NEW YORK -- July 8, 2008 -- The European Commission has approved etanercept (Enbrel) 50 mg once-weekly dosage regimen as an alternative to the currently approved etanercept 25 mg twice-weekly regimen for the treatment of patients with moderate to severe plaque psoriasis.
The approval is based on the outcome of an open-label, placebo-controlled study involving 318 patients with moderate to severe plaque psoriasis.
Patients' quality of life was measured with patient-reported outcome (PRO) impairment, Dermatology Life Quality Index (DLQI) score, and Psoriasis Area and Severity Index (PASI). The primary endpoint was 75% in PASI score.
For 12 weeks, one group of patients received etanercept while the other group was given placebo. After 12 weeks all patients were then prescribed etanercept for an additional 12 weeks. Primary endpoint was achieved at week 12. Patients continued to improve with etanercept treatment at week 24, with a 64%, "clear" or "almost clear" PRO impairment.
SOURCE: Wyeth
