Treatment of ankylosing spondylitis with a recombinant human tumor necrosis factor receptor-Fc fusion protein: a multicenter, randomized, double blind, controlled trial
- VernacularTitle:重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗强直性脊柱炎的多中心双盲随机对照临床研究
- Author:
Feng HUANG
;
Xiaohu DENG
;
Yamei ZHANG
;
Jieruo GU
;
Chunde BAO
;
Jianglin ZHANG
;
Dawei HU
;
Zhiming LIN
;
Chunhua YANG
;
Dongfeng LIANG
;
Junhua GUO
;
Zetao LIAO
- Publication Type:Journal Article
- Keywords:
Spondylitis,ankylosing;
Tumour necrosis factor;
Clinical trial
- From:
Chinese Journal of Rheumatology
2008;12(5):314-320
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety profile of a recombinant human tumor necrosis factor receptor: Fc fusion protein in ankylosing spondylitis (AS). Methods This was a multicenter,randomized, double-blind, placebo-controlled trial in the first 6 weeks and then followed by an open-labeled trial in the next 6 weeks. One hundred and forty-three patients of active AS were randomly assigned to receive 25 mg twice-weekly subcutaneous injections of rhTNFR:Fc or placebo for 6 weeks. The primary endpoint was proportion of ASAS20 responders at week 6. The secondary endpoints were the proportion of subjects achieving a BASDAI 20%, BASDAI 50% and BASDAI 70% improvement at week 6. Other secondary endpoints, related to reducing signs and symptoms of AS and improving range of motion and physical function, were evaluated.Results Treatment with rhTNFR:Fc resulted in significant improvement. At 6 weeks, 68% of the 71 patients in the rhTNFR: Fc group had a treatment response, as compared with 28% of those in the placebo group(P＜0.01). Improvements over base-line values for other measures of disease activity were significantly greater in the rhTNFR:Fc group, rhTNFR:Fc was well tolerated, The most frequently treatment related adverse event was injection site reaction. Conclusion rhTNFR:Fc has demonstrated consistent evidence of efficacy and is well tolerated in the treatment of active AS.
