Wyeth Pharmaceuticals (MAIDENHEAD, England) reported that the European Commission announced a new 50 mg Enbrel^® (etanercept) once-weekly dosage regimen as an alternative to the currently approved 25 mg Enbrel twice-weekly regimen for the treatment of moderate-to-severe plaque psoriasis.

The marketing authorization for the EU was based on the outcome of the European 318 study in adult patients with moderate-to-severe plaque psoriasis. Patients entered the trial with serious patient-reported outcome (PRO) impairment and a mean Dermatology Life Quality Index (DLQI) score, (a QoL index) comparable with that of patients with severe chronic obstructive pulmonary disease (COPD). The 318 study design comprised a primary endpoint of 75% improvement in Psoriasis Area and Severity Index (PASI 75) score and included a number of measures to determine moderate-to-severe psoriasis patients' quality of life. For 12 weeks one group received etanercept while the other received placebo, after which time all patients were prescribed etanercept in an open-label period for a further 12 weeks. The study achieved its primary endpoint at Week 12, however, patients continued to improve with etanercept treatment at Week 24 demonstrating serious PRO impairment was largely abated with 64% "clear" or "almost clear."

Enbrel, a fully-human soluble TNF receptor, was first approved in 1998 for moderate-to-severe rheumatoid arthritis (RA) and has since been used in nearly 500,000 patients worldwide across indications. In addition to RA, Enbrel in the EU is approved for polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and treatment of adults with moderate-to-severe plaque psoriasis who failed to respond to, who have a contraindication to, or who are intolerant to other systemic therapy including cyclosporine, methotrexate, or phototherapy.