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Effect of Anakinra on Functional Status in Patients with Active Rheumatoid Arthritis Receiving Concomitant Therapy with Traditional Disease Modifying Antirheumatic Drugs: Evidence from the OMEGA Trial XAVIER LE LOËT, DAN NORDSTRÖM, MANUEL RODRIGUEZ, ANDREA RUBBERT, PIERCARLO SARZI-PUTTINI, JACQUES M.G.W. WOUTERS, J. MICHAEL WOOLLEY, NICOLA WRIGHT, CHRISTINA LAWRENCE, and BRENT APPLETON
ABSTRACT. Methods. In this large, multicenter, open-label, single-arm study, adult patients with RA receiving methotrexate, sulfasalazine, or hydroxychloroquine for ≥ 3 months were given anakinra 100 mg once daily for up to 36 weeks. The primary objective was to evaluate changes from baseline to week 36 in the Health Assessment Questionnaire (HAQ) disability index and subscales. Changes in the 28-joint Disease Activity Score (DAS28), proportion of patients meeting European League Against Rheumatism (EULAR) response criteria, and the safety of each combination regimen were also assessed. Results. A total of 1207 patients were enrolled, received ≥ 1 dose of anakinra, and were included in the efficacy and safety analyses. A statistically significant change in the HAQ disability index was observed (p = 0.0001); no significant differences were seen among the 3 DMARD groups. A clinically meaningful improvement in HAQ (> 0.22) was observed in 51% of patients. Mean improvement in DAS28 was 1.5 (p < 0.0001), and 64% of patients achieved a good or moderate EULAR response score. Injection site reaction was the most frequently (62%) reported adverse event. The incidence of infections (24%), most commonly respiratory infection, was similar across treatment groups. No notable changes were observed in laboratory findings and vital signs. Conclusion. These findings indicate that anakinra 100 mg/day in combination with DMARD therapy safely improved functional status in patients with active RA. (First Release July 15 2008; J Rheumatol 2008;35:1538–44) Key Indexing Terms:
INTERLEUKIN-1 RECEPTOR ANTAGONIST
From Rouen University Hospital, Rouen, France; Helsinki University Central Hospital, Helsinki, Finland; Complejo Hospitalario de Orense, Orense, Spain; Klinik I für Innere Medizin der Universität zu Köln, Köln, Germany; University Hospital L. Sacco, Milano, Italy; Sint Franciscus Gasthuis, Rotterdam, Netherlands; Amgen Inc., Thousand Oaks, California, USA; and Amgen Inc., Cambridge, UK. Supported by Amgen, Inc. X. Le Loët, MD, Rouen University Hospital; D. Nordström, MD, PhD, Helsinki University Central Hospital; M. Rodriguez, Complejo Hospitalario de Orense; A. Rubbert, MD, Klinik I für Innere Medizin der Universität zu Köln; P. Sarzi-Puttini, MD, University Hospital L. Sacco; J.M.G.W. Wouters, MD, Sint Franciscus Gasthuis; J.M. Woolley, PhD; B. Appleton, MD, Amgen Inc., Thousand Oaks, CA, USA; N. Wright, MSc; C. Lawrence, Amgen Inc., Cambridge, UK. Address reprint requests to Dr. X. Le Loët, Department of Rheumatology, CHU-Hôpitaux de Rouen, 76031 Rouen Cedex, France. E-mail: xavier.le-loet@chu-rouen.fr Accepted for publication March 10, 2008. |
