ASSESSMENT OF FUNCTIONAL STATUS AMONG PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS IN A DOUBLE-BLIND TRIAL OF ETANERCEPT AND METHOTREXATE, ALONE AND COMBINED (TEMPO TRIAL)

Background: Previous studies have shown that etanercept improves functional status among either methotrexate (MTX)-naïve or DMARD-refractory patients with active rheumatoid arthritis.Objectives: To evaluate the impact of etanercept, MTX, and the etanercept + MTX combination on patient's functional status among patients with active rheumatoid arthritis.Methods: HAQ was administered at baseline, and at regular intervals for 1 year in a double-blind, parallel-group, 52-week study of 682 patients at 92 centers in Europe, Israel, and Australia. Patients were randomly assigned to etanercept 25 mg twice weekly (N=223), MTX up to 20 mg/week (N=228), or etanercept + MTX (N=231). Mean percent change from baseline in HAQ scores were analyzed. Average area under curve minus baseline (AUCMB) was calculated for HAQ Disability Index score and the 8 HAQ categories. AUCMB was analyzed using analysis of variance (ANOVA). The analyses were implemented for the intent-to-treat population using the last-observation-carried-forward technique for missing data.Results: The patient population was predominantly female (77%) and white (98%), with a mean age of 52.9 years and disease duration of 6.6 years. At baseline, HAQ (MTX 1.7, etanercept 1.8, etanercept + MTX 1.8) scores were comparable among the 3 treatment groups. At week 52, mean percent improvement in HAQ scores were 36%, 39% and 56% in the MTX, etanercept, and combination groups, respectively. The mean percent improvement in HAQ was significantly higher (p<0.01) for the combination group compared with either monotherapy. The average AUCMB improvement in HAQ scores for patients in the combination group (0.8) was also significantly (p<0.05) higher compared with patients in the etanercept (0.6) or MTX (0.6) alone groups. At week 52, 77%, 77%, and 86% of patients had a clinically meaningful improvement in HAQ disability score (0.22 or higher) in the MTX, etanercept, and combination groups, respectively. The impact of treatment on restoring normal function (HAQ <0.5) was also assessed. At week 52, 34%, 34%, and 44% of patients had a HAQ < 0.5 in the MTX, etanercept, and combination groups, respectively. Both of the above proportions were significantly (p<0.05) higher for the combination group compared with either monotherapy. Analysis of the 8 HAQ categories supported the overall results (see Table). Change From Baseline in HAQ Categories Based on Average AUCMB (Week 52) HAQ MTX Etanercept Etanercept+MTX Statistical Category Summary* Activities 0.5 0.6 0.8 A,b Arising 0.7 0.7 0.8 a Dressing 0.6 0.7 0.9 A,B Eating 0.6 0.7 0.9 A,B Grip 0.5 0.7 0.8 A Hygiene 0.5 0.5 0.7 A,b Reaching 0.5 0.6 0.8 A,B Walking 0.5 0.4 0.7 A,B *a,A: combination vs. MTX p<0.05, p<0.01; b,B Combination vs. ETN, p<0.05, p<0.01 A: combination vs. MTX p<0.05, p<0.01; b,B Combination vs. ETN, p<0.05, p<0.01Conclusion: Patients in the combination group had significantly greater improvement in HAQ Disability Index compared to the patients in the MTX or etanercept groups. Significantly (p<0.05) greater proportion of patients in the combination group were restored to normal function (HAQ<0.05) compared with patients in MTX or etanercept group.Citation: , volume , supplement , year 2004, page Session: Advances in health services and outcome research