To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Liquid IV Immunogblobulin Effective, Well Tolerated in Children With Primary Immunodeficiency: Presented at ESPID URL: http://www.pslgroup.com/dg/221782.htm Doctor's Guide May 16, 2008
By Neil Osterweil GRAZ, Austria -- May 16, 2008 -- A formulation of immunoglobulin administered by the IV route (IVIG) appears to be effective for preventing infection in children with primary immunodeficiency (PID), according to a study presented here at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Treatment with IVIG at an infusion rate of 8 mg/kg/min resulted in stable serum concentrations of immunoglobulin G (IgG) throughout the treatment period, and in most patients the infusions were well tolerated. Michael Borte, MD, Professor of Immunology, Department of Paediatrics, University of Leipzig, Leipzig, Germany, and colleagues evaluated data on 31 children with PID aged 3 to 15 years, who were studied as part of a larger prospective, open-label, single-arm, phase 3 study of IVIG. The study, conducted in Europe and the United States, was designed to assess the efficacy and safety of the liquid formulation, which is reputed to be stable at room temperature for longer periods than the standard formulation, and to limit the formation of IgG dimmers. The children received the IVIG at 3- or 4-week intervals for 12 months. The main study endpoint was the annual rate of acute, serious bacterial infections per patient. The predefined target for determination of efficacy was 1.0 infection per patient per year. The annual rate of acute, serious bacterial infections was 0.11 (upper one-sided 99% confidence interval, 0.369), which was below the efficacy target. Three patients (10%) experienced an acute serious bacterial infection, but none discontinued therapy for this reason. The overall annual rate of any infection was 3.79; among children aged 3 to 11 years, the annual infection rate was 4.63 compared with 2.42 for children aged 12 to 15 years. Among all children, the overall rate of days missed from school or daycare was 8.97. Younger children missed school or daycare at a rate of 11.51 days per year, compared with 4.83 for preteens and adolescents. The overall annual rate of hospitalisations was 0.33, with the rate for children aged 3 to 11 years being 0.53, and for those aged 12 to 15 years being 0.0. Older children required antibiotics at a higher rate, however: 56.64 prescriptions annually compared with 47.88 for the younger children (overall annual rate 51.21). Most adverse events were either mild (62%) or moderate (32%), with serious adverse events occurring in 6% of patients. In 1 patient, who suffered 5 of the 17 reported serious adverse events, the adverse effects were thought to be related to the IVIG and included hypersensitivity, chills, dizziness, fatigue, and elevated body temperature. Four patients discontinued therapy, 3 because of adverse events, and 1 because of withdrawal of consent for unspecified reason. The authors concluded that the efficacy of the liquid formulation was demonstrated by the low incidence of infections in children with PID, and that this was achieved with high infusion rates and an acceptable safety profile. Funding for this study was provided by CSL Behring. [Presentation title: Efficacy and Safety of Privigen in Children With Primary Immunodeficiency. Abstract 163] --------------------------------------------------------------------------------------------- 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.