PMID- 20454851
OWN - NLM
STAT- MEDLINE
DCOM- 20110315
LR  - 20220409
IS  - 1573-2592 (Electronic)
IS  - 0271-9142 (Print)
IS  - 0271-9142 (Linking)
VI  - 30
IP  - 5
DP  - 2010 Sep
TI  - Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous 
      administration, IgPro20, in patients with primary immunodeficiency.
PG  - 734-45
LID - 10.1007/s10875-010-9423-4 [doi]
AB  - Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers 
      sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) 
      compared to intravenous immunoglobulin (IVIG). A phase I study showed good local 
      tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A 
      prospective, open-label, multicenter, single-arm, phase III study evaluated the 
      efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine 
      patients (5-72 years) previously treated with IVIG received weekly subcutaneous 
      infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial 
      infections were reported. There were 96 nonserious infections (rate 2.76/patient 
      per year). The rate of days missed from work/school was 2.06/patient per year, 
      and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of 
      AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 
      effectively protected patients with PID against infections and maintained serum 
      IgG levels without causing unexpected AEs.
FAU - Hagan, John B
AU  - Hagan JB
AD  - Division of Allergic Diseases, Mayo Clinic, 200 First St. S.W., Rochester, MN 
      55905, USA. hagan.john@mayo.edu
FAU - Fasano, Mary B
AU  - Fasano MB
FAU - Spector, Sheldon
AU  - Spector S
FAU - Wasserman, Richard L
AU  - Wasserman RL
FAU - Melamed, Isaac
AU  - Melamed I
FAU - Rojavin, Mikhail A
AU  - Rojavin MA
FAU - Zenker, Othmar
AU  - Zenker O
FAU - Orange, Jordan S
AU  - Orange JS
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100508
PL  - Netherlands
TA  - J Clin Immunol
JT  - Journal of clinical immunology
JID - 8102137
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Immunologic Factors)
RN  - Bruton type agammaglobulinemia
SB  - IM
CIN - J Clin Immunol. 2011 Oct;31(5):924-6. PMID: 21643892
MH  - Adolescent
MH  - Adult
MH  - Agammaglobulinemia/blood/drug therapy/immunology/physiopathology
MH  - Aged
MH  - Bacterial Infections/prevention & control
MH  - Child
MH  - Common Variable Immunodeficiency/blood/*drug therapy/immunology/physiopathology
MH  - Female
MH  - Genetic Diseases, X-Linked/blood/drug therapy/immunology/physiopathology
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Immunoglobulins, Intravenous/therapeutic use
MH  - Immunologic Factors/*administration & dosage/adverse effects/therapeutic use
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Protein Stability
PMC - PMC2935975
EDAT- 2010/05/11 06:00
MHDA- 2011/03/16 06:00
PMCR- 2010/05/08
CRDT- 2010/05/11 06:00
PHST- 2010/02/15 00:00 [received]
PHST- 2010/04/13 00:00 [accepted]
PHST- 2010/05/11 06:00 [entrez]
PHST- 2010/05/11 06:00 [pubmed]
PHST- 2011/03/16 06:00 [medline]
PHST- 2010/05/08 00:00 [pmc-release]
AID - 9423 [pii]
AID - 10.1007/s10875-010-9423-4 [doi]
PST - ppublish
SO  - J Clin Immunol. 2010 Sep;30(5):734-45. doi: 10.1007/s10875-010-9423-4. Epub 2010 
      May 8.