Inosine monophosphate dehydrogenase (IMPDH) activity as a pharmacodynamic biomarker of mycophenolic acid effects in pediatric kidney transplant recipients

Journal of Clinical Pharmacology

Volumn 51, Issue 3, 2011, Pages 309-320

  Fukuda, Tsuyoshi ^a,b   Goebel, Jens ^a,b   Thøgersen, Håvard ^a   Maseck, Denise ^a   Cox, Shareen ^a   Logan, Barbara ^a   Sherbotie, Joseph ^c   Seikaly, Mouin ^d   Vinks, Alexander A ^a,b  

^a CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

inosine monophosphate dehydrogenase (IMPDH); kidney transplantation; mycophenolic acid; pediatric patient; pharmacodynamics; pharmacokinetics

Indexed keywords

CORTICOSTEROID DERIVATIVE; INOSINATE DEHYDROGENASE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG EXPOSURE; ENZYME ACTIVITY; ENZYME BLOOD LEVEL; ENZYME INHIBITION; FEMALE; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY GRAFT; MALE; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MULTICENTER STUDY; PEDIATRIC SURGERY; PRESCHOOL CHILD; SCHOOL CHILD; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADOLESCENT; BIOLOGICAL MARKERS; BIOTRANSFORMATION; CHILD; CHILD, PRESCHOOL; ENZYME INHIBITORS; FEMALE; GLUCURONIDES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; IMP DEHYDROGENASE; KIDNEY TRANSPLANTATION; LEUKOCYTES, MONONUCLEAR; MALE; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; MYCOPHENOLIC ACID; PREOPERATIVE PERIOD; PRODRUGS;

EID: 79953811641     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010368542     Document Type: Article

References (50)

1. Filler G, Zimmering M, Mai I. Pharmacokinetics of mycophenolate mofetil are influenced by concomitant immunosuppression. Pediatr Nephrol. 2000;14:100-104. (Pubitemid 30085288)
2. Oellerich M, Shipkova M, Schutz E, et al. Pharmacokinetic and metabolic investigations of mycophenolic acid in pediatric patients after renal transplantation: implications for therapeutic drug monitoring. German Study Group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients. Ther Drug Monit. 2000;22:20-26.
3. Weber LT, Hoecker B, Armstrong VW, Oellerich M, Tönshoff B. Long-term pharmacokinetics of mycophenolic acid in pediatric renal transplant recipients over 3 years posttransplant. Ther Drug Monit. 2008;30:570-575.
4. Allison AC, Kowalski WJ, Muller CD, Eugui EM. Mechanisms of action of mycophenolic acid. Ann N Y Acad Sci. 1993;696:63-87. (Pubitemid 24062779)
5. Fulton B, Markham A. Mycophenolate mofetil: a review of its pharmacodynamic and pharmacokinetic properties and clinical efficacy in renal transplantation. Drugs. 1996;51:278-298.
6. North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS). Annual Report 2008. https://web.emmes.com/study/ped/annlrept/ annlrept.html
7. Ettenger R, Cohen A, Nast C, Moulton L, Marik J, Gales B. Mycophenolate mofetil as maintenance immunosuppression in pediatric renal transplantation. Transplant Proc. 1997;29:340-341.
8. CellCept[prescribing information]. Basel, Switzerland: Roche; 2009. http://www.rocheusa.com/products/cellcept/
9. Filler G, Feber J, Lepage N, Weiler G, Mai I. Universal approach to pharmacokinetic monitoring of immunosuppressive agents in children. Pediatr Transplant. 2002;6:411-418. (Pubitemid 35265193)
10. Weber LT, Shipkova M, Armstrong VW, et al. The pharmacokinetic- pharmacodynamic relationship for total and free mycophenolic acid in pediatric renal transplant recipients: a report of the German Study Group on Mycophenolate Mofetil Therapy. J Am Soc Nephrol. 2002;13:759-768. (Pubitemid 34183943)
11. David-Neto E, Pereira Araujo LM, Sumita NM, et al. Mycophenolic acid pharmacokinetics in stable pediatric renal transplantation. Pediatr Nephrol. 2003;18:266-272. (Pubitemid 36790053)
12. van Gelder T, Hilbrands LB, Vanrenterghem Y, et al. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999;68:261-266. (Pubitemid 29360288)
13. Cox VC, Ensom MH. Mycophenolate mofetil for solid organ transplantation: does the evidence support the need for clinical pharmacokinetic monitoring? Ther Drug Monit. 2003;25:137-157.
14. Le Meur Y, Buchler M, Thierry A, et al. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant. 2007;7:2496-2503. (Pubitemid 47566324)
15. van Gelder T, Silva HT, de Fijter JW, et al. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008;86:1043-1051.
16. Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant. 2003;3:534-542. (Pubitemid 36612836)
17. van Hest RM, van Gelder T, Bouw R, et al. Time-dependent clearance of mycophenolic acid in renal transplant recipients. Br J Clin Pharmacol. 2007;63:741-752. (Pubitemid 46753575)
18. Hale MD, Nicholls AJ, Bullingham RE, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998;64:672-683. (Pubitemid 29011387)
19. Pape L, Ehrich JH, Offner G. Long-term follow-up of pediatric transplant recipients: mycophenolic acid trough levels are not a good indicator for long-term graft function. Clin Transplant. 2004;18:576-579. (Pubitemid 39264357)
20. Glander P, Braun KP, Hambach P, et al. Non-radioactive determination of inosine 5′-monophosphate dehydrogenase (IMPDH) in peripheral mononuclear cells. Clin Biochem. 2001;34:543-549. (Pubitemid 34014847)
21. Vethe NT, Bergan S. Determination of inosine monophosphate dehydrogenase activity in human CD4+ cells isolated from whole blood during mycophenolic acid therapy. Ther Drug Monit. 2006;28:608-613. (Pubitemid 44564058)
22. Glander P, Sombogaard F, Budde K, et al. Improved assay for the nonradioactive determination of inosine 5′-monophosphate dehydrogenase activity in peripheral blood mononuclear cells. Ther Drug Monit. 2009;31:351-359.
23. Budde K, Glander P, Braun KP, et al. Pharmacodynamic monitoring of mycophenolate mofetil in renal allograft recipients. Transplant Proc. 2001;33:3313-3315.
24. Glander P, Hambach P, Braun KP, et al. Pre-transplant inosine monophosphate dehydrogenase activity is associated with clinical outcome after renal transplantation. Am J Transplant. 2004;4:2045-2051. (Pubitemid 39611633)
25. Weimert NA, Derotte M, Alloway RR, et al. Monitoring of inosine monophosphate dehydrogenase activity as a biomarker for mycophenolic acid effect: potential clinical implications. Ther Drug Monit. 2007;29:141-149. (Pubitemid 46716179)
26. Kamar N, Glander P, Nolting J, et al. Pharmacodynamic evaluation of the first dose of mycophenolate mofetil before kidney transplantation. Clin J Am Soc Nephrol. 2009;4:936-942.
27. Hocker B, Weber LT, Feneberg R, et al. Prospective, randomized trial on late steroid withdrawal in pediatric renal transplant recipients under cyclosporine microemulsion and mycophenolate mofetil. Transplantation. 2009;87:934-941.
28. US Food and Drug Administration. Guidance for Industry: E11 Clinical Investigation of Medicinal Product in the Pediatric Population. Washington, DC: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER); 2000.
29. Premaud A, Le Meur Y, Debord J, et al. Maximum a posteriori Bayesian estimation of mycophenolic acid pharmacokinetics in renal transplant recipients at different postgrafting periods. Ther Drug Monit. 2005;27:354-361. (Pubitemid 40770993)
30. Schwartz GJ, Haycock GB, Edelmann CM Jr, et al. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976;58:259-263.
31. Cox S, Cabovska B, Vinks AA. Determination of mycophenolic acid and mycophenolic acid glucuronide in human plasma using solid phase extraction and HPLC. Ther Drug Monit. 2005;27:215-216.
32. Shipkova M, Niedmann PD, Armstrong VW, Niedmann PD, Oellerich M, Wieland E. Simultaneous determination of mycophenolic acid and its glucuronide in human plasma using a simple high-performance liquid chromatography procedure. Clin Chem. 1998;44:1481-1488. (Pubitemid 28309109)
33. Nilsson C, Aboud S, Karlen K, Hejdeman B, Urassa W, Biberfeld G. Optimal blood mononuclear cell isolation procedures for gamma interferon enzyme-linked immunospot testing of healthy Swedish and Tanzanian subjects. Clin Vaccine Immunol. 2008;15:585-589. (Pubitemid 351967037)
34. van Hest RM, Mathot RA, Vulto AG, Ijzermans JN, van Gelder T. Within-patient variability of mycophenolic acid exposure: therapeutic drug monitoring from a clinical point of view. Ther Drug Monit. 2006;28:31-34. (Pubitemid 44391690)
35. Bunchman T, Navarro M, Broyer M, et al. The use of mycophenolate mofetil suspension in pediatric renal allograft recipients. Pediatr Nephrol. 2001;16:978-984. (Pubitemid 34026706)
36. Ettenger R, Sarwal MM. Mycophenolate mofetil in pediatric renal transplantation. Transplantation. 2005;80(suppl):S201-S210. (Pubitemid 41552907)
37. Shaw LM, Figurski M, Milone MC, Trofe J, Bloom RD. Therapeutic drug monitoring of mycophenolic acid. Clin J Am Soc Nephrol. 2007;2:1062-1072.
38. Filler G. Value of therapeutic drug monitoring of MMF therapy in pediatric transplantation. Pediatr Transplant. 2006;10:707-711. (Pubitemid 44186293)
39. Shaw LM, Kaplan B, DeNofrio D, et al. Pharmacokinetics and concentration-control investigations of mycophenolic acid in adults after transplantation. Ther Drug Monit. 2000;22:14-19. (Pubitemid 30083089)
40. Naesens M, de Loor H, Vanrenterghem Y, et al. The impact of renal allograft function on exposure and elimination of mycophenolic acid (MPA) and its metabolite MPA 7-O-glucuronide. Transplantation. 2007;84:362-373. (Pubitemid 47258325)
41. Filler G, Bendrick-Peart J, Christians U. Pharmacokinetics of mycophenolate mofetil and sirolimus in children. Ther Drug Monit. 2008;30:138-142. (Pubitemid 351521639)
42. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet. 2007;46:13-58. (Pubitemid 46091591)
43. Jamei M, Marciniak S, Feng K, et al. The Simcyp® population-based ADME simulator. Expert Opin Drug Metab Toxicol. 2009;5:211-223.
44. Bolger MB, Lukacova V, Woltosz WS. Simulations of the nonlinear dose dependence for substrates of influx and efflux transporters in the human intestine. AAPS J. 2009;11:353-363.
45. Kuypers DR, Naesens M, Vermeire S, et al. The impact of uridine diphosphate-glucuronosyltransferase 1A9 (UGT1A9) gene promoter region single-nucleotide polymorphisms T-275A and C-2152T on early mycophenolic acid dose-interval exposure in de novo renal allograft recipients. Clin Pharmacol Ther. 2005;78:351-361. (Pubitemid 41393670)
46. Baldelli S, Merlini S, Perico N, et al. C-440T/T-331C polymorphisms in the UGT1A9 gene affect the pharmacokinetics of mycophenolic acid in kidney transplantation. Pharmacogenomics. 2007;8:1127-1141. (Pubitemid 47578222)
47. Levesque E, Delage R, Benoit-Biancamano MO, et al. The impact of UGT1A8, UGT1A9, and UGT2B7 genetic polymorphisms on the pharmacokinetic profile of mycophenolic acid after a single oral dose in healthy volunteers. Clin Pharmacol Ther. 2007;81:392-400.
48. Shaw LM, Holt DW, Oellerich M, Meiser B, van Gelder T. Current issues in therapeutic drug monitoring of mycophenolic acid: report of a roundtable discussion. Ther Drug Monit. 2001;23:305-315. (Pubitemid 32708913)
49. Budde K, Glander P, Kramer BK, et al. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in maintenance renal transplant recipients receiving tacrolimus: clinical, pharmacokinetic, and pharmacodynamic outcomes. Transplantation. 2007;83:417-424. (Pubitemid 46667845)
50. Sombogaard F, Peeters AM, Baan CC, et al. Inosine monophosphate dehydrogenase messenger RNA expression is correlated to clinical outcomes in mycophenolate mofetil-treated kidney transplant patients, whereas inosine monophosphate dehydrogenase activity is not. Ther Drug Monit. 2009;31:549-556.