To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: C1 Esterase Inhibitor Concentrate Effective in Treating Patients With Acute Abdominal and Facial Hereditary Angio-Oedema: Presented at EAACI URL: http://www.pslgroup.com/dg/223756.htm Doctor's Guide June 11, 2008
By Chris Berrie BARCELONA, Spain -- June 11, 2008 -- Highly purified, C1 esterase inhibitor (C1-INH) concentrate is effective in treating acute abdominal or facial hereditary angio-oedema (HAE), according to research presented here at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI). Use of the C1-INH concentrate does not result in oedema rebound and is safe and well tolerated at a dose of 20 U/kg, according to lead investigator Timothy J. Craig, DO, Penn State University, Hershey, Pennsylvania. Dr. Craig presented results from a multicentre, randomised, placebo-controlled, phase 2/3 study here on June 9 on behalf of the International Multicentre Prospective Angioedema C1-Inhibitor Trial (IMPACT1) investigators. After screening 512 patients with HAE, Dr. Craig and colleagues enrolled 127 patients when they presented with an acute facial or abdominal attack. Less than 5 hours after their attack became moderate or severe, 42 patients were randomised to placebo, 39 patients to C1-INH concentrate at 10 U/kg, and 43 patients to C1-INH concentrate at 20 U/kg. C1-INH was administered as a single intravenous dose. The baseline clinical characteristics across treatment groups were similar; 80% to 90% of subjects had type 1 HAE. The majority of patients experienced moderate abdominal attacks. The primary efficacy measure was patient-reported time from the start of treatment to onset of symptom relief. In the placebo group, the median time to onset of symptom relief was 90 minutes. The 10-U/kg dose of C1-INH resulted in onset of relief at a median of 70 minutes, which was not significantly different from placebo. Statistically significant improvement was achieved with the 20-U/kg dose of C1-INH," noted Dr. Craig, which offered a 30-minute median time to onset of symptom relief (P = .003). The secondary efficacy measures showed improvements for C1-INH 20 U/kg that reached significance versus placebo, including: worsened symptoms 2 to 4 hours from treatment (4.7% vs 31.0%, respectively; P = .001); mean vomiting episodes within 4 hours of treatment (0.1 vs 0.8; P = .033); and median time to complete resolution of all HAE symptoms (4.92 vs 7.79 hours; P = .024). No treatment-related worsening of symptoms required redosing, indicating that no rebound oedema occurred. The rate of adverse events was lower in the C1-INH 20-U/kg group (19.6%) compared with the placebo group (43.9%), especially gastrointestinal effects (10.9% vs 31.7%, respectively). There were no serious adverse events. Dr. Craig concluded that the C1-INH concentrate is highly effective and well tolerated for the treatment of acute abdominal and facial attacks in patients with HAE. This study, he noted, demonstrates for the first time that C1-INH 20 U/kg is the more effective dose to treat acute HAE attacks. This trial is now continuing as an open-label extension study. HAE is a rare and debilitating genetic disorder resulting from plasma deficiency in C1-INH. Although C1-INH concentrate is considered the gold standard for treatment of acute attacks, it is not licensed in many countries, including Europe and North America. Funding for this study was provided by CSL Behring GmbH, Marburg, Germany. [Presentation title: Treatment of Hereditary Angioedema With Human C1 Esterase Inhibitor: Results of a Global, Multicentre, Randomised, Placebo-Controlled, Phase 2/3 Dose-Finding Study of Acute Abdominal and Facial Attacks (IMPACT1). Abstract P947] --------------------------------------------------------------------------------------------- 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.