Pharmacodynamic effects of everolimus on anti-CD3 antibody-stimulated T-lymphocyte proliferation and interleukin-10 synthesis in stable kidney-transplant patients

Cytokine

Volumn 42, Issue 3, 2008, Pages 306-311

  Böhler, Torsten ^a   Waiser, Johannes ^b   Lichter, Steffi ^b   Schumann, Brit ^b   Neumayer, Hans H ^b   Kamar, Nassim ^a,c   Budde, Klemens ^b  

^a INSERM   (France)

^b HUMBOLDT UNIVERSITY   (Germany)

^c CHU RANGUEIL   (France)

Author keywords

Biomarker; Everolimus; IL 10; Kidney; Transplantation

Indexed keywords

CD3 ANTIBODY; EVEROLIMUS; INTERLEUKIN 10; LIPOPOLYSACCHARIDE; PLACEBO;

ADULT; ARTICLE; CELL PROLIFERATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOKINE PRODUCTION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; IN VITRO STUDY; KIDNEY TRANSPLANTATION; MALE; MULTICENTER STUDY; PERIPHERAL BLOOD MONONUCLEAR CELL; PHAGOCYTOSIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; T LYMPHOCYTE; TREATMENT DURATION;

ADULT; ANTIBODIES, MONOCLONAL; ANTIGENS, CD3; CELL PROLIFERATION; CELLS, CULTURED; DOUBLE-BLIND METHOD; DRUG MONITORING; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INTERLEUKIN-10; KIDNEY TRANSPLANTATION; LIPOPOLYSACCHARIDES; LYMPHOCYTE ACTIVATION; MALE; MIDDLE AGED; PHAGOCYTOSIS; SIROLIMUS; T-LYMPHOCYTES;

EID: 44549083892     PISSN: 10434666     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cyto.2008.02.015     Document Type: Article

References (37)

1. Kaplan B., Srinivas T.R., and Meier-Kriesche H.U. Factors associated with long-term renal allograft survival. Ther Drug Monit 24 (2002) 36-39
2. Waiser J., Slowinski T., Brinker-Paschke A., Budde K., Schreiber M., Bohler T., et al. Impact of the variability of cyclosporin A trough levels on long-term renal allograft function. Nephrol Dial Transplant 17 (2002) 1310-1317
3. Sedrani R., Cottens S., Kallen J., and Schuler W. Chemical modification of rapamycin: the discovery of everolimus. Transplant Proc 30 (1998) 2192-2194
4. Kovarik J.M., Hartmann S., Figueiredo J., Rordorf C., Golor G., Lison A., et al. Effect of food on everolimus absorption: quantification in healthy subjects and a confirmatory screening in patients with renal transplants. Pharmacotherapy 22 2 (2002) 154-159
5. Neumayer H.H., Pis K., Korn A., Jean C., Fritsche L., Budde K., et al. Entry-into-human study with the novel immunosuppressant Everolimus in stable renal transplant recipients. Br J Clin Pharmacol 48 5 (1999) 694-703
6. Budde K., Neumayer H.H., Lehne G., Winkler M., Hauser I.A., Lison A., et al., Everolimus W 102 Renal Transplant Study Group. Tolerability and steady-state pharmacokinetics of everolimus in maintenance renal transplant patients. Nephrol Dial Transplant 19 10 (2004) 2606-2614
7. Vitko S., Margreiter R., Weimar W., Dantal J., Kuypers D., Winkler M., et al., Everolimus B201 Study Group. Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 5 (2005) 2521-2530
8. Morales J.M., Andres A., Rengel M., and Rodicio J.L. Influence of cyclosporin, tacrolimus and rapamycin on renal function and arterial hypertension after renal transplantation. Nephrol Dial Transplant 16 (2001) 121-124
9. Stepkowski S.M., and Kahan B.D. Rapamycin and cyclosporine synergistically prolong heart and kidney allograft survival. Transplant Proc 23 (1991) 3262-3264
10. Schuurman H.J., Cottens S., Fuchs S., Joergensen J., Meerloo T., Sedrani R., et al. Everolimus, a new rapamycin derivative: synergism with cyclosporine. Transplantation 64 (1997) 32-35
11. Matsumoto Y., Hof A., Baumlin Y., and Hof R.P. Differential effect of cyclosporine A and Everolimus on neointima formation of carotid allografts in apolipoprotein E-deficient mice. Transplantation 76 (2003) 1166-1170
12. Dambrin C., Klupp J., Birsan T., Luna J., Suzuki T., Lam T., et al. Sirolimus (rapamycin) monotherapy prevents graft vascular disease in nonhuman primate recipients of orthotopic aortic allografts. Circulation 107 (2003) 2369-2374
13. Eisen H.J., Tuzcu E.M., Dorent R., Kobashigawa J., Mancini D., Valantine-von Kaeppler H.A., et al., Everolimus B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med 349 (2003) 847-858
14. Oellerich M., and Armstrong V.W. The role of therapeutic drug monitoring in individualizing immunosuppressive drug therapy: recent developments. Ther Drug Monit 28 6 (2006) 720-725 [Review]
15. Oellerich M., Barten M.J., and Armstrong V.W. Biomarkers: the link between therapeutic drug monitoring and pharmacodynamics. Ther Drug Monit 28 1 (2006) 35-38 [Review]
16. Schuler W., Sedrani R., Cottens S., Haberlin B., Schulz M., Schuurman H.J., et al. Everolimus, a new rapamycin derivative: pharmacological properties in vitro and in vivo. Transplantation 64 (1997) 36-42
17. Cohen S.B., Parry S.L., Feldmann M., and Foxwell B. Autocrine and paracrine regulation of human T cell IL-10 production. J Immunol 158 (1997) 5596-5602
18. Bohler T., Nolting J., Kamar N., Gurragchaa P., Reisener K., Glander P., et al. Validation of immunological biomarkers for the pharmacodynamic monitoring of immunosuppressive drugs in humans. Ther Drug Monit 29 1 (2007) 77-86
19. Asadullah K., Sterry W., and Volk H.D. Interleukin-10 therapy-review of a new approach. Pharmacol Rev 55 2 (2003) 241-269 [Review]
20. Jinquan T., Larsen C.G., Gesser B., Matsushima K., and 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 9 (1993) 4545-4551
21. MacNeil I.A., Suda T., Moore K.W., Mosmann T.R., and Zlotnik A. IL-10, a novel growth cofactor for mature and immature T cells. J Immunol 145 12 (1990) 4167-4173
22. Elloso M.M., Azrolan N., Sehgal S.N., Hsu P.L., Phiel K.L., Kopec C.A., et al. Protective effect of the immunosuppressant sirolimus against aortic atherosclerosis in apo E-deficient mice. Am J Transplant 3 5 (2003) 562-569
23. Mogens T., Galvani S., Canivet C., Kamar N., and Böhler T. Reconstitution of immunodeficient SCID/Beige mice with human cells. Applications in preclinical studies. Toxicology 246 (2008) 18-23
24. Halloran P.F. Immunosuppressive drugs for kidney transplantation. N Engl J Med 351 26 (2004) 2715-2729 [Review]
25. Manuela B., Angela S., and Maria-Grazia R. Rapamycin selectively expands CD4+CD25+FoxP3+ regulatory T cells. Blood 105 (2005) 4743-4748
26. Battaglia M., Stabilini A., Draghici E., Gregori S., Mocchetti C., Bonifacio E., et al. Rapamycin and interleukin-10 treatment induces T regulatory type 1 cells that mediate antigen-specific transplantation tolerance. Diabetes 55 1 (2006) 40-49
27. Dharnidharka V.R., Tejani A.H., Ho P.L., and Harmon W.E. Post-transplant lymphoproliferative disorder in the United States: young Caucasian males are at highest risk. Am J Transplant 2 (2002) 993-998
28. Majewski M., Korecka M., Kossev P., Li S., Goldman J., Moore J., et al. The immunosuppressive macrolide Everolimus inhibits growth of human Epstein-Barr virus-transformed B lymphocytes in vitro and in vivo: a potential approach to prevention and treatment of posttransplant lymphoproliferative disorders. Proc Natl Acad Sci USA 97 (2000) 4285-4290
29. Majewski M., Korecka M., Joergensen J., Fields L., Kossev P., Schuler W., et al. Immunosuppressive TOR kinase inhibitor everolimus (Everolimus) suppresses growth of cells derived from posttransplant lymphoproliferative disorder at allograft-protecting doses. Transplantation 75 (2003) 1710-1717
30. Dominguez J., Mahalati K., Kiberd B., McAlister V.C., and MacDonald A.S. Conversion to rapamycin immunosuppression in renal transplant recipients: report of an initial experience. Transplantation 70 (2000) 1244-1247
31. Czarneski J., Lin Y.C., Chong S., McCarthy B., Fernandes H., Parker G., et al. Studies in NZB IL-10 knockout mice of the requirement of IL-10 for progression of B-cell lymphoma. Leukemia 18 (2004) 597-606
32. Muti G., Klersy C., Baldanti F., Granata S., Oreste P., Pezzetti L., et al., Co-operative Study Group on PTLDs. Epstein-Barr virus (EBV) load and interleukin-10 in EBV-positive and EBV-negative post-transplant lymphoproliferative disorders. Br J Haematol 122 6 (2003) 927-933
33. Brod S.A., Nelson L.D., Khan M., and Wolinsky J.S. Increased in vitro induced CD4+ and CD8+ T cell IFN-gamma and CD4+ T cell IL-10 production in stable relapsing multiple sclerosis. Int J Neurosci 90 (1997) 187-202
34. Ziegler-Heitbrock H.W., Pechumer H., Petersmann I., Durieux J.J., Vita N., Labeta M.O., et al. CD14 is expressed and functional in human B cells. Eur J Immunol 24 (1994) 1937-1940
35. Kielian T.L., and Blecha F. CD14 and other recognition molecules for lipopolysaccharide: a review. Immunopharmacology 29 (1995) 187-205
36. Ziegler-Heitbrock H.W. Molecular mechanism in tolerance to lipopolysaccharide. J Inflamm 45 (1995) 13-26
37. Cooper E.L. Comparative immunology. Curr Pharm Des 9 (2003) 119-131