Article Text
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.
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Footnotes
*Etanercept Study 309 investigators are listed at the end of the paper
Funding: Supported by Wyeth Research, Collegeville, PA, USA (study drug and grants to investigational sites).
Competing interests: Declared. BC was a consultant and a speaker for Wyeth. CC received investigator fees for carrying out Wyeth trials. UF received reimbursement from 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, RK, AS and SF are employees of Wyeth Research.
Ethics approval: Ethics committees of the participating centres approved the study protocol.
Patient consent: Obtained.
List of the Etanercept Study 309 Investigators in Europe and Australia (other than the authors): Professor Maxime Dougados, Hopital Cochin, Paris, France; Professor Joël Dehais, Hopital Pellegrin, Bordeaux, France; Professor Philippe Goupille, Hopital Trousseau, Tours, France; Professor Pierre Miossec, Hopital E Herriot, Lyon, France; Dr Anett Grässler, University Hospital, Dresden, Germany; Professor Umberto Ambanelli, Universita di Parma, Parma, Italy; Professor Silvano Todesco, Policlinico Universitario, Padova, Italy; Dr Hillary Capell, Glasgow Royal Infirmary, Glasgow, UK; Dr Ian Griffiths, Freeman Hospital, Newcastle upon Tyne, UK; Dr Richard Hull, Queen Alexandra Hospital, Portsmouth, Hants, UK; Dr George Kitas, Corbett Hospital, Stourbridge, West Midlands, UK; Dr Robert Moots, Fazakerley Hospital, Liverpool, UK; Professor David GI Scott, Norfolk and Norwich Hospital, Norwich, UK; Professor David L Scott, Dulwich Hospital, London, UK; Dr Peter Sheldon, Leicester Royal Infirmary, Leicester, UK; Dr Bryan Williams, University Hospital of Wales, Cardiff, South Wales, UK; Dr Gary Wright, Musgrave Park Hospital, Belfast, UK; Dr Paresh Jobanputra, University of Birmingham, Birmingham, UK; Dr Knut Mikkelsen, Lillehammers Sanitetsforening, Lillehammer, Norway; Dr Olav Bjorneboe, Martina Hansens Hospital, Gjetterum, Norway; Dr Petr Vitek, Centrum Rehabilitace, Zlin, Czech Republic; Dr Ladislav Bortlik, NZZ Bormed, Ostrava, Czech Republic; Dr Marie Sedlackova, Thomayer University Hospital, Praha, Czech Republic; Dr Sevda Augustinova, Medipont, (Jerzy Lech) Ceske Budejovice, Czech Republic; Dr Peter Nash, Sixth Avenue Specialist Centre, Maroochydore, Australia; Dr Stephen Hall, Cabrini Medical Centre, Malvern, Australia; Dr Florin Radulescu, Ambulatoriul Centrului Metodologic de Reumatologie, Bucuresti, Romania; Dr Coman Tanasescu, Institutul de Medicina Interna, Bucuresti, Romania; Dr Horatiu Bolosiu, Spitalul Clinic Judetean Cluj, Cluj-Napoca, Romania.