Wyeth announces positive results from Phase III psoriasis study

During the 48-week study, the standard Psoriasis Area and Severity Index (PASI 75) was used to evaluate the efficacy of Enbrel in patients between 4 and 17 years old. The primary efficacy endpoint was PASI 75 at week 12. There were 106 patients initially randomized to receive Enbrel and 105 patients randomized to receive placebo. At week 12, 57% of pediatric patients treated with Enbrel achieved PASI 75, compared with 11% of pediatric patients who received placebo (p less than or equal to 0.001).

At week 36, after 24 weeks of open-label treatment during which all patients in the study received Enbrel, PASI 75 was achieved by 68% of the patients initially treated with Enbrel from the start of the study and 65% of those who initially received placebo from the start of the study. At the conclusion of the open-label treatment period (week 36), 138 patients were re-randomized to receive either Enbrel or placebo. During this period, patients who lost PASI 75 were re-treated and no patient had a rebound of psoriasis or a change in the type of their psoriasis. In addition, the Enbrel response rates were similar during re-treatment compared to the initial double-blind period.

The trial showed 57% of patients on etanercept for 12 weeks achieved the ‘gold-standard’ in improvement compared to 11% of patients who received the placebo. An application for use of Enbrel in managing psoriasis in children and adolescents has been submitted by Wyeth to the European Medicines Authority and is under review.