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New Four Year STELARA® Data Show Consistent Safety Profile Over Time in Patients With Moderate to Severe Plaque Psoriasis
Date:5/25/2011

SEOUL, Korea, May 25, 2011 /PRNewswire/ -- New findings presented from pooled analyses of the STELARA® (ustekinumab) psoriasis clinical development program showed that the safety profile of STELARA and rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment.  Investigators also reported findings from an analysis of four placebo-controlled Phase 3 trials across patient populations on three continents and found that the efficacy and safety of STELARA in patients of Japanese and Korean-Taiwanese descent were consistent with findings previously reported in North American and European populations.  Both sets of data were presented at the 22nd World Congress of Dermatology in Seoul, Korea.

Psoriasis, a chronic, immune-mediated disease that results from the overproduction of skin cells, affects 125 million people worldwide. Plaque psoriasis often results in patches of thick, red or inflamed skin covered with silvery scales known as plaques. These plaques usually itch or feel sore, can crack and bleed, and can occur anywhere on the body.  The disease symptoms can range from mild, to moderate, to severe and disabling.  STELARA is currently approved in 57 countries for the treatment of moderate to severe plaque psoriasis.

"These findings are promising and support a favorable benefit-to-risk profile for STELARA with up to four years of treatment," said Kristian Reich, MD, Department of Dermatology of Dermatolgikum, Hamburg, Germany, and lead trial investigator for the PHOENIX 2 study. "Ongoing studies in psoriasis and psoriatic arthritis will continue to define the safety profile of STELARA in the psoriatic population."

Pooled safety data from a total of 3,117 patients who participated in a Phase 2 STELARA trial and the Phase 3 PHOENIX 1, PHOENIX 2 and ACCEPT studies showed rates of adverse events (AEs) to be generally s
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SOURCE Centocor Ortho Biotech Inc.
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