Once weekly administration of etanercept 50mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension

BackgroundIn previous studies, etanercept 25mg twice weekly (BIW) or 50mg BIW significantly reduced disease severity in patients with plaque psoriasis and demonstrated a favourable safety profile. ObjectivesTo assess the efficacy and safety of etanercept 50mg administered once weekly (QW) compared with placebo in patients with moderate-to-severe plaque psoriasis over 24weeks. MethodsThis study was conducted in two parts: (i) a 12-week, double-blind, placebo-controlled phase, in which patients received etanercept 50mg QW or placebo QW; and (ii) a 12-week, open-label extension phase, in which all patients received etanercept 50mg QW. Primary endpoint was a 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included percentage PASI improvement and Physician's Global Assessment (PGA). ResultsOne hundred and forty-two patients were analysed in the double-blind phase; 126 patients entered the open-label phase. At week 12, significantly more patients receiving etanercept 50mg QW (37.5%) achieved PASI 75 response than patients receiving placebo (2.2%; P