PMID- 21674136
OWN - NLM
STAT- MEDLINE
DCOM- 20120214
LR  - 20211020
IS  - 1573-2592 (Electronic)
IS  - 0271-9142 (Print)
IS  - 0271-9142 (Linking)
VI  - 31
IP  - 5
DP  - 2011 Oct
TI  - Efficacy and safety of hizentra(R), a new 20% immunoglobulin preparation for 
      subcutaneous administration, in pediatric patients with primary immunodeficiency.
PG  - 752-61
LID - 10.1007/s10875-011-9557-z [doi]
AB  - Subcutaneous IgG treatment for primary immunodeficiencies (PI) is particularly 
      well suited for children because it does not require venous access and is mostly 
      free of systemic adverse events (AEs). In a prospective, open-label, multicenter, 
      single-arm, Phase III study, 18 children and five adolescents with PI were 
      switched from previous intravenous (IVIG) or subcutaneous (SCIG) IgG treatment to 
      receive dose-equivalent, weekly subcutaneous infusions of Hizentra((R)) for 
      40 weeks. Mean IgG trough levels were maintained in patients previously on SCIG, 
      or increased in those previously on IVIG, regardless of age. No serious bacterial 
      infections were reported during the efficacy period of the study. The rates of 
      non-serious infections were 4.77 (children) and 5.18 (adolescents) infections per 
      patient per year. Related AEs were observed in seven children (38.9%) and two 
      adolescents (40%). Three serious AEs and two AEs leading to discontinuation (all 
      unrelated) were reported in children. Hizentra((R)) is an effective and 
      well-tolerated treatment for pediatric patients.
FAU - Borte, Michael
AU  - Borte M
AD  - Hospital St. Georg GmbH Leipzig, Academic Teaching Hospital of the University of 
      Leipzig, Delitzscher Strasse 141, 04129, Leipzig, Germany. 
      Michael.Borte@sanktgeorg.de
FAU - Pac, Malgorzata
AU  - Pac M
FAU - Serban, Margit
AU  - Serban M
FAU - Gonzalez-Quevedo, Teresa
AU  - Gonzalez-Quevedo T
FAU - Grimbacher, Bodo
AU  - Grimbacher B
FAU - Jolles, Stephen
AU  - Jolles S
FAU - Zenker, Othmar
AU  - Zenker O
FAU - Neufang-Hueber, Jutta
AU  - Neufang-Hueber J
FAU - Belohradsky, Bernd
AU  - Belohradsky B
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110615
PL  - Netherlands
TA  - J Clin Immunol
JT  - Journal of clinical immunology
JID - 8102137
RN  - 0 (Hizentra)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Drug Substitution
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/*administration & dosage/adverse effects
MH  - Immunoglobulins, Intravenous/*administration & dosage/adverse effects
MH  - Immunologic Deficiency Syndromes/immunology/pathology/physiopathology/*therapy
MH  - Injections, Subcutaneous
MH  - Male
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Withholding Treatment
PMC - PMC3221851
EDAT- 2011/06/16 06:00
MHDA- 2012/02/15 06:00
PMCR- 2011/06/15
CRDT- 2011/06/16 06:00
PHST- 2011/03/29 00:00 [received]
PHST- 2011/06/02 00:00 [accepted]
PHST- 2011/06/16 06:00 [entrez]
PHST- 2011/06/16 06:00 [pubmed]
PHST- 2012/02/15 06:00 [medline]
PHST- 2011/06/15 00:00 [pmc-release]
AID - 9557 [pii]
AID - 10.1007/s10875-011-9557-z [doi]
PST - ppublish
SO  - J Clin Immunol. 2011 Oct;31(5):752-61. doi: 10.1007/s10875-011-9557-z. Epub 2011 
      Jun 15.