A multicenter,double-blind, placebo-controlled, randomized, phase Ⅲ clinical study of etanercept in treatment of ankylosing spondylitis
10.3760/cma.j.issn.0578-1426.2010.09.005
- VernacularTitle:依那西普治疗强直性脊柱炎的多中心、随机、双盲、安慰剂对照临床研究
- Author:
Feng HUANG
;
Jie ZHANG
;
Jianlin HUANG
;
Donghai WU
;
Zhanguo LI
;
Shunle CHEN
;
Yunfeng PAN
;
Li MA
;
Shi CHEN
;
Liangjing Lü
;
Zunming YANG
- Publication Type:Journal Article
- Keywords:
Spondylitis,ankylosing;
Etanercept;
Treatment outcome;
Safety
- From:
Chinese Journal of Internal Medicine
2010;49(9):741-745
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the short-term efficacy and safety of etanercept treatment in Chinese patients with active ankylosing spondylitis ( AS ). Methods This was a 12-week multicenter,double-blind, placebo-controlled, randomized phase Ⅲ clinical study. The first part was a 6-week placebocontrolled period followed by a 6-week open-label period. The primary efficacy endpoint was the percentage of subjects achieving a 20% improvement in assessment in ankylosing spondylitis (ASAS) ( ASAS 20). The secondary efficacy endpoints were the percentage of patients achieving a 40% improvement in ASAS (ASAS 40), achieving a 50% improvement in ASAS( ASAS 50), achieving a 70% improvement in ASAS (ASAS 70), and ASAS 5/6 responses at all visits, and the improvement in subject global assessment,physician global assessment, nocturnal and total back pain, bath AS functional index ( BASFI ), bath AS disease activity index (BASDAI), spinal mobility, joint assessment and quality of life assessment. All subjects in the study were evaluated for safety. Results The primary endpoint, ASAS 20 at week 6, was achieved by 86. 5% (64/74) patients in the etanercept group compared to 29. 5% (23/78) patients in the placebo group(P ＜0. 001 ). As early as week 2, the percentages of patients achieving the ASAS 20 between the two groups were significantly different. Furthermore, the majority of secondary efficacy end points were also significantly improved. Most of adverse events (AE) were mild in nature, the commonest adverse events were elevated liver function levels, injection site reactions and nasopharyngitis. No death or serious AE were observed. Conclusion Etanercept can improve symptoms fastly,significantly and safely in Chinese patients with active AS.
