Subcutaneous immunoglobulin therapy in pediatric primary antibody deficiency

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Bibliography

• 1  Lindegren ML, Kobrynski L, Rasmussen SA et al.: Applying public health strategies to primary immunodeficiency diseases: a potential approach to genetic disorders. MMWR Recomm. Rep.53(RR-1),1–29 (2004).
  MedlineGoogle Scholar
• 2  Baumgart KW, Britton WJ, Kemp A, French M, Roberton D: The spectrum of primary immunodeficiency disorders in Australia. J. Allergy Clin. Immunol.100(3),415–423 (1997).
  Medline CASGoogle Scholar
• 3  Boyle JM, Buckley RH: Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J. Clin. Immunol.27(5),497–502 (2007).
  Medline CASGoogle Scholar
• 4  Berger M: A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodies. Curr. Allergy Asthma Rep.2(5),368–378 (2002).• Interesting discussion of the history of immune globulin development for treatment of immune deficiency.
  MedlineGoogle Scholar
• 5  Good RA, Lorenz E: Historic aspects of intravenous immunoglobulin therapy. Cancer68(6 Suppl.),1415–1421 (1991).
  Medline CASGoogle Scholar
• 6  Bruton OC: Agammaglobulinemia. Pediatrics9(6),722–728 (1952).•• The first reported case of the use of immune globulin in primary immunodeficiency.
  Medline CASGoogle Scholar
• 7  Gitlin D, Janeway CA: Agammaglobulinemia, congenital, acquired and transient forms. Prog. Hematol.1,318–329 (1956).
  Medline CASGoogle Scholar
• 8  Stiehm ER: Standard and special human immune serum globulins as therapeutic agents. Pediatrics63(2),301–319 (1979).
  Medline CASGoogle Scholar
• 9  Berger M, Cupps TR, Fauci AS: Immunoglobulin replacement therapy by slow subcutaneous infusion. Ann. Intern. Med.93(1),55–56 (1980).
  Medline CASGoogle Scholar
• 10  Ugazio AG, Duse M, Re R, Mangili G, Burgio GR: Subcutaneous infusion of gammaglobulins in management of agammaglobulinaemia. Lancet1(8265),226 (1982).
  Medline CASGoogle Scholar
• 11  Roord JJ, van der Meer JW, Kuis W et al.: Home treatment in patients with antibody deficiency by slow subcutaneous infusion of gammaglobulin. Lancet1(8273),689–690 (1982).
  Medline CASGoogle Scholar
• 12  Cunningham-Rundles C, Siegal FP, Smithwick EM et al.: Efficacy of intravenous immunoglobulin in primary humoral immunodeficiency disease. Ann. Intern. Med.101(4),435–439 (1984).
  Medline CASGoogle Scholar
• 13  Misbah SA, Chapel HM: Adverse effects of intravenous immunoglobulin. Drug Saf.9(4),254–262 (1993).
  Medline CASGoogle Scholar
• 14  Orange JS, Hossny EM, Weiler CR et al.: Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J. Allergy Clin. Immunol.117(4 Suppl.),S525–553 (2006).• Evidence-based review of the use of immune globulin for different diseases.
  Medline CASGoogle Scholar
• 15  Gardulf A: Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs21(2),105–116 (2007).
  Medline CASGoogle Scholar
• 16  Gregori L, Maring JA, MacAuley C et al.: Partitioning of TSE infectivity during ethanol fractionation of human plasma. Biologicals32(1),1–10 (2004).
  Medline CASGoogle Scholar
• 17  Poelsler G, Berting A, Kindermann J et al.: A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity. Vox Sang.94(3),184–192 (2008).
  Medline CASGoogle Scholar
• 18  Trejo SR, Hotta JA, Lebing W et al.: Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang.84(3),176–187 (2003).
  Medline CASGoogle Scholar
• 19  Ochs HD, Fischer SH, Wedgwood RJ: Modified immune globulin: its use in the prophylactic treatment of patients with immune deficiency. J. Clin. Immunol.2(2 Suppl),22S–30S (1982).
  Medline CASGoogle Scholar
• 20  Ochs HD, Fischer SH, Wedgwood RJ et al.: Comparison of high-dose and low-dose intravenous immunoglobulin therapy in patients with primary immunodeficiency diseases. Am. J. Med.76(3A),78–82 (1984).
  Medline CASGoogle Scholar
• 21  Bonilla FA: Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol. Allergy Clin. N. Am.28(4),803–819, ix (2008).
  MedlineGoogle Scholar
• 22  Gardulf A, Nicolay U, Math D et al.: Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J. Allergy Clin. Immunol.114(4),936–942 (2004).
  Medline CASGoogle Scholar
• 23  Smith GN, Griffiths B, Mollison D, Mollison PL: Uptake of IgG after intramuscular and subcutaneous injection. Lancet1(7762),1208–1212 (1972).
  Medline CASGoogle Scholar
• 24  Remvig L, Andersen V, Hansen NE, Karle H: Prophylactic effect of self-administered pump-driven subcutaneous IgG infusion in patients with antibody deficiency: a triple-blind cross-over study comparing P-IgG levels of 3 g l-1 versus 6 g l-1. J. Intern. Med.229(1),73–77 (1991).
  Medline CASGoogle Scholar
• 25  Vivaglobin^®, package insert. ZLB Behring, Marburg, Germany, 2007.
  Google Scholar
• 26  Gardulf A, Hammarstrom L, Smith CI: Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet338(8760),162–166 (1991).
  Medline CASGoogle Scholar
• 27  Gardulf A, Nicolay U, Asensio O et al.: Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies – a prospective, multi-national study. J. Clin. Immunol.26(2),177–185 (2006).
  Medline CASGoogle Scholar
• 28  Radinsky S, Bonagura VR: Subcutaneous immunoglobulin infusion as an alternative to intravenous immunoglobulin. J. Allergy Clin. Immunol.112(3),630–633 (2003).
  Medline CASGoogle Scholar
• 29  Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J: The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J. Clin. Immunol.20(2),94–100 (2000).
  Medline CASGoogle Scholar
• 30  Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M: Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J. Clin. Immunol.26(3),265–273 (2006).
  Medline CASGoogle Scholar
• 31  Eijkhout HW, van Der Meer JW, Kallenberg CG et al.: The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial. Ann. Intern. Med.135(3),165–174 (2001).
  Medline CASGoogle Scholar
• 32  Ochs HD, Pinciaro PJ: Octagam 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J. Clin. Immunol.24(3),309–314 (2004).
  Medline CASGoogle Scholar
• 33  Pac M, Bernatowska E: Polish experience with immunoglobulin replacement treatment by subcutaneous infusion. Centr. Eur. J. Immunol.30(3–4),78–82 (2005).
  CASGoogle Scholar
• 34  Fasth A, Nystrom J: Safety and efficacy of subcutaneous human immunoglobulin in children with primary immunodeficiency. Acta. Paediatr.96(10),1474–1478 (2007).
  MedlineGoogle Scholar
• 35  Ballow M: Safety of IGIV therapy and infusion-related adverse events. Immunol. Res.38(1–3),122–132 (2007).
  Medline CASGoogle Scholar
• 36  Ballow M, Berger M, Bonilla FA et al.: Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%). Vox Sang84(3),202–210 (2003).
  Medline CASGoogle Scholar
• 37  Schiff RI, Williams LW, Nelson RP, Buckley RH, Burks W, Good RA: Multicenter crossover comparison of the safety and efficacy of Intraglobin-F with Gamimune-N, Sandoglobulin, and Gammagard in patients with primary immunodeficiency diseases. J. Clin. Immunol.17(1),21–28 (1997).
  Medline CASGoogle Scholar
• 38  Gardulf A, Bjorvell H, Gustafson R, Hammarstrom L, Smith CI: Safety of rapid subcutaneous gammaglobulin infusions in patients with primary antibody deficiency. Immunodeficiency4(1–4),81–84 (1993).
  Medline CASGoogle Scholar
• 39  Gardulf A, Andersen V, Bjorkander J et al.: Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet345(8946),365–369 (1995).
  Medline CASGoogle Scholar
• 40  Hansen S, Gustafson R, Smith CI, Gardulf A: Express subcutaneous IgG infusions: decreased time of delivery with maintained safety. Clin. Immunol.104(3),237–241 (2002).
  Medline CASGoogle Scholar
• 41  Abrahamsen TG, Sandersen H, Bustnes A: Home therapy with subcutaneous immunoglobulin infusions in children with congenital immunodeficiencies. Pediatrics98(6 Pt 1),1127–1131 (1996).
  Medline CASGoogle Scholar
• 42  Thomas MJ, Brennan VM, Chapel HH: Rapid subcutaneous immunoglobulin infusions in children. Lancet342(8884),1432–1433 (1993).
  Medline CASGoogle Scholar
• 43  Gaspar J, Gerritsen B, Jones A: Immunoglobulin replacement treatment by rapid subcutaneous infusion. Arch. Dis. Child.79(1),48–51 (1998).
  Medline CASGoogle Scholar
• 44  Nicolay U, Kiessling P, Berger M et al.: Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home. J. Clin. Immunol.26(1),65–72 (2006).
  Medline CASGoogle Scholar
• 45  Hogy B, Keinecke HO, Borte M: Pharmacoeconomic evaluation of immunoglobulin treatment in patients with antibody deficiencies from the perspective of the German statutory health insurance. Eur. J. Health Econ.6(1),24–29 (2005).
  MedlineGoogle Scholar
• 46  Membe SK, Ho C, Cimon K, Morrison A, Kanani A, Roifman CM: Economic assessment of different modalities of immunoglobulin replacement therapy. Immunol. Allergy Clin. N. Am.28(4),861–874, x (2008).
  MedlineGoogle Scholar
• 47  Berger M: Subcutaneous administration of IgG. Immunol. Allergy Clin. N. Am.28(4),779–802, viii (2008).• Excellent review of the use of subcutaneous immunoglobulin (SCIG) for immune deficiency with a detailed discussion of the pharmacokinetic properties comparing SCIG and intravenous immunoglobulin.
  MedlineGoogle Scholar
• 48  Fasth A, Nystrom J: Quality of life and health-care resource utilization among children with primary immunodeficiency receiving home treatment with subcutaneous human immunoglobulin. J. Clin. Immunol.28(4),370–378 (2008).• Recent article evaluating the impact SCIG has on the quality of life of children receiving home-based therapy and their families.
  Medline CASGoogle Scholar
• 49  Stiehm ER, Casillas AM, Finkelstein JZ et al.: Slow subcutaneous human intravenous immunoglobulin in the treatment of antibody immunodeficiency: use of an old method with a new product. J. Allergy Clin. Immunol.101(6 Pt 1),848–849 (1998).
  Medline CASGoogle Scholar
• 50  MacLeish S, Hostoffer R: Subcutaneous Versus Intravenous immunoglobulin for the treatment of DiGeorge syndrome related hypogammaglobulinemia. J. Allergy Clin. Immunol.117(2),S174 (2006).
  Google Scholar
• 51  Arora R, Newton TC, Nelson MR: Subcutaneous immunoglobulin therapy in an 11-year-old patient with common variable immunodeficiency and von Willebrand disease. Ann. Allergy Asthma Immunol.99(4),367–370 (2007).
  Medline CASGoogle Scholar
• 52  Eijkhout HW, van den Broek PJ, van der Meer JW: Substitution therapy in immunodeficient patients with anti-IgA antibodies or severe adverse reactions to previous immunoglobulin therapy. Neth. J. Med.61(6),213–217 (2003).
  Medline CASGoogle Scholar
• 53  Sundin U, Nava S, Hammarstrom L: Induction of unresponsiveness against IgA in IgA-deficient patients on subcutaneous immunoglobulin infusion therapy. Clin. Exp. Immunol.112(2),341–346 (1998).
  Medline CASGoogle Scholar
• 54  Waniewski J, Gardulf A, Hammarstrom L: Bioavailability of gamma-globulin after subcutaneous infusions in patients with common variable immunodeficiency. J. Clin. Immunol.14(2),90–97 (1994).
  Medline CASGoogle Scholar
• 55  Bohle MV, Burton J, Chapel HM: Self-infusion programmes for immunoglobulin replacement at home: feasibility, safety and efficacy. Immunol. Allergy Clin. N. Am.28(4),821–832 (2008).
  MedlineGoogle Scholar
• 101  European Society for Immunodeficiencies Database 2009. www.esid.org/statistics.php
  Google Scholar
• 102  Research carried out by the Immune Deficiency Foundation. www.primaryimmune.org/publications/surveys/Treatment_Experiences_and_Preferences_(2003).pdf
  Google Scholar
• 103  Research carried out by the Immune Deficiency Foundation. www.primaryimmune.org/pubs/IDF_survey_complete.pdf
  Google Scholar
• 104  International Patient Organisation for Primary Immunodeficiencies: IPOPI global immunoglobulin list. www.ipopi.org/documents/global-immunoglobulin-list/Ig%20Global%20list%202008-1112.htm
  Google Scholar
• 105  Berger M, Duff K: Subcutaneous IgG replacement therapy. www.uhhospitals.org/Portals/0/Docs/OurServices/Rainbow_Sub-Cu.pdf•• Provides excellent pictures demonstrating the mechanics of SCIG infusions and possible local reactions. Includes chart listing commonly used SCIG pumps and infusion needles.
  Google Scholar