Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin infusion in primary immunodeficiency diseases

被引:55
|
作者
Wasserman, Richard L. [1 ]
机构
[1] Med City Childrens Hosp, Allergy Partners North Texas, Dallas, TX 75230 USA
关键词
immunoglobulin; intravenous administration of immunoglobulin; primary immunodeficiency disease; recombinant human hyaluronidase; rHuPH20-facilitated subcutaneous infusion of IG; subcutaneous administration of immunoglobulin; INTRAVENOUS IMMUNOGLOBULIN; EFFICACY; SAFETY; THERAPY; PHARMACOKINETICS; TOLERABILITY; RHUPH20; PH-20; IGG; HYPOGAMMAGLOBULINEMIA;
D O I
10.2217/imt-2017-0092
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Most primary immunodeficiency diseases (PIDDs) resulting in antibody deficiency require intravenous or subcutaneous immunoglobulin G (SCIG) replacement therapy. The flow and distribution of SCIG to the vasculature is impeded by the glycosaminoglycan hyaluronan in the extracellular matrix, which limits the infusion rate and volume per site, necessitating frequent infusions and multiple infusion sites. Hyaluronidase depolymerizes hyaluronan and is a spreading factor for injectable biologics. Recombinant human hyaluronidase (rHuPH20) increases SCIG absorption and dispersion. In patients with PIDD, SCIG facilitated with rHuPH20 (IGHy) has been shown to prevent infections, be well-tolerated and reduce infusion frequency and number of infusion sites as compared with conventional SCIG. This article reviews IGHy clinical studies and real-world practice data in patients with PIDD.
引用
收藏
页码:1035 / 1050
页数:16
相关论文
共 50 条
  • [41] Interim analysis of the global post authorization safety study of hyaluronidase-facilitated subcutaneous immunoglobulin 10% treatment in patients with primary immunodeficiency disease
    Rubinstein, Arye
    Bridges, Tracy
    McNeil, Donald
    Tachdjian, Raffi
    Wedner, H. James
    Wasserman, Richard L.
    Leibl, Heinz
    Rabbat, Christopher J.
    Yel, Leman
    ALLERGY AND ASTHMA PROCEEDINGS, 2019, 40 (05) : 357 - 357
  • [42] Population pharmacokinetics of immunoglobulin G after intravenous, subcutaneous, or hyaluronidase-facilitated subcutaneous administration in immunoglobulin-naive patients with primary immunodeficiencies
    Li, Zhaoyang
    Follman, Kristin
    Freshwater, Ed
    Engler, Frank
    Yel, Leman
    INTERNATIONAL IMMUNOPHARMACOLOGY, 2024, 128
  • [43] Tolerability and safety of recombinant human hyaluronidase-facilitated subcutaneous infusion of human immune globulin G, 10%, in patients with primary immunodeficiencies: A study from North America
    Kobayashi, R.
    Stein, M.
    Darter, A.
    Gupta, S.
    Engl, W.
    Leibl, H.
    Fielhauer, K.
    Schiff, R. I.
    ALLERGY AND ASTHMA PROCEEDINGS, 2013, 34 (03) : 298 - 298
  • [44] TOLERABILITY AND SAFETY OF RECOMBINANT HUMAN HYALURONIDASE-FACILITATED SUBCUTANEOUS INFUSION OF HUMAN IMMUNE GLOBULIN G, 10%, IN PATIENTS WITH PRIMARY IMMUNODEFICIENCIES: A STUDY FROM NORTH AMERICA
    Kobayashi, R.
    Stein, M. R.
    Darter, A.
    Paris, K.
    Gupta, S.
    Testori, A.
    Engl, W.
    Leibl, H.
    Filhauer, K.
    Schiff, R. I.
    ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 2012, 109 (05) : A98 - A98
  • [45] Modeled Economic Impact of Facilitated-Subcutaneous Infusion of Immune Globulin (Human), 10% with Recombinant Human Hyaluronidase (IGHy) or Intravenous Immunoglobulin (IGIV) in Primary Immunodeficiency (PI) Patients
    Iyer, Ravi
    Luo, Michelle
    Li-McLeod, Josephine
    JOURNAL OF CLINICAL IMMUNOLOGY, 2012, 32 (02) : 397 - 397
  • [46] INTERIM ANALYSIS OF THE GLOBAL POST AUTHORIZATION SAFETY STUDY OF HYALURONIDASE-FACILITATED SUBCUTANEOUS IMMUNOGLOBULIN 10% TREATMENT IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASE
    Rubinstein, Arye
    Bridges, Tracy
    McNeil, Donald
    Tachdjian, Raffi
    Wedner, H. James
    Wasserman, Richard
    Leibl, Heinz
    Rabbat, Christopher
    Yel, Leman
    MUSCLE & NERVE, 2019, 60 : S61 - S61
  • [47] Tolerability and Efficacy of Facilitated-Subcutaneous Infusion of Immune Globulin (Human), 10% and Recombinant Human Hyaluronidase (Ighy) In Patients With Primary Immunodeficiency (Pi)
    Stein, Mark
    Wasserman, Richard
    Melamed, Isaac
    Rubinstein, Arye
    Engl, Werner
    Leibl, Heinz
    McCoy, Barbara
    Gelmont, David
    Schiff, Richard
    JOURNAL OF CLINICAL IMMUNOLOGY, 2012, 32 (02) : 354 - 354
  • [48] LOCAL ADVERSE REACTION RATES DECREASED OVER TIME DURING RECOMBINANT HUMAN HYALURONIDASE-FACILITATED SUBCUTANEOUS INFUSION OF IMMUNOGLOBULIN G (IgG) (IGHy) TREATMENT IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISORDERS (PIDD) IN THE IGHy PHASE 3 STUDIES
    Stein, Mark
    Wasserman, Richard L.
    Melamed, Isaac
    Gupta, Sudhir
    Kobrynski, Lisa
    Rubenstein, Arye
    Rabbat, Christopher
    Engl, Werner
    McCoy, Barbara
    Leibl, Heinz
    Yel, Leman
    JOURNAL OF CLINICAL IMMUNOLOGY, 2016, 36 (03) : 269 - 270
  • [49] Interim Analysis of a Post-authorisation Safety Study on the Long-Term Safety of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% in Patients with Primary Immunodeficiency Diseases in Europe
    Ellerbroek, P. M.
    Van Paassen, P.
    Hanitsch, L.
    Plebani, A.
    Schmidt, R. E.
    Van Hagen, P. M.
    Wang, P.
    Fielhauers, K.
    Leibls, H.
    Chavan, S.
    Yel, L.
    EUROPEAN JOURNAL OF NEUROLOGY, 2020, 27 : 402 - 403
  • [50] Long-Term Efficacy, Adverse Events, and Tolerability of Recombinant Human Hyaluronidase -Facilitated Subcutaneous Infusion of Immunoglobulin G (FSCIG) in Patients Aged <18 Years with Primary Immunodeficiency Diseases (PID)
    Wasserman, Richard L.
    Melamed, Isaac
    Stein, Mark
    Kobrynski, Lisa
    Gupta, Sudhir
    Engl, Werner
    McCoy, Barbara
    Leibl, Heinz
    Yel, Leman
    JOURNAL OF CLINICAL IMMUNOLOGY, 2017, 37 : S53 - S54