IGIV-C, a novel intravenous immunoglobulin: Evaluation of safety, efficacy, mechanisms of action, and impact on quality of life

Thrombosis and Haemostasis

Volumn 91, Issue 4, 2004, Pages 771-778

  Bussel, James B ^a   Eldor, Amiram ^b   Kelton, John G ^c   Varon, David ^d   Brenner, Benjamin ^e   Gillis, Shmuel ^d   Angiolillo, Anne ^f   Kulkarni, Roshni ^g   Abshire, Thomas C ^h   Kelleher, Jack ⁱ   Luke, Kung Hung ^j   Whitlock, Pierre ^k   Richard, Leon ^k   Ritchie, Bruce ^l   Wilson, Jonathan ^m   Warrier, Indira ⁿ   Cherrick, Irene ^o   Blanchard, Kerry ^p   Hall, Scott ^q   Aledort, Louis M ^r   Kessler, Craig M ^s   Cooper, Herbert ^t   Gonzalez, M Francisco ^u   Owen, William ^v   Blayney, Douglas W ^w   Bodensteiner, David ^x   Karabus, C ^y   Vaithilingum, M ^z   more..

^a NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^b TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^c MCMASTER UNIVERSITY MEDICAL CENTRE   (Canada)

^d HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^e RAMBAM MEDICAL CENTER   (Israel)

^f CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^g MICHIGAN STATE UNIVERSITY   (United States)

^h EMORY UNIVERSITY   (United States)

ⁱ BAYER CORPORATION   (United States)

^j CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^k Oncology Centre   (Canada)

^l UNIVERSITY OF ALBERTA   (Canada)

^m HUMBER RIVER REGIONAL HOSPITAL   (Canada)

ⁿ CHILDREN'S HOSPITAL OF MICHIGAN   (United States)

^o University Hospital   (United States)

^p LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^q STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^r MOUNT SINAI MEDICAL CENTER   (United States)

^s GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

^t UNIVERSITY OF NORTH CAROLINA   (United States)

^u UNIVERSITY OF SOUTH CAROLINA   (United States)

^v CHILDREN S HOSPITAL OF THE KING S DAUGHTERS   (United States)

^w Wilshire Oncology Medical Group   (United States)

^x UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

^y RED CROSS WAR MEMORIAL CHILDREN S HOSPITAL   (South Africa)

^z ADDINGTON HOSPITAL   (South Africa)

more..

Author keywords

Immunoglobulin; Immunotherapy; IVIG; Viral safety

Indexed keywords

ALLOANTIBODY; ANDROGEN; AZATHIOPRINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; DETERGENT; DRUG SOLVENT; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G;

ACUTE DISEASE; ADOLESCENT; ADULT; AGE; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; CHILD; CHRONIC DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG MECHANISM; DRUG SAFETY; FEMALE; FEVER; HEADACHE; HEPATITIS B VIRUS; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; IDIOPATHIC THROMBOCYTOPENIC PURPURA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NECK PAIN; PARALLEL DESIGN; PARVOVIRUS; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; THROMBOCYTE COUNT; VOMITING;

EID: 11144354527     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/th03-10-0650     Document Type: Article

References (27)

1. George JN, Woolf SH, Raskob GE, et al. Idiopathic thrombocytopenic purpura: A practice guideline developed by explicit methods for the American Society of Hematology. Blood 1996; 88: 3-40.
2. Cines D, Blanchette V. Immune thrombocytopenic purpura. N Engl J Med 2002; 346: 995-1008.
3. Portielje JE, Westendorp RG, Kluin-Nelemans HC, et al. Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Blood 2001; 97: 2549-54.
4. Cooper N, Woloski BM, Fodero EM, et al. Does treatment with intermittent infusions of intravenous and-D allow a proportion of adults with recently diagnosed immune thrombocytopenic purpura to avoid splenectomy? Blood 2002; 99: 1922-7.
5. Souid AK, Sadowitz PD. Acute childhood immune thrombocytopenic purpura. Diagnosis and treatment. Clinical Pediatrics (Philadelphia) 1995; 34: 487-94.
6. Woerner SJ, Abildgaard CF, French BN. Intracranial hemorrhage in children with idiopathic thrombocytopenic purpura. Pediatrics 1981; 67: 453-60.
7. Imbach P, Barandun S, d'Apuzzo V, et al. High-dose intravenous gammaglobulin for idiopathic thrombocytopenic purpura in childhood. Lancet 1981; 1: 1228-31.
8. Bussel JB, Kimberly RP, Inman RD, et al. Intravenous gammaglobulin treatment of chronic idiopathic thrombocytopenic purpura. Blood 1983; 62: 480-6.
9. Bussel JB, Pham LC. Intravenous treatment with gammaglobulin in adults with immune thrombocytopenic purpura: Review of the literature. Vox Sang 1987; 52: 206-11.
10. Carroll RR, Noyes WD, Rosse WF, et al. Intravenous immunoglobulin administration in the treatment of severe chronic immune thrombocytopenic purpura. Am J Med 1984; 76: 181-6.
11. Oral A, Nusbacher J, Hill JB, et al. Intravenous gamma globulin in the treatment of chronic idiopathic thrombocytopenic purpura in adults. Am J Med 1984; 76: 187-92.
12. Warrier I, Lusher JM. Intravenous gamma globulin treatment for chronic idiopathic thrombocytopenic purpura in children. Am J Med 1984; 76: 193-8.
13. Bussel JB, Schulman I, Hilgartner MW, et al. Intravenous use of gammaglobulin in the treatment of chronic immune thrombocytopenic purpura as a means to defer splenectomy. J Pediatr 1983; 103: 651-4.
14. Kurlander R, Coleman RE, Moore J, et al. Comparison of the efficacy of a two-day and a five-day schedule for infusing intravenous gamma globulin in the treatment of immune thrombocytopenic purpura in adults. Am J Med 1987; 83: 17-24.
15. Blanchette V, Imbach P, Andrew M, et al. Randomised trial of intravenous immunoglobulin G, intravenous anti-D, and oral prednisone in childhood acute immune thrombocytopenic purpura. Lancet 1994; 344: 703-7.
16. Colovic M, Dimitrijevic M, Sonnenburg C, et al. Clinical efficacy and safety of a novel intravenous immunoglobulin preparation in adult chronic ITP. Hematol J 2003; 4: 358-62.
17. Godeau B, Lesage S, Divine M, et al. Treatment of adult chronic autoimmune thrombocytopenic purpura with repeated high-dose intravenous immunoglobulin. Blood 1993; 82: 1415-21.
18. 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.
19. Lebing W, Remington K, Schreiner C, et al. Properties of a new intravenous immunoglobulin (IVIG-C, 10%) produced by caprylate virus inactivation and column chromatography. Vox Sang 2003; 84: 193-201.
20. 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.
21. Ballow M, Berger M, Bonilla FA, et al. Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex™, 10%). Vox Sang 2003; 84: 202-10.
22. Blanchette VS, Luke B, Andrew M, et al. A prospective, randomized trial of high-dose intravenous immune globulin G therapy, oral prednisone therapy, and no therapy in childhood acute immune thrombocytopenic purpura. J Pediatr 1993; 123: 989-95.
23. Imbach P, Wagner HP, Berchtold W, et al. Intravenous immunoglobulin versus oral corticosteroids in acute immune thrombocytopenic purpura in childhood. Lancet 1985; 2: 464-8.
24. Salama A, Mueller-Eckhardt C, Kiefel V. Effect of intravenous immunoglobulin in immune thrombocytopenia. Lancet 1983; 2: 193-5.
25. Bussel JB, Graziano JN, Kimberly RP, et al. Intravenous anti-D treatment of immune thrombocytopenic purpura: Analysis of efficacy, toxicity, and mechanism of effect. Blood 1991; 77: 1884-93.
26. George JN, el-Harake MA, Raskob GE. Chronic idiopathic thrombocytopenic purpura. N Engl J Med 1994; 331: 1207-11.
27. Godeau B, Caulier MT, Decuypere L, et al. Intravenous immunoglobulin for adults with autoimmune thrombocytopenic purpura: results of a randomized trial comparing 0.5 and 1 g/kg b.w. Br J Haematol 1999; 107: 716-9.