Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study

Autor: B, Combe, C, Codreanu, U, Fiocco, M, Gaubitz, P P, Geusens, T K, Kvien, K, Pavelka, P N, Sambrook, J S, Smolen, R, Khandker, A, Singh, J, Wajdula, S, Fatenejad, Horatiu, Bolosiu
Rok vydání: 2008
Předmět:
Zdroj: Annals of the Rheumatic Diseases
ISSN: 0003-4967
DOI: 10.1136/ard.2007.087106
Popis: Objective: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy. Methods: Patients were randomly assigned to etanercept (25 mg twice weekly; sulfasalazine was discontinued at baseline), etanercept plus sulfasalazine (unchanged regimen of 2–3 g/day) or sulfasalazine in a double-blind, randomised, 2-year study in adult patients with active RA despite sulfasalazine therapy. Efficacy was assessed using the American College of Rheumatology criteria, disease activity scores (DAS) and patient-reported outcomes (PRO). Results: Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS 5.1, 5.2 and 5.1 for etanercept (n = 103), etanercept plus sulfasalazine (n = 101) and sulfasalazine (n = 50), respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 (52%) vs 6 (6%) for either etanercept group, p
Databáze: OpenAIRE