Vol.20 No.6

Original Article

Etanercept (ETN) with methotrexate (MTX) is better than ETNmonotherapy in patients with active rheumatoid arthritis despiteMTX therapy: a randomized trial

Authors

Hideto Kameda1,2 , Yukitaka Ueki3 , Kazuyoshi Saito4 , Shouhei Nagaoka5 , Toshihiko Hidaka6 , Tatsuya Atsumi7 , Michishi Tsukano8 , Tsuyoshi Kasama9 , Shunichi Shiozawa10 , Yoshiya Tanaka4 , Tsutomu Takeuchi1,2 , Japan Biological Agent Study Integrated Consortium (JBASIC)

  • Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Kawagoe, Japan
  • Division of Rheumatology/Clinical Immunology, Department of Internal Medicine, Faculty of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
  • Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Japan
  • First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  • Department of Rheumatology, Yokohama Minami Kyosai Hospital, Yokohama, Japan
  • Institute of Rheumatology, Zenjinkai Shimin-No-Mori-Hospital, Miyazaki, Japan
  • Department of Medicine II, Hokkaido University Graduate School of Medicine, Sapporo, Japan
  • Kumamoto Orthopaedic Hospital, Kumamoto, Japan
  • Division of Rheumatology and Clinical Immunology, Showa University School of Medicine, Tokyo, Japan
  • Division of Rheumatology, Kobe University Graduate School of Medicine, Kobe, Japan
Received:

19 May 2010

Accepted:

26 May 2010

Published online:

24 June 2010

Full Text

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Abstract

The superiority of the combination therapy of methotrexate (MTX) and anti-tumor necrosis factor (TNF) biological agents over anti-TNF monotherapy in MTX-naïve patients with rheumatoid arthritis (RA) has been demonstrated. We investigated the efficacy and safety of continuation versus discontinuation of MTX at the commencement of etanercept (ETN) in patients with active RA despite MTX therapy. In total, 151 patients with active RA despite treatment with MTX were randomized to either ETN 25 mg twice a week and MTX 6?8 mg/week (the E + M group) or ETN alone (the E group). Co-primary endpoints included the European League Against Rheumatism (EULAR) good response rate and the American College of Rheumatology (ACR) 50 response rate at week 24. Demographic and clinical features between groups at baseline were similar. The EULAR good response rates were significantly higher in the E + M group (52%) than in the E group (33%) at week 24 (p = 0.0001). Although the ACR50 response rate, one of the co-primary endpoints, and the ACR70 response rate at week 24 were not significantly greater in the E + M group (64 and 38%, respectively) than in the E group (48 and 26%, respectively), the ACR20 response rate was significantly greater in the E + M group (90%) than in the E group (64%; p = 0.0002). Safety profiles were similar for the groups. Thus, MTX should be continued at the commencement of ETN therapy, even in RA patients who show an inappropriate response to MTX.

Key words

ACR response - Anti-TNF - Biological agent - Combination therapy - EULAR response