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



A retrospective chart review involved 88 PIDD infants and children less than 5 years of age who received Hizentra®.



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.



Hizentra® is effective in preventing infections, and is well tolerated in children less than age 5 years.
Department of Pediatrics, Section of Infectious Disease and Immunology, Levine Children's Hospital at Carolinas Medical Center, PO Box 32861, Charlotte, NC, 28203, USA. Niraj.Patel@carolinashealthcare.org.
Niraj C
NC
Patel
Department of Pediatrics, Section of Infectious Disease and Immunology, Levine Children's Hospital at Carolinas Medical Center, PO Box 32861, Charlotte, NC, 28203, USA.|Medical College of Wisconsin, Milwaukee, WI, USA.
Joel L
JL
Gallagher
Department of Pediatrics, Seattle Children's Research Institute and University of Washington, Seattle, WA, USA.
Hans D
HD
Ochs
Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.
Thomas Prescott
TP
Atkinson
Department of Pediatrics, University of California, San Francisco, CA, USA.
Justin
J
Wahlstrom
Department of Pediatrics, University of California, San Francisco, CA, USA.|Department of Pediatrics, University of South Florida, Tampa, FL, USA.
Morna
M
Dorsey
Department of Pediatrics, Boston Children's Hospital, Boston, MA, USA.
Francisco A
FA
Bonilla
Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Jennifer
J
Heimall
Department of Pediatrics, Emory University, Atlanta, GA, USA.
Lisa
L
Kobrynski
WebbWrites, Durham, NC, USA.
David
D
Morris
Department of Pediatrics, Department of Microbiology, Infectiology, and Immunology, University of Montreal, Québec, Canada.
Elie
E
Haddad
D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage*; D007153:Immunologic Deficiency Syndromes / Q000276:immunology / Q000628:therapy*; D007223:Infant; D007279:Injections, Subcutaneous; D008297:Male; D012189:Retrospective Studies; D015430:Weight Gain / Q000187:drug effects
C558471:Hizentra; D007074:Immunoglobulin G
Children; Efficacy; Immunodeficiency; Immunoglobulin; Safety; Subcutaneous