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CNTO 1275 Shows Efficacy for Psoriasis: Presented at AAD By Bruce Sylvester SAN FRANCISCO, C.A. -- March 6, 2006 -- Results from a 1-year phase 2 study of subcutaneously administered CNTO 1275 show this investigative agent is efficacious for the treatment of plaque psoriasis. Researchers reported these results here on March 5th during a discussion session of selected research at the 64th Annual Meeting of the American Academy of Dermatology (AAD). "Patients who receive this drug can expect a good response," said lead investigator Gerald Krueger, MD, Professor of Dermatology, University of Utah Health Sciences Center, Salt Lake City, Utah, United States. "There appears to be a group of patients who are particularly responsive to it, and they are the patients who respond to one 50-mg injection," Dr. Krueger noted, "though we cannot know who these will be ahead of treatment." CNTO 1275 is an antagonist to interleukins 12 and 23, two key cytokines known to be involved in type 1 immune responses. The study was 52-week, double-blind and placebo-controlled trial. The investigators enrolled 320 patients and randomized them to placebo or one of four doses of CNTO 1275 administered subcutaneously: one injection of 50 mg; one injection of 100 mg; four weekly injections of 50 mg; four weekly 100-mg injections. Each of the five groups had 64 subjects. CNTO 1275 subjects also received an additional dose at week 16 if they did not achieve an excellent or complete response (75% clearing) as measured by the standard Physician's Global Assessment (PGA). Subjects in the placebo group also received 100 mg of CNTO 1275 at week 20. Patient response to treatment was evaluated using the Psoriasis Area and Severity Index (PASI), a standard measure of overall psoriasis severity and coverage. At week 12, more than 75% improvement in PASI score was achieved by 52%, 59%, 67%, and 81% of subjects treated with 50 mg, 100 mg, four weekly 50-mg injections, or four weekly 100-mg injections of CNTO 1275, respectively. This compared to 2% of placebo subjects, the researchers reported. There was also at least a 90% improvement in PASI score, or virtual clearing of disease, in 23%, 30%, 44%, and 52% of subjects in the respective CNTO 1275 groups, versus 2% of placebo. Only 87 patients were re-treated with CNTO 1275 at week 16. No uncommon adverse events were reported during treatment in any of the CNTO 1275 groups. "The next step is getting into phase 3, and that is happening," added Dr. Krueger. "There is a multicenter trial going on now as well as another long-term study that will be in place very soon." The study was sponsored by Centocor, Inc. [Presentation title: Results of a Phase II study of CNTO 1275 in the Treatment of Psoriasis. Abstract P38] E-mail this page to a friend or colleague! To print, use this version