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Ustekinumab (CNTO 1275) Phase 3 Data Show Long-Term Improvement Of Chronic Plaque Psoriasis
Date:2/2/2008

New Findings from a Second Pivotal Phase 3 Study Show Subjects Receiving Infrequently Administered Ustekinumab Maintained Improvement from Psoriasis

Through One Year

SAN ANTONIO, Feb. 2 /PRNewswire/ -- One-year data from a second double-blind, placebo-controlled Phase 3 study showed therapy with ustekinumab given every 12 weeks provided sustained, clinically meaningful improvement in the treatment of moderate to severe plaque psoriasis through one year. According to findings presented at the Annual Meeting of the American Academy of Dermatology, 87 percent of patients responding to ustekinumab 45 mg maintenance therapy and 91 percent of patients responding to ustekinumab 90 mg maintenance therapy sustained at least a 75 percent improvement in psoriasis through one year, as measured by the Psoriasis Area and Severity Index (PASI 75). Ustekinumab is a new human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body's regulation of immune responses and that are also believed to play a role in immune-mediated inflammatory disorders, including psoriasis.

In December 2007, Centocor announced that a Biologics License Application (BLA) had been submitted to the U.S. Food and Drug Administration (FDA) and Janssen-Cilag International NV announced its submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA).

"These findings show that ustekinumab may control plaque psoriasis with as few as four injections a year," says lead study investigator Kenneth Gordon, MD, associate professor, Feinberg School of Medicine, Northwestern University, and Head of Dermatology, Evanston Northwestern Healthcare, Skokie, IL. "We are encouraged by the results seen in clinical trials to date and the hope that ustekinumab may hold for patients and the dermatology commun
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SOURCE Centocor, Inc.
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Related medicine technology :

1. Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
2. Promising Phase 3 Trial Results Show Novel Biologic Therapy Ustekinumab (CNTO 1275) Significantly Improved Psoriasis
3. Pivotal Ustekinumab (CNTO 1275) Phase 3 Data to Debut at World Congress of Dermatology Meeting
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