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Promising Phase 3 Trial Results Show Novel Biologic Therapy Ustekinumab (CNTO 1275) Significantly Improved Psoriasis
Date:10/3/2007

stekinumab 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 Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension 2 (PHOENIX 2) trial involved 1,230 patients with chronic plaque psoriasis. Patients were randomized to receive subcutaneously administered ustekinumab or placebo. Patients randomized to receive ustekinumab received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Patients in the placebo group crossed over to receive either 45 mg or 90 mg doses of ustekinumab at weeks 12 and 16 and every subsequent 12 weeks. The primary end point of the study was the proportion of patients who achieved PASI 75 at week 12.

Through week 12, the placebo-controlled portion of the study, the percentages of study participants who experienced at least one adverse event (AE) were comparable between the placebo group (49 percent) and the ustekinumab 45 mg group (53 percent) and 90 mg group (48 percent). Discontinuation due to an AE occurred in 0.2 percent and one percent of patients in the respective ustekinumab groups, compared with two percent of patients in the placebo group. Two percent and one percent of patients receiving 45 mg or 90 mg ustekinumab, respectively, experienced at least one serious AE compared with two percent of patients receiving placebo.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease that results from inflammation in the skin and overproduction of skin cells that accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven in part by IL-12 and IL-23, cytokines involved in the regulation of the body's immune response. It is estimated that 125 million people worldwide have psoriasis, including two percent of
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SOURCE Centocor, Inc.
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