PMID- 11497339
OWN - NLM
STAT- MEDLINE
DCOM- 20011211
LR  - 20190813
IS  - 0031-6970 (Print)
IS  - 0031-6970 (Linking)
VI  - 57
IP  - 3
DP  - 2001 Jun
TI  - Pharmacokinetics of viral antibodies after administration of intravenous 
      immunoglobulin in patients with chronic lymphocytic leukaemia or multiple 
      myeloma.
PG  - 235-41
AB  - OBJECTIVE: Intravenous immunoglobulin (IVIG) preparations are derived from human 
      pooled plasma and should fulfil high standards of purity and viral safety. 
      Introduction of additional purification steps, however, may result in modulation 
      of the biological properties of immunoglobulins. Since cleavage of the 
      Fab-fragment leads to a significant decrease in half-life, the latter provides 
      information about the integrity of the immunoglobulin G (IgG) molecules. 
      Therefore, a pharmacokinetic study of a novel preparation is required to 
      determine safety and disposition in the target population. METHODS: Twenty-seven 
      patients with chronic lymphocytic leukaemia (CLL) and 12 with multiple myeloma 
      received intravenous infusions of IVIG containing antibodies against hepatitis B 
      virus (anti-HBs; n= 15; 8960 IU), cytomegalovirus (anti-CMV; n = 9; 14,250 U) or 
      varizella-zoster-virus (anti-VZV; n = 15; 6000 IU), respectively. Serum 
      concentrations of viral antibodies were determined for 71 days during and after 
      infusion. RESULTS: Maximum serum concentrations of anti-HBs, anti-CMV and 
      anti-VZV were observed at about 4 h (median) after start of the infusion. Total 
      body clearances came to 0.14 +/- 0.08 ml/min (anti-HBs), 0.10 +/- 0.02 ml/ min 
      (anti-CMV) and 0.14 +/- 0.07 ml/min (anti-VZV). The terminal elimination 
      half-lives were determined to be 25.34 +/- 8.34 days (anti-HBs), 24.66 7.28 days 
      (anti-CMV) and 31.79 +/- 12.47 days (anti-VZV). Clinical chemistry parameters 
      including C3- and C4-complement serum concentrations revealed no pathological 
      changes, seroconversion for hepatitis B and C and HIV did not occur. CONCLUSIONS: 
      The pharmacokinetic parameters of the IgG antibodies calculated after 
      administration of the novel IVIG preparations to patients with CLL and multiple 
      myeloma are in close agreement with data obtained from healthy volunteers and 
      with values of native IgG, suggesting that the production process did not impair 
      clinically relevant characteristics of the viral antibodies.
FAU - Thurmann, P A
AU  - Thurmann PA
AD  - University Witten/Herdecke, Hospital Wuppertal GmbH, Germany. 
      petra.thuermann@klinikum-wuppertal.de
FAU - Sonnenburg, C
AU  - Sonnenburg C
FAU - Valentova, K
AU  - Valentova K
FAU - Gregora, E
AU  - Gregora E
FAU - Freischlager, F
AU  - Freischlager F
FAU - Lissner, R
AU  - Lissner R
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
RN  - 0 (Antibodies, Viral)
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Antibodies, Viral/blood/*metabolism
MH  - Area Under Curve
MH  - Cytomegalovirus/immunology
MH  - Female
MH  - Half-Life
MH  - Hepatitis B/immunology
MH  - Herpesvirus 3, Human/immunology
MH  - Humans
MH  - *Immunoglobulins, Intravenous
MH  - Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy/*metabolism/radiotherapy
MH  - Male
MH  - Metabolic Clearance Rate
MH  - Middle Aged
MH  - Multiple Myeloma/drug therapy/*metabolism/radiotherapy
MH  - Pharmacokinetics
EDAT- 2001/08/11 10:00
MHDA- 2002/01/05 10:01
CRDT- 2001/08/11 10:00
PHST- 2001/08/11 10:00 [pubmed]
PHST- 2002/01/05 10:01 [medline]
PHST- 2001/08/11 10:00 [entrez]
AID - 10.1007/s002280100305 [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2001 Jun;57(3):235-41. doi: 10.1007/s002280100305.