Pharmacokinetics and immunomodulatory properties of intravenously administered recombinant human interleukin-10 in healthy volunteers

Blood

Volumn 87, Issue 2, 1996, Pages 699-705

  Huhn, Richard D ^a   Radwanski, Elaine ^b   O'Connell, Sean M ^b   Sturgill, Marc G ^b   Clarke, Laura ^b   Cody, Ronald P ^b   Affrime, Melton B ^b   Cutler, David L ^b  

^a ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIUM LIPOPOLYSACCHARIDE; CD14 ANTIGEN; HLA DR ANTIGEN; INTERLEUKIN 1BETA; PLACEBO; RECOMBINANT INTERLEUKIN 10; TUMOR NECROSIS FACTOR ALPHA;

ADULT; ANTIGEN EXPRESSION; ARTHRITIS; ARTICLE; AUTOIMMUNITY; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG HALF LIFE; DRUG TOLERABILITY; FEVER; GRAFT REJECTION; GRAFT VERSUS HOST REACTION; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOMODULATION; INFLAMMATION; INTRAVENOUS DRUG ADMINISTRATION; MALE; MYALGIA; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0030031182     PISSN: 00064971     EISSN: None     Source Type: Journal    
DOI: 10.1182/blood.v87.2.699.bloodjournal872699     Document Type: Article

References (32)

1. Moore KW, O'Garra A, de Waal Malefyt R, Vieira P, Mosmann TR: Interleukin-10 Annu Rev Immunol 11:165, 1993
2. Moore KW, Vieira P, Fiorentino DF, Trounstine ML, Khan TA, Mosmann TR: Homology of cytokine synthesis inhibitory factor (IL-10) to the Epstein-Barr virus gene BCRFI. Science 248:1230, 1990
3. Vieira P, de Waal Malefyt R, Dang M-N, Johnson KE, Kastelein R, Fiorentino DF, deVries JE, Roncarolo M-G, Mosmann TR, Moore KW: Isolation and expression of human cytokine synthesis inhibitory factor cDNA clones: Homology to Epstein-Barr virus open reading frame BCRFI. Proc Natl Acad Sci USA 88:1172, 1991
4. Howard M, O'Garra A: Biological properties of interleukin-10. Immunol Today 13:198, 1992
5. Rousset F, Garcia E, Defrance T, Pérrone C, Vezzio N, Hsu D-H, Kastelein R, Moore KW, Banchereau J: Interleukin-10 is a potent growth and differentiation factor for activated human B lymphocytes. Proc Natl Acad Sci USA 89:1890, 1992
6. Fiorentino DF, Zlotnik A, Mosmann TR, Howard M, O'Garra A: IL-10 inhibits cytokine production by activated macrophages. J Immunol 147:3815, 1991
7. Wang P, Wu P, Siegel MI, Egan RW, Billah MM: IL-10 inhibits transcription of cytokine genes in human peripheral blood mononuclear cells. J Immunol 153:811, 1994
8. Kasama T, Strieter RM, Lukacs NW, Burdick MD, Kunkel MD: Regulation of neutrophil-derived chemokine expression by IL-10. J Immunol 152:3559, 1994
9. de Waal Malefyt R, Haanen J, Spits H, Roncarolo M-G, te Velde A, Figdor C, Johnson K, Kastelein R, Yssel H, De Vries JE: Interleukin-10 (IL-10) and viral IL-10 strongly reduce antigen-specific human T cell proliferation by diminishing the antigen-presenting capacity of moncytes via downregulation of class II major histocompatibility complex expression. J Exp Med 174:915, 1991
10. Taga K, Tosato G: IL-10 inhibits human T cell proliferation and IL-2 production. J Immunol 149:1143, 1992
11. Howard M, Muchamuel T, Andrade S, Menon S: Interleukin 10 protects mice from lethal endotoxemia. J Exp Med 177:1205, 1993
12. Gibaldi M: Noncompartmental pharmacokinetics, in Biopharmaceutics and Clinical Pharmacokinetics, Philadelphia, Lea and Febiger, 1984, p 17
13. van der Meer JW, Endres S, Lonnemann G, Cannon JG, Ikejima T, Okusawa S, Gelfand JA, Dinarello CA: Concentrations of immunoreactive human tumor necrosis factor alpha produced by human mononuclear cells in vitro. J Leukoc Biol 43:216, 1988
14. Cannon JG, van der Meer JW, Kwiatkowski D, Endres S, Lonnemann G, Burke JF, Dinarello CA: Intereleukin-1 beta in human plasma: Optimization of blood collection, plasma extraction and radioimmunoassay methods. Lymphokine Res 7:457, 1988
15. Lifter J: Methodologies for enumerating peripheral T lymphocytes. J Clin Immunol 2:205, 1982
16. Talle MA, Allegar N, Makowski M, Rao PE, Mitter RS, Goldstein G: Classification of human lymphocytes and monocytes with the OK series of monoclonal antibodies. Diag Immunol 1:129, 1983
17. Kung PC, Goldstein G, Reinharz EL, Schlossman SF: Monoclonal antibodies defining distinctive human T cell surface antigens. Science 208:347, 1979
18. Talle MA, Rao PE, Westberg E, Allegar N, Makowski M, Mittler RS, Goldstein G: Patterns of antigenic expression on human monocytes as defined by monoclonal antibodies. Cell Immunol 78:83, 1983
19. Ebert EC, Roberts AI, O'Connell SM, Robertson FM, Nagase H. Characterization of an immunosuppressive factor derived from colon cancer cells J Immunol 138:2161, 1987
20. Lieschke GJ, Maher D, Cebon J, O'Connor M, Green M, Sheridan W, Boyd A, Rallings M, Bonnem E, Metcalf D, Burgess AW, McGrath K, Fox RM, Morstyn G: Effects of bacterially synthesized recombinant human granulocyte-macrophage colony-stimulating factor in patients with advanced malignancy. Ann Intern Med 110:357, 1989
21. Liberati AM, Horisberger MA, Palmisano L, Astolfi S, Nastari A, Mechati S, Villa A, Mancini S, Arzano S, Grignani F: Double-blind randomized phase I study on the clinical tolerance and biological effects of natural and recombinant interferon-β. J Interferon Res 12:329, 1992
22. Huhn RD, Yurkow EJ, Kuhn JG, Clarke L, Gunn H, Resta D, Shah R, Myers LA, Seibold JR: Pharmacodynamics of daily subcutaneous recombinant interleukin-3 in normal volunteers. Clin Pharmacol Ther 57:32, 1995
23. Huhn RD: Clinical pharmacology and development of recombinant human biological agents, in Thomas JA, Myers LA (eds): Biotechnology and Safety Assessment. New York, NY, Raven, 1993, p 59
24. Bocci V: Interleukins: Clinical pharmacokinetics and practical implications. Clin Pharmacokinet 21:274, 1991
25. Saunders AM: Sources of physiological variation in differential leukocyte counting. Blood Cells 11:31, 1985
26. Kushner I: The phenomenon of the acute phase response. Ann NY Acad Sci 389:39, 1982
27. Clark GH, Fraser CG: Biological variation of acute phase proteins. Ann Clin Biohem 30.373, 1995
28. Benet LZ, Mitchell JR, Sheiner LB: Pharmacokinetics: The dynamics of drug absorption, distribution, and elimination, in Gilman AG, Rall TW, Nies AS, Taylor P (eds): Goodman and Gilman's The Pharmacological Basis of Therapeutics. New York, NY, Pergammon, 1990, p 3
29. Wang P, Wu P, Anthes JC, Siegel MI, Egan RW, Billah MM: Interleukin-10 inhibits interleukin-8 production in human neutrophils. Blood 83:2678, 1994
30. Jinquan T, Larsen CG, Gesser B, Matsushima K, Thestrup-Pedersen K: Human IL-10 is a chemoattractant for CD8+ T lymphocytes and an inhibitor of IL-8-induced CD4+ T lymphocyte migration. J Immunol 151:4545, 1993
31. Wu J, Cunha FQ, Liew FY, Weiser WY: IL-10 inhibits the synthesis of migration inhibitory factor and migration inhibitory factor-mediated macrophage activation. J Immunol 151:4325, 1993
32. Chernoff AE, Granowitz EV, Shapiro L, Vannier E, Lonnemann G, Angel JB, Kennedy JS, Rabson AR, Wolff SM, Dinarello CA: A randomized, controlled trial of IL-10 in humans: Inhibition of inflammatory cytokine production and immune responses. J Immunol 154:5492, 1995