Prophylactic and therapeutic effects of a humanized monoclonal antibody against the IL-2 receptor (DACLIZUMAB) on collagen-induced arthritis (CIA) in rhesus monkeys
H. P. M. Brok
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorJ. M. Tekoppele
Division of Vascular and Connective Tissue Research, TNO Prevention and Health, Leiden,
Search for more papers by this authorJ. Hakimi
Department of Inflammation/Autoimmune Diseases, Hoffmann-La Roche Inc., Nutley, NJ, USA
Search for more papers by this authorJ. A. Kerwin
Department of Inflammation/Autoimmune Diseases, Hoffmann-La Roche Inc., Nutley, NJ, USA
Search for more papers by this authorE. M. Nijenhuis
Department of Psychological and Research Methodology, Faculty of Social Sciences, Leiden University, Leiden, The Netherlands and
Search for more papers by this authorC. W. De Groot
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorR. E. Bontrop
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorB. A. ‘t Hart
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorH. P. M. Brok
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorJ. M. Tekoppele
Division of Vascular and Connective Tissue Research, TNO Prevention and Health, Leiden,
Search for more papers by this authorJ. Hakimi
Department of Inflammation/Autoimmune Diseases, Hoffmann-La Roche Inc., Nutley, NJ, USA
Search for more papers by this authorJ. A. Kerwin
Department of Inflammation/Autoimmune Diseases, Hoffmann-La Roche Inc., Nutley, NJ, USA
Search for more papers by this authorE. M. Nijenhuis
Department of Psychological and Research Methodology, Faculty of Social Sciences, Leiden University, Leiden, The Netherlands and
Search for more papers by this authorC. W. De Groot
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorR. E. Bontrop
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorB. A. ‘t Hart
Department of Immunobiology, Biomedical Primate Research Centre, Rijswijk,
Search for more papers by this authorAbstract
CIA in the rhesus monkey is an autoimmune-based polyarthritis with inflammation and erosion of synovial joints that shares various features with human rheumatoid arthritis (RA). The close phylogenetic relationship between man and rhesus monkey makes the model very suitable for preclinical safety and efficacy testing of new therapeutics with exclusive reactivity in primates. In this study we have investigated the prophylactic and therapeutic effects of a humanized monoclonal antibody (Daclizumab) against the α-chain of the IL-2 receptor (CD25). When Daclizumab treatment was started well after immunization but before the expected onset of CIA a significant reduction of joint-inflammation and joint-erosion was observed. A therapeutic treatment, initiated as soon as the first clinical signs of CIA were observed, proved also effective since joint-degradation was abrogated. The results of this study indicate that Daclizumab has clinical potential for the treatment of RA during periods of active inflammation and suppression of the destruction of the joint tissues.
References
- 1 Smith KA. T-cell growth factor. Immunol Rev 1980; 51: 337–57.
- 2 Uchiyama T, Broder S, Waldmann TA. A monoclonal antibody (anti-Tac) reactive with activated and functional mature human T cells. I. Production of anti-Tac monoclonal antibody and distribution of Tac (+) cells. J Immunol 1981; 126: 1393–7.
- 3 Tsudo M, Kozak RW, Goldman CK, Waldmann TA. Demonstration of new (non-Tac) peptide that binds interleukin-2: a potential participant in a multichain interleukin-2 receptor complex. Proc Natl Acad USA 1986; 83: 9694–8.
- 4 Takeshita T, Asao H, Ohtani K et al. Cloning of the γ chain and the human IL-2 receptor. Science 1992; 257: 379–82.
- 5 Waldmann TA. The interleukin-2 receptor. J Biol Chem 1991; 266: 2681–4.
- 6 Depper JM, Leonard WJ, Robb RJ, Waldmann TA, Greene WC. Blockage of the interleukin-2 receptor by anti-Tac antibody: Inhibition of human lymphocyte activation. J Immunol 1983; 131: 690–6.
- 7 Kirkman RL, Barrett LV, Gaulton GN, Kelly VE, Ythier A, Storm TA. Administration of an anti-interleukin 2 receptor monoclonal antibody prolongs cardiac allograft in mice. J Exp Med 1985; 162: 358–62.
- 8 Soulillou JP, Peyronnet P, Le Mauff M et al. Randomized controlled trial of a monoclonal antibody against the interleukin-2 receptor (33B3.1) as compared with antithymocyte globulin for prophylaxis against rejection of renal allografts. N Engl J Med 1990; 322: 1175–82.
- 9 Reed MH, Shapiro ME, Strom TB et al. Prolongation of primate renal allograft survival by anti-Tac, an anti-human IL-2 receptor monoclonal antibody. Transplantation 1989; 47: 55–9.
- 10 Kirkman RL, Shapiro ME, Carpenter CB et al. A randomized prospective trial of anti-Tac monoclonal antibody in human renal transplantation. Transplantation 1991; 51: 107–13.
- 11 Kyle V, Coughlan RJ, Tighe H et al. Beneficial effect of monoclonal antibody to interleukin 2 receptor on activated T cells in rheumatoid arthritis. Ann Rheum Dis 1989; 48: 428–9.
- 12 Queen C, Schneider WP, Selick HE et al. A humanized antibody that binds to the interleukin 2 receptor. Proc Natl Acad Sci USA 1989; 86: 10029–33.
- 13 Hakimi J, Chizzonite R, Luke DR et al. Reduced immunogenicity and improved pharmacokinetics of humanized anti-Tac in cynomolgus monkeys. J Immunol 1991; 147: 1352–9.
- 14 Brown Ps Jr, Parenteau GL, Dirbas FM et al. Anti-Tac-H, a humanized antibody to the IL-2 receptor, prolongs primate cardiac allograft survival. Proc Natl Acad Sci USA 1991; 88: 2663–7.
- 15 Vincenti F, Lantz M, Birnbaum J et al. A phase I trial of humanized anti-interleukin 2 receptor antibody in renal transplantation. Transplantation 1997; 63: 33–8.
- 16 Anasetti C, Hansen JA, Waldmann TA et al. Treatment of acute graft-versus-host disease with humanized anti-Tac: an antibody that binds to the interleukin-2 receptor. Blood 1994; 84: 1320–7.
- 17 Vincenti F, Kirkman R, Light S et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998; 338: 161–5.
- 18 Ekberg H, Backman L, Tufveson G, Tyden G. Zenapax (daclizumab) reduces the incidence of acute rejection episodes and improves patient survival following renal transplantation. No 14874 No 14393 Zenapax Study Groups Transplant Proc 1999; 31: 267–8.
- 19 El-Gabalawy HS & Keillor J. Immunohistologic study of T-cell receptor delta-chain expression in rheumatoid synovial membranes. Sem Arthritis Rheum 1992; 21: 239–45.
- 20 Chen E, Keystone EC, Fish EN. Restricted cytokine expression in rheumatoid arthritis. Arthritis Rheum 1993; 36: 901–10.
- 21 Firestein GS, Xu WD, Townsend K et al. Cytokines in chronic inflammatory arthritis. I. Failure to detect T cell lymphokines (interleukin 2 and interleukin 3) and presence of macrophage colony-stimulating factor (CSF-1) and a novel mast cell growth factor in rheumatoid synovitis. J Exp Med 1998; 168: 1573–86.
- 22 Sewell KL, Parker KC, Woodworth TG et al. DAB486IL-2 fusion toxin in refractory rheumotoid arthritis. Arthritis Rheum 1993; 36: 1223–33.
- 23 Schrohenloher RE, Koopman WJ, Woodworth TG, Moreland LW. Suppression of in vitro IgM rheumotoid factor production by diphtheria toxin interleukin 2 recombinant fusion protein (DAB 486IL-2) in patients with refractory rheumatoid arthrtis. J Rheumatol 1996; 23: 1845–8.
- 24 Bakker NPM, Van Erck MGM, Zurcher C et al. Experimental immune-mediated arthritis in rhesus monkeys. A model for human rheumatoid arthritis? Rheumatol Int 1990; 10: 21–9.
- 25 Bakker NPM, Van Erck MGM, Botman CAD, Jonker M, ′t Hart BA. Collagen-induced arthritis in an outbred group of rhesus monkeys comprising responder and nonresponder animals. Relation between the course of arthritis and collagen-specific immunity. Arthritis Rheum 1991; 34: 616–24.
- 26 ′t Hart BA & Bontrop RE. The relevance of arthritis research in nonhuman primates (Editorial). Br J Rheum 1998; 37: 314–23.
- 27 ′t Hart BA, Bank RA, De Roos JADM et al. Collagen-induced arthritis in rhesus monkeys: evaluation of markers for inflammation and joint-degradation. Br J Rheumatol, 1998; 37: 239–45.DOI: 10.1093/rheumatology/37.3.239
- 28 Bakker NPM, Van Erck MGM, Otting N et al. Resistance to collagen-induced arthritis in rhesus monkeys maps to the major histocompatibility complex class I region. J Exp Med 1992; 175: 933–7.
- 29 ′t Hart BA, Bakker NPM, Jonker M, Bontrop RE. Resistance to collagen-induced arthritis in rats and rhesus monkeys after immunization with attenuated type II collagen. Eur J Immunol 1993; 23: 1588–94.
- 30 Te Koppele JM & ′t Hart BA. Urinary collagen crosslinks to monitor bone and cartilage degradation in collagen-induced arthritis in rhesus monkeys. Acta Orthop Scand 1995; 66: 202–4.
- 31 Ronday HK. TeKoppele JM, Greenwald RA et al. Tranexamic acid, an inhibitor of plasminogen activation, reduces urinary collagen crosslink excretion in arthritis. Br J Rheumatol 1998; 37: 34–8.DOI: 10.1093/rheumatology/37.1.34
- 32 Kraan MC, Versendaal H, Jonker M et al. Asymptomatic synovitis precedes clinically manifest arthritis. Arthritis Rheum 1998; 41: 1481–8.
- 33 Bresnihan B, Mulherin D, Fitzgerald O. Synovial pathology and articular erosion in reumatoid arthritis. Rheumatol Europe 1995; 24: 158–60.
- 34 Mulherin D, Fitzgerald O, Bresnihan B. Clinical improvement and radiological deterioration in rheumatoid arthritis: evidence that the pathogenesis of synovial inflammation and articular erosion may differ. Br J Rheumatol 1996; 35: 1263–8.
