PMID- 21932110
OWN - NLM
STAT- MEDLINE
DCOM- 20120413
LR  - 20220318
IS  - 1573-2592 (Electronic)
IS  - 0271-9142 (Linking)
VI  - 31
IP  - 6
DP  - 2011 Dec
TI  - Efficacy and safety of subcutaneous vivaglobin(R) replacement therapy in previously 
      untreated patients with primary immunodeficiency: a prospective, multicenter 
      study.
PG  - 952-61
LID - 10.1007/s10875-011-9588-5 [doi]
AB  - Treatment of primary immunodeficiency (PI) is typically initiated with 
      intravenous immunoglobulin (IVIG) loading and then continued with IVIG or 
      subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study 
      evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously 
      untreated patients. In the loading phase, SCIG 100 mg/kg was administered for 
      five consecutive days (total loading dose 500 mg/kg). During the maintenance 
      phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy 
      endpoint of IgG levels >/=5 g/L on day 12 was achieved in 17 patients (94.4%; 95% 
      CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. 
      Improvement was found in many subscales of the health-related quality of life 
      questionnaires. SCIG treatment was well tolerated, with no related serious 
      adverse events (AEs). Nine (50%) patients experienced related AEs, including 
      local reactions (rate 0.105 events/infusion). The results suggest that therapy of 
      newly diagnosed patients with PI can be initiated directly with SCIG.
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 - Quinti, Isabella
AU  - Quinti I
FAU - Soresina, Annarosa
AU  - Soresina A
FAU - Fernandez-Cruz, Eduardo
AU  - Fernandez-Cruz E
FAU - Ritchie, Bruce
AU  - Ritchie B
FAU - Schmidt, Dirk S
AU  - Schmidt DS
FAU - McCusker, Christine
AU  - McCusker C
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110920
PL  - Netherlands
TA  - J Clin Immunol
JT  - Journal of clinical immunology
JID - 8102137
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins)
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Vivaglobin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Infective Agents/*administration & dosage/adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Immunoglobulins/*administration & dosage/adverse effects
MH  - Immunoglobulins, Intravenous/administration & dosage/adverse effects
MH  - Immunologic Deficiency Syndromes/blood/*drug therapy/immunology/physiopathology
MH  - Infant
MH  - Injections, Subcutaneous
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
EDAT- 2011/09/21 06:00
MHDA- 2012/04/14 06:00
CRDT- 2011/09/21 06:00
PHST- 2011/06/21 00:00 [received]
PHST- 2011/09/01 00:00 [accepted]
PHST- 2011/09/21 06:00 [entrez]
PHST- 2011/09/21 06:00 [pubmed]
PHST- 2012/04/14 06:00 [medline]
AID - 10.1007/s10875-011-9588-5 [doi]
PST - ppublish
SO  - J Clin Immunol. 2011 Dec;31(6):952-61. doi: 10.1007/s10875-011-9588-5. Epub 2011 
      Sep 20.