Based on the outcome of the extensive European 318 study in adult patients with moderate-to-severe plaque psoriasis, the European Commission issued the marketing authorization for the EU for a once weekly 50mg Enbrel dosing.
The 318 study design comprised a primary endpoint of 75% improvement in psoriasis area and severity index score and included a number of measures to determine moderate-to-severe psoriasis patients’ quality of life. For 12 weeks one group received etanercept whilst the other group was given placebo.
After 12 weeks all patients were then prescribed etanercept in an open label period for a further 12 weeks. Study 318 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’.
Stevo Knezevic, chief medical officer of Wyeth Europe, said: “The study results confirm that Enbrel can achieve sustained efficacy both in the short and longer term. Furthermore the European Commission’s announcement affirms the important role that Enbrel can play in optimally managing the condition whilst providing greater flexibility and convenience for patients.”