Effects of PEGylation and immune complex formation on the pharmacokinetics and biodistribution of recombinant interleukin 10 in mice

Drug Metabolism and Disposition

Volumn 40, Issue 2, 2012, Pages 360-373

  Alvarez, Hamsell M ^a   So, On Yee ^a   Hsieh, SuChun ^a   Shinsky Bjorde, Natasha ^a   Huiping, Ma ^a   Song, Yaoli ^a   Pang, Yinuo ^a   Marian, Melinda ^a   Escandón, Enrique ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FC RECEPTOR; MACROGOL; RECOMBINANT INTERLEUKIN 10;

ANIMAL EXPERIMENT; ANTIGEN ANTIBODY COMPLEX; AREA UNDER THE CURVE; ARTICLE; COMPLEX FORMATION; CONTROLLED STUDY; DRUG CLEARANCE; DRUG CONJUGATION; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG STABILITY; DRUG TRANSFORMATION; DRUG UPTAKE; FLUORESCENCE ANALYSIS; GEL PERMEATION CHROMATOGRAPHY; IN VIVO STUDY; MOUSE; NONHUMAN; PRIORITY JOURNAL; RECEPTOR BINDING;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIGEN-ANTIBODY COMPLEX; ANTIGEN-ANTIBODY REACTIONS; FEMALE; HALF-LIFE; HISTOCOMPATIBILITY ANTIGENS CLASS I; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; INTERLEUKIN-10; KIDNEY; LIVER; METABOLIC CLEARANCE RATE; MICE; MICE, INBRED STRAINS; POLYETHYLENE GLYCOLS; RECEPTORS, FC; RECOMBINANT PROTEINS; TISSUE DISTRIBUTION;

MURINAE; MUS;

EID: 84862968677     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.111.042531     Document Type: Article

References (42)

1. Asadullah K, Döcke WD, Ebeling M, Friedrich M, Belbe G, Audring H, Volk HD, and Sterry W (1999) Interleukin 10 treatment of psoriasis: clinical results of a phase 2 trial. Arch Dermatol 135:187-192. (Pubitemid 29098366)
2. Asadullah K, Sterry W, Stephanek K, Jasulaitis D, Leupold M, Audring H, Volk HD, and Döcke WD (1998) IL-10 is a key cytokine in psoriasis. Proof of principle by IL-10 therapy: a new therapeutic approach. J Clin Invest 101:783-794. (Pubitemid 28096075)
3. Braat H, Rottiers P, Hommes DW, Huyghebaert N, Remaut E, Remon JP, van Deventer SJ, Neirynck S, Peppelenbosch MP, and Steidler L (2006) A phase I trial with transgenic bacteria expressing interleukin-10 in Crohn's disease. Clin Gastroenterol Hepatol 4:754-759. (Pubitemid 43841860)
4. Charles P, Elliott MJ, Davis D, Potter A, Kalden JR, Antoni C, Breedveld FC, Smolen JS, Eberl G, deWoody K, et al. (1999) Regulation of cytokines, cytokine inhibitors, and acute-phase proteins following anti-TNF-α therapy in rheumatoid arthritis. J Immunol 163:1521-1528. (Pubitemid 29352775)
5. Deng R, Loyet KM, Lien S, Iyer S, DeForge LE, Theil FP, Lowman HB, Fielder PJ, and Prabhu S (2010) Pharmacokinetics of humanized monoclonal anti-tumor necrosis factor-α antibody and its neonatal Fc receptor variants in mice and cynomolgus monkeys. Drug Metab Dispos 38:600-605.
6. Fedorak RN, Gangl A, Elson CO, Rutgeerts P, Schreiber S, Wild G, Hanauer SB, Kilian A, Cohard M, LeBeaut A, et al. (2000) Recombinant human interleukin 10 in the treatment of patients with mild to moderately active Crohn's disease. The Interleukin 10 Inflammatory Bowel Disease Cooperative Study Group. Gastroenterology 119:1473-1482. (Pubitemid 32198672)
7. Ferrara N, Hillan KJ, Gerber HP, and Novotny W (2004) Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nat Rev Drug Discov 3:391-400. (Pubitemid 38618122)
8. Fox JA, Hotaling TE, Struble C, Ruppel J, Bates DJ, and Schoenhoff MB (1996) Tissue distribution and complex formation with IgE of an anti-IgE antibody after intravenous administration in cynomolgus monkeys. J Pharmacol Exp Ther 279:1000-1008. (Pubitemid 27166878)
9. Gérard CM, Bruyns C, Delvaux A, Baudson N, Dargent JL, Goldman M, and Velu T (1996) Loss of tumorigenicity and increased immunogenicity induced by interleukin-10 gene transfer in B16 melanoma cells. Hum Gene Ther 7:23-31. (Pubitemid 26119480)
10. Gessner JE, Heiken H, Tamm A, and Schmidt RE (1998) The IgG Fc receptor family. Ann Hematol 76:231-248. (Pubitemid 28321079)
11. Gordon MS, Margolin K, Talpaz M, Sledge GW Jr, Holmgren E, Benjamin R, Stalter S, Shak S, and Adelman D (2001) Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer. J Clin Oncol 19:843-850. (Pubitemid 32119100)
12. Hsei V, Deguzman GG, Nixon A, and Gaudreault J (2002) Complexation of VEGF with bevacizumab decreases VEGF clearance in rats. Pharm Res 19:1753-1756. (Pubitemid 35305529)
13. Ito S, Ansari P, Sakatsume M, Dickensheets H, Vazquez N, Donnelly RP, Larner AC, and Finbloom DS (1999) Interleukin-10 inhibits expression of both interferon α- and interferon γ-induced genes by suppressing tyrosine phosphorylation of STAT1. Blood 93:1456-1463. (Pubitemid 29102470)
14. Johansson A, Erlandsson A, Eriksson D, Ullén A, Holm P, Sundström BE, Roux KH, and Stigbrand T (2002) Idiotypic-anti-idiotypic complexes and their in vivo metabolism. Cancer 94:1306-1313. (Pubitemid 34150894)
15. Johansson AG, Løvdal T, Magnusson KE, Berg T, and Skogh T (1996) Liver cell uptake and degradation of soluble immunoglobulin G immune complexes in vivo and in vitro in rats. Hepatology 24:169-175. (Pubitemid 26249430)
16. Johansson AG, Sundqvist T, and Skogh T (2000) IgG immune complex binding to and activation of liver cells. An in vitro study with IgG immune complexes, Kupffer cells, sinusoidal endothelial cells and hepatocytes. Int Arch Allergy Immunol 121:329-336. (Pubitemid 30229646)
17. Keystone E, Wherry J, and Grint P (1998) IL-10 as a therapeutic strategy in the treatment of rheumatoid arthritis. Rheum Dis Clin North Am 24:629-639. (Pubitemid 28416813)
18. Kim JK, Firan M, Radu CG, Kim CH, Ghetie V, and Ward ES (1999) Mapping the site on human IgG for binding of the MHC class I-related receptor, FcRn. Eur J Immunol 29:2819-2825. (Pubitemid 30099006)
19. Kosugi I, Muro H, Shirasawa H, and Ito I (1992) Endocytosis of soluble IgG immune complex and its transport to lysosomes in hepatic sinusoidal endothelial cells. J Hepatol 16:106-114. (Pubitemid 23013185)
20. Kotenko SV (2002) The family of IL-10-related cytokines and their receptors: related, but to what extent? Cytokine Growth Factor Rev 13:223-240.
21. Liu X, Lu L, Yang Z, Palaniyandi S, Zeng R, Gao LY, Mosser DM, Roopenian DC, and Zhu X (2011) The neonatal FcR-mediated presentation of immune-complexed antigen is associated with endosomal and phagosomal pH and antigen stability in macrophages and dendritic cells. J Immunol 186:4674-4686.
22. Maack T, Johnson V, Kau ST, Figueiredo J, and Sigulem D (1979) Renal filtration, transport, and metabolism of low-molecular-weight proteins: a review. Kidney Int 16:251-270. (Pubitemid 10208487)
23. Mannik M (1980) Physicochemical and functional relationships of immune complexes. J Invest Dermatol 74:333-338.
24. 125I-labeled recombinant human tumor necrosis factor in the tumor-bearing mouse. Biotherapy 1:7-18.
25. Moore KW, de Waal Malefyt R, Coffman RL, and O'Garra A (2001) Interleukin-10 and the interleukin-10 receptor. Annu Rev Immunol 19:683-765. (Pubitemid 32368050)
26. Mocellin S, Marincola F, Rossi CR, Nitti D, and Lise M (2004) The multifaceted relationship between IL-10 and adaptive immunity: putting together the pieces of a puzzle. Cytokine Growth Factor Rev 15:61-76. (Pubitemid 38121291)
27. Mousavi SA, Sporstøl M, Fladeby C, Kjeken R, Barois N, and Berg T (2007) Receptor-mediated endocytosis of immune complexes in rat liver sinusoidal endothelial cells is mediated by FcgammaRIIb2. Hepatology 46:871-884. (Pubitemid 47436133)
28. Pestka S, Krause CD, Sarkar D, Walter MR, Shi Y, and Fisher PB (2004) Interleukin-10 and related cytokines and receptors. Annu Rev Immunol 22:929-979. (Pubitemid 38680445)
29. Presta LG (2007) inventor; Schering Corporation, assignee. Interleukin-10 antibodies. U.S. patent 7,662,379. 2007 Jan 12.
30. Presta LG (2008) Molecular engineering and design of therapeutic antibodies. Curr Opin Immunol 20:460-470.
31. Qiao SW, Kobayashi K, Johansen FE, Sollid LM, Andersen JT, Milford E, Roopenian DC, Lencer WI, and Blumberg RS (2008) Dependence of antibody-mediated presentation of antigen on FcRn. Proc Natl Acad Sci USA 105:9337-9342.
32. Rabkin R, Ryan MP, and Duckworth WC (1984) The renal metabolism of insulin. Diabetologia 27:351-357. (Pubitemid 14044457)
33. Shields RL, Namenuk AK, Hong K, Meng YG, Rae J, Briggs J, Xie D, Lai J, Stadlen A, Li B, et al. (2001) High resolution mapping of the binding site on human IgG1 for FcγRI, FcγRII, FcγRIII, and FcRn and design of IgG1 variants with improved binding to the FcγR. J Biol Chem 276:6591-6604.
34. Suzuki T, Ishii-Watabe A, Tada M, Kobayashi T, Kanayasu-Toyoda T, Kawanishi T, and Yamaguchi T (2010) Importance of neonatal FcR in regulating the serum half-life of therapeutic proteins containing the Fc domain of human IgG1: a comparative study of the affinity of monoclonal antibodies and Fc-fusion proteins to human neonatal FcR. J Immunol 184:1968-1976.
35. Tabrizi M, Bornstein GG, and Suria H (2010) Biodistribution mechanisms of therapeutic monoclonal antibodies in health and disease. AAPS J 12:33-43.
36. Takagi A, Masuda H, Takakura Y, and Hashida M (1995) Disposition characteristics of recombinant human interleukin-11 after a bolus intravenous administration in mice. J Pharmacol Exp Ther 275:537-543. (Pubitemid 26023602)
37. Takagi A, Yabe Y, Oka Y, Sawai K, Takakura Y, and Hashida M (1997) Renal disposition of recombinant human interleukin-11 in the isolated perfused rat kidney. Pharm Res 14:86-90. (Pubitemid 27113320)
38. Veronese FM and Pasut G (2005) PEGylation, successful approach to drug delivery. DDT 10:1451-1458. (Pubitemid 41483874)
39. Vieira P, de Waal-Malefyt R, Dang MN, Johnson KE, Kastelein R, Fiorentino DF, deVries JE, Roncarolo MG, Mosmann TR, and Moore KW (1991) Isolation and expression of human cytokine synthesis inhibitory factor cDNA clones: homology to Epstein-Barr virus open reading frame BCRF1. Proc Natl Acad Sci USA 88:1172-1176. (Pubitemid 21916187)
40. 125I]-labeled therapeutic proteins: application in protein drug development beyond oncology. J Pharm Sci 99:1028-1045.
41. Wang W, Lu P, Fang Y, Hamuro L, Pittman T, Carr B, Hochman J, and Prueksaritanont T (2011) Monoclonal antibodies with identical Fc sequences can bind to FcRn differentially with pharmacokinetic consequences. Drug Metab Dispos 39:1469-1477.
42. Xiang H, Nguyen CB, Kelley SK, Dybdal N, and Escandón E (2004) Tissue distribution, stability, and pharmacokinetics of Apo2 ligand/tumor necrosis factor-related apoptosisinducing ligand in human colon carcinoma COLO205 tumor-bearing nude mice. Drug Metab Dispos 32:1230-1238. (Pubitemid 39410906)