两种剂量（50毫克与100毫克）的依那西普治疗活动性类风湿关节炎的比较：一项随机双盲研究。

Comparison of 2 doses of etanercept (50 vs 100 mg) in active rheumatoid arthritis: a randomized double blind study.

作者信息

Johnsen Alyssa K, Schiff Michael H, Mease Philip J, Moreland Larry W, Maier Agnes L, Coblyn Jonathan S, Helfgott Simon M, Leff Jonathan A, Weinblatt Michael E

机构信息

Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.

出版信息

J Rheumatol. 2006 Apr;33(4):659-64. Epub 2006 Feb 15.

PMID:16482646

Abstract

OBJECTIVE

To assess the safety and efficacy of etanercept 50 mg administered twice weekly versus 25 mg administered twice weekly as monotherapy in patients with tumor necrosis factor-alpha (TNF-alpha) blocker-naäve active rheumatoid arthritis (RA).

METHODS

Seventy-seven patients with RA were randomized in an unequal allocation (2:1) in a blinded fashion to receive either 50 mg (51 patients) or 25 mg (26 patients) of etanercept twice a week for 24 weeks.

RESULTS

The primary outcome measure, the ACR-N AUC at 24 weeks, showed no difference between the 2 dose groups. In addition, there was no difference in ACR 20, 50, and 70 responses or in EULAR response criteria by Week 24. There were no statistically significant differences between the 2 groups in the proportion of patients with any non-infectious adverse event. The proportion of patients with upper respiratory tract infections was significantly higher in patients receiving 50 mg etanercept compared with those receiving 25 mg (26% vs 4%, p = 0.027).

CONCLUSION

Etanercept as a monotherapy at 50 mg twice weekly does not provide increased efficacy when compared to the standard dose of 25 mg twice weekly in TNF-alpha blocker-naäve patients.

摘要

目的

评估对于肿瘤坏死因子-α（TNF-α）阻滞剂初治的活动性类风湿关节炎（RA）患者，每周两次注射50mg依那西普与每周两次注射25mg依那西普作为单一疗法的安全性和有效性。

方法

77例RA患者以盲法按2:1不等比例随机分组，分别接受每周两次注射50mg依那西普（51例患者）或25mg依那西普（26例患者），共24周。

结果

主要结局指标，即24周时的美国风湿病学会（ACR）-曲线下面积（AUC），在两个剂量组之间无差异。此外，到第24周时，ACR 20、50和70反应或欧洲抗风湿病联盟（EULAR）反应标准方面也无差异。两组中出现任何非感染性不良事件的患者比例无统计学显著差异。接受50mg依那西普的患者上呼吸道感染的比例显著高于接受25mg依那西普的患者（26%对4%，p = 0.027）。