Rheumatology Advance Access originally published online on March 23, 2004
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Rheumatology 2004; 43: 712-718
Rheumatology Vol. 43 No. 6 © British Society for Rheumatology 2004; all rights reserved
Clinical |
Improvement in health utility among patients with rheumatoid arthritis treated with adalimumab (a human anti-TNF monoclonal antibody) plus methotrexate
1 McMaster University, Hamilton, Ontario, 2 Innovus Research Inc, Burlington, Ontario, 3 Health Utilities Inc, Dundas, Ontario, 4 University of Ottawa, Ottawa, Ontario, Canada, 5 Innovus Research Inc, Medford, MA, 6 Abbott Laboratories, Parsippany, NJ, 7 Abbott Laboratories, Abbott Park, IL, USA.
Correspondence to: G. Torrance, Innovus Research Inc., 1016-A Sutton Drive, Burlington, ON, L7L 6B8, Canada. E-mail: torrance{at}mcmaster.ca
Objectives. To compare health-related quality of life (HRQoL), as measured by health utility, in patients with rheumatoid arthritis (RA) treated with adalimumab (a human anti-tumour necrosis factor (anti-TNF) monoclonal antibody) plus methotrexate or placebo plus methotrexate.
Methods. HRQoL data were obtained in two randomized, double-blind, placebo-controlled, multidose clinical trials conducted in the United States and Canada. The Health Utilities Index Mark 3 (HUI3) was administered in both studies at baseline, at the end of the study and at two time points in between. Patients’ HUI3 scores were compared with population norm scores. Change in HUI3 was defined as the end-of-study score minus the baseline score. Utility gained throughout the study was measured by area under the utility curve and expressed as quality-adjusted life years (QALYs). Statistical testing adjusted for confounders and used the Dunnett test to account for multiple comparisons.
Results. Patients’ utility scores at baseline were low (range of treatment group means 0.38–0.44) compared with population norms (0.88). HUI3 mean changes from baseline scores for adalimumab-treated patients were 0.22 and 0.21 in the two trials, whereas placebo patients’ changes were 0.04 and 0.07. The rate of QALYs gained per year in the treatment group compared with the placebo group were 0.145 in the ARMADA trial and 0.104 in the DE019 trial. All gains were clinically important and statistically significant.
Conclusions. Treatment with adalimumab plus methotrexate provides clinically important and statistically significant improvements in HRQoL as measured by health utility in patients with RA. This translates into measurable and important gains in QALYs.
KEY WORDS: Rheumatoid arthritis, Adalimumab, TNF-antagonists, Health-related quality of life, Health utility, Health utilities index, Outcomes, Quality-adjusted life years.
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