PMID- 20550545
OWN - NLM
STAT- MEDLINE
DCOM- 20110202
LR  - 20211020
IS  - 1365-2249 (Electronic)
IS  - 0009-9104 (Print)
IS  - 0009-9104 (Linking)
VI  - 161
IP  - 3
DP  - 2010 Sep
TI  - A multi-centre study of efficacy and safety of Intratect(R), a novel intravenous 
      immunoglobulin preparation.
PG  - 512-7
LID - 10.1111/j.1365-2249.2010.04187.x [doi]
AB  - We studied the efficacy, safety and pharmacokinetic profiles of Intratect(R), a 
      recently developed polyvalent intravenous immunoglobulin (IVIG) preparation. 
      Fifty-one patients (aged 6-48 years) with primary immunodeficiencies (PID) and 
      established replacement therapy using a licensed IVIG were enrolled and treated 
      for 12 months with Intratect(R). Retrospective patient data served as prestudy 
      controls. The primary efficacy variable was the annual rate of acute serious 
      bacterial infection (ASBI) per patient. Secondary parameters were annual rate of 
      acute relevant infection (ARI), days with antibiotic use, fever, absence from 
      school/work and hospitalization. The average IVIG dose was 0.49 g/kg, with an 
      average infusion rate of 2.4 ml/kg/h. The annual ASBI rate/patient was 0.02 and 
      ARIs were detected 128 times during the 630 adverse events in 40 patients, 
      specified mainly as bronchitis, sinusitis, respiratory tract infection, rhinitis 
      and pharyngitis. The annual rate of respiratory ARIs/patient was 2.0 and the 
      rates/patient for days with fever >38 degrees C, school/work absence and hospitalization 
      were 1.81, 3.99 and 0.36, respectively. A total of 630 adverse events (AEs) were 
      observed in 50 of 51 (98.0%) of patients. In 46 of 51 patients the AEs were not 
      related to infusion. Pharmacokinetic studies after the first infusion revealed a 
      mean elimination half-life of 50.8 +/- 30.3 days. During this study, 19 of 649 
      (2.9%) IgG trough levels were below 6 g/l, better than that of reference IVIGs 
      during the 6 months before study start (10 of 201). These data suggest that 
      Intratect(R) is a well tolerated, safe and effective IgG concentrate for the 
      treatment of patients with PID.
CI  - (c) 2010 British Society for Immunology.
FAU - Kreuz, W
AU  - Kreuz W
AD  - Department of Pediatrics, Johann Wolfgang Goethe University, Frankfurt, Germany.
FAU - Erdos, M
AU  - Erdos M
FAU - Rossi, P
AU  - Rossi P
FAU - Bernatowska, E
AU  - Bernatowska E
FAU - Espanol, T
AU  - Espanol T
FAU - Marodi, L
AU  - Marodi L
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Exp Immunol
JT  - Clinical and experimental immunology
JID - 0057202
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Immunologic Factors)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Area Under Curve
MH  - Bronchitis/chemically induced
MH  - Child
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Immunoglobulins, Intravenous/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Immunologic Deficiency Syndromes/*drug therapy/metabolism/pathology
MH  - Immunologic Factors/administration & dosage/pharmacokinetics/therapeutic use
MH  - Infections/chemically induced
MH  - Infusions, Intravenous
MH  - Male
MH  - Metabolic Clearance Rate
MH  - Middle Aged
MH  - Prospective Studies
MH  - Sinusitis/chemically induced
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC2962969
EDAT- 2010/06/17 06:00
MHDA- 2011/02/03 06:00
PMCR- 2011/09/01
CRDT- 2010/06/17 06:00
PHST- 2010/06/17 06:00 [entrez]
PHST- 2010/06/17 06:00 [pubmed]
PHST- 2011/02/03 06:00 [medline]
PHST- 2011/09/01 00:00 [pmc-release]
AID - CEI4187 [pii]
AID - 10.1111/j.1365-2249.2010.04187.x [doi]
PST - ppublish
SO  - Clin Exp Immunol. 2010 Sep;161(3):512-7. doi: 10.1111/j.1365-2249.2010.04187.x.