Patient-reported outcomes in a randomized trial of etanercept in psoriatic arthritis.
Author(s): Mease PJ, Woolley JM, Singh A, Tsuji W, Dunn M, Chiou CF
Affiliation(s): Seattle Rheumatology Associates and Swedish Medical Center, 1101 Madison Street, Seattle, WA 98104, USA. email@example.com
Publication date & source: 2010-06, J Rheumatol., 37(6):1221-7. Epub 2010 Apr 15.
Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA). METHODS: A 24-week double-blind comparison to placebo was followed by a 48-week open-label phase in which all eligible patients received etanercept. PRO were measured using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), the Medical Outcomes Study Short-Form (SF-36), the EQ-5D visual analog scale (VAS), and the American College of Rheumatology (ACR) patient pain assessment. RESULTS: Beginning at Week 4 and continuing through Week 24 of double-blind treatment, patients treated with etanercept had significantly higher mean percentage improvement in HAQ-DI relative to baseline than patients given placebo (53.6% vs 6.4% at Week 24; p < 0.001). After 48 weeks of open-label treatment with etanercept, the mean percentage change from study baseline was 52.8% for the original etanercept group and 46.9% for the original placebo group, with 41.2% of patients overall achieving a HAQ-DI of 0. Mean changes relative to baseline for SF-36 physical component summary scores, EQ-5D VAS, and ACR pain assessment were also significant in the double-blind period for etanercept compared with placebo (p < 0.001 for all 3 measures). Patients taking placebo achieved similar improvements once they began treatment with etanercept in the open-label period. CONCLUSION: Patients with PsA treated with etanercept reported significant improvements in physical function that were almost 10 times the improvement seen with placebo and were maintained for up to 2 years. Almost half of patients treated with etanercept reported no disability by the end of the study.