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A comparison study of a recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) and methotrexate in treatment of patients with active rheumatoid arthritis in China

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Abstract

The objective of this study is to evaluate the efficacy and safety of rhTNFR:Fc: a recombinant tumor necrosis factor receptor:Fc fusion protein compared with methotrexate (MTX) in patients with rheumatoid arthritis in China. We treated 238 patients with active rheumatoid arthritis with either twice weekly subcutaneous injection rhTNFR:Fc (25 mg) or weekly oral MTX (mean 15 mg per week) for 24 weeks (registration number: 2003L01264). Clinical responses were defined as the percent improvement in disease activity according to the criteria of the American College of Rheumatology (ACR-N). As compared with MTX-treated patients, more patients who received rhTNFR:Fc had ACR20 improvement in disease activity during the first 2 weeks (P < 0.05). Similarly, more patients treated with rhTNFR:Fc having ACR20, ACR50, ACR70 improvement in disease activity during 8 weeks (P < 0.05). At the end of 12-week treatment, patients received rhTNFR:Fc also had significant improvement at ACR20 (P < 0.05). Compared with oral MTX, patients received rhTNFR:Fc also had significant improvement at ACR70 at the end of 24 weeks treatment (P < 0.05). In conclusion, compared with oral MTX subcutaneous injection, rhTNFR:Fc acted more rapidly to release symptoms and signs of active RA in Chinese patients, and well tolerated in patients with rheumatoid arthritis in China.

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Authors and Affiliations

  1. Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 20001, China

    Dawei Hu, Chunde Bao & Shunle Chen

  2. Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, China

    Jieruo Gu

  3. Department of Rheumatology, People’s Hospital, Peking University, Beijing, 100044, China

    Zhanguo Li

  4. Department of Rheumatology, Nanjing Drum Tower Hospital, Medical School of Nanjing University, Nanjing, 210008, China

    Lingyun Sun

  5. Department of Rheumatology, Changhai Hospital, The Second Military Medical University, Shanghai, 200433, China

    Xinghai Han

  6. Department of Rheumatology, Guanghua Hospital, Shanghai, 200052, China

    Liqing Ni

Authors
  1. Dawei Hu
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  2. Chunde Bao
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  3. Shunle Chen
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  4. Jieruo Gu
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  5. Zhanguo Li
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  6. Lingyun Sun
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  7. Xinghai Han
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  8. Liqing Ni
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Correspondence to Chunde Bao.

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Hu, D., Bao, C., Chen, S. et al. A comparison study of a recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) and methotrexate in treatment of patients with active rheumatoid arthritis in China. Rheumatol Int 29, 297–303 (2009). https://doi.org/10.1007/s00296-008-0681-x

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  • DOI: https://doi.org/10.1007/s00296-008-0681-x

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