To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Experimental Biologic Ustekinumab Produces Substantial Responses in Psoriatic Arthritis: Presented at ACR URL: http://www.pslgroup.com/dg/21712E.htm Doctor's Guide November 13, 2007
By Ed Susman BOSTON, MA -- November 13, 2007 -- Researchers said they have successfully targeted interleukin-12/23 (IL-12/23) with a biologic agent and produced rapid, substantial, and sustained reductions in symptoms among patients with psoriatic arthritis. "This is the first successful demonstration of targeting interleukin-12/23 in treating inflammatory arthritis," said Alice Gottlieb, MD, Professor of Dermatology, Tufts Sackler School of Graduate Biomedical Sciences, Boston, Massachusetts. In previous studies, ustekinumab -- being developed by the sponsor of the study, Centocor, Inc. -- has shown effectiveness in some patients with psoriasis. "Patients with psoriatic arthritis have increased serum IL-12/23p40 protein compared with healthy controls," Dr. Gottlieb said at a late-breaking clinical trials session here on November 10 at the 71st annual meeting of the American College of Rheumatology (ACR). In the crossover study, 76 patients were injected with ustekinumab -- a monoclonal antibody directed at IL-12/23 -- at baseline and at weeks 1, 2, and 3 and then received placebo injections at weeks 12 and 16. They were evaluated at week 36. "You have to appreciate that these patients did not receive any more therapy after the first treatment with ustekinumab," Dr. Gottlieb said, "yet their responses did not abate." Another group of 70 patients received placebo through the first 4 weeks of the study and then were injected with ustekinumab at weeks 12 and 36. Dr. Gottlieb demonstrated that at week 12, 42.1% of patients in the active treatment group had achieved an ACR20 response -- meaning a 20% improvement in symptoms -- compared with 14.3% of patients on placebo (P <.001). In addition, 25% of the ustekinumab patients achieved an ACR50 response -- a 50% improvement -- compared with 7.1% of placebo patients (P =.004); and 10.4% of ustekinumab patients achieved an ACR70 response -- a reduction in symptoms that was not attained by any placebo patients (P =.005). Dr. Gottlieb noted that when the placebo patients were injected with ustekinumab at week 12, about 45% of them almost immediately experienced an ACR20. By the end of the 36-week study period, 42% of the original placebo patients who had received injections of ustekinumab at weeks 12 and 16 were evaluated as having an ACR20 response compared with baseline, and 36% of the first group to receive the drug retained their ACR20 status despite not having any booster injections in 32 weeks. Through the first 12 weeks of the study, 3 serious side effects occurred among the placebo patients; no serious adverse events occurred in the ustekinumab patients. Quality-of-life assessments showed that patients on ustekinumab had decreases in disability, as well as arthritis and psoriasis symptoms, Dr. Gottlieb said. [Presentation title: Phase 2, Randomized, Placebo-Controlled Study of CNTO 1275, a Human Interleukin-12/23 Monoclonal Antibody, in Psoriatic Arthritis. Abstract L16] --------------------------------------------------------------------------------------------- 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.