A new intravenous immunoglobulin (BIVIGAM®) for primary humoral immunodeficiency

Expert Review of Clinical Immunology

Volumn 10, Issue 3, 2014, Pages 325-337

  Wasserman, Richard L ^a  

^a Pediatric Allergy/Immunology Associates   (United States)

Author keywords

immunodeficiency treatment; immunoglobulin efficacy; immunoglobulin safety; intravenous immunoglobulin; Pantibody deficiency treatment; primary immunodeficiency

Indexed keywords

CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNITY, HUMORAL; IMMUNOGLOBULINS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES; INFECTION; INFECTION CONTROL;

EID: 84894299046     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2014.891438     Document Type: Review

References (79)

1. Behring EA, Kitasato S. U ̈ ber das zustandekommen der Diphtherie-Immunität und der Tetanus-Immunität bei Thieren. Deutsche Med Wschr 1890;49:1113-14
2. Gronski P, Seiler FR, Schwick HG. Discovery of antitoxins and development of antibody preparations for clinical uses from 1890 to 1990. Mol Immunol 1991;28: 1321-32
3. Cohn EJ, Strong LE, Hughes WL Jr, et al. Preparation and properties of serum and plasma proteins III: a system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946;68:459-75
4. Oncley JL, Melin M, Richert DA, et al. The separation of the antibodies, isoagglutinins, prothrombin, plasminogen and beta-lipoprotein into subfractions of human plasma. J Am Chem Soc 1949;71: 541-50
5. Hooper JA, Alpern M, Mankarious S. Immunoglobulin manufacturing procedures. In: Krijnen HW, Strengers PFW, van Aken WG, editors. Immunoglobulins. Central Laboratory of the Netherlands Red Cross Blood Transfusion Service; Amsterdam, The Netherlands: 1988. p. 361-80
6. Painter RH, Minta JO. Stability of immune serum globulin during storage: effects of modifications in the fractionation scheme. Vox Sang 1969;17:434-44
7. Bruton OC. Agammaglobulinema. Pediatrics 1952;9:722-7
8. Aronson DL, Finlayson JS. Historical and future therapeutic plasma derivatives [Epilogue]. Semin Thromb Hemost 1980; VI:1231-9
9. Schiff RI. Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action. Pediatr Allergy Immunol 1994;5: 63-87
10. Barandun S, Kistler P, Jeunet F, Isliker H. Intravenous administration of human gamma globulin. Vox Sang 1962;7:157-74
11. Schultze HE, Schwick G. Uber neue Möglichkeiten intravenöser Gammaglobulin-Applikation. Deutsche Med Wschr 1962;87:1643-50
12. Sgouris JT. The preparation of plasmin-treated immune serum globulin for intravenous application. Vox Sang 1967;13: 71-84
13. Stephan W. Undegraded human immunoglobulin for intravenous use. Vox Sang 1975;28:422-37
14. Masuho Y, Tomibe K, Matsuzawa K, Ohtsu A. Development of an intravenous gamma-globulin with Fc activities I: preparation and characteristics of S-sulfonated human gamma-globulin. Vox Sang 1977;32:175-81
15. Schroeder DD, Tankersley DL, Lundblad JL. A new preparation of modified immune serum globulin [human] suitable for intravenous administration I: standardization of the reduction and alkylation reaction. Vox Sang 1980;40: 373-82
16. Pollack M. Antibody activity against Pseudomonas aeruginosa in immune globulins prepared for intravenous use in humans. J Infect Dis 1983;147:1090-8
17. Kim KS, Wass CA, Kang JH, Anthony B. Functional activities of various preparations of human intravenous immunoglobulin against type III group B streptococcus. J Infect Dis 1986;153:1092-7
18. Bender S, Hetherington S. Haemophilus influenzae type b opsonins of intravenous imunoglobulins. J Clin Immunol 1987;7: 475-80
19. Steele RW, Steele RW. Functional capacity of immunoglobulin G preparations and the F[ab́]2 split product. J Clin Microbiol 1989;27:640-64
20. Janeway CA, Merler E, Rosen FS, et al. Intravenous gamma globulin. Metabolism of gamma globulin fragments in normal and agammaglobulinemic persons. N Engl J Med 1968;278:919-23
21. Winston DJ, Ho WG, Rasmussen LE, et al. Use of intravenous immune globulin in patients receiving bone marrow transplants. J Clin Immunol 1982;2(Suppl):42S-7S
22. Hagenbeek A, Brummelhuis GJ, Donkers A, et al. Rapid clearance of cytomegalovirus-specific IgG after repeated intravenous infusions of human immunoglobulin into allogeneic bone marrow transplant recipients. J Infect Dis 1987;155: 897-902
23. Tankersley DL, Alving BM, Yi M, et al. Predictive tests for fragmentation of immune globulins. In: Alving BM, Finlayson JS, editors. Immunoglobulins, characteristics and uses of intravenous preparations. US Government Printing Office; Washington, PA, USA: 1980. p. 173-7
24. McCue JP, Hein RH, Tenold R. Three generations of immunoglobulin G preparations for clinical use. Rev Infect Dis 1986;8(Suppl):S374-81
25. Gellis SS, Neefe JR, Stokes J, et al. Chemical, clinical and immunological studies on the products of human plasma fractionation. XXXVI. Inactivation of the virus of homologous serum hepatitis in the solutions of normal human serum by means of heat. J Clin Invest 1948;27:239-44
26. Lane RS. Non-A, non-B hepatitis from intravenous immunoglobulin. Lancet 1983;2:974-5
27. Barré-Sinoussi F, Chermann JC, Rey F, et al. Isolation of a T-lymphotropic retrovirus from a patient at risk for AIDS. Science 1983;220:868-71
28. CDC. Provisional public health service interagency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome. Morb Mortal Wkly Rep 1985;34:1-5
29. Ochs HD, Fisher SG, Virant FS, et al. Non-A, non-B hepatitis after intravenous gammaglobulin. Lancet 1985;i:322-3
30. Björkander J, Cunningham-Rundles C, Lundin P, et al. Intravenous immunoglobulin prophylaxis causing liver damage in 16 of 77 patients with hypogammglobulinemia or IgG subclass deficiency. Am J Med 1988;84:107-11
31. Prince AM, Stephan W, Dichtelmüller H, et al. Inactivation of the Hutchinson strain of non-A, non-B hepatitis virus by combined use of ß-propiolactone and ultraviolet irradiation. J Med Virol 1985;16: 119-25
32. Piszkiewicz D, Kingdon H, Apfelsweig R, et al. Inactivation of HTLV-III/LAV during plasma fractionation. Lancet 1985;ii:1188-9
33. Wells MA, Wittek AE, Epstein JS, et al. Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma. Transfusion 1986;26:210-13
34. Mitra G, Wong MF, Mozen MM, et al. Elimination of infectious retroviruses during preparation of immunoglobulin. Transfusion 1986;26:394-7
35. Hénin Y, Maréchal V, Barré-Sinoussi F, et al. Inactivation and partition of human immunodeficiency virus during Kistler and Nitschmann fractionation of human blood plasma. Vox Sang 1988;54:78-83
36. Yei S, Yu MW, Tankersley DL. Partitioning of hepatitis C virus during Cohn-Oncley fractionation of plasma. Transfusion 1992;32:824-8
37. Louie RE, Galloway CJ, Dumas ML, et al. Inactivation of hepatitis C virus in low pH intravenous immunoglobulin. Biologicals 1994;22:13-19
38. Reid KG, Cuthbertson B, Jones ADL, McIntosh RV. Potential contribution of mild pepsin treatment at pH 4 to the viral safety of human immunoglobulin products. Vox Sang 1988;55:75-80
39. Kempf C, Jentsch P, Poirier B, et al. Virus inactivation during production of intravenous immunoglobulin,.Transfusion. 1991;31:423-7
40. Hamamoto Y, Harada S, Yamamoto N, et al. Elimination of viruses [Human Immunodeficiency, Hepatitis B, Vesicular Stomatitis and Sindbis Viruses] from an intravenous immunoglobulin preparation. Vox Sang 1987;53:65-9
41. Funakoshi S, Uemura Y, Yamamoto N. Virus inactivation and elimination by liquid heat treatment and PEG fractionation in the manufacture of immune globulin intravenous. In: Krijnen HW, Strengers PFW, van Aken WG, editors. Immunoglobulins. Central Laboratory of the Netherlands Red Cross Blood Transfusion Service; Amsterdam, The Netherlands: 1988. p. 313-25
42. Horowitz B. Preparation of virus sterilized immune globulin solutions by treatment with organic solvent/detergent mixtures. In: Krijnen HW, Strengers PFW, van Aken WG, editors. Immunoglobulins. Central Laboratory of the Netherlands Red Cross Blood Transfusion Service; Amsterdam, The Netherland: 1988. p. 285-95
43. Korneyeva M, Hotta J, Lebing W, et al. Enveloped virus inactivation by Caprylate: a robust alternative to solvent-detergent treatment in plasma derived intermediates. Biologicals 2002;30:153-62
44. Burnouf-Radosevich M, Appourchaux P, Huart J, Burnouf T. Nanofiltration, a new specific virus elimination method applied to high-purity Factor IX and Factor XI concentrates. Vox Sang 1994;67:132-8
45. O'Grady J, Losikoff J, Poily A, et al. Virus removal studies using nanofiltration membranes. Dev Biol Stand 1996;88: 319-26
46. Omar A, Kempf C. Removal of neutralized model parvoviruses and enteroviruses in human IgG solutions by nanofiltration. Transfusion 2002;42:1005-10
47. Alter HJ, Holland PV, Purcell RH, Gerin JL. The Ausria test: critical evaluation of sensitivity and specificity. Blood 1973;42: 947-57
48. Kuo G, Choo Q-L, Alter HJ, et al. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science 1989;244:362-4
49. Sarngadharan MG, Popovic M, Bruch L, et al. Antibodies reactive with human T-lymphotropic retroviruses [HTLV-III] in serum of patients with AIDS. Science 1984;224:506-8
50. Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products", (August 2006. Available from: www.fda.gov/cber/gdlns/cjdvcjd.htm
51. Trejo SR, Hotta J, Lebing W, et al. Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 2003;84: 176-87
52. Gregori L, Maring J, MacAuley C, et al. Partitioning of TSE infectivity during ethanol fractionation of human plasma. Biologicals 2004;32:1-10
53. Imbach P, Barandun S, Baumgartner C, et al. High dose intravenous immunoglobulin therapy in refractory, in particular idiopathic, thrombocytopenia in childhood. Helv Paediatr Acta 1981;46:81-6
54. Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. N Engl J Med 1988;319:902-7
55. Newburger JW, Takahashi M, Burns JC, et al. The treatment of Kawasaki syndrome with intravenous gamma globulin. N Engl J Med 1986;315:341-7
56. Immune Globulin Intravenous (IGIV) Indications. US FDA. Available from: www. fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/ licensedproductsblas/fractionatedplasmaproducts/ucm133691.htm
57. Marketing Research Bureau-IVIG/SCIG 2017. A Forecast Of The Polyvalent Immune Globulin Market (IVIG/SCIG) Market In The United States From 2012-2017, November 2011
58. Hizentra, Immune Globulin Subcutaneous [Human], 20% Liquid, Prescribing information. CSL Behring LLC; 2010
59. Biotest Pharmaceuticals: Data on File. Certificate Certificates of analysis, 3-FIN 0783-0786, Bivigam conformance lots, of analysis. Biotest Pharmaceuticals Corporation, Inc: Boca Raton, FL, USA
60. Scott D. Center for Biologics Evaluation and Research, Public Workshop: Risk Mitigation Strategies to address potential procoagulant activity in immune globulin products. 17-18 May 2011; Rockville, MD, USA
61. Roemisch JR, Kaar W, Zoechling, et al. Identification of activated FXI as the major biochemical root cause in IVIG batches associated with thromboembolic events. Analytical and experimental approaches resulting in corrective and preventive measures implemented into the Octagam manufacturing process. Webmed Central Immunotherapy 2011;2(6):WMC002002
62. Kahwaji J, Barker E, Pepkowitz S, et al. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitive patients. Clin J Am Soc Nephrol 2009;4:1993-7
63. Bruhns P. Properties of mouse and human IgG receptors and their contribution to disease models. Blood 2012;116(24):5640-9
64. Turner M. Antibodies. In Roitt I, Brostoff J, Male D, editors. Immunology. Harcourt Publishers Limited, London, UK 2012;74-8
65. Kavari SV, Maddur MS, Hegde P, et al. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol 2011;164(Suppl 2):2-5
66. Schreiber JR, Barrus V, Cates KL, Siber JR. Functional Characterization of Human IgG, IgM, and IgA Antibody Directed to the Capsule of Haemophilus influenzae Type b. J Infect Dis 1986;153:8-16
67. Wasserman RL, Church J, Stein M, et al. Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (BivigamTM IVIG) in patients with primary immunodeficiency. J Clin Immunol 2012;32(4):663-9
68. FDA/CBER Guidance for Industry. Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) As Replacement Therapy for Primary Humoral Immunodeficiency. Available from: www. fda.gov.cber/gdlns/igivimmuno.htm [Last Accessed June 2008]
69. Schroeder HW Jr, Dougherty CJ. Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients. Infection 2012; 40(6):601-11
70. Ochs HD, Pinciaro PJ; The Octagam Study Group. Octagam 5%, an Intravenous IgG Product, is efficacious and well tolerated in patients with primary immunodeficiency diseases. J Clin Immunol 2004;24(3): 309-14
71. Berger M, Pinciaro PJ; Flebogamma. Safety, efficacy and pharmacokinetics of flebogamma 5% (Immune Globulin Intravenous [Human]) for replacement therapy in primary immunodeficiency diseases. J Clin Immunol 2004;24(4): 389-96
72. Berger M. A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in primary immunodeficiency diseases (PID) patients of Flebogamma 5% DIF, the next generation of Flebogamma. J Clin Immunol 2007;27: 628-33
73. Church JA, Leibl H, Stein MR, et al. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. J Clin Immunol 2006;26:388-95
74. Stein MR, Nelson RP, Church JA, et al. Safety and efficacy of Privigen-, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol 2009;29:137-44
75. Berger M, Pinciaro PJ, Althaus A, et al. Efficacy, pharmacokinetics, safety, and tolerability of flebogamma-10% DIF, a high-purity human intravenous immunoglobulin, in primary immunodeficiency. J Clin Immunol 2010;30:321-9
76. Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies. Clin Immunol 2010;137: 21-30
77. Orange JS, Belohradsky BH, Berger M, et al. Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy. Clin Exp Immunol 2012;169(2):172-81
78. Quinti I, Soresina A, Guerra A, et al. Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. J Clin Immunol 2011;31: 315-22
79. Lucas M, Lee M, Lortan J, et al. Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years. J Allergy Clin Immunol 2010;125:1354-60