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Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison
  1. B Combe1,
  2. C Codreanu2,
  3. U Fiocco3,
  4. M Gaubitz4,
  5. P P Geusens5,
  6. T K Kvien6,
  7. K Pavelka7,
  8. P N Sambrook8,
  9. J S Smolen9,
  10. J Wajdula10,
  11. S Fatenejad10,
  12. for the Etanercept European Investigators Network (The Etanercept Study 309 Investigators)
  1. 1Service d’Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France
  2. 2Centrul Metodologic de Reumatologie, Bucuresti, Romania
  3. 3Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy
  4. 4Medical Clinic B Westfalian-Wilhelms-University, Munster, Germany
  5. 5Biomedical Research Center, Hasselt University, Diepenbeek, Belgium
  6. 6Department of Rheumatology, Diakonhjemmets Hospital, Oslo, Norway
  7. 7Institute of Rheumatology, Praha, Czech Republic
  8. 8Rheumatology Department, Royal North Shore Hospital, St Leonards, Australia
  9. 92nd Department of Medicine, Krankenhaus Lainz, Lainz, Austria
  10. 10Wyeth Research, Collegeville, Pennsylvania, USA
  1. Correspondence to:
    J Wajdula
    Clinical Research and Development, Wyeth Research, 500 Arcola Road, Collegeville, PA 19426, USA; wajdulj{at}


Objective: To compare the efficacy and safety of etanercept and sulfasalazine, alone and in combination, in patients with active rheumatoid arthritis despite sulfasalazine treatment.

Methods: A double-blind, randomised study in adult patients with active rheumatoid arthritis despite stable sulfasalazine (2–3 g/day) treatment. The primary end point was a 20% response by the American College of Rheumatology (ACR) criteria at 24 weeks.

Results: At baseline, the three treatment groups (sulfasalazine, n = 50; etanercept, n = 103; etanercept and sulfasalazine, n = 101) were comparable for demographic variables and disease activity. Lack of efficacy was the primary reason for discontinuation (sulfasalazine, n = 12; etanercept, n = 1; etanercept and sulfasalazine, n = 4; p<0.001). Significantly more patients receiving etanercept, alone or in combination (74% for each), achieved ACR 20 responses at 24 weeks than those receiving sulfasalazine (28%; p<0.01). Similarly, more patients in the etanercept groups achieved ACR 50 and ACR 70 responses than those in the sulfasalazine group (p<0.01). In the groups receiving etanercept, significant differences in the ACR core components were observed by week 2 compared with those receiving sulfasalazine alone (p<0.01). The incidences of several common adverse events (headache, nausea, asthenia) were lower with etanercept alone than with the combination (p<0.05), but infections and injection site reactions were higher with etanercept alone (p<0.05). The safety profiles of both etanercept treatment groups were comparable with previous experience of etanercept.

Conclusions: For all efficacy variables assessed, etanercept alone or in combination with sulfasalazine resulted in substantial and similar improvement in disease activity from baseline to week 24 compared with sulfasalazine alone in patients with active rheumatoid arthritis despite their sulfasalazine treatment. All three treatments were generally well tolerated.

  • ACR, American College of Rheumatology
  • CRP, C reactive protein
  • DAS, Disease Activity Score
  • DMARD, disease-modifying antirheumatic drug
  • ESR, erythrocyte sedimentation rate
  • HAQ, Health Assessment Questionnaire
  • ISR, injection site reaction
  • TNF, tumour necrosis factor
  • VAS, Visual Analogue Scale
  • WBC, white blood cell

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  • Published Online First 10 April 2006

  • Competing interests: CC received investigator fees for carrying out Wyeth trials. UF was paid by Wyeth Italia for running educational programmes. MG was reimbursed by Wyeth for attending several conferences and was paid for giving educational talks. PPG received support for clinical studies from Wyeth Research. TKK was a consultant and a speaker for Wyeth and received funds for research. JW and SF are employees of Wyeth Research.

  • Etanercept Study 309 Investigators in Europe and Australia (other than the authors): Maxime Dougados, Hopital Cochin, Paris, France; Joël Dehais, Hopital Pellegrin, Bordeau, France; Philippe Goupille, Hopital Trousseau, Tours, France; Pierre Miossec, Hopital E Herriot, Lyon, France; Anett Grässler, University Hospital, Dresden, Germany; Umberto Ambanelli Universita di Parma, Parma, Italy; Silvano Todesco, Policlinico Universitario, Padova, Italy; Hillary Capell, Glasgow Royal Infirmary, Glasgow, UK; Ian Griffiths, Freeman Hospital, Newcastle upon Tyne, UK; Richard Hull, Queen Alexandra Hospital, Portsmouth, Hampshire, UK; George Kitas, Corbett Hospital, Stourbridge, West Midlands, UK; Robert Moots, Fazakerley Hospital, Liverpool, UK; David G I Scott, Norfolk and Norwich Hospital, Norwich, UK; David L Scott, Dulwich Hospital, London, UK; Peter Sheldon, Leicester Royal Infirmary, Leicester, UK; Bryan Williams, University Hospital of Wales, Cardiff, South Wales, UK; Gary Wright, Musgrave Park Hospital, Belfast, UK; Paresh Jobanputra, University of Birmingham, Birmingham, UK; Knut Mikkelsen, Lillehammers sanitetsf rening, Lillehammer, Norway; Olav Bjorneboe, Martina Hansens Hospital, Gjetterum, Norway; Petr Vitek, Centrum Rehabilitace, Zlin, Czech Republic; Ladislav Bortlik, NZZ Bormed, Ostrava, Czech Republic; Marie Sedlackova, Thomayer University Hospital, Praha, Czech Republic; Sevda Augustinova, Medipont, (Jerzy Lech) Ceske Budejovice, Czech Republic; Peter Nash, Sixth Avenue Specialist Centre, Maroochydore, Australia; Stephen Hall, Cabrini Medical Centre, Malvern, Australia; Florin Radulescu, Ambulatoriul Centrului Metodologic de Reumatologie, Bucuresti, Romania; Coman Tanasescu, Institutul de Medicina Interna, Bucuresti, Romania; Horatiu Bolosiu, Spitalul Clinic Judetean Cluj, Cluj-Napoca, Romania.