To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Adalimumab Treatment Benefits Children With Juvenile Arthritis in Long-Term Test: Presented at ACR URL: http://www.pslgroup.com/dg/217096.htm Doctor's Guide November 12, 2007
By Ed Susman BOSTON, MA -- November 12, 2007 -- Adalimumab appears to offer long-term control of juvenile polyarticular arthritis (JPA) in children, researchers suggest. Speaking at the 71st annual meeting of the American College of Rheumatology (ACR) on November 10, Daniel Lovell, MD, Professor of Pediatrics, Children's Hospital Medical Center, Cincinnati, Ohio, said, "The results of this 2-year study of adalimumab were very positive." About one child in every 1,000 develops some type of juvenile arthritis. There are several types of juvenile rheumatoid arthritis; all cause joint inflammation, beginning before the age of 16 years, but otherwise are often associated with distinct symptoms and complications, and may require different approaches to treatment. Its cause is unknown. "Juvenile rheumatoid arthritis is a painful, progressive disease that can leave children with permanent disability if not treated appropriately, so it's critical that we continue to investigate new treatment options that will help patients over the long term," said Dr. Lovell. Dr. Lovell and his colleagues enrolled 171 children with active JPA, aged 4 to 17 years into a phase 3, multicenter study of the biologic agent adalimumab. During the open-label period, all patients received 24 mg/m2 adalimumab, with a maximum dose of 40 mg, injected every other week. To confirm adalimumab's efficacy, the patients who responded during the first phase then were entered into a double-blind, placebo-controlled withdrawal phase. They were also allowed to have treatment with methotrexate along with adalimumab. Efficacy and safety of the treatments were assessed at routine intervals throughout the study. The children were also stratified for methotrexate use. Patients experienced substantial and sustained improvement during 2 years of adalimumab treatment, with or without concomitant methotrexate, reported Dr. Lovell. He observed that after 16 weeks of adalimumab therapy, marked decreases in disease activity were noted. He said 84% of patients achieved a 30% response according to American College of Rheumatology Pediatric (ACR Pedi) criteria and 77% of patients achieved an ACR Pedi 50 response, representing a decrease of at least 50% in disease symptoms. Fifty-eight percent of the children in this trial achieved an ACR Pedi 70 response and 27% achieved an ACR Pedi 90 response. An ACR 90 achievement suggests the patient has virtually no symptoms nor signs of the disease. At week 48, the response to adalimumab continued to be sustained and improved, with 93% of patients who remained on treatment achieving an ACR Pedi 50 response and 60% achieving an ACR Pedi 90 response. After the 32-week, placebo-controlled phase, patients receiving adalimumab had significantly fewer flare-ups versus the placebo group and achieved better ACR Pedi responses. In an extension of the study, long-term safety was evaluated in patients who continued to receive adalimumab. The safety profile of adalimumab was favorable, Dr. Lovell said. The study was supported by Abbott. [Presentation title: Adalimumab is Safe and Effective During Long-Term Treatment of Patients With Juvenile Rheumatoid Arthritis: Results From a 2-Year Study. Abstract 681] --------------------------------------------------------------------------------------------- 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.