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Clinical Outcomes of Patients with Rheumatoid Arthritis After Switching from Infliximab to Etanercept
BOULOS HARAOUI, EDWARD C. KEYSTONE, J. CARTER THORNE, JANET E. POPE, ISAAC CHEN, CHARLES G. ASARE, and JONATHAN A. LEFF
ABSTRACT. Methods. Adult patients with active RA who were discontinuing treatment with infliximab were eligible to enroll in this prospective, 12-week, open label, single-arm, observational study. Four to 10 weeks after their last infusion of infliximab, patients began treatment with etanercept (twice weekly subcutaneous injections of 25 mg). Clinical assessments using the American College of Rheumatology (ACR) criteria for improvement were performed at baseline and at Weeks 6 and 12, and serious adverse events were monitored throughout the study. Results. Twenty-five patients were enrolled, 18 of whom had discontinued infliximab because of lack of efficacy, and 22 completed 12 weeks of etanercept treatment. After 12 weeks, 14 of 22 patients (64%) achieved at least a 20% improvement in ACR criteria (ACR20), 13 (59%) experienced improvements in physical function that were considered clinically important (≥ 0.22 point decrease in overall Health Assessment Questionnaire score), and mean values of all individual components of the ACR criteria had improved. No serious adverse events were reported during the study and no patient discontinued because of lack of efficacy. Conclusion. Etanercept, a soluble tumor necrosis factor (TNF) receptor, provided a well tolerated and effective treatment option for some patients even when infliximab, a monoclonal antibody to TNF, had been ineffective. (J Rheumatol 2004;31:2356-9) Key Indexing Terms:
TUMOR NECROSIS FACTOR
From the Centre Hospitalier de l'Université de Montréal, Montréal, Quebec; Division of Advanced Therapeutics, University of Toronto, Toronto; Arthritis Program Research Group, Newmarket; St. Joseph's Health Care, London; Wyeth Pharmaceuticals, Markham, Ontario, Canada; and Amgen Inc., Thousand Oaks, California, USA. Supported by Immunex Corporation, a wholly owned subsidiary of Amgen Inc. (Thousand Oaks, CA, USA), and by Wyeth Pharmaceuticals (Markham, ON, Canada). B. Haraoui, MD, Associate Professor of Medicine and Director of Clinical Research, Centre Hospitalier de l'Université de Montréal; E.C. Keystone, MD, Division of Advanced Therapeutics, University of Toronto; J.C. Thorne, MD, Director, Arthritis Program Research Group; J.E. Pope, MD, Associate Professor of Medicine, Epidemiology and Biostatistics, St. Joseph's Health Care; I. Chen, BSc, Wyeth Pharmaceuticals; C. Asare, MD, MPH; J. Leff, MD, Medical Director, Amgen Inc. Address reprint requests to Dr. B. Haraoui, Centre Hospitalier de l'Université de Montréal (CHUM), Hôpital Notre-Dame, 1560 Sherbrooke Est, Montréal, Quebec H2L 4M1, Canada. E-mail: paulharaoui@attglobal.net Submitted November 13, 2003; revision accepted July 29, 2004. |