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Title: 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
Authors: Combe, B.
Codreanu, C.
Fiocco, U.
Gaubitz, M.
Kvien, T. K.
Pavelka, K.
Sambrook, P. N.
Smolen, J. S.
Khandker, R.
Singh, A.
Wajdula, J.
Fatenejad, S.
Issue Date: 2009
Citation: ANNALS OF THE RHEUMATIC DISEASES, 68(7). p. 1146-1152
Abstract: 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 < 0.001). Patients receiving etanercept or etanercept plus sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS 2.8, 2.5 versus 4.5, respectively (p < 0.05); ACR 20 response was achieved by 67%, 77% versus 34% of patients, respectively (p < 0.01) Overall, PRO followed a similar pattern; a clinically significant improvement in health assessment questionnaire was achieved by 76%, 78% versus 40% of patients, respectively (p < 0.01). Commonly reported adverse events occurring in the etanercept groups were injection site reactions and pharyngitis/laryngitis (p < 0.01). Conclusion: Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.
Notes: [Wajdula, J.] Wyeth Res, Clin Res & Dev, Collegeville, PA 19426 USA. [Combe, B.] Hop Lapeyronie, Serv Immunorhumatol, Montpellier, France. [Codreanu, C.] Cent Metodol Reumatol, Bucharest, Romania. [Fiocco, U.] Univ Padua Polyclin, Cattedra & Div Reumatol, Padua, Italy. [Gaubitz, M.] Univ Munster, Med Clin B, Munster, Germany. [Geusens, P. P.] Univ Hasselt, Biomed Res Ctr, Hasselt, Belgium. [Geusens, P. P.] Univ Maastricht, Dept Internal Med Rheumatol, Maastricht, Netherlands. [Kvien, T. K.] Diakonhjemmet Hosp Oslo, Dept Rheumatol, Oslo, Norway. [Pavelka, K.] Inst Rheumatol, Prague, Czech Republic. [Sambrook, P. N.] Univ Sydney, Kolling Inst, Sydney, NSW 2006, Australia. [Smolen, J. S.] Med Univ Vienna, Dept Rheumatol, Vienna, Austria. [Smolen, J. S.] Krankenhaus Lainz, Dept Med 2, Vienna, Austria.
URI: http://hdl.handle.net/1942/9800
DOI: 10.1136/ard.2007.087106
ISI #: 000266956800012
ISSN: 0003-4967
Category: A1
Type: Journal Contribution
Validation: ecoom, 2010
Appears in Collections: Research publications

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