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Effects of Pegylation and Immune Complex Formation on the Pharmacokinetics and Biodistribution of Recombinant Interleukin 10.
MedLine Citation:
PMID:  22083830     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Interleukin 10 (IL-10) is a potent cytokine homodimer with multiple immunoregulatory functions. Here, we have characterized the effects of pegylation and formation of hIL-10/hαhIL-10 (humanized anti-hIL-10) immune complexes in the pharmacokinetics (PK), biodistribution and biotransformation of IL-10 in mice. In order to assess the fate of native, pegylated and antibody bound IL-10; we implemented an analytical set of fluorescent-emission-linked assays (FELA). Plasma size exclusion chromatography analysis indicated that fluoro-labeled native and pegylated murine IL-10 (mIL-10 and PEG-mIL-10) are stable in the circulation. Pegylation of IL-10 resulted in a 21-fold increased exposure, 2.7-fold increase in half-life and a 20-fold reduction in clearance. Kidney is the major organ of disposition for both native and pegylated mIL-10 with renal uptake directly related to systemic clearance. Fluorescent signal in the kidneys reached tissue-to-blood ratios up to 150 and 20 for native and PEG-mIL10, respectively. hIL-10/hαhIL-10 immune complexes are detectable in the circulation without evidence of unbound or degraded hIL-10. The exposure of hIL-10 present in immune complexes vs. hIL-10 alone, increased from 0.53 to 11.28 μg*day/ml, with a half-life of 1.16 days and a 23-fold reduction in clearance. Unlike hIL-10 alone, antibody bound hIL-10 was targeted mainly to the liver with minimal renal distribution. In addition, we found an 11-fold reduction (from 9.9 to 113 nM) in binding to the Neonatal Fc Receptor (FcRn) when the hαhIL10 antibody is conjugated to hIL-10. The potential changes in FcRn binding in vivo and increased liver uptake may explain the unique PK properties of hIL-10/hαhIL-10 immune complexes.
Authors:
Hamsell M Alvarez; On-Yee So; Suchun Hsieh; Natasha Shinsky-Bjorde; Huiping Ma; Yaoli Song; Yinuo Pang; Melinda Marian; Enrique Escandon
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-11-14
Journal Detail:
Title:  Drug metabolism and disposition: the biological fate of chemicals     Volume:  -     ISSN:  1521-009X     ISO Abbreviation:  -     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9421550     Medline TA:  Drug Metab Dispos     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
1 Merck Research Laboratories;
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