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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8.	吳慶軍, 張卓莉, 李振彬, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤治療活動性類風濕關節炎的療效和對骨代謝的影響[J]. 中華醫學雜志, 2010, 90(35):2481-2485.
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13.	胡大偉, 鮑春德, 陳順樂, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎雙盲隨機多中心對照臨床研究[J]. 中華風濕病學雜志, 2005, 9(11):28-32.
14.	夏琳, 田東華, 季康, 等. 來氟米特聯合重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎療效比較[J]. 武警醫學, 2012, 23(4):349-350.
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16.	陳俊偉, 李小峰, 張莉蕓, 等. 短期益賽普與甲氨蝶呤環磷酰胺聯合治療類風濕關節炎的安全性研究[J]. 中國藥物與臨床, 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, 王衛遠, 賈彬, 等. 應用重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤或來氟米特治療早期類風濕關節炎的療效及安全性研究[J]. 山西醫藥雜志·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.	趙浩, 趙福濤, 王艷玲. 不同劑量重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎療效分析[J]. 上海交通大學學報·醫學版, 2009, 29(12):1509-1511.
21.	楊壘, 張子陽, 蒲濤, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎[J]. 中國實用醫刊, 2011, 38(13):88-89.
22.	吳慶軍, 張卓莉, 李振彬, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤治療活動性類風濕關節炎的療效和安全性的開放多中心臨床研究[J]. 中華風濕病學雜志, 2011, 15(9):600-603.

1. 蔣明, Yu D, 林孝義. 中華風濕病學[M]. 北京:華夏出版社, 2004:8.
2. 高潔生, 康志平, 彭文峰, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白劑量遞減聯合改善病情的抗風濕藥治療外周型活動性強直性脊柱炎的臨床評價[J]. 中華風濕病學雜志, 2010, 14(1):48-52.
3. 尤欣, 唐福林. 類風濕關節炎臨床和基礎研究進展[J]. 武警醫學, 2010, 21(3):185-188.
4. 黃建林, 吉潔若, 趙麗珂, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎有效性和安全性研究[J]. 中國藥物與臨床, 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. 艾脈興, 馬麗, 趙孟君, 等. 依那西普治療活動性類風濕關節炎的安全性和有效性[J]. 中國新藥雜志, 2007, 16(15):1208-1211.
7. 付文軼, 張寧. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤對改善病情抗風濕藥治療無效活動性類風濕關節炎的療效[J]. 中華臨床免疫和變態反應雜志, 2008, 2(3):184-189.
8. 吳慶軍, 張卓莉, 李振彬, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤治療活動性類風濕關節炎的療效和對骨代謝的影響[J]. 中華醫學雜志, 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, 張奉春, 黃烽, 等. Infliximab治療類風濕關節炎的隨機雙盲平行多中心臨床試驗[J]. 中華風濕病學雜志, 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. 吳燕紅. 類風濕關節炎藥物治療的新認識[J]. 河北醫藥, 2008, 30(1):82-83.
13. 胡大偉, 鮑春德, 陳順樂, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎雙盲隨機多中心對照臨床研究[J]. 中華風濕病學雜志, 2005, 9(11):28-32.
14. 夏琳, 田東華, 季康, 等. 來氟米特聯合重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎療效比較[J]. 武警醫學, 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. 陳俊偉, 李小峰, 張莉蕓, 等. 短期益賽普與甲氨蝶呤環磷酰胺聯合治療類風濕關節炎的安全性研究[J]. 中國藥物與臨床, 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, 王衛遠, 賈彬, 等. 應用重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤或來氟米特治療早期類風濕關節炎的療效及安全性研究[J]. 山西醫藥雜志·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. 趙浩, 趙福濤, 王艷玲. 不同劑量重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎療效分析[J]. 上海交通大學學報·醫學版, 2009, 29(12):1509-1511.
21. 楊壘, 張子陽, 蒲濤, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風濕關節炎[J]. 中國實用醫刊, 2011, 38(13):88-89.
22. 吳慶軍, 張卓莉, 李振彬, 等. 重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白聯合甲氨蝶呤治療活動性類風濕關節炎的療效和安全性的開放多中心臨床研究[J]. 中華風濕病學雜志, 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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