Influence of dosing schedule on organ exposure to cyclosporin in pediatric hematopoietic stem cell transplantation: Analysis with a PBPK model

Pharmaceutical Research

Volumn 27, Issue 12, 2010, Pages 2602-2613

  Tod, Michel ^a,b,d   Gérard, Cécile ^a,b   Bleyzac, Nathalie ^b,c   Girard, Pascal ^a,b   Freyer, Gilles ^a,b   Bertrand, Yves ^c  

^a UNIVERSITÉ DE LYON   (France)

^b UNIVERSITÉ LYON 1   (France)

^c Institut d'Hematologie et d'Oncologie Pediatrique   (France)

^d CROIX ROUSSE HOSPITAL   (France)

Author keywords

Cyclosporin; GVHD; Hematopoietic stem cell transplantation; PBPK modelling

Indexed keywords

CYCLOSPORIN; THYMOCYTE ANTIBODY;

ACUTE GRAFT VERSUS HOST DISEASE; ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; AREA UNDER THE CURVE; ARTICLE; CHILD; CONTINUOUS INFUSION; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EXPOSURE; DRUG INTERMITTENT THERAPY; FEMALE; HEMATOLOGIC MALIGNANCY; HUMAN; INFANT; INTERSTITIAL FLUID; KIDNEY; MAJOR CLINICAL STUDY; MALE; PRESCHOOL CHILD; PRIMARY PREVENTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SCHOOL CHILD; SIMULATION; TARGET ORGAN; TISSUE DISTRIBUTION;

ANIMALS; AREA UNDER CURVE; CHILD; CYCLOSPORINE; DRUG ADMINISTRATION SCHEDULE; GRAFT VS HOST DISEASE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; RATS; RETROSPECTIVE STUDIES; TISSUE DISTRIBUTION;

EID: 78651287396     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-010-0252-1     Document Type: Article

References (42)

1. Welniak LA, Blazar BR, Murphy WJ. Immunobiology of allogeneic hematopoietic stem cell transplantation. Annu Rev Immunol. 2007;25:139-70.
2. Appelbaum FR. Haematopoietic cell transplantation as immunotherapy. Nature. 2001;411:385-9.
3. Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009;373:1550-61.
4. Bowers LD. Therapeutic monitoring for cyclosporine: Difficulties in establishing a therapeutic window. Clin Biochem. 1991;24:81-7.
5. Martin P, Bleyzac N, Souillet G, Galambrun C, Bertrand Y, Maire PH, et al. Relationship between CsA trough blood concentration and severity of acute graft-versus-host disease after paediatric stem cell transplantation from matched-sibling or unrelated donors. Bone Marrow Transplant. 2003;32:777-84.
6. Martin P, Bleyzac N, Souillet G, Galambrun C, Bertrand Y, Maire PH, et al. Clinical and pharmacological risk factors for acute graft-versus-host disease after paediatric bone marrow transplantation from matched-sibling or unrelated donors. Bone Marrow Transplant. 2003;32:881-7. (Pubitemid 37369265)
7. Yee GC, Self SG, McGuire TR, Carlin J, Sanders JE, Deeg HJ. Serum cyclosporine concentration and risk of acute graft-versushost disease after allogeneic marrow transplantation. N Engl J Med. 1988;319:65-70.
8. Przepiorka D, Shapiro S, Schwinghammer TL, Bloom EJ, Rosenfeld CS, Shadduck RK, et al. Cyclosporine and methylprednisolone after allogeneic marrow transplantation: Association between low cyclosporine concentration and risk of acute graftversus- host disease. Bone Marrow Transplant. 1991;7:461-5.
9. Ghalie R, Fitzsimmons WE, Weinstein A, Manson S, Kaizer H. Cyclosporine monitoring improves graft-versus-host disease prophylaxis after bone marrow transplantation. Ann Pharmacother. 1994;28:379-83.
10. Eisner MD, August CS. Impact of donor and recipient characteristics on the development of acute and chronic graft-versus-host disease following pediatric bone marrow transplantation. Bone Marrow Transplant. 1995;15:663-8.
11. Punnett A, Sung L, Price V, Das P, Diezi M, Doyle J, et al. Achievement of target cyclosporine concentrations as a predictor of severe acute graft versus host disease in children undergoing hematopoietic stem cell transplantation and receiving cyclosporine and methotrexate prophylaxis. Ther Drug Monit. 2007;29:750-7.
12. Byrne JL, Stainer C, Hyde H, Miflin G, Haynes AP, Bessell EM, et al. Low incidence of acute graft-versus-host disease and recurrent leukaemia in patients undergoing allogeneic haemopoietic stem cell transplantation from sibling donors with methotrexate and dose-monitored cyclosporin A prophylaxis. Bone Marrow Transplant. 1998;22:541-5.
13. Carlens S, Aschan J, Remberger M, Dilber M, Ringden O. Lowdose cyclosporine of short duration increases the risk of mild and moderate GVHD and reduces the risk of relapse in HLA-identical sibling marrow transplant recipients with leukaemia. Bone Marrow Transplant. 1999;24:629-35.
14. Ruutu T, Niederwieser D, Gratwohl A, Apperley JF. A survey of the prophylaxis and treatment of acute GVHD in Europe: A report of the European Group for Blood and Marrow, Transplantation (EBMT). Chronic Leukaemia Working Party of the EBMT. Bone Marrow Transplant. 1997;19:759-64.
15. Hendriks MP, Blijlevens NM, Schattenberg AV, Burger DM, Donnelly JP. Cyclosporine short infusion and C2 monitoring in haematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2006;38:521-5.
16. Tanaka C, Kawai R, Rowland M. Physiologically based pharmacokinetics of cyclosporine A: Reevaluation of dose-nonlinear kinetics in rats. J Pharmacokinet Biopharm. 1999;27:597-623.
17. Kawai R, Mathew D, Tanaka C, Rowland M. Physiologically based pharmacokinetics of cyclosporine A: Extension to tissue distribution kinetics in rats and scale-up to human. J Pharmacol Exp Ther. 1998;287:457-68.
18. Dartois C, FreyerG,Michallet M,Henin E, You B,Darlavoix I, et al. Exposure-effect population model of inolimomab, a monoclonal antibody administered in first-line treatment for acute graft-versushost disease. Clin Pharmacokinet. 2007;46:417-32.
19. Bernareggi A, Rowland M. Physiologic modeling of cyclosporin kinetics in rat and man. J Pharmacokinet Biopharm. 1991;19:21-50.
20. Kawai R, Lemaire M. Role of blood cell uptake on cyclosporin pharmacokinetics. In: Tillement P, Eckert H, editors. Proceeding of the International Symosium on Blood Binding and Drug Transfer. Paris: EFC; 1993. p. 89-108.
21. Brown RP, Delp MD, Lindstedt SL, Rhomberg LR, Beliles RP. Physiological parameter values for physiologically based pharmacokinetic models. Toxicol Ind Health. 1997;13:407-84.
22. Niederberger W, Lemaire M, Maurer G, Nussbaumer K, Wagner O. Distribution and binding of cyclosporin in blood and tissues. Transplant Proc. 1983;15:2419-21.
23. Kawai R, Lemaire M, Steimer JL, Bruelisauer A, Niederberger W, Rowland M. Physiologically based pharmacokinetic study on a cyclosporin derivative, SDZ IMM 125. J Pharmacokinet Biopharm. 1994;22:327-65.
24. Wagner O, Schreier E, Heitz F, Maurer G. Tissue distribution, disposition, and metabolism of cyclosporine in rats. Drug Metab Dispos. 1987;15:377-83.
25. Kelly P, Kahan BD. Review: Metabolism of immunosuppressant drugs. Curr Drug Metab. 2002;3:275-87.
26. D'Argenio D, Schumitzky A. ADAPT II User's guide. Pharmacokinetic/ Pharmacodynamic Systems Analysis Software. Los Angeles: Biomedical Simulations Ressource; 1997.
27. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303-32.
28. Bjorkman S. Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: Theophylline and midazolam as model drugs. Br J Clin Pharmacol. 2005;59:691-704.
29. Edginton AN, Schmitt W, Willmann S. Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin Pharmacokinet. 2006;45:1013-34.
30. Legg B, Gupta SK, Rowland M. A model to account for the variation in cyclosporin binding to plasma lipids in transplant patients. Ther Drug Monit. 1988;10:20-7.
31. National Cholesterol Education Program (NCEP). highlights of the report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 1992;89:495-501.
32. Girardet J-P. Management of children with hypercholesterolemia. Pédiatrie. 2006;13:104-10.
33. Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet. 2006;45:931-56.
34. Wong SH. Therapeutic drug monitoring for immunosuppressants. Clin Chim Acta. 2001;313:241-53.
35. Stein CM, Murray JJ, Wood AJ. Inhibition of stimulated interleukin-2 production in whole blood: A practical measure of cyclosporine effect. Clin Chem. 1999;45:1477-84.
36. Marshall JD, Kearns GL. Developmental pharmacodynamics of cyclosporine. Clin Pharmacol Ther. 1999;66:66-75.
37. Caruso R, Perico N, Cattaneo D, Piccinini G, Bonazzola S, Remuzzi G, et al. Whole-blood calcineurin activity is not predicted by cyclosporine blood concentration in renal transplant recipients. Clin Chem. 2001;47:1679-87.
38. Barama A, Perner F, Beauregard-Zollinger L. Absorption profiling of cyclosporine therapy for de novo kidney transplantation: A retrospective randomized study comparing sparse sampling to trough monitoring [abstract no. 190]. Transplantation. 2000;69(Suppl):S162.
39. Keown PA. New concepts in cyclosporine monitoring. Curr Opin Nephrol Hypertens. 2002;11:619-26.
40. Lanino E, Rondelli R, Locatelli F, Messina C, Pession A, Balduzzi A, et al. Early (day -7) versus conventional (day -1) inception of cyclosporine-A for graft-versus-host disease prophylaxis after unrelated donor hematopoietic stem cell transplantation in children. Long-term results of an AIEOP prospective, randomized study. Biol Blood Marrow Transplant. 2009;15:741-8.
41. Dini G, Lamparelli T, Rondelli R, Lanino E, Barbanti M, Costa C, et al. Unrelated donor marrow transplantation for chronic myelogenous leukaemia. Br J Haematol. 1998;102:544-52. (Pubitemid 28346599)
42. Busauschina A, Schnuelle P, van der Woude FJ. Cyclosporine nephrotoxicity. Transplant Proc. 2004;36:229S-33S.