Current immunosuppressive agents: Efficacy, side effects, and utilization

Pediatric Clinics of North America

Volumn 50, Issue 6, 2003, Pages 1283-1300

  Smith, Jodi M ^a   Nemeth, Thomas Lajos ^a   McDonald, Ruth A ^a  

^a SEATTLE CHILDREN S RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGLYCOSYL GAMMA1 CD3 MONOCLONAL ANTIBODY; ALEMTUZUMAB; AZATHIOPRINE; BASILIXIMAB; CALCINEURIN INHIBITOR; CD3 IMMUNOTOXIN; CD40 LIGAND MONOCLONAL ANTIBODY; CORTICOSTEROID; CYCLOSPORIN A; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; DACLIZUMAB; EVEROLIMUS; FINGOLIMOD; IMMUNOSUPPRESSIVE AGENT; LYMPHOCYTE ANTIBODY; METHYLPREDNISOLONE; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY HUM291; MONOCLONAL ANTIBODY HUOKT3GAMMA1; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OKT 3; ORTHOCLONE; PARACETAMOL; PREDNISONE; RAPAMYCIN; RAPAMYCIN DERIVATIVE; RIFAMPICIN; STEROID; TACROLIMUS; THYMOCYTE ANTIBODY; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ACNE; ALLOGRAFT; ALOPECIA; ANAPHYLAXIS; ANEMIA; ARTHRALGIA; ASEPTIC MENINGITIS; ASEPTIC NECROSIS; BONE MARROW SUPPRESSION; BRADYCARDIA; BRONCHOSPASM; BULIMIA; CATARACT; CHILD; CHILL; CLINICAL TRIAL; CUSHINGOID SYNDROME; DEPRESSIVE PSYCHOSIS; DIABETES MELLITUS; DIARRHEA; DYSPEPSIA; DYSPNEA; ESOPHAGITIS; FEVER; FLUID RETENTION; GASTRITIS; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; GINGIVA HYPERPLASIA; GLUCOSE INTOLERANCE; GRAFT REJECTION; GRAFT SURVIVAL; GROWTH INHIBITION; HEADACHE; HEART FAILURE; HEMATOLOGIC DISEASE; HIRSUTISM; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERKALEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPERTRICHOSIS; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOTENSION; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; INFECTION SENSITIVITY; INSOMNIA; KIDNEY DYSFUNCTION; LEUKOPENIA; LIVER TOXICITY; LUNG EDEMA; LYMPHOCYTOPENIA; MAINTENANCE THERAPY; MALIGNANT NEOPLASTIC DISEASE; MANIC PSYCHOSIS; MEGALOBLASTIC ANEMIA; MENTAL INSTABILITY; MULTICENTER STUDY; NAUSEA; NEOPLASM; NEPHROTOXICITY; NEUROLOGICAL COMPLICATION; NEUROTOXICITY; NEUTROPENIA; OBESITY; ORGAN TRANSPLANTATION; OSTEOPOROSIS; PANCREATITIS; PREMEDICATION; RASH; RESPIRATORY FAILURE; REVIEW; SIDE EFFECT; SNEEZING; STOMACH ULCER; TACHYCARDIA; THROMBOCYTOPENIA; THROMBOEMBOLISM; TRANSPLANTATION TOLERANCE; URTICARIA; VOMITING; WOUND HEALING IMPAIRMENT;

EID: 0347626159     PISSN: 00313955     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0031-3955(03)00121-4     Document Type: Review

References (89)

1. Benfield MR, Stablein D, Tejani A. Trends in immunosuppressive therapy. Pediatr Transplant 1999;3(1):27-32.
2. Hariharan S. Long-term renal transplant management: long-term kidney transplant survival. Am J Kidney Dis 2001;38(6 Suppl 6):S44-50.
3. Mayes JT, Thistlethwaite JJ, Stuart JK, Buckingham MR, Stuart FP. Reexposure to OKT3 in renal allograft recipients. Transplantation 1988;45:349-53.
4. Cole MS, Stellrecht KE, Shi JD, et al. HuM291, a humanized anti-CD3 antibody, is immunosuppressive to T cells while exhibiting reduced mitogenicity in vitro. Transplantation 1999;68:545-54.
5. Ettenger RB. Antibody therapy as an induction regimen in pediatric renal transplantation. Transplant Proc 1999;31:2677-8.
6. Brennan DC, Flavin K, Lowell JA. A randomized, double-blinded comparison of Thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients. Transplantation 1999;67:1011-8.
7. Brennan DC, Flavin JA, Lowell JA. Leukocyte response to Thymoglobulin or Atgam for induction immunosuppression in a randomized, double-blind clinical trial in renal transplant recipients. Transplant Proc 1999;31:16S-8S.
8. Bell L, Girardin C, Sharma A, Goodyer P, Mazer B. Lymphocyte subsets during and after rabbit anti-thymocyte globulin induction in pediatric renal transplantation: sustained T cell depletion. Transplant Proc 1997;29:6S-9S.
9. Gaber AO, et al. Results of the double-blind, randomized, multicenter, phase III clinical trial of Thymoglobulin versus Atgam in the treatment of acute graft rejection episodes after renal transplantation. Transplantation 1998;66:29-37.
10. Nashan B, Moore R, Amlot PL, et al. Randomized trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. Lancet 1997;350:1193.
11. Kahan BD, Rajagopalan PR, Hall MI. Reduction of the occurrence of acute cellular rejection among allograft recipients treated with basiliximab, a chimeric anit-interleukin-2 receptor monoclonal antibody. Transplantation 1999;67:276.
12. Sterkers G, et al. Duration of action of a chimeric interleukin-2 receptor monoclonal antibody, Basliximab, in pediatric kidney transplant recipients. Transplant Proc 2000;32:2757-9.
13. Kahan BD, Rajagopalan PR, Hall M. United States simulect renal study group: reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with basiliximab, a chimeric anti-interleukin-2-receptor monoclonal antibody. Transplantation 1999;67:276-84.
14. Chan L, Gaston R, Hariharan S. Evolution of immunosuppression and continued importance of acute rejection in renal transplantation. Am J Kidney Dis 2001;38(6 Suppl 6):S2-9.
15. Bumgardner GL, Hardie IR, Johnson RW, Lin A, Nashan B, Pescovitz MD, et al. Phase III Daclizumab Study Group: results of 3-year phase III clinical trials with daclizumab prophylaxis for prevention of acute rejection after renal transplantation. Transplantation 2001;72(5): 839-45.
16. Nashan B, Light S, Hardie IR, Johnson JR. Reduction of acute renal allograft rejection by daclizumab: daclizumab double therapy study group. Transplantation 1999;67:110-5.
17. Vincenti F, Kirkman R, Light S. Interleukin-2-receptor blockade with daclizumab to prevent rejection in renal transplantation. N Engl J Med 1998;338:1700-1.
18. Ettenger R, Potter D, Peskovitz M, et al. Humanized monoclonal anti-interleukin-2 receptor (IL 2R) antibody daclizumab in pediatric renal transplantation. Transplantation 1998;65:S16.
19. Benfield M, Tejani A, Ping-Leung H. Comparative study of the safety, efficacy, and practice patterns of monoclonal antibodies in pediatric renal transplantation. American Journal of Transplantation 2002;2(suppl 3):S192.
20. Vincenti F, Kirkman R, Light S, Bumgardner G, Pescovitz M, Halloran P, et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998;338:161-5.
21. Krensky AM, Clayberger C. Transplantation immunology. Clin Immunol 1994;41:819-39.
22. Sarwal MM, Yorgin PD, Alexander S, Millan MT, Belson A, Belanger N, et al. Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation. Transplantation 2001;72(1):13-21.
23. Hoyer PF, Boekenkamp A, Vester U, Offner G, Brodehl J. Conversion from Sandimmune to Neoral and induction therapy with Neoral in pediatric renal transplant recipients. Transplant Proc 1996;28(4):2259-61.
24. First MR, Alloway R, Schroeder TJ. Development of Sang-35: a cyclosporine formulation bioequivalent to Neoral. Clin Transplant 1998;12(6):518-24.
25. Schroeder TJ, Levy R, Pouletty P, First MR. A generic cyclosporine development program. Transplant Proc 1997;29:1235-8.
26. Tejani A, Harmon WE. Clinical transplantation. In: Barratt MT, Avner ED, Harmon WE, editors. Pediatric nephrology. 4th edition. Baltimore: Lippincott, Williams & Wilkins; 1999. p. 1309-38.
27. Harmon WE, Sullivan EK. Cyclosporine dosing and its relationship to outcome in pediatric renal transplantation. Kidney Int Suppl 1993;43:S50-5.
28. Feld LG, Stablein D, Fivush B, Harmon W, Tejani A. Renal transplantation in children from 1987-1996: the 1996 annual report of the North American Pediatric Renal Transplant Cooperative Study. Pediatr Transplant 1997;1:146-62.
29. Tejani A, Sullivan EK. Higher maintenance cyclosporine dose decreases the risk of graft failure in North American children: a report of the North American Pediatric Renal Transplant Cooperative Study. J Am Soc Nephrol 1996;7:550-5.
30. Shaw LM, Holt DW, Keown P, Venkataramanan R, Yatscoff RW. Current opinions on therapeutic drug monitoring of immunosuppressive drugs. Clin Ther 1999;21:1632-53.
31. Matas AJ, Gillingham KJ, Chavers BM. The importance of early cyclosporine levels in pediatric kidney transplantation. Clin Transplant 1996;10:482-6.
32. Medeiros M, Pérez-Urizar J, Muñoz R, Castañ eda-Hernádez G. Limited sampling model for area-under-the-curve monitoring in pediatric patients receiving either Sandimmune or Neoral cyclosporin A oral formulations. Pediatr Transplant 1999;3:225-30.
33. Belitsky P, Levy GA, Johnston A. Neoral absorption profiling: an evolution in effectiveness. Transplant Proc 2000;32(Suppl.3A):45S-52S.
34. Johnston A, David OJ, Cooney GF. Pharmacokinetic validation of neoral absorption profiling. Transplant Proc 2000;32(Suppl.3A):53S-6S.
35. Belitsky P, Dunn S, Johnston A, et al. Impact of absorption profiling on efficacy and safety of cyclosporine therapy in transplant recipients. Clin Pharmacokinet 2000;39:117-25.
36. Barama A, Perner F, Beauregard-Zollinger L, et al, for the neural phase IV study group. Absorption profiling of cyclosporine therapy for de novo kidney transplantation: a prospective randomized study comparing sparse sampling to trough monitoring [abstract 190]. Transplantation 2000;69(Suppl):S162.
37. David-Neto E. A strategy to calculate cyclosporin A area under the time-concentration curve in pediatric renal transplantation. Pediatr Transplant 2002;6(4):313-8.
38. March CL. Abbreviated pharmacokinetic profiles in area-under-the-curve monitoring of cyclosporine therapy in de novo renal transplant patients treated with Sandimmune or Neoral: Neoral study group. Ther Drug Monit 1999;21(1):27-34.
39. Balram C. A limited sampling strategy for the estimation of 12-hour Neoral systemic drug exposure in heart transplant recipients. J Heart Lung Transplant 2002;21(9):1016-21.
40. Wacke R. Comparison of several approaches for therapeutic drug monitoring of cyclosporin A based on individual pharmacokinetics. Eur J Clin Pharmacol 2000;56(1):43-8.
41. Wyeth Laboratories. Sirolimus (package insert). Philadelphia: Wyeth Laboratories; 2001.
42. Kahan BD. Rapamycin: personal algorithms for use based on 250 treated renal allograft recipients. Transplant Proc 1998;30(5):2185-8.
43. Khanna AK. Mechanism of the combination immunosuppressive effects of rapamycin with either cyclosporine or tacrolimus. Transplantation 2000;70(4):690-4.
44. Schenck FX, Jordan ML, Jensen CWB, et al. Pediatric renal transplantation under FK-506 immunosuppression. J Urol 1991;147:1585-7.
45. Ellis D, Shapiro R, Jordan ML, et al. Comparison of FK-506 and cyclosporine regimens in pediatric renal transplantation. Pediatr Nephrol 1994;8:193-200.
46. Shapiro R. Tacrolimus in pediatric renal transplantation: a review. Pediatr Transplant 1998;2:270-6.
47. Shapiro R, Scantlebury VP, Jordan ML, et al. FK 506 in pediatric kidney transplantation: primary and rescue experience. Pediatr Nephrol 1995;9:S43-8.
48. Birk PE, Cook ME, Schmidt WJ, Chavers BM. Preliminary experience with FK 506 in pediatric renal transplant recipients: a single center report. Transplant Proc 1996;28:993-4.
49. Ingle GR. Sirolimus: continuing the evolution of transplant immunosuppression. Ann Pharmacother 2000;34(9):1044-55.
50. Soldner A, Christians U, Susanto M, Wacher VJ, Silverman JA, Benet LZ. Grapefruit juice activates P-glycoprotein-mediated drug transport. Pharm Res 1999;16:478-85.
51. Preiss R. P-glycoprotein and related transporters. Int J Clin Pharmacol Ther 1998;36:3-8.
52. Benfield MR, Stablein D, Tejani A. Trends in immunosuppressive therapy. Pediatr Transplant 1999;3:27-32.
53. Krensky AM, Clayberger C. Transplantation immunology. Clin Immunol 1994;41:819-39.
54. Young CJ, Sollinger HW. RS-61443: a new immunosuppressive agent. Transplant Proc 1994;26(6):3144-6.
55. European Mycophenolate Mofetil Cooperative Study Group. Placebo controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. Lancet 1995;345:1321-5.
56. Sollinger HW. US Renal Transplant Mycophenolate Mofetil Study Group. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. Transplantation 1995;60:225-32.
57. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized, clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation 1996;61:1029-37.
58. Benfield MR, Symons JM, Bynon S. Mycophenolate mofetil in pediatric renal transplantation. Pediatr Transplant 1999;3:33-7.
59. Ettenger R, Menster M, Warshaw B, et al. The long-term use ofmycophenolate mofetil in pediatric renal transplantation: a report of the pediatric MMF study group. Transplantation 1999;67(7):S124.
60. Seikaly MG. Mycophenolate mofetil: is it worth the cost? The in-favor opinion. Pediatr Transplant 1999;3(1):79-82.
61. Neu AM, Benfield M. What is the role for mycophenolate mofetil in pediatric renal transplantation? Pediatr Transplant 1999;3(1):83-7.
62. Gaston RS. Maintenance immunosuppression in the renal transplant recipient: an overview. Am J Kidney Dis 2001;38(6 Suppl 6):S25-35.
63. Tsaroucha AK, Zucker K, Esquenazi V, de Faria L, Miller J, Tzakis AG. Levels of mycophenolic acid and its glucuronide derivative in the plasma of liver, small bowel and kidney transplant patients receiving tacrolimus and cellcept combination therapy. Transplant Immunol 2000;8:143-6.
64. Dumont FJ, Staruch MJ, Koprach SL, et al. The immunosuppressive and toxic effects of FK 506 are mechanistically related: pharmacology of a novel antagonism of FK 506 and rapamycin. J Exp Med 1992;176:751-60.
65. Baeder WL, Adams LM. Effect of rapamycin, cyclosporin A, and prednisolone on murine thymocyte proliferation in vitro (GTR-18812). Philadelphia: Wyeth-Ayerst Research; 1989.
66. Sirolimus European Renal Transplant Study Group. Sirolimus-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Transplantation 1999;67(7):1036-42.
67. Kahan BD. The potential role of rapamycin in pediatric transplantation as observed from adult studies. Pediatr Transplant 1999;3(3):175-80.
68. Brattstrom C, Wilcek H, Tyden G. Hyperlipidemia in renal transplant recipients treated with sirolimus (rapamycin). Transplantation 1998;65(9):1272-4.
69. Streit F, Christians U, Schiebel HM, Napili KL, Ernst L, Linck A, et al. Sensitive and specific quantification of sirolimus and its metabolites in blood of kidney graft recipients by HPLC/electrospray-mass spectrometry. Clin Chem 1996;42:1417-25.
70. McAlister VC. A clinical pharmacokinetic study of tacrolimus and sirolimus combination immunosuppression comparing simultaneous to separated administration. Ther Drug Monit 2002;24(3):346-50.
71. Schuler W, Sedrani R, Cottens S. SDZ RAD, a new rapamycin derivative: pharmacological properties in vitro and in vivo. Transplantation 1997;64(1):36-42.
72. Pinschewer D, Ochsenbeing AF, Odermatt B, et al. FTY720 immunosuppression inhibits effector T-cell peripheral homing without affecting induction, expansion and memory. J Immunol 2000;164:5761-70.
73. Suzuki S, Li XK, Enosawa T, Shinomiya T. A new immunosuppressant FTY720 induces bcl-2-associated apoptotic cell death in human lymphocytes. Immunology 1996;89:518-23.
74. Chiba K, Yanagawa Y, Masubuchi Y, Kataoka H, Kawaguchi T, Ohtsuki M, et al. FTY720, a novel immunosuppressant, induces sequestration of circulating mature lymphocytes by acceleration of lymphocyte homing in rats. I. FTY720 selectively decreases the number of circulating mature lymphocytes by acceleration of lymphocyte homing. J Immunol 1998;160:5037-44.
75. Pinschewer DD, Ochsenbein AF, Odermatt B, Brinkmann V, Hengartner H, Zinkemagel RM. FTY720 immunosuppression impairs effector T cell peripheral homing without affecting induction, expansion, and memory. J Immunol 2000;164:5761-70.
76. Budde K, Schmouder RL, Brunkhorst R, Nashan B, Lucker PW, Mayer T, et al. First human trial of FTY720, a novel immunomodulator, in stable renal transplant patients. J Am Soc Nephrol 2002;13(4):1073-83.
77. Nashan B. The role of certican (everolimus, rad) in the many pathways of chronic rejection. Transplant Proc 2001;33:3215-20.
78. Van Damme-Lombaerts R. Single-dose pharmaockinetics and tolerability of everolimus in stable pediatric renal transplant patients. Pediatr Transplant 2002;6(2):147-52.
79. Ettenger RB. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis 2001;38(4 Suppl 2):S22-8.
80. Kahan BD, Kaplan B, Lorber M, et al. Efficacy and safety of RAD in de novo renal transplant recipients evaluated in a multicenter, randomized, double-blind, dose-finding study. Presented at the XVIII International Congress of the Transplantation Society. Rome, August, 2000.
81. Tadaki DK, Xu H, Graham L, Harlan DH, Kirk AD. Capath-1H resistant monocytes are deficient in indirect but capable of direct alloantigen presentation. Transplant 2001: The Joint American Transplant meeting. Chicago, May, 2001.
82. Calne R, Moffatt SD, Friend PJ, et al. Campath-1H allows low-dose cyclosporine monotherapy in 31 cadaveric renal allograft recipients. Transplantation 1999;68:1613.
83. Kirk A, Swanson SJ, Mannon RB, et al. Preliminary results from a human tolerance trial using Campath-1H. Transplant 2001:The Joint American Transplant meeting. Chicago, May, 2001.
84. Yamada A, Salama AD, Sayegh MH. The role of novel T cell costimulatory pathways in autoimmunity and transplantation. J Am Soc Nephrol 2002;13(2):559-75.
85. Tivol EA, Borriello F, Schweitzer AN, et al. Loss of CTLA-4 leads to massive lymphoproliferation and fatal multiorgan tissue destruction, revealing a critical negative regulatory role of CTLA-4. Immunity 1995;3:541-7.
86. Greenwald RJ, Boussiotis VA, Lorshbach RB, Abbas AK, Sharp AH. CTLA-4 regulates induction of anergy in vivo. Immunity 2001;14:P145-55.
87. Sayegh MH, Turka LA. The role of T-cell costimulatory activation pathways in transplant rejection. N Engl J Med 1998;338:1813-21.
88. Noelle RJ. CD40 and its ligand in host defense. Immunity 1996;4:415-9.
89. Kirk AD, Burkly LC, Batty DS, et al. Treatment with humanized monoclonal antibody against CD154 prevents acute renal allograft rejection in nonhuman primates. Nat Med 1999;5:686.