Department of Nephrology and Rheumatology, Medicine III, University Clinic Hamburg-Eppendorf, Hamburg, Germany,
Private Practice, Hildesheim, Germany.
Rheumatology (Oxford). 2016 Apr;55(4):624-35. doi: 10.1093/rheumatology/kev372. Epub 2015 Oct 29.
To evaluate the tolerability, effectiveness and utilization of tocilizumab for the treatment of RA in a usual care setting.
ROUTINE was a prospective, non-interventional, observational 52-week study performed at 174 sites throughout Germany. RA patients were selected and treated according to label. Study objectives included the targeted documentation of infections, other adverse events, and various effectiveness outcomes (e.g. DAS28, clinical disease activity). Statistical analyses were performed primarily based on the data as observed.
A total of 850 patients (75% women, mean age: 56 ± 13 years, mean RA duration: 10.3 ± 8.6 years) were enrolled. Most patients (79%) were pretreated with TNF-inhibitors, whereas 21% were pretreated with conventional DMARDs only. Most common DMARD pretreatments were MTX (79%), LEF (68%), adalimumab (53%) and etanercept (50%). At baseline, 60.5% of patients received tocilizumab in combination with any other RA drugs, while 39.5% were treated in monotherapy. Mean baseline DAS28 was 5.5 ± 1.3, and this decreased to 2.6 ± 1.6 at week 52. At week 52, good EULAR response was achieved in 62.3%, low disease activity state in 66.4%, and DAS28 remission in 55.1% of patients (adjusted relative frequencies). 35.3% of patients discontinued the study prematurely; common reasons were lack of effectiveness (10.5%) and intolerability (7.3%). Any infections and severe infections occurred in 37.6% and 7.2% of patients, respectively (N = 836); serious infections were seen in 5.3% (N = 850). Event rates of any, severe and serious infections were 70.3, 9.8 and 4.4 events/100 patient-years, respectively.
Tocilizumab administered in a real-life setting showed clinically meaningful improvements and a safety profile that was consistent with data reported from pre-approval Phase III studies.
评估托珠单抗在常规治疗环境下治疗类风湿关节炎的耐受性、疗效和利用情况。
ROUTINE 是一项在德国 174 个地点进行的前瞻性、非干预性、观察性的 52 周研究。根据标签选择和治疗 RA 患者。研究目标包括有针对性地记录感染、其他不良事件和各种疗效结果（例如 DAS28、临床疾病活动度）。统计分析主要基于观察到的数据进行。
共纳入 850 例患者（75%为女性，平均年龄：56±13 岁，平均 RA 病程：10.3±8.6 年）。大多数患者（79%）之前接受过 TNF 抑制剂治疗，而 21%仅接受过传统 DMARD 治疗。最常见的 DMARD 预处理药物是 MTX（79%）、LEF（68%）、阿达木单抗（53%）和依那西普（50%）。基线时，60.5%的患者接受托珠单抗联合其他任何 RA 药物治疗，而 39.5%的患者接受单药治疗。平均基线 DAS28 为 5.5±1.3，第 52 周降至 2.6±1.6。第 52 周时，62.3%的患者达到了良好的 EULAR 反应，66.4%的患者达到了低疾病活动状态，55.1%的患者达到了 DAS28 缓解（调整后的相对频率）。35.3%的患者提前退出研究；常见原因是无效（10.5%）和不耐受（7.3%）。任何感染和严重感染分别发生在 37.6%和 7.2%的患者中（N=836）；严重感染发生在 5.3%的患者中（N=850）。任何感染、严重感染和严重感染的发生率分别为 70.3、9.8 和 4.4 例/100 患者-年。
在真实环境中使用托珠单抗治疗可显著改善临床疗效，安全性与预批准的 III 期研究报告的数据一致。
