In this global, double blind, placebo-controlled, multi-center study, 583 patients were randomized to receive 50 mg of ENBREL twice weekly (n=194), 25 mg of ENBREL twice weekly (n=196) or placebo (n=193). The primary endpoint of the study was the proportion of patients achieving a 75 percent or greater improvement in the Psoriasis Area and Severity Index (also known as PASI 75) after 12 weeks of treatment. Nearly half (49 percent) of the patients treated with 50 mg of ENBREL twice weekly and more than a third (34 percent) of patients treated with 25 mg of ENBREL twice weekly achieved a PASI 75 versus 3 percent of patients receiving placebo.
"In this study, a significant number of patients experienced rapid improvement in as quickly as two weeks after receiving ENBREL," said primary investigator Dr. Kim Papp of Probity Medical Research in Waterloo, Canada. "In addition, physicians assessed their patients as having 'clear' or 'almost clear' skin in 57 percent of patients treated with ENBREL 50 mg twice weekly, and 39 percent treated with ENBREL 25 mg twice weekly, compared with 4 percent of placebo-treated patients."
Patients were asked to assess the effect of ENBREL on their psoriasis and the impact that ENBREL treatment had on their lives as measured by the Dermatology Life Quality Index over the course of the study. Patients treated with ENBREL 50 mg twice weekly reported 71 percent improvement after 12 weeks and patients t
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Contact: Rebecca Hamm, Amgen
805-447-3872
Porter Novelli
20-Jun-2003