A Phase 3 study showed that children and adolescents with moderate to severe plaque psoriasis who received treatment with Enbrel experienced significant improvements in the signs and symptoms of their disease psoriasis.
Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced the study results published in the New England Journal of Medicine.
“Moderate to severe plaque psoriasis is a chronic disease of the immune system that can significantly impact many aspects of the daily lives of children and teens,” says Amy Paller, M.D., study investigator and Professor and Chair of Dermatology, Northwestern University School of Medicine. “These etanercept data are encouraging and reinforce the importance of continuing to investigate treatment options that may help this particularly vulnerable patient population manage their disease.”
During the 48-week study, the percentage of patients achieving 75 percent or greater disease improvement from baseline, as measured by 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, which was the conclusion of the double-blind, placebo-controlled portion of the study, 57 percent (n=60) of pediatric patients treated with ENBREL achieved PASI 75, compared with 11 percent (n=12) of pediatric patients who received placebo (p less than 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 percent (n=71) of the patients initially treated with ENBREL from the start of the study and 65 percent (n=67) 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.
This study was designed to assess the safety and efficacy of ENBREL therapy in children and adolescents between 4 and 17 years old with moderate to severe plaque psoriasis whose disease had been inadequately controlled with topical therapy or who received systemic therapy or phototherapy.
Source: Amgen, USA