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Efficacy, safety, and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomized two-year study
  1. B. Combe
  1. Service d’Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France
    1. C. Codreanu
    1. Centrul Metodologic de Reumatologie, Bucuresti, Romania
      1. U. Fiocco
      1. Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy
        1. M. Gaubitz
        1. Medical Clinic B Westfalian-Wilhelms-Univ, Munster, Germany
          1. P. P. Geusens
          1. Biomedical Research Ctr, Univ Hasselt, Belgium & Dept of Internal Med/Rheum Univ Maastricht, Netherlands
            1. T. K. Kvien
            1. Department of Rheumatology, Diakonhjemmets Hospital, Oslo, Norway
              1. K. Pavelka
              1. Institute of Rheumatology, Praha, Czech Republic
                1. P. N. Sambrook
                1. Kolling Institute, University of Sydney, Sydney, Australia
                  1. J. S. Smolen
                  1. 2nd Dept of Med, Krankenhaus Lainz & Dept of Rheum, Internal Med II, Austria
                    1. R. Khandker
                    1. Wyeth Research, Collegeville, Pennyslvania, United States
                      1. A. Singh
                      1. Wyeth Research, Collegeville, Pennyslvania, United States
                        1. J. Wajdula (wajdulj{at}
                        1. Wyeth Research, Collegeville, Pennyslvania, United States
                          1. S. Fatenejad
                          1. Wyeth Research, Collegeville, Pennyslvania, United States


                            Objective: To determine efficacy and safety of etanercept and etanercept+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+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 (ACR) criteria, disease activity scores (DAS), and patient-reported outcomes (PROs).

                            Results: Demographic variables and baseline disease characteristics were comparable among treatment groups; mean DAS was 5.1, 5.2 and 5.1, for etanercept (n=103), etanercept+sulfasalazine (n=101), and sulfasalazine (n=50) respectively. Withdrawal due to lack of efficacy was highest with sulfasalazine (26 [52%] versus 6 [6%] for either etanercept group, p<0.001). Patients receiving etanercept or etanercept+sulfasalazine had a more rapid initial response, which was sustained at 2 years, than those receiving sulfasalazine: mean DAS was 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, PROs followed a similar pattern; 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+sulfasalazine are efficacious for the long-term management of patients with RA. Therefore, addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.

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