Patient-reported Outcomes in a Randomized Trial of Etanercept in Psoriatic Arthritis

• Published in: Journal of rheumatology 2010-06, Vol.37 (6), p.1221-1227
• Main Authors: MEASE, Philip J, WOOLLEY, J. Michael, SINGH, Amitabh, TSUJI, Wayne, DUNN, Meleana, CHIOU, Chiun-Fang
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antirheumatic Agents - therapeutic use; Arthritis, Psoriatic - drug therapy; Arthritis, Psoriatic - physiopathology; Biological and medical sciences; Dermatology; Disability Evaluation; Diseases of the osteoarticular system; Double-Blind Method; Etanercept; Female; Health Status; Humans; Immunoglobulin G - therapeutic use; Immunomodulators; Inflammatory joint diseases; Male; Medical sciences; Middle Aged; Outcome Assessment (Health Care); Pain - drug therapy; Pain - physiopathology; Pain Measurement; Patient Satisfaction; Pharmacology. Drug treatments; Psoriasis. Parapsoriasis. Lichen; Quality of Life; Receptors, Tumor Necrosis Factor - therapeutic use; Severity of Illness Index; Treatment Outcome; Young Adult
• ISSN: 0315-162X; 1499-2752
• DOI: 10.3899/jrheum.091093

To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA). 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. 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. 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.