Pharmacokinetics, immunogenicity, and efficacy of dimeric TNFR binding proteins in healthy and bacteremic baboon

Journal of Applied Physiology

Volumn 84, Issue 4, 1998, Pages 1119-1130

  Solorzano, Carmen C ^a   Kaibara, Atsushi ^a   Hess, Phillip J ^a   Edwards, Paul D ^a   Ksontini, Riadh ^a   Abouhamze, Amer ^a   Mcdaniel, Sherry ^a   Frazier, Janet ^b   Trujillo, Deborah ^b   Kieft, Gary ^b   Seely, James ^b   Kohno, Tadahiko ^b   Cosenza, Mary Ellen ^b   Clare Salzler, Michael ^a   Mackay, Sally L D ^a   Martin, Steven W ^b   Moldawer, Lyle L ^a   Edwards III, Carl K ^b  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b AMGEN INC   (United States)

Author keywords

Antibodies; Baboons; Sepsis; Tumor necrosis factor receptor

Indexed keywords

DIMER; MACROGOL; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR BINDING PROTEIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; BABOON; BACTEREMIA; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; ESCHERICHIA COLI; FEMALE; IMMUNOGENICITY; MALE; NONHUMAN; PRIORITY JOURNAL; PROTEIN DOMAIN; SEPSIS; TREATMENT OUTCOME;

EID: 15144359413     PISSN: 87507587     EISSN: None     Source Type: Journal    
DOI: 10.1152/jappl.1998.84.4.1119     Document Type: Article

References (30)

1. Abraham, E., M. P. Glauser, T. Butler, J. Garbino, D. Gelmont, P. F. Laterre, K. Kudsk, H.A. Bruining, C. Otto, E. Tobin, C. Zwingelstein, W. Lesslauer, and A. Leighton. p55 Tumor necrosis factor receptor fusion protein in the treatment of patients with severe sepsis, and septic shock. A randomized controlled multicenter trial. Ro 45-2081 study group. JAMA 277: 1531-1538, 1997.
2. Abraham, E., R. Wunderink, H. Silverman, T. M. Perl, S. Nasraway, H. Levy, R. Bone, R. P. Wenzel, R. Balk, R. Allred, J. E. Pennington, and J. C. Wherry. Efficacy and safety of monoclonal antibody to human tumor necrosis factor α in patients with sepsis syndrome: a randomized, controlled, double-blind, multicenter clinical trial. JAMA 273: 934-941, 1995.
3. Brynskov, J., O. H. Nielson, I. Ahnfelt-Ronne, and K. Bendtzen. Cytokines (immunoinflammatory hormones) and their natural regulation in inflammatory bowel disease (Crohn's disease and ulcerative colitis): a review. Dig. Dis. 12: 290-304, 1994.
4. Elliott, M. J., M. Feldmann, and R. N. Maini. TNF-α blockade in rheumatoid arthritis: rationale, clinical outcomes and mechanisms of action. Int. J. Immunopharmacol. 17: 141-145, 1995.
5. Espat, N. J., J. C. Cendan, E. A. Beierle, T. A. Auffenberg, J. Rosenberg, D. Russell, J. S. Kenney, E. Fischer, W. Montegut, S. F. Lowry, E. M. Copeland III, and L. L. Moldawer. PEG-BP-30 monotherapy attenuates the cytokine-mediated inflammatory cascade in baboon Escherichia coli septic shock. J. Surg. Res. 59: 153-158, 1995.
6. Feldmann, M., F. M. Brennan, M. J. Elliot, R. O. Williams, and R. N. Maini. TNF alpha is a therapeutic target for rheumatoid arthritis. Ann. NY Acad. Sci. 766: 272-278, 1995.
7. Fink, M. P. Another negative clinical trial of a new agent for the treatment of sepsis: rethinking the process of developing adjuvant treatments for serious infections (Editorial comment). Crit. Care Med. 23: 989-991, 1995.
8. Fisher, C. J., Jr., J. M. Agosti, S. M. Opal, S. F. Lowry, R. A. Balk, J. C. Sadoff, E. Abraham, R. M. Schein, and E. Benjamin. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. N. Engl. J. Med. 334: 1697-1702, 1996.
9. Fisher, C. J., Jr., J.-F. A. Dhainaut, S. M. Opal, J. P. Pribble, R. A. Balk, G. J. Slotman, T. J. Iberti, E. C. Rackow, M. J. Shapiro, R. L. Greenman, H. D. Reines, M. P. Shelly, B. W. Thompson, J. F. LaBrecque, M. A. Catalane, W. A. Knaus, and J. C. Sadoff. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome: results from a randomized, double-blind, placebo-controlled trial. JAMA 271: 1836-1843, 1994.
10. Fisher, C. J., Jr., S. M. Opal, J. F. Dhainaut, S. Stephens, J. L. Zimmerman, P. Nightingale, S. J. Harris, R. M. Schein, E. A. Panacek, J. L. Vincent, G. E. Faulke, E. L. Warren, C. Garrard, G. Park, M. W. Bodmer, J. Cohen, C. Van der Linden, A. S. Cross, J. C. Sadoff, and the CB0006 Sepsis Syndrome Study Group. Influence of an anti-tumor necrosis factor monoclonal antibody on cytokine levels in patients with sepsis. The CB0006 Sepsis Syndrome Study Group. Crit. Care Med. 21: 318-327, 1993.
11. Fischer, E., M. A. Marano, K. J. Van Zee, C. S. Rock, A. S. Hawes, W. A. Thompson, L. DeForge, J. S. Kenney, D. G. Remick, D. C. Bloedow, R. C. Thompson, S. F. Lowry, and L. L. Moldawer. Interleukin-1 receptor blockade improves survival and hemodynamic performance in Escherichia coli septic shock, but fails to alter host responses to sublethal endotoxemia. J. Clin. Invest. 89: 1551-1557, 1992.
12. Fong, Y., K. J. Tracey, L. L. Moldawer, D. G. Hesse, K. B. Manogue, J. S. Kenney, A. T. Lee, G. C. Kuo, A. C. Allison, S. F. Lowry, and A. Cerami. Antibodies to cachectin/tumor necrosis factor reduce interleukin 1 beta and interleukin 6 appearance during lethal bacteremia. J. Exp. Med. 170: 1627-1633, 1989.
13. Gearing, A. J. H., P. Beckett, M. Christodoulou, M. Churchill, J. M. Clements, M. Crimmin, A. H. Davidson, A. H. Drummond, W. A. Galloway, R. Gilbert, J. L. Gordon, T. M. Leber, M. Mangan, K. Miller, P. Nayee, K. Owen, S. Patel, W. Thomas, G. Wells, L. M. Wood, and K. Woolley. Matrix metalloproteinases and processing of pro-TNF-α. J. Leukoc. Biol. 57: 774-777, 1995.
14. Hinshaw, L. B., P. Tekamp Olson, A. C. Chang, P. A. Lee, F. B. Taylor, Jr., C. K. Murray, G. T. Peer, T. E. Emerson, Jr., R. B. Passey, and G. C. Kuo. Survival of primates in LD100 septic shock following therapy with antibody to tumor necrosis factor (TNF alpha). Circ. Shock 30: 279-292, 1990.
15. Jones, M. D., J. Hunt, J. L. Liu, S. D. Patterson, T. Kohno, and H. S. Lu. Determination of tumor necrosis factor binding protein disulfide structure. Biochemistry 36: 14914-14923; 1997.
16. Maini, R. N., M. J. Elliott, F. M. Brennan, and M. Feldmann. Beneficial effects of tumour necrosis factor-alpha (TNF-α) blockade in rheumatoid arthritis (RA). Clin. Exp. Immunol. 101: 207-212, 1995.
17. Moldawer, L. L. Biology of proinflammatory cytokines and their antagonists. Crit. Care Med. 22, Suppl.: 3-11, 1996.
18. Moreland, L. W., S. W. Baumgartner, M. H. Schiff, E. A. Tindall, R. M. Fleischmann, A. L. Weaver, R. E. Ettlinger, S. Cohen, W. J. Koopman, K. Mohler, M. B. Widmer, and C. M. Blosch. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N. Engl. J. Med. 337: 141-147, 1997.
19. Neuner, P., G. Klosner, E. Schauer, M. Pourmojib, W. Macheiner, C. Grünwald, R. Knobler, A. Schwarz, T. A. Luger, and T. Schwarz. Pentoxifylline in vivo down-regulates the release of IL-1β, IL-6, IL-8 and tumour necrosis factor-α by human peripheral blood mononuclear cells. Immunology 83: 262-267, 1994.
20. Parmely, M. J., W. W. Zhou, C. K. Edwards, D. R. Borcherding, R. Silverstein, and D. C. Morrison. Adenosine and a related carbocyclic nucleoside analogue selectively inhibit tumor necrosis factor-alpha production and protect mice against endotoxin challenge. J. Immunol. 151: 389-396, 1993.
21. Russell, D. A., K. K. Tucker, N. Chinookoswong, R. C. Thompson, and T. Kohno. Combined inhibition of interleukin-1 and tumor necrosis factor in rodent endotoxemia: improved survival and organ function. J. Infect. Dis. 171: 1528-1538, 1995.
22. Seely, J., C. Richey, T. Grasel, and J. Wilson. Issues encountered in the production of site-specific mono-pegylated therapeutic proteins. Polymer Reprints 38: 572-573, 1997.
23. Solorzano, C. C., R. Ksontini, J. H. Pruitt, P. J. Hess, P. D. Edwards, A. Kaibara, A. Abouhamze, T. Auffenberg, R. E. Galardy, J. N. Vauthey, E. M. Copeland, C. K. Edwards, G. Y. Lauers, M. Clare-Salzler, S. L. D. MacKay, L. L. Moldawer, and D. D. Lazarus. Involvement of 26kD cell-associated TNF in experimental hepatitis and exacerbation of liver injury with a matrix metalloproteinase inhibitor. J. Immunol. 158: 414-419, 1997.
24. Taylor, F. B., Jr., A. C. Chang, C. T. Esmon, and L. B. Hinshaw. Baboon model of Escherichia coli sepsis: description of its four stages and the role of tumor necrosis factor, tissue factors, and the protein C system in septic shock. Curr. Stud. Hematol. Blood Transfus. 58: 8-14, 1991.
25. Tracey, K. J., and A. Cerami. Tumor necrosis factor: a pleiotropic cytokine and therapeutic target. Annu. Rev. Med. 45: 491-503, 1996.
26. Tracey, K. J., Y. Fong, D. G. Hesse, K. R. Manogue, A. T. Lee, G. C. Kuo, S. F. Lowry, and A. Cerami. Anti-cachectin/TNF monoclonal antibodies prevent septic shock during lethal bacteraemia. Nature 330: 662-664, 1987.
27. Van Zee, K. J., L. E. DeForge, E. Fischer, M. A. Marano, J. S. Kenney, D. G. Remick, S. F. Lowry, and L. L. Moldawer. IL-8 in septic shock, endotoxemia, and after IL-1 administration. J. Immunol. 146: 3478-3482, 1991.
28. Van Zee, K. J., T. Kohno, E. Fischer, C. S. Rock, L. L. Moldawer, and S. F. Lowry. Tumor necrosis factor soluble receptors circulate during experimental and clinical inflammation and can protect against excessive tumor necrosis factor alpha in vitro and in vivo. Proc. Natl. Acad. Sci. USA 89: 4845-4849, 1992.
29. Van Zee, K. J., L. L. Moldawer, H. S. Oldenburg, W. A. Thompson, S. A. Stackpole, W. J. Montegut, M. A. Rogy, C. Meschter, H. Gallati, C. D. Schiller, W. F. Richter, H. Loetscher, A. Ashkenazi, S. M. Chamow, F. Wurm, S. E. Galvano, S. F. Lowry, and W. Lesslauer. Protection against lethal Escherichia coli bacteremia in baboons (Papio anubis) by pretreatment with a 55-kDa TNF receptor (CD120a)-Ig fusion protein, Ro 45-2081. J. Immunol. 156: 2221-2230, 1996.
30. Welborn, M. B., III, W. G. Douglas, Z. Abouhamze, T. Auffenburg, A. S. Abouhamze, J. Baumhofer, J. M. Seeger, J. H. Pruitt, P. D. Edwards, R. Chizzonite, D. Martin, L. L. Moldawer, and T. R. S. Harward. Visceral ischemia-reperfusion injury promotes tumor necrosis factor (TNF) and interleukin-1 (IL-1) dependent organ injury in the mouse. Shock 6: 171-176, 1996.