Everolimus in Combination with Cyclosporin A as Pre- and Posttransplantation Immunosuppressive Therapy in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Biology of Blood and Marrow Transplantation

Volumn 18, Issue 7, 2012, Pages 1061-1068

  Junghanss, Christian ^a   Rathsack, Susanne ^a   Wacke, Rainer ^a   Weirich, Volker ^a   Vogel, Heike ^a   Drewelow, Bernd ^a   Mueller, Sabrina ^a   Altmann, Simone ^a   Freund, Mathias ^a   Lange, Sandra ^a  

^a UNIVERSITY OF ROSTOCK   (Germany)

Author keywords

Dog; Everolimus RAD001; Hematopoietic stem cell transplantation; Nonmyeloblative; Pharmacokinetic

Indexed keywords

CREATININE; CYCLOSPORIN A; EVEROLIMUS; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; SANDIMMUM OPTORAL; TRIACYLGLYCEROL; UNCLASSIFIED DRUG;

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; DIARRHEA; DOG; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; GRAFT REJECTION; IMMUNOSUPPRESSIVE TREATMENT; LOOSE FECES; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; NONMYELOABLATIVE STEM CELL TRANSPLANTATION; PLASMA CONCENTRATION-TIME CURVE; THROMBOCYTE COUNT; TRIACYLGLYCEROL BLOOD LEVEL;

ANIMALS; AREA UNDER CURVE; BLOOD PLATELETS; CHOLESTEROL; CYCLOSPORINE; DOGS; DRUG COMBINATIONS; GRAFT REJECTION; GRAFT SURVIVAL; HEMATOPOIETIC STEM CELL TRANSPLANTATION; IMMUNOSUPPRESSIVE AGENTS; MYCOPHENOLIC ACID; PLATELET COUNT; SIROLIMUS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; WHOLE-BODY IRRADIATION;

EID: 84862122358     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2011.12.522     Document Type: Article

References (31)

1. Nashan B., Curtis J., Ponticelli C., Mourad G., Jaffe J., Haas T. Everolimus and reduced-exposure cyclosporine in de novo renal-transplant recipients: a three-year phase II, randomized, multicenter, open-label study. Transplantation 2004, 78:1332-1340. for the 156 Study Group.
2. Eisen H.J., Tuzcu E.M., Dorent R., et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med 2003, 349:847-858.
3. Kovarik J.M., Snell G.I., Valentine V., et al. Everolimus in pulmonary transplantation: pharmacokinetics and exposure-response relationships. J Heart Lung Transplant 2006, 25:440-446.
4. Vítko S., Margreiter R., Weimar W., et al. Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2005, 5:2521-2530.
5. Hill J.A., Hummel M., Starling R.C., et al. A lower incidence of cytomegalovirus infection in de novo heart transplant recipients randomized to everolimus. Transplantation 2007, 84:1436-1442.
6. Platzbecker U., von Bonin M., Goekkurt E., et al. Graft-versus-host disease prophylaxis with everolimus and tacrolimus is associated with a high incidence of sinusoidal obstruction syndrome and microangiopathy: results of the EVTAC trial. Biol Blood Marrow Transplant 2009, 15:101-108.
7. Burnett R.C., Francisco L.V., DeRose S.A., Storb R., Ostrander E.A. Identification and characterization of a highly polymorphic microsatellite marker within the canine MHC class I region. Mamm Genome 1995, 6:684-685.
8. Wagner J.L., Burnett R.C., DeRose S.A., Francisco L.V., Storb R., Ostrander E.A. Histocompatibility testing of dog families with highly polymorphic microsatellite markers. Transplantation 1996, 62:876-877.
9. Hilgendorf I., Weirich V., Zeng L., et al. Canine haematopoietic chimerism analyses by semiquantitative fluorescence detection of variable number of tandem repeat polymorphism. Vet Res Commun 2005, 29:103-110.
10. Kovarik J.M., Beyer D., Bizot M.N., Jiang Q., Allison M.J., Schmouder R.L. Pharmacokinetic interaction between verapamil and everolimus in healthy subjects. Br J Clin Pharmacol 2005, 60:434-437.
11. Kovarik J.M., Beyer D., Bizot M.N., Jiang Q., Shenouda M., Schmouder R.L. Blood concentrations of everolimus are markedly increased by ketoconazole. J Clin Pharmacol 2005, 45:514-518.
12. Sánchez-Brotons J.A., Sobrino-Márquez J.M., Lage-Gallé E., et al. Preliminary experience with conversion from calcineurin inhibitors to everolimus in cardiac transplantation maintenance therapy. Transplant Proc 2008, 40:3046-3048.
13. Kovarik J.M., Beyer D., Schmouder R.L. Everolimus drug interactions: application of a classification system for clinical decision making. Biopharm Drug Dispos 2006, 27:421-426.
14. Kovarik J.M., Curtis J.J., Hricik D.E., Pescovitz M.D., Scantlebury V., Vasquez A. Differential pharmacokinetic interaction of tacrolimus and cyclosporine on everolimus. Transplant Proc 2006, 38:3456-3458.
15. Brandhorst G., Tenderich G., Zittermann A., et al. Everolimus exposure in cardiac transplant recipients is influenced by concomitant calcineurin inhibitor. Ther Drug Monit 2008, 30:113-116.
16. Budde K., Neumayer H.H., Lehne G., et al. Tolerability and steady-state pharmacokinetics of everolimus in maintenance renal transplant patients. Nephrol Dial Transplant 2004, 19:2606-2614.
17. Chapman J.R., Valantine H., Albanell J., et al. Proliferation signal inhibitors in transplantation: questions at the cutting edge of everolimus therapy. Transpl Proc 2007, 39:2937-2950.
18. Kovarik J.M., Kahan B.D., Kaplan B., et al. Longitudinal assessment of everolimus in de novo renal transplant recipients over the first post-transplant year: pharmacokinetics, exposure-response relationships, and influence on cyclosporine. Clin Pharmacol Ther 2001, 69:48-56.
19. Lange S., Mueller S.C., Altmann S., et al. Pharmacokinetics of oral mycophenolate mofetil in combination with CsA in dogs after nonmyeloablative allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant 2008, 41:667-674.
20. Budde K., Lehne G., Winkler M., et al. Influence of everolimus on steady-state pharmacokinetics of cyclosporine in maintenance renal transplant patients. J Clin Pharmacol 2005, 45:781-791.
21. Kirchner G.I., Winkler M., Mueller L., et al. Pharmacokinetics of SDZ RAD and cyclosporin including their metabolites in seven kidney graft patients after the first dose of SDZ RAD. Br J Clin Pharmacol 2000, 50:449-454.
22. Storb R., Yu C., Wagner J.L., et al. Stable mixed hematopoietic chimerism in DLA-identical littermate dogs given sublethal total body irradiation before and pharmacological immunosuppression after marrow transplantation. Blood 1997, 89:3048-3054.
23. Jochum C., Beste M., Zellmer E., Graves S.S., Storb R. CD154 blockade and donor-specific transfusions in DLA-identical marrow transplantation in dogs conditioned with 1-Gy total body irradiation. Biol Blood Marrow Transplant 2007, 13:164-171.
24. Hogan W.J., Little M.T., Zellmer E., et al. Postgrafting immunosuppression with sirolimus and cyclosporine facilitates stable mixed hematopoietic chimerism in dogs given sublethal total body irradiation before marrow transplantation from DLA-identical littermates. Biol Blood Marrow Transplant 2003, 9:489-495.
25. Budde K., Becker T., Arns W., et al. Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. Lancet 2011, 377:837-847.
26. Lehmkuhl H.B., Mai D., Dandel M., et al. Observational study with everolimus (Certican) in combination with low-dose cyclosporine in de novo heart transplant recipients. J Heart Lung Transplant 2007, 26:700-704.
27. Levy G., Schmidli H., Punch J., et al. Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results. Liver Transpl 2006, 12:1640-1648.
28. Vítko S., Margreiter R., Weimar W., et al. Everolimus (Certican) 12-month safety and efficacy versus mycophenolate mofetil in de novo renal transplant recipients. Transplantation 2004, 78:1532-1540.
29. Wolff D., Andree H., Hilgendorf I., Casper J., Freund M., Junghanss C. Sirolimus in combination with tacrolimus in allogeneic stem cell transplantation-timing and conditioning regimen may be crucial. Biol Blood Marrow Transplant 2008, 14:942-943.
30. Furlong T., Kiem H.P., Appelbaum F.R., et al. Sirolimus in combination with cyclosporine or tacrolimus plus methotrexate for prevention of graft-versus-host disease following hematopoietic cell transplantation from unrelated donors. Biol Blood Marrow Transplant 2008, 14:531-537.
31. Lange S., Altmann S., Brandt B., et al. Investigation of immunological approaches to enhance engraftment in a 1 Gy TBI canine hematopoietic stem cell transplantation model. Exp Hematol 2009, 37:143-150.