| The effect of intravenous administration of a chimeric anti-IgE antibody on serum IgE levels in atopic subjects: efficacy, safety, and pharmacokinetics. | |
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MedLine Citation:
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PMID: 9062345 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CGP 51901 is a non-anaphylactogenic mouse/human chimeric anti-human IgE antibody that binds to free IgE and surface IgE of IgE-expressing B cells but not to IgE bound to high affinity IgE receptors (Fc epsilonR1) on mast cells and basophils or low affinity IgE receptors (Fc epsilonR2) on other cells. A phase 1 double-blind, placebo-controlled, single dose study with doses of 3, 10, 30, and 100 mg of CGP 51901 was conducted in 33 pollen-sensitive subjects who had raised levels of serum IgE and received either intravenous CGP 51901 or placebo. The administration of CGP 51901 was well tolerated and resulted in a decrease of serum free IgE levels in a dose-dependent manner, with suppression after 100 mg of CGP 51901 reaching > 96%. Time of recovery to 50% of baseline IgE correlated with the dose of administered antibody and ranged from a mean of 1.3 d for the 3 mg to 39 d for the 100 mg dose. Total IgE, comprised of free and complexed IgE, increased as stored and newly synthesized IgE bound to CGP 51901. Complexed IgE was eliminated at a rate comparable with the terminal half-life of free CGP 51901 (11-13 d at all doses). Only one subject showed a weak antibody response against CGP 51901. We conclude that the use of anti-human IgE antibody is safe and effective in reducing serum IgE levels in atopic individuals and provides a potential therapeutic approach to the treatment of atopic diseases. |
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Authors:
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J Corne; R Djukanovic; L Thomas; J Warner; L Botta; B Grandordy; D Gygax; C Heusser; F Patalano; W Richardson; E Kilchherr; T Staehelin; F Davis; W Gordon; L Sun; R Liou; G Wang; T W Chang; S Holgate |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of clinical investigation Volume: 99 ISSN: 0021-9738 ISO Abbreviation: J. Clin. Invest. Publication Date: 1997 Mar |
Date Detail:
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Created Date: 1997-04-04 Completed Date: 1997-04-04 Revised Date: 2009-11-18 |
Medline Journal Info:
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Nlm Unique ID: 7802877 Medline TA: J Clin Invest Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 879-87 Citation Subset: AIM; IM |
Affiliation:
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University Medicine, Southampton General Hospital, United Kingdom. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Animals Antibodies, Anti-Idiotypic / administration & dosage, adverse effects, therapeutic use* Antibodies, Monoclonal / administration & dosage, adverse effects, therapeutic use Basophils / secretion Chimera / immunology* Chromatography, High Pressure Liquid Dose-Response Relationship, Drug Dose-Response Relationship, Immunologic Double-Blind Method Histamine Release Humans Immunoglobulin E / analysis*, blood, immunology* Male Mice Middle Aged Pollen / immunology Radioallergosorbent Test Rhinitis, Allergic, Seasonal / drug therapy* Skin Tests |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Anti-Idiotypic; 0/Antibodies, Monoclonal; 37341-29-0/Immunoglobulin E |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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