4% with golimumab, 12.4% with infliximab, 28.9% with abatacept, 14.8% with rituximab, and 6.3% with tocilizumab. During followup, we identified 2,530 hospitalized infections; incidence rates ranged from 13.1 per 100 person-years (abatacept) to 18.7 per 100 person-years (rituximab). After adjustment, etanercept (HR 1.24, 95% confidence interval [95% CI] 1.07-1.45), infliximab (HR 1.39, 95% CI 1.21-1.60), and rituximab (HR 1.36, 95% CI 1.21-1.53) had significantly higher HRs for hospitalized infection compared with abatacept.
In RA patients with prior exposure to a biologic agent, exposure to etanercept, infliximab, or rituximab was associated with a greater 1-year risk of hospitalized infection compared with the risk associated with exposure to abatacept.
用于治疗类风湿关节炎（RA）的生物制剂相关的住院感染风险尚不清楚。本研究旨在确定用于治疗 RA 的特定生物制剂之间是否存在住院感染风险的差异。
本研究采用 2006 年至 2011 年 Medicare 数据，对所有纳入的 RA 患者进行回顾性队列研究，对依那西普、阿达木单抗、塞妥珠单抗、古塞奇尤单抗、英夫利昔单抗、阿巴西普、利妥昔单抗和托珠单抗的新治疗期进行识别。患者需要之前接受过另一种生物制剂治疗，并在基线期和整个随访期间持续参加 Medicare 医疗和药房计划。随访从新生物制剂治疗开始（在之前接受不同生物制剂治疗后），在最早的住院感染日期、12 个月、暴露间隔超过 30 天、或死亡或失去 Medicare 覆盖时结束。采用 Cox 回归分析计算住院感染的调整后危险比（HR），调整感染风险评分和其他混杂因素。
在先前接受过另一种生物制剂的 31801 例新生物治疗期患者中，12.0%为依那西普、15.2%为阿达木单抗、5.9%为塞妥珠单抗、4.4%为古塞奇尤单抗、12.4%为英夫利昔单抗、28.9%为阿巴西普、14.8%为利妥昔单抗和 6.3%为托珠单抗。在随访期间，我们发现了 2530 例住院感染；发病率从 13.1/100 人年（阿巴西普）到 18.7/100 人年（利妥昔单抗）不等。调整后，依那西普（HR 1.24，95%置信区间[95%CI]1.07-1.45）、英夫利昔单抗（HR 1.39，95%CI 1.21-1.60）和利妥昔单抗（HR 1.36，95%CI 1.21-1.53）与阿巴西普相比，住院感染的 HR 显著更高。
在先前接触过生物制剂的 RA 患者中，与接触阿巴西普相比，接触依那西普、英夫利昔单抗或利妥昔单抗与 1 年住院感染风险增加相关。
