The European Commission (EC) has approved a new 50mg Enbrel (etanercept) once weekly dosage regimen as an alternative to the currently approved 25mg Enbrel twice weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis.
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 European Union for a once weekly 50mg Enbrel dosing.
Stevo Knezevic, MD, PhD, chief medical officer of Wyeth Europe said that Psoriasis impacts greatly on the daily lives of patients, as demonstrated in the 318 study where patients prior to etanercept treatment reported quality of life scores comparable to those of severe chronic obstructive pulmonary disease (COPD). The study results confirm that Enbrel can achieve sustained efficacy both in the short and longer term.
Furthermore the European Commission's announcement today affirms the important role that Enbrel can play in optimally managing the condition whilst providing greater flexibility and convenience for patients."
Patients with moderate-to-severe psoriasis entered this trial with serious patient-reported outcome (PRO) impairment, with a mean Dermatology Life Quality Index (DLQI) score, (a QoL index) comparable to that of patients with severe chronic obstructive pulmonary disease (COPD). The 318 study design comprised a primary endpoint of 75 per cent 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 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 per cent "clear" or "almost clear".
Enbrel is a fully human soluble tumour necrosis factor (TNF) receptor. Enbrel was first approved in 1998 for moderate to severe rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.