Induction therapy in renal transplantation: An overview of current developments

Drugs

Volumn 67, Issue 18, 2007, Pages 2667-2680

  Ciancio, Gaetano ^a   Burke, George W ^a   Miller, Joshua ^a  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

Author keywords

Alemtuzumab, therapeutic use; Antithymocyte globulin, therapeutic use; Basiliximab, therapeutic use; Daclizumab, therapeutic use; Renal transplant

Indexed keywords

ALEMTUZUMAB; AZATHIOPRINE; BASILIXIMAB; CORTICOSTEROID; CYCLOSPORIN; DACLIZUMAB; INTERCELLULAR ADHESION MOLECULE 1 ANTIBODY; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OKT 3; PLACEBO; PREDNISONE; RAPAMYCIN; RITUXIMAB; TACROLIMUS; THYMOCYTE ANTIBODY;

ADD ON THERAPY; BLOOD TOXICITY; CANCER; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CYTOMEGALOVIRUS INFECTION; DELAYED GRAFT FUNCTION; DEVELOPMENT; DRUG DOSE REDUCTION; DRUG MECHANISM; EXPERIENCE; HIGH RISK PATIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LEUKOPENIA; MAINTENANCE THERAPY; MONOTHERAPY; RETRANSPLANTATION; REVIEW; SINGLE DRUG DOSE; UNITED STATES; UNIVERSITY; VIRUS INFECTION;

EID: 36849028633     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200767180-00003     Document Type: Review

References (91)

1. Pirsch JD, Miller J, Deierhoi MH, et al. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. Transplantation 1997; 63: 977-83
2. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaver transplantation. Transplantation 1996; 61: 1029-37
3. MacDonald AS, RAPAMUNE Global Study Group. A worldwide, phase III, randomized, controlled, safety and efficacy study of a sirolimus/cyclosporine regimen for prevention of acute rejection in recipients of primary mismatched renal allografts. Transplantation 2001; 71: 271-80
4. Ojo AO, Meier-Kriesche HU, Hanson JA, et al. Mycophenolate mofetil reduces late renal allograft loss independent of acute rejection. Transplantation 2000; 69: 2405-9
5. Ciancio G, Burke GW, Suzart K, et al. Daclizumab induction, tacrolimus, mycophenolate mofetil and steroids as an immunosuppression regimen for primary kidney transplant recipients. Transplantation 2002; 73: 1100-6
6. Hariharan S, Johnson CP, Bresnahan BA, et al. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med 2000; 342: 605-12
7. Burke Jr JF, Pirsch JD, Ramos EL, et al. Long-term efficacy and safety of cyclosporine in renal transplant recipients. N Engl J Med 1994; 331: 358-63
8. Humar A, Hassoun A, Kandaswamy R, et al. Immunologic factors: the major risk for decreased long-term renal allograft survival. Transplantation 1999; 68: 1842-6
9. Terasaki PI, Ozawa M. Predictive value of HLA antibodies and serum creatinine in chronic rejection: results of a 2-year prospective trial. Transplantation 2005; 80: 1194-7
10. Halloran PF. The clinical importance of alloantibody-mediated rejection. Am J Transplant 2003; 3: 639-40
11. Ciancio G, Burke GW, Gaynor JJ, et al. A randomized long-term trial of tacrolimus/sirolimus vs. tacrolimus/mycophenolate mofetil vs. cyclosporine (Neoral®)/sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation 2004; 77: 244-51
12. Ciancio G, Burke GW, Gaynor JJ, et al. A randomized long-term trial of tacrolimus/sirolimus vs. tacrolimus/mycophenolate mofetil vs. cyclosporine (Neoral®)/sirolimus in renal transplantation. II. Survival, function, and protocol compliance at one year. Transplantation 2004; 77: 252-8
13. Ciancio G, Miller J, Garcia-Morales RO, et al. Six year clinical effect of donor bone marrow infusions in renal transplant patients. Transplantation 2001; 71: 827-35
14. Spitzer TR, Delmonico F, Tolkoff-Rubin N, et al. Combined histocompatibility leukocyte antigen-matched donor bone marrow and renal transplantation for multiple myeloma with end stage renal disease: the induction of allograft tolerance through mixed lymphohematopoietic chimerism. Transplantation 1999; 68: 480-4
15. Gaber AO, First MR, Tesi RJ, 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
16. Brennan DC, Flavin K, Lowell JA, et al. A randomized, double-blinded comparison of thymoglobulin versus atgam for induction immunosuppressive therapy in adult renal transplant recipients. Transplantation 1999; 67: 1011-8
17. Szczech LA, Berlin JA, Feldman HI. The effect of antilymphocyte induction therapy on renal allograft survival: a metathat analysis of individual patient-level data. Anti-Lymphocyte Antibody Induction Therapy Study Group. Ann Intern Med 1998; 128: 817-26
18. Charpentier B, Rostaing L, Berthoux F, et al. Three-arm study comparing immediate tacrolimus therapy with antithymocyte globulin induction therapy followed by tacrolimus or cyclosporine A in adult renal transplant recipients. Transplantation 2003; 75: 844-51
19. Swanson SJ, Hale DA, Mannon RB, et al. Kidney transplantation tion with rabbit antithymocyte globulin induction and sirolimus monotherapy. Lancet 2002; 360: 1662-4
20. Shapiro R, Jordan ML, Basu A, et al. Kidney transplantation under a tolerogenic regimen of recipient pretreatment and low dose postoperative immunosuppression with subsequent weaning. Ann Surg 2003; 238: 520-5
21. Goggins WC, Pascual MA, Powelson JA, et al. A prospective, randomized, clinical trial of intraoperative versus postoperative thymoglobulin in adult cadaveric renal transplant recipients. Transplantation 2003; 76: 798-802
22. Agha IA, Jose R, Alejandro A, et al. Short course induction immunosuppression with thymoglobulin for renal transplant recipients. Transplantation 2002; 73: 473-5
23. Hale G, Dyer MJ, Clark MR, et al. Remission induction in non-Hodgkin lymphoma with reshaped human monoclonal antibody CAMPATH-1H. Lancet 1988; II (8625): 1394-9
24. Hale G, Swirsky DM, Hayhoe FG, et al. Effects of monoclonal anti-lymphocyte antibodies in vivo in monkeys and humans. Mol Biol Med 1983; 1: 321-34
25. Hale G, Bright S, Chumbley G, et al. Removal of T cells from bone marrow for transplantation: a monoclonal antilymphocyte antibody that fixes human complement. Blood 1983; 62: 873-82
26. Hale G. Therapeutic antibodies: delivering the promise? Adv Drug Deliv Rev 2006; 58: 633-9
27. Calne R, Moffatt SD, Friend PJ, et al. Campath 1H allows low-dose cyclosporine monotherapy in 31 cadaveric renal allograft recipients. Transplantation 1999; 68: 1613-6
28. Watson CJE, Bradley JA, Friend PJ, et al. Alemtuzumab (Campath 1H) induction therapy in cadaveric kidney transplantation: efficacy and safety at five years. Am J Transplant 2005; 5: 1347-53
29. Kirk AD, Hale DA, Mannon RB, et al. Results from a human renal allograft tolerance trial evaluating the humanized CD52-specific monoclonal antibody alemtuzumab (Campath-1H). Transplantation 2003; 76: 120-9
30. Calne R, Friend P, Moffat S, et al. Prope tolerance, perioperative Campath 1H, and low dose cyclosporine monotherapy in renal allograft recipients. Lancet 1998; 351: 1701-2
31. Knechtle SJ, Pirsch JD, Fechner Jr J, et al. Campath-1H induction plus rapamycin monotherapy for renal transplantation: results of a pilot study. Am J Transplant 2003; 3: 722-30
32. Knechtle SJ, Fernandez LA, Pirsch JD, et al. Campath-1H in renal transplantation: the University of Wisconsin experience. Surgery 2004; 136: 754-60
33. Shapiro R, Basu A, Tzan H, et al. Kidney transplantation under minimal immunosuppression after pretransplant lymphoid depletion with thymoglobulin or Campath. J Am Coll Surg 2005; 200: 505-15
34. Tan HP, Kaczorowski DJ, Basu A, et al. Living-related donor renal transplantation in HIV+ recipients using alemtuzumab preconditioning and steroid-free tacrolimus monotherapy: a single center preliminary experience. Transplantation 2004; 78: 1683-8
35. Kirk AD, Mannon RB, Kleiner DE, et al. Results from a human renal allograft tolerance trial evaluating T-cell depletion with alemtuzumab combined with deoxypergualin. Transplantation 2005; 80: 1051-9
36. Flechner SM, Friend PJ, Brockmann J, et al. Alemtuzumab induction and sirolimus plus mycophenolate mofetil maintenance for CNI and steroid-free kidney transplant immunosuppression. Am J Transplant 2005; 5: 3009-14
37. Ciancio G, Burke GW, Gaynor JJ, et al. The use of Campath-1H as induction therapy in renal transplantation: preliminary results. Transplantation 2004; 78: 426-33
38. Ciancio G, Sageshima J, Gaynor JJ, et al. The use of campath-1H as induction therapy to achieve steroid avoidance in African-American and Hispanic first renal transplant recipients [abstract no. 1324]. Am J Transplant 2006; 6 Suppl. 2: 513
39. Chapman TM, Keating GM. Basiliximab: a review of its use as induction therapy in renal transplantation. Drugs 2003; 63: 2803-35
40. Ciancio G, Mattiazzi A, Miller J, et al. Daclizumab as induction therapy in kidney and simultaneous pancreas-kidney transplantation. Minerva Urol Nefrol 2003; 55: 43-56
41. Vincenti F, Lantz M, Birnbaum J, et al. A phase I trial of humanized anti-interleukin 2 receptor antibody in renal transplantation. Transplantation 1997; 63: 33-8
42. Vincenti F, Kirkman R, Light S, et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998; 338: 161-5
43. Nashan B, Light S, Hardie IR, et al., for the Daclizumab Double Therapy Study Group. Reduction of acute renal allograft rejection by daclizumab. Transplantation 1999; 67: 110-5
44. Ekberg H, Bäckman L, Tufveson G, et al. Daclizumab prevents acute rejection and improves patient survival post transplantation: 1 year pooled analysis. Transpl Int 2000; 13: 151-9
45. Bumgardner GL, Hardie I, Johnson RWG, et al. Results of 3-year phase III clinical trials with daclizumab prophylaxis for prevention of acute rejection after renal transplantation. Transplantation 2001; 72: 839-45
46. Ciancio G, Burke GW, Suzart K, et al. Efficacy and safety of daclizumab induction for primary kidney transplant recipients in combination with tacrolimus, mycophenolate mofetil and steroids as maintenance immunosuppression. Transplant Proc 2003; 35: 873-4
47. Iverson AJ, Vick SC, Sarnacki CT, et al. Daclizumab in live donor renal transplantation. Transplant Proc 2000; 32: 790-2
48. Vincenti F. Daclizumab: novel biologic immunoprophylaxis for prevention of acute rejection in renal transplantation. Transplant Proc 1999; 31: 2206-7
49. Ivanoski N, Popov Z, Cakalaroski G, et al. Interleukin-2R antagonists in the prevention of acute rejection in living donor transplantation. Transplant Proc 2001; 33: 3203-4
50. ter Meulen CG, Baan CC, Hené RJ, et al. Two doses of daclizumab are sufficient for prolonged interleukin-2Rα-chain blockade. Transplantation 2001; 72: 1709-10
51. Vincenti F, Lantz MV, Birnbaum JL, et al. Pharmacokinetic and pharmacodynamic studies of one or two doses of daclizumab in renal transplant patients. Am J Transplant 2001; 1: 385
52. Ahsan N, Holman MJ, Jarowenko MV, et al. Limited dose monoclonal IL-2R antibody induction protocol after primary kidney transplantation. Am J Transplant 2002; 2: 568-73
53. Meier-Kriesche H-U, Kaza H, Palekar SS, et al. The effect of daclizumab in a high-risk renal transplant population. Clin Transplantation 2000; 14: 509-13
54. Meier-Kriesche H-U, Palekar SS, Friedman GS, et al. Efficacy of daclizumab in an African-American and Hispanic renal transplant population. Transpl Int 2000; 13: 142-5
55. Ciancio G, Burke GW, Suzart K, et al. Effect of daclizumab, tacrolimus and mycophenolate mofetil in racial minority first renal transplant recipients. Transplant Proc 2002; 34: 1617-8
56. Ciancio G, Burke GW, Suzart K, et al. The use of daclizumab, tacrolimus and mycophenolate mofetil in African-American and Hispanic first renal transplant recipients. Am J Transplant 2003; 3: 1010-6
57. Pirsh JD, Miller J, Deierhoi MH, et al. Comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. Transplantation 1997; 63: 977-83
58. Sollinger HW, for the 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
59. Vincenti F. The role of newer monoclonal antibodies in renal transplantation. Transplant Proc 2001; 33: 1000-1
60. Vincenti F, Ramos E, Brattstrom C, et al. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation 2001; 71: 1282-7
61. Tran HTB, Acharya MK, Mckay DB, et al. Avoidance of cyclosporine in renal transplantation: effects of daclizumab, mycophenolate mofetil, and steroids. J Am Soc Nephrol 2000; 11: 1903-9
62. Weimar W, van Riemsdijk IC, Smak Gregoor PJH, et al. Anti-CD25 prophylaxis allows steroid free kidney transplantation. Transplant Proc 2001; 33: 3176-7
63. Cole E, Landsberg D, Russell D, et al. A pilot study of steroid-free immunosuppression in the prevention of acute rejection in renal allograft recipients. Transplantation 2001; 72: 845-50
64. Rostaing L, Cantarovich D, Mourad G, et al. Corticosteroid-free immunosuppression with tacrolimus, mycophenolate mofetil, and daclizumab induction in renal transplantation. Transplantation 2005; 79: 807-14
65. Hong JC, Kahan BD. Use of anti-CD25 monoclonal antibody in combination with rapamycin to eliminate cyclosporine treatment during the induction phase of immunosuppression. Transplantation 1999; 68: 701-4
66. Chang GJ, Mahanty HD, Vincenti F, et al. A calcineurin inhibitor-sparing regimen with sirolimus, mycophenolate mofetil, and anti-CD25 mAB provides effective immunosuppression in kidney transplant recipients with delayed or impaired graft function. Clin Transplant 2000; 14: 50-4
67. Cantarovich M, Metrakos P, Giannetti N, et al. Anti-CD25 monoclonal antibody coverage allows for calcineurin inhibitor "holiday" in solid organ transplant patients with acute renal dysfunction. Transplantation 2002; 73: 1169-72
68. Ciancio G, Mattiazzi A, Roth D, et al. The use of daclizumab as induction therapy in combination with tacrolimus, mycophenolate mofetil in recipients with previous transplants. Clin Transplant 2003; 17: 428-32
69. Kahan BD, Rajagopalan PR, Hall M, et al. 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
70. Nashan B, Moore R, Amlot P, et al. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. Lancet 1997; 350: 1193-8
71. Ponticelli C, Yussim A, Cambi V, et al. A randomized double-blind trial of basiliximab immunoprophylaxis plus triple therapy in kidney transplant recipients. Transplantation 2001; 72: 1261-7
72. Lawen JG, Davies EA, Mourad G, et al. Randomized double-blind study of immunoprophylaxis with basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, in combination with mycophenolate mofetil-containing triple therapy in renal transplantation. Transplantation 2003; 75: 37-43
73. Adu D, Cockwell P, Ives NJ, et al. Interleukin-2 receptor monoclonal antibodies in renal transplantation: meta-analysis of randomized trials. BMJ 2003; 326: 789-93
74. Keown PA, Balshaw R, Khorasheh S, et al. Meta-analysis of basiliximab for immunoprophylaxis in renal transplantation. BioDrugs 2003; 17: 271-9
75. Olyaei AJ, Thi K, deMattos AM, et al. Use of basiliximab and daclizumab in kidney transplantation. Prog Transplant 2001; 11: 33-9
76. Ciancio G, Miller A, Burke GW, et al. Daclizumab induction, for primary kidney transplant recipients using tacrolimus, mycophenolate mofetil and steroids as maintenance. Transplant Proc 2001; 33: 1013-4
77. Nair MP, Nampoory MR, Johny KV, et al. Induction immunosuppression with interleukin-2 receptor antibodies (basiliximab and daclizumab) in renal transplant recipients. Transplant Proc 2001; 33: 2767-9
78. Nampoory MR, Abdulhalim M, Johny KV, et al. Bolus anti-thymocyte globulin induction in renal transplant recipients: a comparison with conventional ATG or anti-interleukin-2 receptor antibody induction. Transplant Proc 2002; 34: 2916-9
79. Kaufman DB, Leventhal JR, Axelrod D, et al. Alemtuzumab induction and prednisone-free maintenance immunotherapy in kidney transplantation: comparison with basiliximab induction - long-term results. Am J Transplant 2005; 5: 2539-48
80. Brennan DC, Daller JA, Lake KD, et al., for the Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med 2006; 355 (19): 1967-77
81. Ciancio G, Burke G, Gaynor JJ, et al. A randomized trial of three renal transplant induction antibodies: early comparison of tacrolimus, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring. Transplantation 2005; 80: 457-65
82. Ciancio G, Sageshima J, Burke GW, et al. Evaluation of a randomized trial of three induction antibodies in deceased donor (DD) renal transplantation at 18 months of follow-up [abstract no. 919]. Am J Transplant 2006; 6 Suppl. 2: 376-7
83. Salmela K, Wrammer L, Ekberg H, et al. A randomized multicenter trial of the anti-ICAM-1 monoclonal antibody (enlimomab) for the prevention of acute rejection and delayed graft function in cadaver renal transplantation: a report of the European Anti-ICAM- 1 Renal Transplant Study Group. Transplantation 1999; 67: 729-36
84. Hourmant M, Bedrossian J, Durand D, et al. A randomized multicenter trial comparing leukocyte function-associated antigen-1 monoclonal antibody with rabbit antithymocyte globulin as induction treatment in first kidney transplantation. Transplantation 1996; 62: 1565-70
85. Isobe M, Yagita H, Okumura K, et al. Specific acceptance of cardiac allograft after treatment with antibodies to ICAM-1 and LFA-1. Science 1992; 255: 1125-7
86. Nadler LM, Ritz J, Hardy R, et al. A unique cell surface antigen identifying lymphoid malignancies of B-cell origin. J Clin Invest 1981; 67: 134-40
87. Anderson DR, Grillo-Lopez A, Varns C, et al. Targeted anticancer therapy using rituximab, a chimeric anti-CD20 antibody (IDEC-C2B*) in the treatment of non-Hodgkin's B cell lymphoma. Biochem Soc Trans 1997; 25: 705-8
88. Becker YT, Becker BN, Pirsch JD. Rituximab as treatment for refractory kidney transplant rejection. Am J Transplant 2004; 4: 996-1001
89. Sonnenday CJ, Warren DS, Cooper M, et al. Plasmapheresis, CMV hyperimmune globulin, and anti-CD20 allow ABO-incompatible renal transplantation without splenectomy. Am J Transplant 2004; 4: 1315-22
90. Jain AB, Marcos A, Pokharna R, et al. Rituximab (chimeric anti-CD20 antibody) for posttransplant lymphoproliferative disorder after solid organ transplantation in adults: long-term experience from a single center. Transplantation 2005; 80: 1692-8
91. Viera CA, Agarwal A, Book BK, et al. Rituximab for reduction of anti-HLA antibodies in patients awaiting renal transplantation: 1. Safety, pharmacodynamics and pharmacokinetics. Transplantation 2004; 27: 542-8