CLINICAL AND EPIDEMIOLOGICAL RESEARCH

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

B Combe¹, C Codreanu², U Fiocco³, M Gaubitz⁴, P P Geusens^5,6, T K Kvien⁷, K Pavelka⁸, P N Sambrook⁹, J S Smolen¹⁰, R Khandker¹¹, A Singh¹¹, J Wajdula¹¹, S Fatenejad¹¹, for the Etanercept European Investigators Network^*

¹ Service d’Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France
² Centrul Metodologic de Reumatologie, Bucuresti, Romania
³ Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy
⁴ Medical Clinic B Westfalian-Wilhelms-Univ, Munster, Germany
⁵ Biomedical Research Center, University Hasselt, Hasselt, Belgium
⁶ Department of Internal Medicine/Rheumatology, University Maastricht, Maastricht, The Netherlands
⁷ Department of Rheumatology, Diakonhjemmets Hospital, Oslo, Norway
⁸ Institute of Rheumatology, Praha, Czech Republic
⁹ Kolling Institute, University of Sydney, Sydney, Australia
¹⁰ 2nd Department of Medicine, Krankenhaus Lainz and Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Vienna, Austria
¹¹ Wyeth Research, Collegeville, Pennsylvania, USA

Dr J Wajdula, Clinical Research and Development, Wyeth Research, 500 Arcola Road, Collegeville, PA 19426, USA; wajdulj{at}wyeth.com

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.

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