In a publication by Mease etal (Lancet 356:385-390, 2000), the safety and efficacy of etanercept was compared to placebo in patients with psoriatic arthritis and psoriasis in a 12-week, randomized, double-blind, placebo-controlled clinical trial. Patients received either placebo (n=30) or etanercept (25 mg twice weekly, s.c., n=30) and improvement was assessed using the Psoriatic Arthritis Response Criteria (PsARC), the American College of Rheumatology 20% Improvement Criteria (ACR20), the psoriasis area and severity index (PASI), the improvement in prospectively-identified individual target lesions.
87% of patients receiving etanercept met the PsARC compared with 23% of patients receiving placebo. ACR20 was achieved in 37% of patients treated with etanercept compared with 13% treated with placebo. 19 patients in each treatment group were assessed for improvement in psoriasis. The median PASI improvement was 46% in patients treated with etanercept versus 9% in patients receiving placebo, while median target lesion improvements were 50% and 0, respectively.
The results of this randomized trial confirm the short-term efficacy of etanercept in treating psoriatic arthritis and psoriasis.