ADALIMUMAB IMPROVES UTILITY AND QUALITY-ADJUSTED LIFE DAYS IN RHEUMATOID ARTHRITIS

Background: Preferences for patient health states (utilities) help policymakers compare the benefits of therapeutic interventions across diseases. Clinical trials of DMARDs in RA rarely measure utility. Adalimumab (HUMIRA, Abbott) is a human TNF inhibitor shown to improve signs and symptoms of disease and inhibit radiographic progression.Objectives: This study compared utility and quality-adjusted life days (QALDs) in patients with rheumatoid arthritis (RA) treated with adalimumab vs. placebo in 2 clinical trials.Methods: Data were obtained from 2 randomized, double-blind, placebo-controlled clinical trials: ARMADA (n=271; 20 mg, 40 mg, 80 mg adalimumab every other week [eow], or placebo for 24 weeks) and DE019 (n=619; 20 mg weekly or 40 mg eow adalimumab, or placebo for 52 weeks). This study focuses on 40 mg adalimumab eow vs. placebo. (The US Food and Drug Administration has approved 40 mg eow dosing.) At baseline, all patients had active disease despite background methotrexate. The Health Utilities Index Mark 3 (HUI3) was used in both studies at baseline, at end of study and at 1 or 2 points during the study. Utility is a score measuring preference or desirability of a health state, with "1" denoting perfect health and "0" denoting death. Net utility gain was measured as the differences between end of study and baseline scores, comparing treatment groups with placebo. HUI3 score changes of ≥0.03 are considered clinically important. Utility gain was measured in terms of QALDs gained per day on study based on area under the utility curve.Results: RA patients' baseline utility scores were about half the age- and sex-adjusted population norm of 0.88. A baseline score of 0.40 represents a health state for which people would be willing to undergo a hypothetical treatment that has a 60% chance of death and a 40% chance of obtaining perfect health as opposed to living a lifetime in the health state. Net HUI3 change scores for the 2 studies were 0.18 and 0.14, and QALDs gained per day on drug were 0.15 and 0.10. A QALD gain of 0.10 per day on study can be interpreted as gaining 1 day of perfect health for each 10 days on treatment. All gains relative to placebo were clinically important and statistically significant. Results are presented in the table below. Baseline Mean HUI3 change QALDs gained HUI3 scores from baseline per day vs. placebo ARMADA (24 weeks) 40 mg eow 0.38 0.22a,b 0.15b Placebo 0.40 0.04 NA DE019 (52 weeks) 40 mg eow 0.44 0.21a,b 0.10b Placebo 0.39 0.07 NA a: clinically important improvement compared with placebo (clinically important QALDs have not been defined); b: p<0.001 vs. placebo clinically important improvement compared with placebo (clinically important QALDs have not been defined); b: p<0.001 vs. placeboConclusion: Adalimumab treatment provides clinically important and statistically significant improvements in health-related quality of life as measured by health utility in patients with active rheumatoid arthritis.Citation: , volume , supplement , year 2003, page Session: Health services, economics and outcome research