Dr. van der Heijde has served as a consultant to, and has received speaking fees and/or honoraria (less than $10,000 each) from Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Schering-Plough, UCB, and Wyeth.
Rheumatoid Arthritis Clinical Studies
Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis†
Version of Record online: 29 NOV 2007
Copyright © 2007 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 56, Issue 12, pages 3928–3939, December 2007
How to Cite
van der Heijde, D., Klareskog, L., Landewé, R., Bruyn, G. A. W., Cantagrel, A., Durez, P., Herrero-Beaumont, G., Molad, Y., Codreanu, C., Valentini, G., Zahora, R., Pedersen, R., MacPeek, D., Wajdula, J. and Fatenejad, S. (2007), Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis & Rheumatism, 56: 3928–3939. doi: 10.1002/art.23141
ClinicalTrials.gov identifier: NCT00393471.
- Issue online: 29 NOV 2007
- Version of Record online: 29 NOV 2007
- Manuscript Accepted: 7 SEP 2007
- Manuscript Received: 19 DEC 2006
- Wyeth Pharmaceuticals, Collegeville, PA
- European Agency for the Evaluation of Medicinal Products
The Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) is a 3-year, double-blind, multicenter study evaluating the efficacy and safety of etanercept, methotrexate, and the combination of etanercept plus methotrexate in patients with active rheumatoid arthritis (RA). The results after 1 and 2 years of the study have been previously reported. Here we provide the 3-year clinical and radiographic outcomes and safety of etanercept, methotrexate, and the combination in patients with RA.
In this randomized, double-blind, multicenter TEMPO study, 682 patients received etanercept 25 mg twice weekly, methotrexate ≤20 mg weekly, or the combination. Key efficacy assessments included the Disease Activity Score (DAS) and the DAS in 28 joints.
Combination therapy resulted in significantly greater improvement in the DAS and in more patients with disease in remission than either monotherapy. This finding was confirmed by longitudinal analysis; patients receiving combination therapy were more than twice as likely to have disease in remission than those receiving either monotherapy. Independent predictors of remission included male sex, lower disease activity, lower level of joint destruction, and/or better physical function. Combination and etanercept therapy both resulted in significantly less radiographic progression than did methotrexate (P < 0.05). Etanercept and combination treatment were well tolerated, with no new safety findings.
Etanercept plus methotrexate showed sustained efficacy through 3 years and remained more effective than either monotherapy, even after adjustment for patient withdrawal. Combination therapy for 3 years led to disease remission and inhibition of radiographic progression, 2 key goals for treatment of patients with RA.