Quality of life in patients receiving auranofin therapy: confirmation of efficacy using nontraditional health status measures.

Traditionally, assessment of therapeutic efficacy in patients with rheumatoid arthritis (RA) has been based on objective measurement of disease parameters, such as the number of tender and swollen joints, 10-cm analogue pain scale, or grip strength. More recently, however, it has been realized that these parameters may not provide a true reflection of the impact of disease or therapy on the patient's overall emotional state and ability to function--the "quality of life." Nontraditional measurements of health status have been used by several researchers in order to provide comprehensive data about the benefits of drug therapy. Most recently the Auranofin Cooperating Group conducted a prospective, 6-month, randomized, double-blind, multicenter study that compared auranofin (AF) oral gold with placebo in the treatment of RA. The study was unique in that it assessed the efficacy of AF using a battery of nontraditional health status measures ("quality-of-life" measures) in addition to the traditional parameters used to chart rheumatic disease activity. Composite scores were calculated for 4 distinct dimensions of RA: physical, functional, pain, and global. Pairwise correlations between composite scores ranged from 0.45 to 0.67, indicating that the scores represented different dimensions of the impact of RA. Results indicated that AF effectively improves several dimensions of RA. In addition, it was apparent that several health status measures are sensitive to changes in clinical status. These measures may be useful in future clinical trials of RA, perhaps indicating when DMARD therapy should be initiated. They should also prove useful in drug trials for other diseases.