A history of immune globulin therapy, from the harvard crash program to monoclonal antibodies

Current Allergy and Asthma Reports

Volumn 2, Issue 5, 2002, Pages 368-378

  Berger, Melvin ^a  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

Author keywords

Gamma Globulin; Idiopathic Thrombocytopenic Purpura; Immune Globulin; Kawasaki Disease; Respiratory Syncytial Virus

Indexed keywords

IMMUNOGLOBULIN; MONOCLONAL ANTIBODY;

ARTICLE; EUROPE; HISTORY; HUMAN; IMMUNOTHERAPY; UNITED STATES;

ANTIBODIES, MONOCLONAL; EUROPE; HISTORY, 20TH CENTURY; HUMANS; IMMUNOGLOBULINS; IMMUNOTHERAPY; UNITED STATES;

EID: 0036720105     PISSN: 15297322     EISSN: 15346315     Source Type: Journal    
DOI: 10.1007/s11882-002-0069-z     Document Type: Article

References (66)

1. Cohn EJ: The history of plasma fractionation. In Advances in Military Medicine, Vol. 1. Edited by Andrus EC, Bronk DW, Carden GA Jr, et al. Boston: Little, Brown and Company; 1948:364–443. An excellent history of the scientific and clinical advances achieved in the “Harvard Crash Program,” which led to the production of albumin for WW II and the other Cohn fractions. Summarizes 23 papers on this subject by Cohn et al. in the July 1944 issue of The Journal of Clinical Investigation (vol. 23, no. 4).
2. Oncley JL, Melin M, Richert DA, et al.: The separation of the antibodies, isoagglutinins, prothrombin, plasminogen and _1-lipoprotein into subfractions of human plasma. J Am Chem Soc 1949, 71:541–550. Summarizes the development of schemes for the further purification of gammaglobulin, including “cookbook” techniques that are still used today.
3. Janeway CA: The development of clinical uses of immunoglobulins: a review. In Immunoglobulins. Edited by Merler E. Washington, DC; National Academy of Sciences: 1970:3–14. A first-hand account of the early clinical development of gamma globulin, including the first attempts at IV infusion.
4. Martin NH: Recognition of the Hypogammaglobulinaemia Syndrome. In Hypogammaglobulinaemia in the United Kingdom. Edited by MRC Working Party on Hypogammaglobulinaemia. London: Her Majesty’s Stationery Office; 1971:1–3.
5. MRC Working Party on Hypogammaglobulinaemia: Hypogammaglobulinaemia in the United Kingdom. London: Her Majesty’s Stationery Office; 1971. An excellent review of the natural history of antibody deficiency syndromes in the 1950s and early 1960s, including more than 200 individual case descriptions and initial studies of the effects of different dosages of IM treatment.
6. Barandun S, Kistler P, Jeunet F, Isliker H: Intravenous administration of human g-globulin. Vox Sang 1962, 7:157–174. A definitive study of reactions to IV gammaglobulin, including still classic descriptions of typical IVIG reactions.
7. Passwell J, Rosen FS, Merler E: The effect of Fc fragments of IgG on human mononuclear cell responses. In Immunoglobulins: Characteristics and Uses of Intravenous Preparations. Edited by Alving BM, Finlayson JS. Washington, DC: US Department of Health and Human Services; 1979:139–166.
8. Alving BM, Tankersley DL, Mason BL, et al.: Vasoactive enzymes in immunoglobulin preparations. In Immunoglobulins: Characteristics and Uses of Intravenous Preparations. Edited by Alving BM, Finlayson JS. Washington, DC: US Department of Health and Human Services; 1979:167–172.
9. Hitzig WH, Müntener U: Conventional immunoglobulin therapy. Birth Defects: Original Article Series 1975, XI:339–342.
10. Schwick HG: Pepsin-disaggregated gamma globulins. In Immunoglobulins: Biologic Aspects and Clinical Uses. Edited by Merler E. Washington, DC: National Academy of Sciences; 1970:184–188.
11. Table of immunoglobulin preparations. In Immunoglobulins: Characteristics and Uses of Intravenous Preparations. Edited by Alving BM, Finlayson JS. Washington, DC: US Department of Health and Human Services; 1979:234.
12. Berger M, Cupps TR, Fauci AS: Immunoglobulin replacement therapy by slow subcutaneous infusion. Ann Intern Med 1980, 98:55–56.
13. Gardulf A, Hammarström L, Smith CIE: Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet 1991, 338:162–166.
14. Gardulf A, Anderson V, Björkander J, et al.: Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: Safety and costs. Lancet 1995, 345:365–369. Includes data on more than 3000 subcutaneous infusions in 165 patients.
15. 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 1998, 101:848–849.
16. Ochs HD, Buckley RH, Tiller TL Jr, et al.: Intravenous immunoglobulin therapy of patients with primary immunodeficiency syndromes: efficacy and safety of a new modified immune globulin preparation. In Immunoglobulins: Characteristics and Uses of Intravenous Preparations. Edited by Alving BM, Finlayson JS. Washington, DC: US Department of Health and Human Services; 1979:9–14.
17. Ammann AJ, Ashman RF, Buckley RH, et al.: Use of intravenous g-globulin in antibody immunodeficiency: Results of a multicenter controlled trial. Clin Immunol Immunopathol 1982, 22:60–67.
18. Pirofsky B, Anderson CJ, Bardana EJ Jr: Therapeutic and detrimental effects of intravenous immunoglobulin therapy. In Immunoglobulins: Characteristics and Uses of Intravenous Preparations. Edited by Alving BM, Finlayson JS. Washington, DC: US Department of Health and Human Services; 1979:15–22.
19. Ochs HD, Buckley RN, Pirofsky B, et al.: Safety and patient acceptability of intravenous immune globulin in 10% maltose. Lancet 1980, 2:1158–1159.
20. Barandun S, Morell A, Skvaril F: Clinical experiences with immunoglobulin for intravenous use. In Immunoglobulins: Characteristics and Uses of Intravenous Preparations. Edited by Alving BM, Finlayson JS. Washington, DC: US Department of Health and Human Services; 1979:31–36.
21. [No authors listed.] Appropriate uses of human immunoglobulin in clinical practice: Memorandum from an IUIS/ WHO meeting. Bull World Health Organ 1982, 60:43-47.
22. Buckley RH, Schiff RI: The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med 1991, 325:110–116.
23. Roifman CM, Levison H, Gelfand EW: High-dose versus low-dose intravenous immunoglobulin in hypogammaglobulinaemia and chronic lung disease. Lancet 1987, 1075–1077. Definitively establishes the superiority of higher doses of IVIG replacement and of the maintenance of trough IgG levels higher than 500 mg/dL.
24. Eijkhout HW, van der Mer JWM, Kallenberg CGM, 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 2001, 135:165–174.
25. 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, 26:210–213.
26. Schiff RI: Transmission of viral infections through intravenous immune globulin. N Engl J Med 1994, 331:1649–1650.
27. Outbreak of Hepatitis C associated with intravenous immunoglobulin administration—United States, October 1993-June 1994. Mor Mortal Wkly Rep CDC Surveill Summ 1994, 43:505-509.
28. Bjoro K, Froland SS, Yun Z, et al.: Hepatitis C infection in patients with primary hypogammaglobulinemia after treatment with contaminated immune globulin. N Engl J Med 1994, 331:1607–1611.
29. Yap PL: The viral safety of intravenous immune globulin. Clin Exp Immunol 1996, 104:35–42.
30. Horowitz B, Wiebe ME, Lippin A, Stryker MH: Inactivation of viruses in labile blood derivatives. I. Disruption of lipidenveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 1985, 25:516–522.
31. Biesert L: Virus validation studies of immunoglobulin preparations. Clin Exp Rheumatol 1996, 14:S47-S52.
32. Lee DC, Stenland CJ, Hartwell RC, et al.: Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000, 84:77–89.
33. Fahey JL: Developments in fundamental research related to clinical uses of immunoglobulins. In Immunoglobulins. Edited by Merler E. Washington, DC: National Academy of Sciences; 1970:15–30.
34. Imbach P, d’Apuzzo V, Hirt A, et al.: High-dose intravenous gammaglobulin for idiopathic thrombocytopenic purpura in childhood. Lancet 1981, 1228–1231.
35. Dwyer JM: Manipulating the immune system with immune globulin. N Engl J Med 1992, 326:107–116. An excellent review that discusses most of the conditions for which IVIG is used today, and the mechanisms by which it is believed to act.
36. [No authors listed.] Intravenous immunoglobulin: prevention and treatment of disease. NIH Consensus Statement Online 1990, 8:1–23. http://consensus.nih.gov/cons/080/ 080_intro.htm. Accessed March 18, 2002.
37. Sultan Y, Maisonneuve P, Kazatchkine MD, Nydegger UE: Anti-idiotypic suppression of autoantibodies to factor VIII (antihaemophilic factor) by high-dose intravenous gammaglobulin. Lancet 1984, 765–768.
38. Furusho K, Sato K, Soeda T, et al.: High-dose intravenous gammaglobulin for Kawasaki disease. Lancet 1983, 2:1359.
39. Furusho K, Kamiya T, Nakano H, et al.: High-dose intravenous gamma globulin for Kawasaki disease. Lancet 1984, 2:1055–1058.
40. Newburger JW, Takahashi M, Burns JC, et al.: The treatment of Kawasaki syndrome with intravenous gamma globulin. N Engl J Med 1986, 315:341–347.
41. Newburger JW, Takahashi M, Beiser AS, et al.: A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome. N Engl J Med 1991, 324:1664–1666.
42. Gajdos PH, Outin H, Elkharrat D, et al.: High-dose intravenous gamma globulin for myasthenia gravis. Lancet 1984, 406–407.
43. Arsura EL, Bick A, Brunner NG, et al.: High-dose intravenous immunoglobulin in the management of myasthenia gravis. Arch Intern Med 1986, 146:1365–1368.
44. Kleyweg RP, van der Meche FG, Meulstee J: Treatment of Guillain-Barre syndrome with high-dose gamma globulin. Neurology 1988, 38:1639–1641.
45. Vermuelen M, van der Meche FGA, Speelman JD, et al.: Plasma and gamma-globulin infusion in chronic inflammatory polyneuropathy. J Neurol Sci 1985, 70:317–326.
46. van Doorn PA, Rossi F, Brand A, et al.: On the mechanism of high-dose intravenous immunoglobulin treatment of patients with chronic inflammatory demyelinating polyneuropathy. J Neuroimmunol 1990, 29:57–64.
47. Dalakas MC: Mechanism of action of intravenous immunoglobulin and therapeutic considerations in the treatment of autoimmune neurologic diseases. Neurology 1998, 51:S2-S8.
48. Latov N, Chaudhry V, Koski CL, et al.: Use of intravenous gamma globulins in neuroimmunologic diseases. J Allergy Clin Immunol 2001, 108:S126-S132.
49. Dalakas MC, Fujii M, Li M, et al.: High-dose intravenous immune globulin for stiff-person syndrome. N Engl J Med 2001, 345:1870–1876.
50. Jolles S: A review of high-dose intravenous immunoglobulin (hdIVIg) in the treatment of the autoimmune blistering disorders. Clin Exp Dermatol 2001, 26:127–131.
51. Ratko RA, Burnett DA, Foulke GE, et al.: Preparations: recommendations for off-label use of intravenously administered immunoglobulin preparations. University Hospital Consortium Expert Panel for Off-Label Use of Polyvalent Intravenously Administered Immunoglobulin. JAMA 1995, 273:1865–1870. An “evidence-based” evaluation of the use of IVIG in conditions other than primary immune deficiency by a panel of experts.
52. Renal insufficiency and failure associated with immune globulin intravenous therapy-United States. Mor Mortal Wkly Rep CDC Surveill Summ 1999, 48:518-521.
53. Misbah SA, Chapel HM: Adverse effects of intravenous immunoglobulin. Drug Saf 1993, 9:254–262.
54. Schiavotto C, Ruggeri M, Rodeghiero F: Adverse reactions after high-dose intravenous immunoglobulin: Incidence in 83 patients treated for idiopathic thrombocytopenic purpura (ITP) and review of the literature. Suppl di Haematol 1993, 78:35–39.
55. Sweet LK, Howell J, McMurray L-G, et al.: The use of normal serum gamma globulin antibodies (human) concentrated (immune serum globulin) in the treatment of premature infants. J Pediatr 1946, 28:571–573.
56. Soothill JF: Treatment of immunoglobulin deficiency syndromes. In Immunoglobulins: Biologic Aspects and Clinical Uses. Edited by Merler E. Washington, DC: National Academy of Sciences; 1970:202–210.
57. Baker CJ, Melish ME, Hall RT, et al.: Intravenous immune globulin for the prevention of nosocomial infection in low-birth-weight neonates. The Multicenter Group for the Study of Immune Globulin in Neonates. N Engl J Med 1992, 327:213–219.
58. Clapp DW, Kliegman R, Baley JE, et al.: Use of intravenously administered immune globulin to prevent nosocomial sepsis in low birth weight infants: Report of a pilot study. J Pediatr 1989, 115:973–978.
59. Fanaroff AA, Korones SB, Wright LL, et al.: A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med 1994, 330:1107–1113.
60. Spector SA, Gelber RD, McGrath N, et al.: A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinic Trials Group. N Engl J Med 1994, 331:1181–1187.
61. Nydegger UE, Mohacsi PJ, Escher R, Morell A: Clinical use of intravenous immunoglobulins. Vox Sang 2000, 78:191–195.
62. Gelfand EW: Antibody-directed therapy: Past, present, and future. J Allergy Clin Immunol 2001, 108:S111-S116.
63. Groothuis JR, Simoes EAF, Levin MJ, et al.: Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. The Respiratory Syncytial Virus Immune Globulin Study Group. N Engl J Med 1993, 329:1524–1530.
64. Saez-Llorens X, Castano E, Null D, et al.: Safety and pharmacokinetics of an intramuscular humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. The MEDI-493 Study Group. Pediatr Infect Dis J 1998, 17:787–791.
65. [No authors listed.] Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The Impact-RSV Study Group. Pediatrics 1998, 102:531–537.
66. Sorrentino M, Powers T: Effectiveness of palivizumab: Evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. The Palivizumab Outcomes Study Group. Pediatr Infect Dis J 2000, 19:1068–1071.