Treatment of Rheumatoid Arthritis Patients with Abatacept and Methotrexate Significantly Improved Health-Related Quality of Life
PAUL EMERY, MARK KOSINSKI, TRACY LI, MARIE MARTIN, G. RHYS WILLIAMS, JEAN-CLAUDE BECKER, BONNIE BLAISDELL, JOHN E. WARE Jr, CHARLES BIRBARA, and ANTHONY S. RUSSELL
Methods. Three hundred thirty-nine patients with RA on a background of methotrexate (MTX), who participated in a multicenter, double-blind, placebo-controlled trial, were randomized to abatacept 2 mg/kg, abatacept 10 mg/kg, or placebo. HRQOL was assessed at pretreatment, and at 3, 6, and 12 months posttreatment using the SF-36 Health Survey (SF-36). Changes in SF-36 scores from baseline to 12 months were compared across treatment and placebo groups to examine HRQOL benefits of abatacept. A link between American College of Rheumatology improvement and changes in SF-36 scores was established to demonstrate the association between HRQOL outcomes and clinical response.
Results. After 12 months of treatment, patients randomized to abatacept 10 mg/kg showed significantly better HRQOL outcomes overall versus patients randomized to placebo (MANOVA F = 4.71, p < 0.001) or to abatacept 2 mg/kg (MANOVA F = 1.97, p = 0.05). Differences in SF-36 change scores between abatacept 10 mg/kg and placebo groups reached statistical significance on all 8 domain scales, the 2 summary measures, and the SF-36 utility index (SF-6D). Differences in SF-36 change scores between abatacept 10 mg/kg and abatacept 2 mg/kg reached statistical significance on 5 of the 8 domain scales, the physical summary measure, and the SF-6D. Improvement in HRQOL was highly related to clinical response.
Conclusion. Abatacept 10 mg/kg plus MTX demonstrated a stronger HRQOL response than placebo plus MTX. The abatacept 2 mg/kg arm showed a very weak and transient response. (First Release Mar 1, 2006; J Rheumatol 2006; 33:681–9)
Key Indexing Terms:
HEALTH-RELATED QUALITY OF LIFE
From the Rheumatology and Rehabilitation Research Unit, University of Leeds, Leeds, UK; QualityMetric Incorporated, Lincoln, Rhode Island, USA; Bristol-Myers Squibb, Princeton, New Jersey, USA; Health Assessment Lab, Boston, Massachusetts, USA; Tufts University School of Medicine, Boston, MA, USA; University of Massachusetts, Worcester, MA, USA; and Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Supported by a grant from Bristol-Myers Squibb.
P. Emery, MA, MD, FRCP, Professor, Rheumatology and Rehabilitation Research Unit, University of Leeds; M. Kosinski, MA, Senior Scientist, QualityMetric Inc.; T. Li, PhD, Associate Director, Immunology, Bristol-Myers Squibb; M. Martin, PhD, Director, Consulting Services, QualityMetric Inc.; G.R. Williams, ScD, Director, Outcomes Research; J-C. Becker, MD, Clinical Director, Bristol-Myers Squibb; B. Blaisdell, MA, Outcomes Research, QualityMetric Inc.; J.E. Ware Jr, PhD, CEO, Chief Science Officer, Chairman of the Board, QualityMetric Inc., Health Assessment Lab, Tufts University School of Medicine; C. Birbara, MD, Rheumatologist, University of Massachusetts; A.S. Russell, MD, Professor of Rheumatology, Department of Medicine, University of Alberta.
Address reprint requests to Prof. P. Emery, Department of Rheumatology and Rehabilitation, University of Leeds, 36 Clarendon Road, Leeds LS2 9N2, UK. E-mail: email@example.com
Accepted for publication November 25, 2005.