To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Ustekinumab Shows Long-Term Efficacy for Chronic Plaque Psoriasis: Presented at AAD URL: http://www.pslgroup.com/dg/21C35A.htm Doctor's Guide February 4, 2008
By Bruce Sylvester SAN ANTONIO, TX -- February 4, 2008 -- Investigative drug ustekinumab (CNTO 1275) shows high and sustained rates of treatment efficacy among patients with moderate to severe plaque psoriasis, researchers reported at the American Academy of Dermatology 66th Annual Meeting (AAD). Researchers presented data from a one-year, phase 3 study on February 2 at a poster discussion session, for which this study was especially selected. "With ustekinumab we have a medicine that has high efficacy that is also well maintained over time," said presenter and investigator Kenneth Gordon, MD, associate professor, at Northwestern University Feinberg School of Medicine in Chicago. "This will be especially important for helping clinicians keep patients compliant with their treatment over the long term." In 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 (PHOENIX 1) trial, investigators randomised 766 subjects to subcutaneously administered ustekinumab (two 45 or 90 mg doses 4 weeks apart followed by 45 or 90 mg every 12 weeks) or placebo. Placebo subjects crossed over to 45 or 90 mg doses at weeks 12 and 16, respectively, with dosing every 12 weeks thereafter. Subjects who responded to ustekinumab through week 40 were randomised to either ongoing ustekinumab treatment or were switched to placebo. The investigators reported that significantly higher proportions of subjects continuing on ustekinumab therapy after week 40 maintained a 75% reduction in scores on the Psoriasis Area and Severity Index (PASI 75) at week 52 compared with those who switched to placebo. Subjects who continued on 45 and 90 mg dosing sustained PASI 75 at a rate of 87% and 91%, respectively, compared with PASI 75 maintenance achieved by 64% (45 mg) and 62% (90 mg) of subjects who switched to placebo at week 40 (P =.001 for 45 mg versus placebo and P <.001 for 90 mg vs placebo). And 97% and 98%, respectively, of the subjects who continued 45 and 90 mg ustekinumab dosing after week 40 maintained at least a PASI 50 at week 52. At week 40 randomization, 66% and 73%, respectively, of subjects in the 45 and 90 mg dosing groups had achieved PASI 90, which denotes virtual clearance. With continued treatment after Week 40, the proportions of PASI 90 responders remained stable through Week 52. However, PASI 90 dropped to 37% and 38%, respectively, among subjects withdrawn from 45 and 90 mg dosing. The authors concluded, "Long-term continuous therapy with CNTO 1275 [ustekinumab] is generally well tolerated and maintains a high level of efficacy." Funding for the study was provided by Centecor Research and Development, Inc. [Presentation title: Long-term Continuous Maintenance Therapy With CNTO 1275 (anti-IL-12/23p40) as Treatment for Psoriasis: Phase 3 Trial Results. Abstract 2620] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.