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Volumn 36, Issue 6, 2016, Pages 590-599

Efficacy, Safety, and Pharmacokinetics of a New 10 % Liquid Intravenous Immunoglobulin Containing High Titer Neutralizing Antibody to RSV and Other Respiratory Viruses in Subjects with Primary Immunodeficiency Disease

(11)  Wasserman, Richard L a   Lumry, William b   Harris, James c   Levy, Robyn d   Stein, Mark e   Forbes, Lisa f   Cunningham Rundles, Charlotte g   Melamed, Isaac h   Kobayashi, Ai Lan i   Du, Wei j   Kobayashi, Roger k  


Author keywords

clinical trial; efficacy; Intravenous immunoglobulin (IVIG); pharmacokinetics; primary immunodeficiency (PIDD); safety

Indexed keywords

ANTIBIOTIC AGENT; BACTERIUM ANTIBODY; CYTOMEGALOVIRUS ANTIBODY; HAEMOPHILUS INFLUENZAE TYPE B ANTIBODY; IMMUNOGLOBULIN; MEASLES ANTIBODY; NEUTRALIZING ANTIBODY; PALIVIZUMAB; RESPIRATORY SYNCYTIAL VIRUS ANTIBODY; RI 002; TETANUS TOXOID; UNCLASSIFIED DRUG; VIRUS ANTIBODY;

EID: 84975322559     PISSN: 02719142     EISSN: 15732592     Source Type: Journal    
DOI: 10.1007/s10875-016-0308-z     Document Type: Article
Times cited : (24)

References (30)
  • 1
    • 85013608736 scopus 로고    scopus 로고
    • Impact of intravenous immunoglobulin (IVIG) treatment among patients with primary immunodeficiency diseases
    • Boyle ML, Scalchunes C. Impact of intravenous immunoglobulin (IVIG) treatment among patients with primary immunodeficiency diseases. Pharm Policy Law. 2008;10:133–46.
    • (2008) Pharm Policy Law , vol.10 , pp. 133-146
    • Boyle, M.L.1    Scalchunes, C.2
  • 2
    • 0036286074 scopus 로고    scopus 로고
    • Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency
    • COI: 1:CAS:528:DC%2BD38XlsVajs7s%3D, PID: 12063531
    • Busse PJ, Razvi S, Cunningham-Rundles C. Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. J Allergy Clin Immunol. 2002;109(6):1001–4.
    • (2002) J Allergy Clin Immunol , vol.109 , Issue.6 , pp. 1001-1004
    • Busse, P.J.1    Razvi, S.2    Cunningham-Rundles, C.3
  • 4
    • 33645341439 scopus 로고    scopus 로고
    • 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
    • COI: 1:CAS:528:DC%2BD28XjtFCqtrk%3D, PID: 16580469
    • 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. 2006;117(4):S525–53.
    • (2006) J Allergy Clin Immunol , vol.117 , Issue.4 , pp. S525-S553
    • Orange, J.S.1    Hossny, E.M.2    Weiler, C.R.3
  • 5
    • 84913610230 scopus 로고    scopus 로고
    • An update on the use of immunoglobulin for the treatment of immunodeficiency disorders
    • COI: 1:CAS:528:DC%2BC2cXhvF2ntLzI, PID: 25428649
    • Albin S, Cunningham-Rundles C. An update on the use of immunoglobulin for the treatment of immunodeficiency disorders. Immunotherapy. 2014;6(10):1113–26.
    • (2014) Immunotherapy , vol.6 , Issue.10 , pp. 1113-1126
    • Albin, S.1    Cunningham-Rundles, C.2
  • 6
    • 79961169935 scopus 로고    scopus 로고
    • Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study
    • COI: 1:CAS:528:DC%2BC3MXoslaltLo%3D, PID: 21365217
    • Quinti I. 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.
    • (2011) J Clin Immunol , vol.31 , pp. 315-322
    • Quinti, I.1
  • 7
    • 77956615735 scopus 로고    scopus 로고
    • Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies
    • COI: 1:CAS:528:DC%2BC3cXhtFyisrzO, PID: 20675197
    • Orange JS, Grossman WJ, Navickis RJ, et al. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies. Clin Immunol. 2010;137:21–30.
    • (2010) Clin Immunol , vol.137 , pp. 21-30
    • Orange, J.S.1    Grossman, W.J.2    Navickis, R.J.3
  • 8
    • 77952741985 scopus 로고    scopus 로고
    • Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years
    • COI: 1:CAS:528:DC%2BC3cXmsleku7k%3D, PID: 20471071
    • 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(6):1354–60.
    • (2010) J Allergy Clin Immunol , vol.125 , Issue.6 , pp. 1354-1360
    • Lucas, M.1    Lee, M.2    Lortan, J.3
  • 9
    • 0032730699 scopus 로고    scopus 로고
    • Goals of therapy in antibody deficiency syndromes
    • COI: 1:STN:280:DC%2BD3c%2FitVWksQ%3D%3D, PID: 10550731
    • Berger M. Goals of therapy in antibody deficiency syndromes. J Allergy Clin Immunol. 1999;104:911–3.
    • (1999) J Allergy Clin Immunol , vol.104 , pp. 911-913
    • Berger, M.1
  • 10
    • 46049100774 scopus 로고    scopus 로고
    • Biologic IgG level in primary immunodeficiency disease: the IgG level that protects against recurrent infection
    • COI: 1:CAS:528:DC%2BD1cXotlajtrc%3D, PID: 18602574
    • Bonagura VR, Marchlewski R, Cox A, et al. Biologic IgG level in primary immunodeficiency disease: the IgG level that protects against recurrent infection. J Allergy Clin Immunol. 2008;122(1):210–2.
    • (2008) J Allergy Clin Immunol , vol.122 , Issue.1 , pp. 210-212
    • Bonagura, V.R.1    Marchlewski, R.2    Cox, A.3
  • 11
    • 67650951478 scopus 로고    scopus 로고
    • Serum immunoglobulins and risk of infection: how low can you go?
    • COI: 1:CAS:528:DC%2BD1MXptVSht70%3D, PID: 18620738
    • Furst DE. Serum immunoglobulins and risk of infection: how low can you go? Semin Arthritis Rheum. 2009;39(1):18–29.
    • (2009) Semin Arthritis Rheum , vol.39 , Issue.1 , pp. 18-29
    • Furst, D.E.1
  • 12
    • 0033511446 scopus 로고    scopus 로고
    • Early and prolonged intravenous immunoglobulin replacement therapy in childhood agammaglobulinemia: a retrospective survey of 31 patients
    • COI: 1:CAS:528:DyaK1MXjsFyjsrg%3D, PID: 10228295
    • Quartier P, Debré M, De Blic J, et al. Early and prolonged intravenous immunoglobulin replacement therapy in childhood agammaglobulinemia: a retrospective survey of 31 patients. J Pediatr. 1999;134(5):589–96.
    • (1999) J Pediatr , vol.134 , Issue.5 , pp. 589-596
    • Quartier, P.1    Debré, M.2    De Blic, J.3
  • 13
    • 7744241823 scopus 로고    scopus 로고
    • Comparison of antibodies directed against human respiratory syncytial virus antigens present in two commercial preparations of human immunoglobulins with different neutralizing activities
    • COI: 1:CAS:528:DC%2BD2cXpsFemt7k%3D, PID: 15530691
    • Sastre P, Melero JA, Garcia-Barreno B, et al. Comparison of antibodies directed against human respiratory syncytial virus antigens present in two commercial preparations of human immunoglobulins with different neutralizing activities. Vaccine. 2004;23(4):435–43.
    • (2004) Vaccine , vol.23 , Issue.4 , pp. 435-443
    • Sastre, P.1    Melero, J.A.2    Garcia-Barreno, B.3
  • 14
    • 79952533229 scopus 로고    scopus 로고
    • Prevention of serious respiratory syncytial virus-related illness II: immunoprophylaxis
    • PID: 21318605
    • Groothuis JR, Hoopes JM, Hemming VG. Prevention of serious respiratory syncytial virus-related illness II: immunoprophylaxis. Adv Ther. 2011;28(2):110–25.
    • (2011) Adv Ther , vol.28 , Issue.2 , pp. 110-125
    • Groothuis, J.R.1    Hoopes, J.M.2    Hemming, V.G.3
  • 15
    • 0030959478 scopus 로고    scopus 로고
    • Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis
    • The PREVENT Study Group. Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. Pediatrics. 1997;99(1):93–9.
    • (1997) Pediatrics , vol.99 , Issue.1 , pp. 93-99
  • 16
    • 0027384670 scopus 로고
    • Prophylactic administration of respiratory syncytial virus immune globulin to high risk infants and young children
    • COI: 1:STN:280:DyaK2c%2FhvFKnsw%3D%3D, PID: 8413475
    • Groothuis J. Prophylactic administration of respiratory syncytial virus immune globulin to high risk infants and young children. NEJM. 1993;329(21):1524–30.
    • (1993) NEJM , vol.329 , Issue.21 , pp. 1524-1530
    • Groothuis, J.1
  • 17
    • 0031729747 scopus 로고    scopus 로고
    • Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV
    • American Academy of Pediatrics: Committee on Infectious Diseases and Committee on Fetus and Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics. 1998;102(5):1211–16.
    • (1998) Pediatrics , vol.102 , Issue.5 , pp. 1211-1216
    • American Academy of Pediatrics: Committee on Infectious Diseases and Committee on Fetus and Newborn1
  • 19
    • 79951812087 scopus 로고    scopus 로고
    • Special populations: do we need evidence from randomized controlled trials to support the need for respiratory syncytial virus prophylaxis?
    • PID: 21273012
    • Paes B, Manzoni P. Special populations: do we need evidence from randomized controlled trials to support the need for respiratory syncytial virus prophylaxis? Early Hum Dev. 2011;87 Suppl 1:S55–8.
    • (2011) Early Hum Dev , vol.87 , pp. S55-S58
    • Paes, B.1    Manzoni, P.2
  • 20
    • 67849117371 scopus 로고    scopus 로고
    • Insights from the Sixth Global Experts’ Meeting (GEM) on respiratory viruses: special populations
    • Faroux B. Insights from the Sixth Global Experts’ Meeting (GEM) on respiratory viruses: special populations. Paediatr Respir Rev. 2009;10 Suppl 1:21–2.
    • (2009) Paediatr Respir Rev , vol.10 , pp. 21-22
    • Faroux, B.1
  • 21
    • 0030378226 scopus 로고    scopus 로고
    • Respiratory syncytial virus-enriched globulin for the prevention of acute otitis media in high-risk children
    • COI: 1:STN:280:DyaK28zkvFeisw%3D%3D, PID: 8765618
    • Simoes EA, Groothius JR, Tristram DA, et al. Respiratory syncytial virus-enriched globulin for the prevention of acute otitis media in high-risk children. J Pediatr. 1996;129(2):214–9.
    • (1996) J Pediatr , vol.129 , Issue.2 , pp. 214-219
    • Simoes, E.A.1    Groothius, J.R.2    Tristram, D.A.3
  • 22
    • 84953364328 scopus 로고    scopus 로고
    • Treatment with novel RSV Ig RI-002 controls viral replication and reduces pulmonary damage in immunocompromised Sigmodon hispidus
    • COI: 1:CAS:528:DC%2BC2MXhsFers7jO, PID: 26367224
    • Boukhvalova MS. Treatment with novel RSV Ig RI-002 controls viral replication and reduces pulmonary damage in immunocompromised Sigmodon hispidus. Bone Marrow Transplant. 2016;51(1):119–26.
    • (2016) Bone Marrow Transplant , vol.51 , Issue.1 , pp. 119-126
    • Boukhvalova, M.S.1
  • 23
    • 84978258813 scopus 로고    scopus 로고
    • Polyclonal human intravenous immune globulin (IGIV) with high-levels of RSV neutralizing antibodies: a summary of animal and human studies
    • Falsey AR. Polyclonal human intravenous immune globulin (IGIV) with high-levels of RSV neutralizing antibodies: a summary of animal and human studies. Annual Conference of the Canadian Blood and Marrow Transplant Group June 11–14, 2014.
    • (2014) Annual Conference of the Canadian Blood and Marrow Transplant Group June , pp. 11-14
    • Falsey, A.R.1
  • 24
    • 84978258806 scopus 로고    scopus 로고
    • Treatment of normal and immune suppressed cotton rats with IVIG containing high neutralizing titer anti-RSV antibody
    • Mond J. Treatment of normal and immune suppressed cotton rats with IVIG containing high neutralizing titer anti-RSV antibody. 9th International Respiratory Syncytial Virus Symposium November 2014.
    • (2014) 9th International Respiratory Syncytial Virus Symposium
    • Mond, J.1
  • 25
    • 84894299046 scopus 로고    scopus 로고
    • A new intravenous immunoglobulin: bivigam for primary humoral immunodeficiency
    • COI: 1:CAS:528:DC%2BC2cXisFaltbY%3D, PID: 24527947
    • Wasserman RL. A new intravenous immunoglobulin: bivigam for primary humoral immunodeficiency. Expert Rev Clin Immunol. 2014;10(3):325–37.
    • (2014) Expert Rev Clin Immunol , vol.10 , Issue.3 , pp. 325-337
    • Wasserman, R.L.1
  • 27
    • 84941274669 scopus 로고    scopus 로고
    • Therapeutic immunoglobulin selected for high antibody titer to RSV also contains high antibody titers to other respiratory viruses
    • Orange JS, Du W, Falsey AR. Therapeutic immunoglobulin selected for high antibody titer to RSV also contains high antibody titers to other respiratory viruses. Front Immunol. 2015;6:1–7.
    • (2015) Front Immunol , vol.6 , pp. 1-7
    • Orange, J.S.1    Du, W.2    Falsey, A.R.3
  • 28
    • 77953538938 scopus 로고    scopus 로고
    • Efficacy, pharmacokinetics, safety, and tolerability of Flebogamma 10% DIF, a high-purity human intravenous immunoglobulin, in primary immunodeficiency
    • COI: 1:CAS:528:DC%2BC3cXjs1ejsr4%3D, PID: 19997861
    • 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.
    • (2010) J Clin Immunol , vol.30 , pp. 321-329
    • Berger, M.1    Pinciaro, P.J.2    Althaus, A.3
  • 29
    • 80052617229 scopus 로고    scopus 로고
    • Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy
    • COI: 1:CAS:528:DC%2BC3MXht1ansbvL, PID: 21705277
    • Jolles S, Bernatowska E, de Garcia J, et al. Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011;141:90–102.
    • (2011) Clin Immunol , vol.141 , pp. 90-102
    • Jolles, S.1    Bernatowska, E.2    de Garcia, J.3
  • 30
    • 59549096424 scopus 로고    scopus 로고
    • Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies
    • COI: 1:CAS:528:DC%2BD1MXht1Ohsbo%3D, PID: 18814020
    • 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.
    • (2009) J Clin Immunol , vol.29 , pp. 137-144
    • Stein, M.R.1    Nelson, R.P.2    Church, J.A.3


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