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STELARA(TM) Shows Greater Efficacy Than Etanercept for Treatment of Moderate to Severe Plaque Psoriasis: Phase 3 Comparator Study Published in The New England Journal of Medicine
Date:1/14/2010

HORSHAM, Pa., Jan. 14 /PRNewswire/ -- Findings from an international, Phase 3 clinical study comparing the efficacy and safety of STELARA™ (ustekinumab) with etanercept (Enbrel®) in the treatment of moderate to severe plaque psoriasis appear today in The New England Journal of Medicine.  The results showed a significantly higher clinical response with both doses of STELARA than with etanercept over a 12-week period.  The first-of-its-kind head-to-head study comparing two biologic agents for plaque psoriasis also shows the efficacy of STELARA among patients in the study who failed to respond to etanercept.

Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain.  It is estimated that approximately 7.5 million Americans and nearly 3 percent of the world's population are living with psoriasis, which can present in various forms, ranging from mild to severe and disabling. 

"This study provides important comparative efficacy information about the treatment of moderate to severe plaque psoriasis with two biologic agents," said professor Christopher Griffiths, MD, FRCP, University of Manchester, Manchester, UK, and lead trial investigator.  "We observed a substantial proportion of patients achieving high levels of skin clearance with ustekinumab, both through the study's primary endpoint at week 12 and following crossover from etanercept, including in those patients who showed a lack of response to etanercept during the study."

In the comparator study, 68 and 74 percent of patients receiving subcutaneous injections of STELARA (45 mg or 90 mg) at weeks 0 and 4 achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis
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SOURCE Centocor Ortho Biotech Inc.
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