Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo

Objective: To compare the functional status and well-being of patients with rheumatoid arthritis (RA) who were randomly assigned to receive placebo, e tanercept 10 mg, or etanercept 25 mg during a 26-week, phase ill, double-bl ind clinical trial. Background: No single indicator of disease activity, severity, or therapeut ic efficacy has been established for RA. During the past decade, health-rel ated quality of life, a multidimensional way to assess physical, emotional, and social aspects of a disease or its treatment, has become an important outcome in RA studies and in assessments of RA drug therapies. Methods: A total of 234 patients completed the Health Assessment Questionna ire (HAQ), the Short-Form 36 (SF-36) (n = 48 patients), items assessing ene rgy and mental health from the Medical Outcomes Study (MOS), and a single-i tem rating scale assessing current health (feeling thermometer) at baseline and several times during 6 months. Results: Significant improvements from baseline to last assessment were rep orted with etanercept versus placebo and in the HAQ Disability Index score tie, the total HAQ score) and all 8 HAQ categories (P < 0.05), with the exc eption of grip. Significant improvements with etanercept in the MOS energy and mental health subscales, current health (from the feeling thermometer), and mental and physical function components of the SF-36 were reported (P < 0.05). Conclusions: Patients receiving 10- or 25-mg doses of etanercept reported s ignificantly better functional status and well-being than did patients rece iving placebo.