PMID- 9433396
OWN - NLM
STAT- MEDLINE
DCOM- 19980206
LR  - 20061115
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 62
IP  - 6
DP  - 1997 Dec
TI  - Efficacy, pharmacodynamics, and pharmacokinetics of CGP 51901, an 
      anti-immunoglobulin E chimeric monoclonal antibody, in patients with seasonal 
      allergic rhinitis.
PG  - 675-90
AB  - The efficacy, pharmacodynamics, and pharmacokinetics of CGP 51901, a recombinant 
      monoclonal mouse-human chimeric anti-human immunoglobulin E (IgE) antibody were 
      evaluated for 153 patients with seasonal allergic rhinitis treated with placebo 
      or with 15, 30, or 60 mg CGP 51901 in six biweekly doses. Seasonal allergic 
      rhinitis was chosen to validate the concept of anti-IgE therapy because the 
      causal and temporal relation between allergen confrontation and IgE-mediated 
      evocation of symptoms is firmly established. A sustained 85% or greater reduction 
      of serum free IgE levels was shown to be effective in improving clinical 
      symptoms. The concentration of CGP 51901 needed to maintain 85% or greater 
      reduction of IgE was estimated to be about 5000 ng/ml. Baseline IgE levels and 
      body weights of the patients greatly influenced the pharmacokinetic and 
      pharmacodynamic profiles of CGP 51901. A population model was developed and 
      refined to take into account patient baseline IgE level and body weight. The 
      model was able to help predict multiple-dose pharmacokinetic and pharmacodynamic 
      profiles on the basis of single-dose pharmacokinetic and pharmacodynamic 
      measurements in the therapeutically effective dose range.
FAU - Racine-Poon, A
AU  - Racine-Poon A
AD  - Novartis Pharma, Basel, Switzerland.
FAU - Botta, L
AU  - Botta L
FAU - Chang, T W
AU  - Chang TW
FAU - Davis, F M
AU  - Davis FM
FAU - Gygax, D
AU  - Gygax D
FAU - Liou, R S
AU  - Liou RS
FAU - Rohane, P
AU  - Rohane P
FAU - Staehelin, T
AU  - Staehelin T
FAU - van Steijn, A M
AU  - van Steijn AM
FAU - Frank, W
AU  - Frank W
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (CGP 51901)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/*pharmacokinetics/*therapeutic use
MH  - Female
MH  - Humans
MH  - Immunoglobulin E/blood/*immunology
MH  - Male
MH  - Middle Aged
MH  - Models, Biological
MH  - Rhinitis, Allergic, Seasonal/blood/*metabolism/*therapy
EDAT- 1998/01/20 00:00
MHDA- 1998/01/20 00:01
CRDT- 1998/01/20 00:00
PHST- 1998/01/20 00:00 [pubmed]
PHST- 1998/01/20 00:01 [medline]
PHST- 1998/01/20 00:00 [entrez]
AID - S0009-9236(97)90087-4 [pii]
AID - 10.1016/S0009-9236(97)90087-4 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 1997 Dec;62(6):675-90. doi: 10.1016/S0009-9236(97)90087-4.