TITLE

Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

AUTHOR(S)
Mark Stein; Robert Nelson; Joseph Church; Richard Wasserman; Michael Borte; Christiane Vermylen; Johann Bichler
PUB. DATE
January 2009
SOURCE
Journal of Clinical Immunology;Jan2009, Vol. 29 Issue 1, p137
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Abstract Purpose  The present study was designed to evaluate the efficacy and safety of a novel, 10% liquid formulation of intravenous immunoglobulin, stabilized with 250 mmol/L l-proline (Privigen®), in patients with primary immunodeficiency disease. Materials and Methods  Eighty adults and children diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous Privigen® infusions (200–888 mg/kg) at 3- or 4-week intervals over a 12-month period, according to their previously established maintenance dose. The primary endpoint was the annual rate of acute serious bacterial infections. Results  There were six episodes of acute serious bacterial infections, corresponding to an annual rate of 0.08; the annual rate for all infections was 3.55. Mean serum IgG trough levels were between 8.84 and 10.27 g/L. A total of 1,038 infusions were administered, most of them at the maximum rate permitted (8.0 mg kg−1 min−1). Temporally associated adverse events, possibly or probably related to study drug, occurred in 9% of infusions, either during or within 72 h after infusion end. Conclusion  Privigen® is well tolerated and effective for the treatment of primary immunodeficiency.
ACCESSION #
36359114

 

Related Articles

  • Impact of HIV-Associated Immunosuppression on Malaria Infection and Disease in Malawi. Laufer, Miriam K.; van Oosterhout, Joep J. G.; Thesing, Philip C.; Thumba, Feston; Zijlstra, Eduard E.; Graham, Stephen M.; Taylor, Terrie E.; Plowe, Christopher V. // Journal of Infectious Diseases;3/15/2006, Vol. 193 Issue 6, p872 

    Background. Human immunodeficiency virus (HIV) infection and malaria coexist in much of Africa. Previous studies differ in their findings on the interactions between the 2 infections. Methods. Adults living with HIV infection in Blantyre, Malawi, were enrolled in a longitudinal observational...

  • Disorders of Apoptosis: Mechanisms for Autoimmunity in Primary Immunodeficiency Diseases. João Oliveira // Journal of Clinical Immunology;May2008, Vol. 28 Issue 0, p20 

    Abstract  A number of primary immunodeficiency diseases represent a paradox of immunodeficiency and autoimmunity. In this minireview, we present basic concepts of apoptosis and disorder of apoptosis as one of the mechanisms to explain such a paradox between immunodeficiency and...

  • Lack of genetic influence on the innate inflammatory response to Helicobacter infection of the gastric mucosa. Nedrud, John G.; Czinn, Steven J.; Hua Ding; Zagorski, Brandon M.; Redline, Raymond W.; Twaddell, William; Blanchard, Thomas G. // Frontiers in Immunology;Jul2012, Vol. 3, p1 

    Helicobacter pylori (H. pylori) is a bacterial pathogen that resides at the gastric mucosa and has a world-wide prevalence of over 50%. Infection usually lasts for the life of the host, and although all infected individuals will develop histologic gastritis only a subset will develop symptomatic...

  • Immunodeficiency. Vohr, Hans-Werner // Encyclopedic Reference of Immunotoxicology;2005, p327 

    A definition of the term "immunodeficiency" is presented. It is a defect or absence of some component of the immune system that may result in inability of the host to eliminate or neutralize foreign substances.

  • Cervicovaginal Secretions Contribute to Innate Resistance to Herpes Simplex Virus Infection. John, Minnie; Keller, Marla J.; Fam, Ehsan H.; Cheshenko, Natalia; Hogarty, Kathleen; Kasowitz, Andrea; Wallenstein, Sylvan; Carlucci, Maria J.; Tuyama, Ana C.; Wuyuan Lu; Klotman, Mary E.; Lehrer, Robert I.; Herold, Betsy C. // Journal of Infectious Diseases;11/15/2005, Vol. 192 Issue 10, p1731 

    Defining and preserving the innate antiviral activity found in cervicovaginal secretions is critical. Cervicovaginal lavage (CVL) samples were obtained from 20 healthy women and evaluated for anti-herpes simplex virus (HSV) activity. CVL samples reduced HSV-2 yields by 23-fold (median), and the...

  • HIV Type 1 Infection in Women: Increased Transcription of HIV Type 1 in Ectocervical Tissue Explants. Asin, Susana N.; Eszterhas, Susan K.; Rollenhagen, Christiane; Heimberg, Alysha M.; Howell, Alexandra L. // Journal of Infectious Diseases;9/15/2009, Vol. 200 Issue 6, p965 

    Background. Mucosal surfaces of the female reproductive tract are the main routes of heterosexual transmission of human immunodeficiency virus type 1 (HIV-1), but the contribution of each of the reproductive sites to mucosal transmission is unknown. Methods. We compared levels of HIV-1...

  • HIV-1 Envelope Protein gp120 Is Present at High Concentrations in Secondary Lymphoid Organs of Individuals with Chronic HIV-1 Infection. Santosuosso, Michael; Righi, Elda; Lindstrom, Victoria; Leblanc, Pierre R.; Poznansky, Mark C. // Journal of Infectious Diseases;10/1/2009, Vol. 200 Issue 7, p1050 

    The envelope protein of human immunodeficiency virus type 1 (HIV-1)-glycoprotein 120 (gp120)-has been demonstrated to dysregulate T cell function in vitro. We obtained autopsy tissues from individuals with chronic HIV-1 infection to determine whether there was enough gp120 in lymphoid tissues...

  • Predicting early renal allograft function using clinical variables. Jason Moore; Kay Tan; Paul Cockwell; Hari Krishnan; Dawn McPake; Andrew Ready; Steve Mellor; Ahmed Hamsho; Simon Ball; Graham Lipkin; Richard Borrows // Nephrology Dialysis Transplantation;Sep2007, Vol. 22 Issue 9, p2669 

    Background. Suboptimal early graft function following renal transplantation remains a significant challenge. It is suggested that clinical variables (or scoring systems based thereon) may predict the occurrence of delayed graft function (DGF), defined as post-operative dialysis requirement....

  • Unraveling TACIt functions. Martin, Flavius; Dixit, Vishva M. // Nature Genetics;Aug2005, Vol. 37 Issue 8, p793 

    Primary immunodeficiencies, ranging from mild to very severe, comprise more than 50 different entities in which part of the body's immune system is missing or does not function properly. Two studies now report defects in the TNFR family member TACI associated with two forms of human...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sign out of this library

Other Topics