OBJECTIVES: To investigate the ability of adalimumab therapy to provide simultaneous, sustained long-term improvement in two important patient-reported outcomes (health utility and fatigue) in patients with severe RA who had failed at least one DMARD. METHODS: The Health Utilities Index Mark 3 (HUI3) and Fatigue (FACIT-F, validated in RA) were simultaneously measured in a health economics companion trial to an adalimumab pivotal study (DE011). For the first 26 weeks patients were followed under double-blind, randomized conditions before rolling over into a long-term, open-label extension (OLE) (n=99). A subset of patients receiving adalimumab 40 mg every other week was evaluated for up to 170 weeks. The HUI3 scale is 0–1, with '1' denoting perfect health and '0' denoting death. FACIT-F scores range from 0–52, with higher scores representing less fatigue. Changes in HUI3 of ≥0.03 and FACIT-F of ≥4 are considered clinically meaningful. RESULTS: Baseline patient characteristics were: female, 80%; age, 53 years; duration of disease, 10 years; TJC (0–68), 34; SJC (0–66), 21; HAQ score, 1.9; C-reactive protein (mg/L), 54;number of previous DMARDs: 4 (all mean values except % female). RA patients' baseline utility and fatigue scores were comparable (vs. placebo) and approximately one-third of the population norm. At week 26, mean changes from baseline in adalimumab-treated patients were 0.18 for HUI3, and 8.54 for FACIT-F (both p<0.001 vs. baseline). These improvements were sustained throughout week 170. CONCLUSIONS: Adalimumab provided clinically important, simultaneous improvements in health utility and fatigue in patients with severe, active RA who had failed at least one DMARD. These improvements were sustained over the 3-year observation period.