Department of Internal Medicine, Division of Rheumatology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Rheumatology (Oxford). 2011 Oct;50(10):1908-15. doi: 10.1093/rheumatology/ker221. Epub 2011 Jul 13.
To evaluate the effectiveness and safety of tocilizumab in RA patients in clinical practice.
We observed 232 consecutive RA patients who began tocilizumab in three rheumatology centres in Japan for 52 weeks. Clinical, radiographic and functional status and safety were evaluated.
Mean age of the 232 patients was 59.1 years, mean duration of disease was 12.4 years and average DAS using the 28-joint count (DAS-28) was 5.6. Although 62.8% of the patients had been treated previously with anti-TNF biologics, clinical remission at Week 52 was achieved in 43.7%, radiographic non-progression in 62.8% and functional remission in 26.4%. Retention rate at Week 52 was 71.1%, and the same for those with or without previous anti-TNF treatment. Adverse drug reactions leading to tocilizumab discontinuation were observed in 15.5% of patients, the most frequent adverse drug reaction being pneumonia in eight cases. On multivariate logistic regression analysis, DAS-28, HAQ-disability index (HAQ-DI), concomitant MTX and concomitant glucocorticoids (GCs) were predictive variables for clinical remission at Week 52 of tocilizumab treatment. In particular, HAQ-DI was found to be a predictive variable for remission of all three types-clinical, radiographic and functional-at Week 52 of tocilizumab treatment.
In daily clinical practice, tocilizumab exhibited excellent effectiveness in established RA patients, some of whom had failed to respond to previous anti-TNF treatment. Although further detailed safety findings are required, this study provides valuable real-world findings on the management of RA with tocilizumab.
评估托珠单抗在临床实践中治疗类风湿关节炎(RA)患者的疗效和安全性。
我们观察了日本三个风湿病中心的 232 例连续 RA 患者,他们开始接受托珠单抗治疗,疗程为 52 周。评估了临床、影像学和功能状态以及安全性。
232 例患者的平均年龄为 59.1 岁,平均病程为 12.4 年,使用 28 个关节计数的 DAS28(DAS-28)平均为 5.6。尽管 62.8%的患者之前曾接受过抗 TNF 生物制剂治疗,但在第 52 周时达到了临床缓解(43.7%)、影像学进展(62.8%)和功能缓解(26.4%)。第 52 周时的保留率为 71.1%,无论是否有先前的抗 TNF 治疗,结果均如此。有 15.5%的患者出现与药物相关的不良反应,导致托珠单抗停药,最常见的不良反应是 8 例肺炎。多变量逻辑回归分析显示,DAS-28、HAQ 残疾指数(HAQ-DI)、同时使用 MTX 和同时使用糖皮质激素(GCs)是托珠单抗治疗第 52 周时达到临床缓解的预测变量。特别是,HAQ-DI 是托珠单抗治疗第 52 周时达到临床、影像学和功能缓解的所有三种类型的预测变量。
在日常临床实践中,托珠单抗在已确诊的 RA 患者中表现出了优异的疗效,其中一些患者对先前的抗 TNF 治疗无反应。尽管需要进一步详细的安全性发现,但本研究提供了托珠单抗治疗 RA 的宝贵真实世界发现。