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
Date
09/05/2015Pubmed ID
26336818Pubmed Central ID
PMC4572047DOI
10.1007/s10875-015-0190-0Scopus ID
2-s2.0-84942197063 (requires institutional sign-in at Scopus site) 16 CitationsAbstract
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.
Author List
Patel NC, Gallagher JL, Ochs HD, Atkinson TP, Wahlstrom J, Dorsey M, Bonilla FA, Heimall J, Kobrynski L, Morris D, Haddad EMESH terms used to index this publication - Major topics in bold
AdultChild
Child, Preschool
Female
Humans
Immunoglobulin G
Immunologic Deficiency Syndromes
Infant
Injections, Subcutaneous
Male
Retrospective Studies
Weight Gain
