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Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial
  1. Qian-wen Lv1,
  2. Wen Zhang1,
  3. Qun Shi1,
  4. Wen-jie Zheng1,
  5. Xin Li1,
  6. Hua Chen1,
  7. Qing-jun Wu1,
  8. Wan-lan Jiang1,
  9. Hong-bin Li2,
  10. Lu Gong3,
  11. Wei Wei3,
  12. Hui Liu4,
  13. Ai-jing Liu5,
  14. Hong-tao Jin5,
  15. Jun-xiang Wang6,
  16. Xiu-mei Liu7,
  17. Zhen-bin Li8,
  18. Bin Liu9,
  19. Min Shen1,
  20. Qian Wang1,
  21. Xiang-ni Wu1,
  22. Di Liang1,
  23. Yu-feng Yin1,
  24. Yun-yun Fei1,
  25. Jing-mei Su1,
  26. Li-dan Zhao1,
  27. Ying Jiang1,
  28. Jing Li1,
  29. Fu-lin Tang1,
  30. Feng-chun Zhang1,
  31. Peter E Lipsky10,
  32. Xuan Zhang1
  1. 1Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  2. 2Department of Rheumatology, Affiliated Hospital of Inner Mongolia Medical College, Huhhot, China
  3. 3Department of Rheumatology, General Hospital of Tianjin Medical University, Tianjin, China
  4. 4Department of Rheumatology, Beijing Dongfang Hospital, Beijing, China
  5. 5Department of Rheumatology, Second Hospital of Hebei Medical University, Hebei, China
  6. 6Department of Rheumatology, Third Hospital of Hebei Medical University, Hebei, China
  7. 7Department of Rheumatology, First Hospital of Shanxi Medical University, Shanxi, China
  8. 8Department of Rheumatology, The Bethune International Heping Hospital of Hebei, Hebei, China
  9. 9Department of Rheumatology, The Affiliated Hospital of QingDao University Medical College, Shandong, China
  10. 10Formerly National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA
  1. Correspondence to Dr Xuan Zhang, Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China; zxpumch2003{at}sina.com and Dr Peter E Lipsky, Formerly National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892, USA; peterlipsky{at}comcast.net

Abstract

Objectives To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) with methotrexate (MTX) in the treatment of active rheumatoid arthritis (RA).

Methods Design: a multicentre, open-label, randomised controlled trial. All patients were assessed by trained investigators who were unaware of the therapeutic regimen. Intervention: 207 patients with active RA were randomly allocated (1:1:1) to treatment with MTX 12.5 mg once a week, or TwHF 20 mg three times a day, or the two in combination. At week 12, if reduction of the 28-joint count Disease Activity Score (DAS28) was <30% in the monotherapy groups, the patient was switched to MTX+TwHF. The primary efficacy point was the proportion of patients achieving an American College of Rheumatology (ACR) 50 response at week 24.

Results 174/207 (84.1%) patients completed 24 weeks of the trial. In an intention-to-treat analysis, the proportion of patients reaching the ACR50 response criteria was 46.4% (32/69), 55.1% (38/69) and 76.8% (53/69), respectively, in the MTX, TwHF and MTX+TwHF groups (TwHF vs MTX monotherapy, p=0.014; MTX+TwHF vs MTX monotherapy, p<0.001). Similar statistically significant patterns at week 24 were found for ACR20, ACR70, clinical Disease Activity Index good responses, EULAR good response, remission rate and low disease activity rate. Significant improvement in the Health Assessment Questionnaire and 36-item Short-Form Health Survey questionnaire scores from baseline to week 24 was seen in each treatment arm (p<0.05), though no significant difference was found among the treatment arms (p>0.05). The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis. Seven, three and five women in the TwHF, MTX and combination groups, respectively, developed irregular menstruation (TwHF vs MTX monotherapy, p=0.216).

Conclusions TwHF monotherapy was not inferior to, and MTX+TwHF was better than, MTX monotherapy in controlling disease activity in patients with active RA.

Trial registration number NCT01613079.

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