Promising Phase 3 trial results show biologic therapy ustekinumab significantly improved...(d at the World Congress of Dermatology t...),Health

Date:10/3/2007

d at the World Congress of Dermatology that show that as early as week four patients treated with either 45 mg or 90 mg ustekinumab experienced significant improvements in quality of life measures compared with patients receiving placebo. At week four, according to the Dermatology Life Quality Index (DLQI), a 10-item questionnaire that measures the impact of psoriasis on quality of life and patient burden of disease, median DLQI improvement was 6.0 for 45 mg and 6.0 for 90 mg versus 1.0 for placebo (each P < 0.001 versus placebo). An improvement of five or more from baseline is considered to be clinically meaningful. At week 12, 72 percent of patients receiving 45 mg ustekinumab and 77 percent of patients receiving 90 mg ustekinumab achieved a reduction of at least five points in DLQI score compared with 21 percent of patients in the placebo group (P < 0.001 for each comparison versus placebo). Also at week 12, a total of 37 percent of patients receiving the 45 mg ustekinumab and 39 percent of patients receiving the 90 mg ustekinumab achieved a DLQI score of zero, indicating no impact of psoriasis or the treatment on quality of life, compared with one percent of those receiving placebo (P < 0.001 for each comparison versus placebo). Upon crossing over to treatment with ustekinumab, patients initially randomized to placebo experienced similar improvements in DLQI after 12 weeks.

Psoriasis is an inflammatory disease that can cause severe emotional, physical and social burdens for patients, said Richard Langley, MD, Dalhousie University, Halifax, Nova Scotia, Canada, and trial investigator. While more therapies have become available for the treatment of psoriasis over the years, dermatologists need additional options to manage this chronic disease, and ustekinumab would represent a much needed addition in the treatment armamentarium.

About the PHOENIX 2 Trial

The Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial E
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Contact: Michael Parks 215-325-4010 Centocor, Inc. Source:Eurekalert

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