Combination of skin, joint and quality of life outcomes with etanercept in psoriasis and psoriatic arthritis in the PRESTA trial.

Author(s): Prinz JC, Fitzgerald O, Boggs RI, Foehl J, Robertson D, Pedersen R, Molta CT, Freundlich B

Affiliation(s): Department of Dermatology, Ludwig-Maximilan-University of Munich, Munich, Germany. joerg.prinz@med.uni-muenchen.de

Publication date & source: 2011-05, J Eur Acad Dermatol Venereol., 25(5):559-64. Epub 2010 Sep 14.

Publication type: Randomized Controlled Trial

BACKGROUND: Psoriasis and psoriatic arthritis (PsA) affect skin, and/or joints and quality of life (QoL). OBJECTIVE: To better assess the success in multiple attributes in subjects with both active psoriasis and PsA, the objective was to quantify the proportion of those who achieved substantial improvement in a composite measure of skin symptoms, joint manifestations, and QoL, on one of two treatment regimens. METHODS: Subjects (n=752) with psoriasis and PsA (mean age: 46.5 years, 62.9% male) received etanercept (ETN) 50mg twice weekly (BIW; n = 379) or 50 mg weekly (QW; n=373) for 12 weeks, followed by open-label ETN 50mg QW for 12 weeks. Skin and joint symptoms and QoL were assessed using psoriasis area and severity index (PASI), American College of Rheumatology criteria (ACR) and Euro-QoL (EQ-5D), respectively. RESULTS: By week 24, 30.6% and 25.8% of subjects receiving ETN 50 mg BIW/QW and ETN 50 mg QW/QW, respectively (P = 0.198) achieved the composite measure of efficacy for skin plus joints plus QoL (PASI 75 + ACR 50 + EQ-5D VAS >82). CONCLUSION: At 24 weeks, 25.8-30.6% met the triad of rigorous efficacy outcomes. Evaluation of treatment efficacy should address the multiple components of this disease complex; therefore it may be important to consider this composite measure in future trials. (c) 2010 The Authors. Journal of the European Academy of Dermatology and Venereology (c) 2010 European Academy of Dermatology and Venereology.