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- Title
Subcutaneous Immunoglobulin Replacement Therapy with Hizentra® is Safe and Effective in Children Less Than 5 Years of Age.
- Authors
Patel, Niraj; Gallagher, Joel; Ochs, Hans; Prescott Atkinson, Thomas; Wahlstrom, Justin; Dorsey, Morna; Bonilla, Francisco; Heimall, Jennifer; Kobrynski, Lisa; Morris, David; Haddad, Elie
- Abstract
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.
- Subjects
IMMUNODEFICIENCY; DRUG administration; IMMUNOGLOBULINS; THERAPEUTIC use of immunoglobulins; JUVENILE diseases; SAFETY; PATIENTS
- Publication
Journal of Clinical Immunology, 2015, Vol 35, Issue 6, p558
- ISSN
0271-9142
- Publication type
Article
- DOI
10.1007/s10875-015-0190-0