Immune deficiencies, infection, and systemic immune disordersRecombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency
Section snippets
Study products
A 10% preparation of normal human immunoglobulin stabilized with glycine (GAMMAGARD LIQUID in the United States/Canada; elsewhere KIOVIG; Baxter Healthcare Corporation, Westlake Village, Calif) was administered intravenously (hereafter referred to as IGIV) and subcutaneously in combination with rHuPH20 (IGHy). The rHuPH20 (Halozyme Therapeutics, Inc, San Diego, Calif) component of IGHy is a preparation of purified soluble human hyaluronidase produced in Chinese hamster ovary cells formulated at
Results
Eighty-nine (89) patients with PI were enrolled; 87 aged 4 to 78 years received IGIV and 83 received IGHy. The majority presented with common variable immune deficiency (n = 49) or hypogammaglobulinemia associated with antibody deficiency (n = 17; Table E2). Participants were distributed evenly with respect to sex (see Table E3 in this article's Online Repository at www.jacionline.org). IGIV was administered for a median of 91 days and IGHy for a median of 366 days per subject during the
Discussion
The present phase III, open-label, multicenter study was conducted to investigate a novel approach to IgG replacement in patients with PI that would allow self-administration of facilitated SC Immune Globulin Infusion with rHuPH20 using the same volume and frequency as IGIV, in a single site.
The rate of acute SBIs was similar to other IGIV and IGSC products.11, 23, 24, 25 The rate of all infections for IGHy was 2.97 (95% CI, 2.51-3.47) per subject-year during the 12-month efficacy observation
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Supported by Baxter Healthcare Corporation; conducted in part at the pediatric research center at the University of California, San Francisco (UCSF; study site J. Puck) supported by the National Institutes of Health (NIH grant UL1 RR024131) to the UCSF Clinical and Translational Science Institute; and conducted in part in facilities (study site A. Rubenstein) supported by Clinical and Translational Service Awards (grants UL1RR025750, TL1RR025748, and KL2RR025749; and UL1TR000086, TL1TR000087, and KL2TR000088).
Disclosure of potential conflict of interest: R. L. Wasserman has served as a consultant and/or speaker for Baxter International, CSL Behring, and Grifols; has served as an investigator for Baxter, CSL Behring, the Korean Green Cross, and Biotest; and has served as a consultant for Biotest. I. Melamed has received one or more payments for speaking from Baxter and has served as a principal investigator for Baxter, CSL Behring, Biotest, Octapharma, and Gammaplex. M. R. Stein has received funding from Baxter International and from CSL Behring and has consultancy arrangements with and/or has provided expert testimony for Baxter International, CSL Behring, and Grifols. S. Gupta has received one or more payments for speaking from Baxter. J. Puck has received funding from Baxter for an immunoglobin clinical trial. H. Leibl is a shareholder and holds stock options in Baxter. B. McCoy is a shareholder in Baxter. The rest of the authors declare that they have no relevant conflicts of interest.
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Names and affiliations of the IGSC, 10% with rHuPH20 Study Group are provided in this article's Online Repository.