Etanercept (ETN) with methotrexate (MTX) is better than ETNmonotherapy in patients with active rheumatoid arthritis despiteMTX therapy: a randomized trial
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)
19 May 2010
26 May 2010
24 June 2010
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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.
ACR response - Anti-TNF - Biological agent - Combination therapy - EULAR response