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- Title
Etanercept (ETN) with methotrexate (MTX) is better than ETN monotherapy in patients with active rheumatoid arthritis despite MTX therapy: a randomized trial.
- Authors
Kameda, Hideto; Ueki, Yukitaka; Saito, Kazuyoshi; Nagaoka, Shouhei; Hidaka, Toshihiko; Atsumi, Tatsuya; Tsukano, Michishi; Kasama, Tsuyoshi; Shiozawa, Shunichi; Tanaka, Yoshiya; Takeuchi, Tsutomu
- 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.
- Subjects
RHEUMATOID arthritis treatment; ETANERCEPT; METHOTREXATE; CLINICAL trials; COMBINATION drug therapy; DRUG efficacy; ANTINEOPLASTIC agents; TUMOR necrosis factors
- Publication
Modern Rheumatology, 2010, Vol 20, Issue 6, p531
- ISSN
1439-7595
- Publication type
Article
- DOI
10.1007/s10165-010-0324-4