Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2006 Mar;65(3):328-34.
doi: 10.1136/ard.2005.035709. Epub 2005 Aug 3.

Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial

D van der Heijde  1 , L Klareskog, A Singh, J Tornero, J Melo-Gomes, C Codreanu, R Pedersen, B Freundlich, S Fatenejad
Affiliations
Randomized Controlled Trial

Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial

D van der Heijde et al. Ann Rheum Dis. 2006 Mar.

Abstract

Objective: To compare patient reported measures of function, health related quality of life (QoL), and satisfaction with medication among patients with rheumatoid arthritis (RA) treated with methotrexate (MTX), etanercept, or both for up to 1 year.

Methods: In a 52 week, double blind, clinical trial, patients with active RA were randomised to receive etanercept 25 mg twice weekly, methotrexate up to 20 mg weekly, or combination therapy. The Health Assessment Questionnaire (HAQ) disability index, EuroQoL health status visual analogue scale (EQ-5D VAS), patient global assessment, and patient general health VAS were administered at baseline and weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52. Satisfaction with the medication was compared at 52 weeks.

Results: Of 682 enrolled patients, 522 completed 52 weeks of treatment. Mean improvement from baseline in HAQ score was 0.65, 0.70, and 1.0 for MTX, etanercept, and the combination, respectively. The mean percentage and absolute improvement in the HAQ was significantly higher (p<0.01) for combination therapy than for either of the monotherapies. Combination therapy produced significantly more rapid achievement of HAQ < or =0.5 sustained for 6 months than either of the monotherapies (p<0.01). Compared with patients receiving monotherapy, those receiving combination therapy achieved a significantly better (p<0.05) health state as measured by the EQ-5D VAS (mean (SD) 63.7 (3.2), 66.8 (3.2), 72.7 (3.1) for MTX, etanercept, and the combination, respectively). Results were similar for other assessments (p<0.01). Patients in combination and etanercept groups were significantly more likely (p<0.0001, p = 0.0009, respectively) to report satisfaction with the medication.

Conclusions: Combination therapy with etanercept and methotrexate improved function, QoL, and satisfaction with the medication significantly more than monotherapy.

PubMed Disclaimer

Conflict of interest statement

Competing interest statement: D van der Heijde has received reimbursement for symposium attendance and speaking and consulting fees from Wyeth, and has acted as an expert witness for Wyeth at an EMEA meeting for radiographic results of the TEMPO study. L Klareskog has received reimbursement for symposium attendance, speaking and consulting fees, and research funds from Wyeth. J Tornero has received reimbursement for symposium attendance, speaking fees, and research funds from Wyeth. J Melo‐Gomes and C Codreanu declare no potential competing interests. A Singh, R Pedersen, B Freundlich, and S Fatenejad are employees of Wyeth and hold stock and/or stock options in Wyeth. B Freundlich has also received funds for research and staff members from Wyeth.

References

    1. ACR American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update, Arthritis Rheum 200246328–346. - PubMed
    1. Bathon J M, Martin R W, Fleischmann R M, Tesser J R, Schiff M H, Keystone E C.et al A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 20003431586–1593. - PubMed
    1. Genovese M C, Bathon J M, Martin R W, Fleischmann R M, Tesser J R, Schiff M H.et al Etanercept versus methotrexate in patients with early rheumatoid arthritis: two‐year radiographic and clinical outcomes. Arthritis Rheum 2002461443–1450. - PubMed
    1. Weinblatt M E, Kremer J M, Bankhurst A D, Bulpitt K J, Fleischmann R M, Fox R I.et al A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999340253–259. - PubMed
    1. Klareskog L, van der Heijde D, De Jager J P, Gough A, Kalden J, Malaise M.et al Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double‐blind randomised controlled trial. Lancet 2004363675–681. - PubMed

Publication types