To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Ustekinumab Is Effective at Treating Psoriasis in Most Patients URL: http://www.pslgroup.com/dg/22156A.htm Doctor's Guide May 15, 2008
LONDON -- May 15, 2008 -- Two studies in this week's The Lancet show the efficacy of ustekinumab for treating moderate-to-severe psoriasis. The currently available therapeutic options have left a substantial need for treatments that are convenient, efficacious, and well tolerated, especially for long-term treatment. The PHOENIX studies have been carried out to determine the efficacy of ustekinumab, a drug which binds to interleukins 12 and 23 and prevents their interaction with specific receptors on the surface of cells. In the PHOENIX I trial, 766 patients with moderate-to-severe psoriasis were randomly assigned to received ustekinumab 45 mg (255 patients) or 90 mg (256 patients) at weeks 0 and 4 and then every 12 weeks; another group was given placebo (255 patients) at weeks 0 and 4, with subsequent crossover to ustekinumab at week 12. Patients initially receiving ustekinumab who achieved long-term response (at least 75% improvement in psoriasis areas and severity index [PASI 75] at weeks 28 and 40) were re-randomised at week 40 to maintenance ustekinumab or withdrawn from treatment until loss of response. The primary endpoint of the trials was proportion of patients achieving PASI 75 at week 12. The researchers found that 171 (67%) of patients receiving ustekinumab 45 mg, 170 (66%) receiving ustekinumab 90 mg, and 8 (3.1%) receiving placebo achieved PASI 75 at week 12. At week 40, long-term response had been achieved by 150 patients in the 45-mg group and 172 in the 90-mg group. Following this, 162 patients were randomly assigned to maintenance ustekinumab and 160 to withdrawal. PASI 75 response was better maintained (at least up to 1 year) in those given maintenance treatment. Rates of adverse events were similar between ustekinumab and placebo groups. In the PHOENIX 2 study 1,230 patients with moderate-to-severe psoriasis (defined by a PASI score >=12, and at least 10% body surface area involvement) were randomly assigned to receive ustekinumab 45 mg (409 patients) or 90 mg (411 patients) at weeks 0 and 4, then every 12 weeks, or placebo (410 patients). Partial responders (ie, patients achieving >=50% but <75% improvement from baseline in PASI) were re-randomised at week 28 to continue dosing every 12 weeks or escalate to dosing every 8 weeks. Again the primary endpoint was the proportion of patients achieving at least PASI 75 at week 12. The researchers found that 273 (67%) of those patients receiving ustekinumab 45 mg, 311 (76%) of those receiving ustekinumab 90 mg, and 15 (4%) of those receiving placebo achieved PASI 75 at week 12. The proportion of partial responders at week 28 who received ustekinumab 90 mg every 8 weeks and achieved PASI 75 (69%) was more than double the proportion who continued on the same dose every 12 weeks (33%). There was no such response change in partial responders given ustekinumab 45 mg every 8 weeks. As in PHOENIX 1, adverse events were similar between ustekinumab and placebo groups. Source: The Lancet --------------------------------------------------------------------------------------------- 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.