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Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age.

Publication ,  Journal Article
Patel, NC; Gallagher, JL; Ochs, HD; Atkinson, TP; Wahlstrom, J; Dorsey, M; Bonilla, FA; Heimall, J; Kobrynski, L; Morris, D; Haddad, E
Published in: J Clin Immunol
August 2015

BACKGROUND: Hizentra® (IGSC 20%) is a 20% liquid IgG product approved for subcutaneous administration in adults and children 2 years of age and older who have primary immunodeficiency disease (PIDD). There is limited information about the use of IGSC 20 % in very young children including those less than 5 years of age. METHODS: A retrospective chart review involved 88 PIDD infants and children less than 5 years of age who received Hizentra®. RESULTS: The mean age at the start of Hizentra® was 34 months (range 2 to 59 months). IGSC 20 % was administered weekly to 86 infants (two additional infants received twice weekly and three times weekly infusions, respectively) and included an average of 63 infusions (range 6-182) for an observation period up to 45.5 months. Infusion by manual delivery occurred in 15 patients. The mean dose was 674 mg/kg/4 weeks. The mean IgG level was 942 mg/dL while on IGSC 20 %, compared to a mean trough IgG level of 794 mg/dL (p < 0.0001) during intravenous or subcutaneous IgG administration prior to IGSC 20 %. Average infusion time was 47 (range 5-120) minutes, and the median number of infusion sites was 2 (range 1-4). Local reactions were mostly mild and observed in 36/88 (41%) children. No serious adverse events were reported. A significant increase in weight percentile (7 % ± 19.2, p = 0.0012) among subjects was observed during IGSC 20% administration. The rate of serious bacterial infections was 0.067 per patient-year while receiving IGSC 20%, similar to previously reported efficacy studies. CONCLUSIONS: Hizentra® is effective in preventing infections, and is well tolerated in children less than age 5 years.

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Published In

J Clin Immunol

DOI

EISSN

1573-2592

Publication Date

August 2015

Volume

35

Issue

6

Start / End Page

558 / 565

Location

Netherlands

Related Subject Headings

  • Weight Gain
  • Retrospective Studies
  • Male
  • Injections, Subcutaneous
  • Infant
  • Immunology
  • Immunologic Deficiency Syndromes
  • Immunoglobulin G
  • Humans
  • Female
 

Citation

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Patel, N. C., Gallagher, J. L., Ochs, H. D., Atkinson, T. P., Wahlstrom, J., Dorsey, M., … Haddad, E. (2015). Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age. J Clin Immunol, 35(6), 558–565. https://doi.org/10.1007/s10875-015-0190-0
Patel, Niraj C., Joel L. Gallagher, Hans D. Ochs, Thomas Prescott Atkinson, Justin Wahlstrom, Morna Dorsey, Francisco A. Bonilla, et al. “Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age.J Clin Immunol 35, no. 6 (August 2015): 558–65. https://doi.org/10.1007/s10875-015-0190-0.
Patel NC, Gallagher JL, Ochs HD, Atkinson TP, Wahlstrom J, Dorsey M, et al. Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age. J Clin Immunol. 2015 Aug;35(6):558–65.
Patel, Niraj C., et al. “Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age.J Clin Immunol, vol. 35, no. 6, Aug. 2015, pp. 558–65. Pubmed, doi:10.1007/s10875-015-0190-0.
Patel NC, Gallagher JL, Ochs HD, Atkinson TP, Wahlstrom J, Dorsey M, Bonilla FA, Heimall J, Kobrynski L, Morris D, Haddad E. Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age. J Clin Immunol. 2015 Aug;35(6):558–565.
Journal cover image

Published In

J Clin Immunol

DOI

EISSN

1573-2592

Publication Date

August 2015

Volume

35

Issue

6

Start / End Page

558 / 565

Location

Netherlands

Related Subject Headings

  • Weight Gain
  • Retrospective Studies
  • Male
  • Injections, Subcutaneous
  • Infant
  • Immunology
  • Immunologic Deficiency Syndromes
  • Immunoglobulin G
  • Humans
  • Female