Review of intravenous immunoglobulin replacement therapy trials for primary humoral immunodeficiency patients

Infection

Volumn 40, Issue 6, 2012, Pages 601-611

  Schroeder Jr , H W ^a   Dougherty, C J ^b  

^a The University of Alabama at Birmingham   (United States)

^b Biotest Pharmaceuticals Corporation   (United States)

Author keywords

Clinical trial; Intravenous immunoglobulin; IVIG; PID; Primary immunodeficiency

Indexed keywords

ANTIBIOTIC AGENT; BIOTEST IVIG; COMPLEMENT; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; UNCLASSIFIED DRUG;

ASEPTIC MENINGITIS; BACTERIAL INFECTION; BACTERIAL PNEUMONIA; BRONCHITIS; CARDIOVASCULAR DISEASE; CHEMOTHERAPY INDUCED EMESIS; CHILL; COMMON VARIABLE IMMUNODEFICIENCY; COMPLEMENT ACTIVATION; COOMBS TEST; DEHYDRATION; DIPHTHERIA; DIZZINESS; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG INFUSION; DRUG MARKETING; DRUG MEGADOSE; DRUG PURIFICATION; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEVER; FOOD AND DRUG ADMINISTRATION; HEMOLYSIS; HEMOLYTIC ANEMIA; HOSPITALIZATION; HUMAN; IMMUNE DEFICIENCY; IMMUNOGLOBULIN AGGREGATE; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOGLOBULIN DEFICIENCY; INFECTION; INFECTION PREVENTION; INFUSION RELATED REACTION; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MIGRAINE; NONHUMAN; PAIN; PNEUMOCOCCAL INFECTION; PRIMARY HUMORAL IMMUNODEFICIENCY; RECURRENT INFECTION; REVIEW; RIGOR; SIDE EFFECT; SINUSITIS; TETANUS; THORAX PAIN; THROMBOSIS; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; URTICARIA; WHEEZING; X LINKED AGAMMAGLOBULINEMIA;

CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES; PRACTICE GUIDELINES AS TOPIC;

EID: 84874116952     PISSN: 03008126     EISSN: 14390973     Source Type: Journal    
DOI: 10.1007/s15010-012-0323-9     Document Type: Review

References (35)

1. FDA Blood Products Advisory Committee 62nd Meeting, Bethesda, Maryland, March 26, 1999. Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ ohrms/dockets/ac/99/transcpt/3504t2.pdf.
2. FDA Blood Products Advisory Committee 65th Meeting, Silver Spring, Maryland, March 17, 2000 Transcript, Miller Reporting Company, Inc. http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3603t2a.pdf.
3. 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, 2005. http://www.fda.gov/OHRMS/DOCKETS/98fr/2005D-0438-gdl0001.pdf.
4. 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, 2008. http://www.fda.gov/downloads/bio logicsbloodvaccines/ guidancecomplianceregulatoryinformation/guidances/blood/ucm078526.pdf.
5. Behring EA, Kitasato S. Ü ber das zustandekommen der Diphtherie-Immunität und der Tetanus-Immunität bei Thieren. Dtsch Med Wochenschr. 1890;16:1113-4.
6. 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.
7. Schiff RI. Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action. Pediatr Allergy Immunol. 1994;5:63-87.
8. Cohn EJ, Strong LE, Hughes WL Jr, Mulford DJ, Ashworth JN, Melin M, Taylor HL. Preparation and properties of serum and plasma proteins. IV. 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.
9. Oncley JL, Melin M, Richert DA, Cameron JW, Gross PM Jr. The separation of the antibodies, isoagglutinins, prothrombin, plasminogen and beta-lipoprotein into subfractions of human plasma. J Am Chem Soc. 1949;71:541-50.
10. Bruton OC. Agammaglobulinema. Pediatrics. 1952;9:722-7.
11. Janeway CA, Apt L, Gitlin D. Agammaglobulinemia. Trans Assoc Am Physicians. 1953;66:200-2.
12. Janeway CA, Rosen FS. The gamma globulins. IV. Therapeutic uses of gamma globulin. N Engl J Med. 1966;275:826-31.
13. Barandun S, Kistler P, Jeunet F, Isliker H. Intravenous administration of human gamma-globulin. Vox Sang. 1962;7:157-74.
14. Pollack M. Antibody activity against Pseudomonas aeruginosa in immune globulins prepared for intravenous use in humans. J Infect Dis. 1983;147:1090-8.
15. Bender S, Hetherington S. Haemophilus influenzae type b opsonins of intravenous immunoglobulins. J Clin Immunol. 1987;7: 475-80.
16. Janeway CA, Merler E, Rosen FS, Salmon S, Crain JD. Intravenous gamma globulin. Metabolism of gamma globulin fragments in normal and agammaglobulinemic persons. N Engl J Med. 1968;278:919-23.
17. Hooper JA, Alpern M, Mankarious S. Immunoglobulin manufacturing procedures. In: Krijnen HW, Strengers PFW, van Aken WG, editors. Immunoglobulins. Amsterdam: Central Laboratory of the Netherlands Red Cross Blood Transfusion Service; 1988. p. 361-80.
18. Nolte MT, Pirofsky B, Gerritz GA, Golding B. Intravenous immunoglobulin therapy for antibody deficiency. Clin Exp Immunol. 1979;36:237-43.
19. Cunningham-Rundles C, Siegal FP, Smithwick EM, Lion-Boulé A, Cunningham-Rundles S, O'Malley J, Barandun S, Good RA. Efficacy of Intravenous immunoglobulin in primary humoral immunodeficiency disease. Ann Intern Med. 1984;101:435-9.
20. Ochs HD, Lee ML, Fischer SH, Kingdon HS, Wedgwood RJ. Efficacy of a new intravenous immunoglobulin preparation in primary immunodeficient patients. Clin Ther. 1987;9:512-22.
21. Roifman CM, Gelfand EW. Replacement therapy with high dose intravenous gamma-globulin improves chronic sinopulmonary disease in patients with hypogammaglobulinemia. Pediatr Infect Dis J. 1988;7:S92-6.
22. Roifman CM, Schroeder H, Berger M, Sorensen R, Ballow M, Buckley RH, Gewurz A, Korenblat P, Sussman G, Lemm G. Comparison of the efficacy of IGIV-C, 10 % (caprylate/chromatography) and IGIV-SD, 10 % as replacement therapy in primary immune deficiency. A randomized double-blind trial. Int Immunopharmacol. 2003;3:1325-33.
23. Ballow M, Berger M, Bonilla FA, Buckley RH, Cunningham-Rundles CH, Fireman P, Kaliner M, Ochs HD, Skoda-Smith S, Sweetser MT, Taki H, Lathia C. Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%). Vox Sang. 2003;84:202-10.
24. Ochs HD, Pinciaro PJ; Octagam Study Group. Octagam 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004;24:309-14.
25. Church JA, Leibl H, Stein MR, Melamed IR, Rubinstein A, Schneider LC, Wasserman RL, Pavlova BG, Birthistle K, Mancini M, Fritsch S, Patrone L, Moore-Perry K, Ehrlich HJ; US-PID-IGIV 10% -Study Group10. 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.
26. Baxter Healthcare Corporation. Gammagard Liquid [Immune Globulin Infusion (Human)] 10% prescribing information, 2009. http://www.baxter.com/products/ biopharmaceuticals/downloads/gamliquid-PI.pdf
27. Berger M; Flebogamma 5% DIF Investigators. 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.
28. Grifols Biologicals. Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] prescribing information, 2006. http://www.fda.gov/downloads/ BiologicsBloodVaccines/BloodBlood Products/ApprovedProducts/ LicensedProductsBLAs/Fractionated PlasmaProducts/UCM172599.pdf.
29. Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group. 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.
30. CSL Behring AG. Privigen, Immune Globulin Intravenous (Human), 10% Liquid prescribing information, 2009. http://www. fda.gov/downloads/ BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/ FractionatedPlasma Products/UCM303092.pdf.
31. Berger M, Pinciaro PJ, Althaus A, Ballow M, Chouksey A, Moy J, Ochs H, Stein M. 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.
32. Grifols Biologicals. Flebogamma 10% DIF, Immune Globulin Intravenous (Human), 10% Liquid prescribing information, 2010. http://www.fda.gov/downloads/ BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/ FractionatedPlasmaProducts/UCM221606.pdf.
33. Moy JN, Scharenberg AM, Stein MR, Suez D, Roberts RL, Levy RJ, Ballow M, Fasano MB, Dash CH, Leach SJ. Efficacy and safety of a new immunoglobulin G product, Gammaplex(-), in primary immunodeficiency diseases. Clin Exp Immunol. 2010; 162:510-5.
34. BioProducts Laboratory. Gammaplex, Immune Globulin Intravenous (Human), 5% Liquid prescribing information, 2009. http://www.fda.gov/downloads/ BiologicsBloodVaccines/Blood BloodProducts/ApprovedProducts/ LicensedProductsBLAs/FractionatedPlasmaProducts/UCM182963.pdf
35. Wasserman RL, Church JA, Stein M, Moy J, White M, Strausbaugh S, Schroeder H, Ballow M, Harris J, Melamed I, Elkayam D, Lumry W, Suez D, Rehman SM. Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency. J Clin Immunol. 2012;32:663-9.