The Efficacy and Safety of Recombinant Human Tumor Necrosis Factor-<i>α</i> Receptor Ⅱ: IgG Fc Fusion Protein for Treatment of Rheumatoid Arthritis_West China Medical Journal

Authors：

 ZHANGRan ¹ , LUOMin ² , YAOChun-rong ¹ , JIANGDong-bo ¹

1. Department of Rheumatology, the First People's Hospital of Guangyuan, Guangyuan, Sichuan 628017, P. R. China;
2. Department of Rheumatology, Traditional Chinese Medicine Hospital of Guangyuan, Guangyuan, Sichuan 628099, P. R. China;

Corresponding author：

Keywords：

Rheumatoid arthritis; Recombinant human tumor necrosis factor-α receptor Ⅱ: IgG Fc fusion protein; Effi cacy; Safety

DOI：

10.7507/1002-0179.20140386

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Objective To investigate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein (rhTNFR:Fc) for treatment of active rheumatoid arthritis (RA). Methods This study included 86 patients with active rheumatoid arthritis treated between September 2011 and January 2013. They were divided into two groups randomly. Forty-three patients in the treatment group received rhTNFR:Fc (25 mg, twice a week) by subcutaneous injection and methotrexate (MTX) (10 mg, orally once a week), and the other 43 patients in the contrast group received MTX (10 mg, orally once a week), hydroxychloroquine (100 mg, orally twice daily), and leflunomide (10 mg, orally once daily). The clinical efficacy of the treatments 12 weeks later were compared between the two groups. American College of Rheumatology (ACR) 20, 50, and 70 evaluation criteria were used for efficacy evaluation. Results The ACR 20, 50 and 70 effective rates in 4, 8 and 12 weeks after the treatment in the treatment group were significantly higher than those in the control group (P<0.05). The seven indicators including the duration of morning stiffness, joint tenderness index, joint swelling index, erythrocyte sedimentation rate, C-reactive protein, platelets and rheumatoid factors within 12 weeks after treatment were significantly improved in both the two groups, and the improvements in the treatment group were more significant (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05). Conclusion RhTNFR:Fc is effecive and safe in treating active RA.

Citation： ZHANGRan, LUOMin, YAOChun-rong, JIANGDong-bo. The Efficacy and Safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ: IgG Fc Fusion Protein for Treatment of Rheumatoid Arthritis. West China Medical Journal, 2014, 29(7): 1259-1262. doi: 10.7507/1002-0179.20140386 Copy

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18.	李俊芳, 王卫远, 贾彬, 等. 应用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合甲氨蝶呤或来氟米特治疗早期类风湿关节炎的疗效及安全性研究[J]. 山西医药杂志·下半月版, 2010, 39(24):1176-1177.
19.	Mmons DP, Silman AJ. The world of biologies[J]. Lupus, 2006, 15(3):122-126.
20.	赵浩, 赵福涛, 王艳玲. 不同剂量重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎疗效分析[J]. 上海交通大学学报·医学版, 2009, 29(12):1509-1511.
21.	杨垒, 张子阳, 蒲涛, 等. 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎[J]. 中国实用医刊, 2011, 38(13):88-89.
22.	吴庆军, 张卓莉, 李振彬, 等. 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[J]. 中华风湿病学杂志, 2011, 15(9):600-603.

1. 蒋明, Yu D, 林孝义. 中华风湿病学[M]. 北京:华夏出版社, 2004:8.
2. 高洁生, 康志平, 彭文峰, 等. 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白剂量递减联合改善病情的抗风湿药治疗外周型活动性强直性脊柱炎的临床评价[J]. 中华风湿病学杂志, 2010, 14(1):48-52.
3. 尤欣, 唐福林. 类风湿关节炎临床和基础研究进展[J]. 武警医学, 2010, 21(3):185-188.
4. 黄建林, 吉洁若, 赵丽珂, 等. 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎有效性和安全性研究[J]. 中国药物与临床, 2006, 6(7):543-545.
5. Keystone E. Recent concepts in the inhibition of radiographic progression with biologics[J]. Curr Opin Rheumatol, 2009, 21(3):231-237.
6. 艾脉兴, 马丽, 赵孟君, 等. 依那西普治疗活动性类风湿关节炎的安全性和有效性[J]. 中国新药杂志, 2007, 16(15):1208-1211.
7. 付文轶, 张宁. 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对改善病情抗风湿药治疗无效活动性类风湿关节炎的疗效[J]. 中华临床免疫和变态反应杂志, 2008, 2(3):184-189.
8. 吴庆军, 张卓莉, 李振彬, 等. 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对骨代谢的影响[J]. 中华医学杂志, 2010, 90(35):2481-2485.
9. Amett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis[J]. Arthritis Rheum, 1998, 31(3):315-324.
10. 侯勇, 张奉春, 黄烽, 等. Infliximab治疗类风湿关节炎的随机双盲平行多中心临床试验[J]. 中华风湿病学杂志, 2006, 11(11):658-663.
11. Noss EH, Brenner MB. The role and therapeutic implications of fibroblast-like synoviocytes in inflammation and cartilage erosion in rheumatoid arthritis[J]. Immunol Rev, 2008, 223(6):252-270.
12. 吴燕红. 类风湿关节炎药物治疗的新认识[J]. 河北医药, 2008, 30(1):82-83.
13. 胡大伟, 鲍春德, 陈顺乐, 等. 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎双盲随机多中心对照临床研究[J]. 中华风湿病学杂志, 2005, 9(11):28-32.
14. 夏琳, 田东华, 季康, 等. 来氟米特联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎疗效比较[J]. 武警医学, 2012, 23(4):349-350.
15. Kang YM, Wang Y, Yang LM, et al. TNF-α in hypothalamic paraventricular nucleus contributes to sympathoexcitation in heart failure by modulating AT1 receptor and neurotransmitters[J]. Tohoku J Exp Med, 2010, 222(4):251-263.
16. 陈俊伟, 李小峰, 张莉芸, 等. 短期益赛普与甲氨蝶呤环磷酰胺联合治疗类风湿关节炎的安全性研究[J]. 中国药物与临床, 2008, 8(6):455-457.
17. St Clair EW, Van Der Heijde DM, Smolen JS, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis:a randomized, controlled trial[J]. Arthritis Rheum, 2004, 50(11):3432-3443.
18. 李俊芳, 王卫远, 贾彬, 等. 应用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合甲氨蝶呤或来氟米特治疗早期类风湿关节炎的疗效及安全性研究[J]. 山西医药杂志·下半月版, 2010, 39(24):1176-1177.
19. Mmons DP, Silman AJ. The world of biologies[J]. Lupus, 2006, 15(3):122-126.
20. 赵浩, 赵福涛, 王艳玲. 不同剂量重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎疗效分析[J]. 上海交通大学学报·医学版, 2009, 29(12):1509-1511.
21. 杨垒, 张子阳, 蒲涛, 等. 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎[J]. 中国实用医刊, 2011, 38(13):88-89.
22. 吴庆军, 张卓莉, 李振彬, 等. 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[J]. 中华风湿病学杂志, 2011, 15(9):600-603.

West China Medical Journal

The Efficacy and Safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ: IgG Fc Fusion Protein for Treatment of Rheumatoid Arthritis

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