ReABLE study on the efficacy and long-term safety of recombinant human tumor necrosis factor-α receptor Ⅱ IgG Fc fusion protein with methotrexate in active rheumatoid arthritis
10.3760/cma.j.issn.1007-7480.2011.09.005
- VernacularTitle:重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白联合甲氨蝶呤治疗活动性类风湿关节炎的疗效和安全性的开放多中心临床研究
- Author:
Qingjun WU
;
Zhuoli ZHANG
;
Zhenbin LI
;
Dong XU
;
Guangtao LI
;
Lifen GENG
;
Mengtao LI
;
Yu WANG
;
Jianjun ZHU
;
Yanjie HAO
;
Nailing HUI
;
Jing YANG
;
Xiaoqing CUI
;
Xiaogang ZHANG
;
Yan ZHAO
- Publication Type:Journal Article
- Keywords:
Arthritis,rheumatoid;
Recombinant human tumor necrosis factor-α receptor Ⅱ IgG Fc fusion protein;
Treatment
- From:
Chinese Journal of Rheumatology
2011;15(9):600-603
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical and radiographic efficacy and safety of the combination of recombinant human tumor necrosis factor-αt receptor Ⅱ IgG Fc fusion protein (rhTNFR:Fc) and methotrexate (MTX) in patients with rheumatoid arthritis (RA). MethodsThirty patients with highly active RA were treated with rhTNFR:Fc (25 mg subcutaneously twice weekly) and oral MTX (up to 15 mg weekly). Clinical efficacy was assessed using ACR response criteria and the disease activity score in 28 joints (DAS28).Radiographs of the hands and wrists were assessed with the modified Sharp score. Chi-square test, Fisher is exact test and paired t-test were performed. ResultsAt week 52, ACR20, ACR50 and ACR70 responses were achieved by 90％, 87％ and 67％ respectively. At week 52, mean DAS28 was 3.4±1.1 compared to 6.4±0.6 at base-line(P＜0.01), with 23％ patients achieving clinical remission and 17％ patients in low disease activity. Similarly, the HAQ was improved significantly, declining from 1.18±0.56 at base-line to 0.25t±0.34 at week 52 (P＜0.01). No radiographic progression was found in 22 cases. Adverse events were mild in general.ConclusionTreatment with rhTNFR:Fc plus MTX has shown good efficacy throughout 52 study period in reducing disease activity, improving function, and retarding radiographic progression. Combination therapy for 52 weeks can achieve disease remission and no radiographic progression, which are the two goals of therapy for RA.
