To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Natalizumab Reduces Hospitalisation Rates in Patients With Crohn's Disease: Presented at UEGW URL: http://www.pslgroup.com/dg/22F392.htm Doctor's Guide October 21, 2008
By Judith Moser, MD VIENNA, Austria -- October 21, 2008 -- In patients with moderate to severe Crohn's disease, use of natalizumab is significantly associated with a reduction in the rate of hospitalisations, especially in patients who have received prior treatment with tumour necrosis factor (TNF)-alpha inhibitors, according to research presented here today at the 16th United European Gastroenterology Week (UEGW). Steve L. Hass, PhD, Elan Pharmaceuticals, Inc., South San Francisco, California, presented the pooled analysis of the Effectiveness Evaluation of Natalizumab in Active Crohn's Disease Trial (ENACT-1) and the Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) studies. In both studies, induction therapy with natalizumab was tested in patients with moderate to severe Crohn's disease, defined as a Crohn's Disease Activity Index of 220 to 450. The analysis tested the hypothesis that documented improvements in clinical symptoms in the 2 trials were accompanied by reductions in rates of hospitalisation during the 84-day induction period. Patient sets were prespecified as intent-to-treat (ITT) population (n = 1,414) and a treatment-experienced population (n = 348) -- previously treated with a TNF-alpha inhibitor and/or having evidence of active inflammation despite TNF-alpha inhibitor therapy. "A total of 136 hospitalisations were identified," Dr. Hass reported. "Out of those, 109 were disease-related." In the individual trials, a trend towards lower hospitalisation rates was observed among patients treated with natalizumab. Analysis of the pooled data showed that natalizumab use was associated with a 35% reduction in the all-cause hospitalisation rate compared with placebo. Elevated C-reactive protein (CRP) levels, increasing severity of disease, lower body mass index, and previous TNF-alpha inhibitor therapy were associated with an increased risk of hospitalisation. In the subset of patients with previous TNF-alpha inhibitor therapy, all-cause hospitalisation rates were 20.8% compared with 11.0% in the total population, Dr. Hass emphasised. By contrast, age, sex, and baseline use of corticosteroid or immunosuppressant therapy had no statistically significant correlation with risk of hospitalisation. In patients with TNF-alpha inhibitor experience, natalizumab induced significant reductions in both all-cause hospitalisations (P = .014) and disease-related hospitalisations (P = .043) of about 50%. Analysis of the ITT population revealed a trend towards reduction in disease-related hospitalisations in favour of natalizumab (P = .081). "To avoid 1 hospitalisation, 27 patients would need to be treated with natalizumab in the ITT set, while only 9 would be needed to treat in the TNF-alpha inhibitor-experienced population to achieve the same benefit," Dr. Hass concluded. [Presentation title: Natalizumab Reduces the Hospitalization Rate in Patients With Moderate to Severe Crohn's Disease: An ENACT-1 and ENCORE Pooled Analysis. Abstract PO738] --------------------------------------------------------------------------------------------- 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.