Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers

Clinical Pharmacology and Therapeutics

Volumn 62, Issue 2, 1997, Pages 171-180

  Huhn, Richard D ^a,b   Radwanski, Elaine ^a   Gallo, Jose ^a   Affrime, Melton B ^a   Sabo, Ron ^a   Gonyo, Gerilyn ^a   Monge, April ^a   Cutler, David L ^a  

^a National Institutes of Health ^*

^b NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INTERLEUKIN 1 RECEPTOR; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; INTERLEUKIN 1BETA; PLACEBO; RECOMBINANT INTERLEUKIN 10; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR RECEPTOR;

ADULT; ARTICLE; BLOOD TOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG SAFETY; FEMALE; FLU LIKE SYNDROME; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SUBCUTANEOUS DRUG ADMINISTRATION;

ADULT; ANTIGENS, CD; DOUBLE-BLIND METHOD; ESCHERICHIA COLI; FEMALE; HALF-LIFE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERLEUKIN 1 RECEPTOR ANTAGONIST PROTEIN; INTERLEUKIN-1; INTERLEUKIN-10; LIPOPOLYSACCHARIDES; LYMPHOCYTE ACTIVATION; MALE; RECEPTORS, INTERLEUKIN-1; RECEPTORS, TUMOR NECROSIS FACTOR; RECEPTORS, TUMOR NECROSIS FACTOR, TYPE I; RECOMBINANT PROTEINS; SAFETY; SIALOGLYCOPROTEINS; T-LYMPHOCYTES; TUMOR NECROSIS FACTOR-ALPHA;

EID: 0030764204     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0009-9236(97)90065-5     Document Type: Article

References (33)

1. H1 clones. J Exp Med 1991;170:2081-95.
2. de Waal Malefyt R, Abrams J, Bennett B, Figdor CG, De Vries JE. Interleukin 10 (IL-10) inhibits cytokine synthesis by human monocytes: an autoregulatory role of IL-10 produced by monocytes. J Exp Med 1991; 174:1209-20.
3. O'Garra A, Stapleton G, Dhar V, Pearce M, Schumacher J, Rugo H, et al. Production of cytokines by mouse B cells: B lymphomas and normal B cells produce interleukin-10. Int Immunol 1990;2:831-2.
4. Benjamin D, Knobloch TJ, Dayton MA. Human B-cell interleukin-10: B-cell lines derived from patients with acquired immunodeficiency syndrome and Burkitt's lymphoma constitutively secrete large quantities of interleukin-10. Blood 1992;80:1289-98.
5. Burdin N, Peronne C, Banchereau J, Rousset F. Epstein-Barr virus transformation induces B lymphocytes to produce human interleukin-10. J Exp Med 1993;177:295-304.
6. Mosmann TR, Coffman RL. Heterogenicity of cytokine secretion patterns and functions of helper T-cells. Adv Immunol 1989;46:111-47.
7. Enk AH, Katz SI. Identification and induction of keratinocyte-derived IL-10. J Immunol 1992;149:92-5.
8. Fiorentino DF, Zlotnik A, Mosmann TR, Howard M, O'Garra A. IL-10 inhibits cytokine production by activated macrophages. J Immunol 1991;147:3815-22.
9. Cunha FQ, Moncada S, Liew FY. Interleukin-10 (IL-10) inhibits the induction of nitric oxide synthase by interferon-gamma in murine macrophages. Biochem Biophys Res Commun 1992;182:1155-9.
10. Gazzinelli RT, Oswald IP, Hieny S, James SL, Sher A. The microbicidal activity of interferon-gamma-treated macrophages against Trypanosoma cruzi involves an 1-arginine-dependent, nitrogen oxide-mediated mechanism inhibitable by interleukin-10 and transforming growth factor-β. Eur J Immunol 1992;22:2501-6.
11. Gazzinelli RJ, Oswald IP, James SL, Sher A. IL-10 inhibits parasite killing and nitrogen oxide production by IFN-gamma-activated macrophages. J Immunol 1992;148:1792-6.
12. Taga K, Tosato G. IL-10 inhibits human T cell proliferation and IL-2 production. J Immunol 1992;149: 1143-8.
13. Howard M, Muchamuel T, Andrade S, Menon S. Interleukin 10 protects mice from lethal endotoxemia. J Exp Med 1993;177:1205-8.
14. Bean AG, Freiberg RA, Andrade S, Menon S, Zlotnik A. Interleukin 10 protects mice against staphylococcal enterotoxin B-induced lethal shock. Infect Immun 1993;61:4937-9.
15. Rennick D, Davidson N, Berg D. Interleukin-10 gene knock-out mice: a model of chronic inflammation. Clin Immunol Immunopathol 1995;76:S174-8.
16. Powrie F, Leach MW, Mauze S, Menon S, Caddie LB, Coffman RL. Inhibition of Th1 responses prevents inflammatory bowel disease in seid mice reconstituted with CD45RBhi CD4+ T cells. Immunity 1994;1:553-62.
17. Huhn RD, Radwanski E, O'Connell SM, Sturgill MG, Clarke L, Cody RP, et al. Pharmacokinetics and immunomodulatory properties of intravenously administered recombinant human interleukin-10 in healthy volunteers. Blood 1996;87:699-705.
18. Chernoff AE, Granowitz EV, Shapiro L, Vannier E, Lonnemann G, Angel JB, et al. A randomized, controlled trial of IL-10 in humans: Inhibition of inflammatory cytokine production and immune responses. J Immunol 1995;154:5492-9.
19. Lisi PJ, Chu CW, Koch GA, Endres S, Lonnemann G, Dinarello CA. Development and use of a radioimmunoassay for human interleukin-1β. Lymphokine Res 1987;7:75-84.
20. Van der Meer JWM, Endres S, Lonnemann G, Cannon JG, Ikejima T, Okusawa S, et al. Concentrations of immunoreactive human tumor necrosis factor alpha produced by human mononuclear cells in vitro. J Leukoc Biol 1988;43:216-23.
21. Shapiro L, Clark BD, Orencole SF, Poutsiaka DD, Granowitz EV, Dinarello CA. Detection of tumor necrosis factor soluble receptor p55 in blood samples from healthy and endotoxemic humans. J Infect Dis 1993;167:1344-50.
22. Poutsiaka DD, Clark BD, Vannier E, Dinarello CA. Production of interleukin-1 receptor antagonist and interleukin-1β by peripheral blood mononuclear cells is differentially regulated. Blood 1991;78:1275-81.
23. Orencole SF, Vannier E, Dinarello CA. Detection of soluble IL-1 receptor type II (IL-1sRII) in sera and plasma from healthy volunteers [Abstract]. Cytokine 1994;6:554.
24. Gibaldi M, Perrier D. Noncompartmental analysis based on statistical moment theory. In: Swarbrick J, editor. Pharmacokinetics. New York: Marcel Dekker, 1982:409-17.
25. Hassard TH. Analysis of variance. In: Understanding biostatistics. St Louis: Mosby-Year Book, 1991:75-97.
26. Kushner I. The phenomenon of the acute phase response. Ann NY Acad Sci 1982;389:39-48.
27. Tan JC, Indelicato SR, Narula SK, Zavondy PJ, Chou CC. Characterization of interleukin-10 receptors on human and mouse cells. J Biol Chem 1993;268:21053-9.
28. Shargel L, Yu ABC. Bioavailability and bioequivalence, In: Applied biopharmaceutics and pharmacokinetics. Norwalk: Appleton-Century-Crofts, 1985: 129-54.
29. Willems F, Marchant A, Delville JP, Gerard C, Delvaux A, Velu T, et al. Interleukin-10 inhibits B7 and intercellular adhesion molecule-1 expression on human monocytes. Eur J Immunol 1994;24:1007-9.
30. Carlos TM, Schwartz BR, Kovach NL. Vascular cell adhesion molecule-1 lymphocyte adherence to cytokine-activated cultured human endothelial cells. Blood 1990;76:965-970.
31. Wellicome SM, Thornhill MH, Pitzalis C, Thomas DS, Lanchbury JS, Panayi GS, et al. A monoclonal antibody that detects a novel antigen on endothelial cells that is induced by tumor necrosis factor, IL-1, or lipopolysaccharide. J Immunol 1990;144:2558-65.
32. Matthes T, Werner-Favre C, Tang H, Zhang H, Kindler V, Zubler RH. Cytokine mRNA expression during an in vitro response of human B lymphocytes: kinetics of B cell tumor necrosis factor alpha, interleukin (IL)6, ILL-10, and transforming growth factor beta 1 mRNAs. J Exp Med 1993;178:521-8.
33. Burdin N, Van Kooten C, Galibert L, Abrams JS, Wijdenes J, Banchereau J, et al. Endogenous IL-6 and IL-10 contribute to the differentiation of CD40-activated human B lymphocytes. J Immunol 1995;154: 2533-44.