The role of basiliximab in the evolving renal transplantation immunosuppression protocol

Biologics: Targets and Therapy

Volumn 2, Issue 2, 2008, Pages 175-188

  Salis, Paola ^a   Caccamo, Chiara ^a   Verzaro, Roberto ^a   Gruttadauria, Salvatore ^a   Artero, Mary ^a  

^a MEDITERRANEAN INSTITUTE FOR TRANSPLANTATION AND ADVANCED SPECIALIZED THERAPIES ISMETT   (Italy)

Author keywords

Basiliximab; Calcineurin inhibitors; Corticosteroids; IL 2 receptor antagonists; Immunosuppression; Induction; Renal transplantation

Indexed keywords

EID: 77949479448     PISSN: 11775475     EISSN: 11775491     Source Type: Journal    
DOI: None     Document Type: Review

References (96)

1. Acott PD, Lawen J, Lee S, et al. 2001. Basiliximab versus ATG/ALG induction in pediatric renal transplants: comparison of herpes virus profile and rejection rates. Transplant Proc, 33:3180-3.
2. Adu D, Cockwell P, Ives NJ, et al. 2003. Interleukin-2 receptor monoclonal antibodies in renal transplantation: meta-analysis of randomised trials. BMJ, 326:789-91.
3. Al Najjar A, Etienne I, Le Pogamp P, et al. 2006. Long-term results of monoclonal anti-IL2-receptor antibody versus polyclonal antilymphocyte antibodies as induction therapy in renal transplantation. Transplant Proc, 38:2298-9.
4. Amlot PL, Rawlings E, Fernando ON, et al. 1995. Prolonged action of a chimeric interleukin-2 receptor (CD25) monoclonal antibody used in cadaveric renal transplantation. Transplantation, 60:748-56.
5. Anil Kumar MS, Sierka DR, Damask AM, et al. 2005. Safety and success of kidney transplantation and concomitant immunosuppression in HIVpositive patients. Kidney Int, 67:1622-9.
6. Auchinloss H Jr 1995. Antigen presentation. In: Bach FH, Auchinloss H Jr ed. Transplantation Immunology. New York: Wiley-Liss, pp. 95-8.
7. Aw MM, Taylor RM, Verma A, et al. 2003. Basiliximab (Simulect) for the treatment of steroid-resistant rejection in pediatric liver transplant recipients: a preliminary experience. Transplantation, 75:796-9.
8. Baan CC, van der Mast BJ, Klepper M, et al. 2005. Differential effect of calcineurin inhibitors, anti-CD25 antibodies and rapamycin on the induction of FOXP3 in human T cells. Transplantation, 80:110-17.
9. Basadonna GP, Matas AJ, Gillingham KJ, et al. 1993. Early versus late acute renal allograft rejection: impact on chronic rejection. Transplantation, 55:993-5.
10. Baudouin V, Crusiaux A, Haddad E, et al. 2003. Anaphylactic shock caused by immunoglobulin E sensitization after retreatment with the chimeric anti-interleukin-2 receptor monoclonal antibody basiliximab. Transplantation, 76:459-63.
11. Boggi U, Danesi R, Vistoli F, et al. 2004. A benefit-risk assessment of basiliximab in renal transplantation. Drug Safety, 27:91-106.
12. Brennan DC. 2003. Thymoglobulin versus Simulect for induction immunosuppression in cadaveric renal transplant recipients: expanded results from a prospective, randomized, multicenter trial. Am J Transplant, 5(Suppl 3):438-9.
13. Brennan DC, Daller JA, Lake KD, et al. 2006. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med, 355:1967-77.
14. Brent L. 1997. A History of Transplantation Immunology. San Diego: Acad Pr, Inc. pp. 319-20.
15. Chan L, Cooper M, Leventhal J, et al. 2006. Excellent renal function at 6 months in de novo kidney transplant recipients treated with everolimus, basiliximab and reduced tacrolimus exposure. Transplantation, 82(Suppl 3):299-300.
16. Chapman TM, Keating GM. 2003. Basiliximab: a review of its use as induction therapy in renal transplantation. Drugs, 63:2803-35.
17. Chariat MN, Erren M, Chariat M, et al. 2001. Basiliximab in the therapy of acute rejection after organ transplantation. Transplant Proc, 33:2380.
18. Chilcott JB, Holmes MW, Walters S, et al. 2002. The economics of basiliximab (Simulect) in preventing acute rejection in renal transplantation. Transplant Int, 15:486-93.
19. Chowdhury S, Kode RK, Ranganna K, et al. 2001. Induction strategy using basiliximab combined with mycophenolate MMF and immediate lowdose cyclosporin is steroid sparing and more effective than OKT3. Transplant Proc, 33:1057-8.
20. Church AC. 2003. Clinical advances in therapies targeting the interleukin-2 receptor. Q J Med. 96:91-102.
21. Clark G, Walsh G, Deshpande P, et al. 2002. Improved efficacy of basiliximab over antilymphocyte globulin induction therapy in paediatric renal transplantation. Nephrol Dial Transplant, 17:1304-9.
22. Crompton JA, Somerville T, Smith L, et al. 2003. Lack of economic benefit with basiliximab induction in living related donor adult renal transplant recipients. Pharmacother. 23:443-50.
23. de Boccardo G. 2002. Latin American study of the efficacy and safety of Simulect in kidney transplant recipients. Transplantation, 74:467.
24. Eguchi S, Yanaga K, Okudaira S, et al. 2004. Immunodynamics of basiliximab in liver allograft recipient under continuous hemodiafiltration. Transplantation, 77:1477-8.
25. Emparan C, Laukötter M, Wolters H, et al. 2003. Calcineurin-free protocols with basiliximab induction allow patients included in "old-to-old" programs to achieve standard kidney transplant function. Transplant Proc, 35:1326-7.
26. + cells in vitro. Am J Transplant, 5:454-64.
27. Goh HK, Lye WC. 2001. Biopsy-proven resolution of steroid-resistant acute rejection with basiliximab therapy in a renal allograft recipient. Transplant Proc, 33:3213-14.
28. Grenda R, Watson A, Vondrak K, et al. 2006. A prospective, randomized, multicenter trial of tacrolimus-based therapy with or without basiliximab in pediatric renal transplantation. Am J Transplant, 6:1666-72.
29. Hagenmeyer E-G, Haussler B, Hempel E, et al. 2004. Resource use and treatment costs after kidney transplantation: impact of demographic factors, comorbidities and complications. Transplantation, 77:1545-50.
30. Hamdy AF, El-Agroudy AE, Bakr MA, et al. 2005. Comparison of sirolimus with low-dose tacrolimus versus sirolimus-based calcineurin inhibitor-free regimen in live donor renal transplantation. Am J Transplant, 5:2531-8.
31. Haririan A, Morawski K, Sillix DH, et al. 2005. Induction therapy with basiliximab versus thymoglobulin in African-American kidney transplant recipients. Transplantation, 79:716-21.
32. Heifets M, Saeed MI, Parikh MH, et al. 2004. Induction immunosuppression in kidney transplant recipients older that 60 years of age: safety and efficacy of ATGAM®, OKT3® and Simulect®. Drugs Aging, 21:747-56.
33. Hong JC, Kahan BD. 2001. A calcineurin antagonist-free induction strategy for immunosuppression in cadaveric kidney transplant recipients at risk for delayed graft function. Transplantation, 71:1320-8.
34. Jirasiritham S, Sumethkul V, Mavichak V, et al. 2004. The role of anti-IL-2 receptor in high-risk kidney transplant patients. Transplant Proc, 36:2110-12.
35. Kahan BD, Rajagopalan PR, Hall M. 1999. Reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with basiliximab, a chimeric anti-interleukin-2-receptor monoclonal antibody. United States Simulect Renal Study Group. Transplantation, 67:276-84.
36. Kaufman DB, Leventhal JR, Axelrod D, et al. 2005. Alemtuzumab induction and prednisone-free maintenance immunotherapy in kidney transplantation: comparison with basiliximab induction - long-term results. Am J Transplant, 5:2539-48.
37. Keown PA, Balshaw R, Khorasheh S, et al. 2003. Meta-analysis of basiliximab for immunoprophylaxis in renal transplantation. Biodrugs, 17:271-9.
38. Knight RJ, Kerman RH, Schoenberg L, et al. 2004. The selective use of basiliximab versus thymoglobulin in combination with sirolimus for cadaveric renal transplant recipients at low risk versus high risk for delayed graft function. Transplantation, 78:904-10.
39. Kode R, Fa K, Chowdhury S, et al. 2003. Basiliximab plus low-dose cyclosporin vs OKT3 for induction immunosuppression following renal transplantation. Clin Transplant, 17:369-76.
40. Kovarik JM, Rawlings E, Sweny P, et al. 1996. Pharmacokinetics and immunodynamics of chimeric IL-2 receptor monoclonal antibody SDZ CHI 621 in renal allograft recipients. Transplant Int, 9(Suppl 1):S32-33.
41. Kovarik J, Wolf P, Cisterne JM, et al. 1997. Disposition of basiliximab, an interleukin-2 receptor monoclonal antibody, in recipients of mismatched cadaver renal allografts. Transplantation, 64:1701-5.
42. Kovarik JM, Kahan BD, Rajagopalan PR, et al. 1999. Population pharmacokinetics and exposure-response relationships for basiliximab in kidney transplantation. Transplantation, 68:1288-94.
43. Kovarik JM, Pescovitz MD, Sollinger HW, et al. 2001. Differential influence of azathioprine and mycophenolate mofetil on the disposition of basiliximab in renal transplant patients. Clin Transplant, 15:123-30.
44. Kovarik JM, Offner G, Broyer M, et al. 2002. A rational dosing algorithm for basiliximab (Simulect) in pediatric renal transplantation based on pharmacokinetic-dynamic evaluations. Transplantation, 74:966-71.
45. Koyama I, Fuchinone S, Iwado K, et al. 2006. Steroid can be safely withdrawn in ABO-incompatible kidney transplant recipients by using basiliximab. Transplantation, 82(Suppl 3):516.
46. Kumar AMS, Fa K, Vankawala R, et al. 2001. Simulect, calcineurin inhibitor, mycophenolate mofetil, and prednisone is more effective than OKT3, calcineurin inhibitor, mycophenolate mofetil, and prednisone in African American kidney recipients in reducing acute rejections and prolonging graft survival. Transplant Proc, 33:3195-6.
47. Kumar MSA, Xiao S-G, Fyfe B, et al. 2004. Steroid avoidance in renal transplantation using basiliximab induction, cyclosporine-based immunosuppression and protocol biopsies. Clin Transplant, 19:61-9.
48. Lawen JG, Davies EA, Mourad G, et al. 2003. 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, 75:37-43.
49. Lebranchu Y, Bridoux F, Buchler M, et al. 2002. Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy. Am J Transplant, 2:48-56.
50. Leggat JE, Ojo AO, Leichtman AB, et al. 1997. Long-term renal allograft survival: prognostic implication of the timing of acute rejection episodes. Transplantation, 63:1268-72.
51. Leonardi G, Messina M, Giraudi R, et al. 2004. Basiliximab in association with tacrolimus and steroids in caucasian cadaveric renal transplanted patients: significant decrease in early acute rejection rate and hospitalization time. Clin Transplant, 18:113-18.
52. Lorber MI, Fastenau J, Wilson D, et al. 2000. A prospective economic evaluation of basiliximab (Simulect®) therapy following renal transplantation. Clin Transplant, 14:479-85.
53. Martinez-Mier G, Mendez-Lopez MT, Budar-Fernandez LF, et al. 2006. Living related kidney transplantation without calcineurin inhibitors: initial experience in a Mexican center. Transplantation, 82:1533-6.
54. Meier-Kriesche H-U, Li S, Gruessner RWG, et al. 2006. Immunosuppression: evolution in practice and trends, 1994-2004. Am J Transplant, 6(Part 2):1111-31.
55. Morris JC, Waldmann TA. 2000. Advances in interleukin 2 receptor targeted treatment. Ann Rheum Dis 59(Suppl I):i109-14.
56. Mourad G, Rostaing L, Legendre C, et al. 2004. Sequential protocols using basiliximab versus anti-thymocyte globulins in renal-transplant patients receiving mycophenolate mofetil and steroids. Transplantation, 78:584-90.
57. Nagai T, Goto Y, Haba T, et al. 2005. The effect of urinary protein excretion in post-renal transplant recurrent nephrotic syndrome on basiliximab pharmacokinetics and pharmacodynamics in a pediatric patient. Transplant Proc, 37:879-80.
58. Nashan B, Moore R, Amlot P, et al. 1997. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. CHIB 201 International Study Group. Lancet, 350(9086):1193-8. (Erratum in: Lancet, 1997. 350(9089):1484.)
59. Nojima M, Yoshimoto T, Nakao A, et al. 2005. Sequential blood level monitoring of basiliximab during multisession plasmapheresis in a kidney transplant recipient. Transplant Proc, 37:875-8.
60. Offner G, Hoecker B, Pape L, et al. 2006. A multicenter, placebo controlled trial evaluating the efficacy and safety of basiliximab (Simulect®) in combination with CsA, MMF and steroids in pediatric renal allograft recipients, 12 months results. Transplantation 82(Suppl 3):99.
61. Ojogho O, Sahney S, Cutler D, et al. 2005. Mycophenolate mofetil in pediatric renal transplantation: non-induction vs induction with basiliximab. Pediatr Transplant, 9:80-3.
62. Okechukwu CN, Meier-Kriesche H-U, Armstrong D, et al. 2001. Removal of basiliximab by plasmapheresis. Am J Kidney Dis, 37:E11.
63. Pallet N, Anglicheau D, Martinez F, et al. 2006. Comparison of sequential protocol using basiliximab versus antithymocyte globulin with highdose mycophenolate mofetil in recipients of a kidney graft from an expanded-criteria donor. Transplantation, 81:949-52.
64. Pape L, Strehlau J, Henne T, et al. 2002. Single centre experience with basiliximab in paediatric renal transplantation. Nephrol Dial Transplant, 17:276-80.
65. Parrott NR, Hammad AQ, Watson CJE, et al. 2005. Multicenter, randomized study of the effectiveness of basiliximab in avoiding addition of steroids to cyclosporine A monotherapy in renal transplant recipients. Transplantation, 79:344-8.
66. Pascual J, Marcén R, Ortuño J. 2001. Anti-interleukin-2 receptor antibodies: basiliximab and daclizumab. Nephrol Dial Transplant, 16:1756-60.
67. Pelletier RP, Davies EA, Elkhammas EA, et al. 2000. Improved outcome in renal transplant recipients treated with Simulect versus OKT3 induction. Transplantation, 69:S157.
68. Ponticelli C, Yussim A, Cambi V, et al. 2001. A randomized, double-blind trial of basiliximab immunoprophylaxis plus triple therapy in kidney transplant recipients. Transplantation, 72:1261-7.
69. Queen C, Schneider WP, Selick HE, et al. 1989. A humanized antibody that binds to the interleukin-2 receptor. Proc Natl Acad Sci USA, 86:10029-33.
70. Ramirez CB, Marino IR. 2007. The role of basiliximab induction therapy in organ transplantation. Expert Opin Biol Ther, 7:137-48.
71. + regulatory T cells in immunological tolerance to self and non-self. Nature Immunol, 6:345-52.
72. Sandrini S. 2005. Use of IL-2 receptor antagonists to reduce delayed graft function following renal transplantation: a review. Clin Transplant, 19:705-10.
73. Schena FP, Vincenti F, Paraskevas S, et al. 2006. 12-month results of a prospective, randomized trial of steroid avoidance, steroid withdrawal and standard steroids in de novo renal transplant patients receiving cyclosporine, enteric-coated mycophenolate sodium (EC-MPS, myfortic®) and basiliximab. Transplantation, 82(suppl 3):84-5.
74. Sheashaa HA, Bakr MA, Ismail AM, et al. 2003. Basiliximab reduces the incidence of acute cellular rejection in live related donor kidney transplantation: a three-year prospective randomized trial. J Nephrol, 16:393-8.
75. Sheashaa HA, Bakr MA, Ismail AM, et al. 2005. Long-term evaluation of basiliximab induction therapy in live donor kidney transplantation: a five-year prospective randomized study. Am J Nephrol, 25:221-5.
76. Shoskes DA, Flechner SM, Shoskes VL, et al. 2006. A randomized prospective trial of OKT3 vs basiliximab induction in renal transplantation with over 5 year follow up. Transplantation, 82(Suppl 3):494.
77. Sifontis NM, Benedetti E, Vasquez EM. 2002. Clinically significant drug interaction between basiliximab and tacrolimus in renal transplant recipients. Transplant Proc, 34:1730-2.
78. Sola R, Alarcon A, Jimenez, et al. 2004. The influence of delayed graft function. Nephrol Dial Transplant, 19(Suppl 3):iii32-7.
79. Sollinger H, Kaplan B, Pescovitz MD, et al. 2001. Basiliximab versus antithymocyte globulin for prevention of acute renal allograft rejection. Transplantation, 72:1915-19.
80. Sollinger HW, Odorico JS, Becker YT, et al. 2006. Campath vs basiliximab after simultaneous pancreas-kidney transplantation in 331 patients. Transplantation, 82(Suppl 3):103.
81. Sterkers G, Baudouin V, Ansart-Pirenne H, et al. 2000. Duration of action of a chimeric interleukin-2 receptor monoclonal antibody, basiliximab, in pediatric kidney transplant recipients. Transplant Proc, 32:2757-9.
82. Strehlau J, Pape L, Offner G, et al. 2000. Interleukine-2 receptor antibodyinduced alterations of ciclosporin dose requirements in paediatric transplant recipients. Lancet, 356:1327-8.
83. Swiatecka-Urban A, Garcia C, Feuerstein D, et al. 2001. Basiliximab induction improves the outcome of renal transplants in children and adolescents. Pediatr Nephrol, 16:693-6.
84. Swiatecka-Urban A. 2003. Anti-interleukin-2 receptor antibodies for the prevention of rejection in pediatric renal transplant patients: current status. Pediatr Drugs, 5:699-716.
85. Tan J, Yang S, Wu W. 2005. Basiliximab (Simulect) reduces acute rejection among sensitized kidney allograft recipients. Transplant Proc, 37:903-5.
86. Thistlethwaite JR Jr, Nashan B, Hall M, et al. 2000. Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus. The Global Simulect Study Group. Transplantation, 70:784-90.
87. Uchiyama T, Nelson DL, Fleisher TA, et al. 1981. A monoclonal antibody (anti-Tac) reactive with activated and functionally mature human T-cells. J Immunol, 126:1398-403.
88. Vester U, Kranz B, Testa G, et al. 2001. Efficacy and tolerability of interleukin- 2 blockade with basiliximab in pediatric renal transplant recipients. Pediatr Transplant, 5:297-301.
89. Vincenti F, Monaco A, Grinyo J, et al. 2003. Multicenter randomized prospective trial of steroid withdrawal in renal transplant recipients receiving basiliximab, cyclosporin microemulsion and mycophenolate mofetil. Am J Transplant, 3:306-11.
90. Vincenti F. 2004. Interleukin-2 receptor antagonists and aggressive steroid minimization strategies for kidney transplant patients. Transplant Int, 17:395-401.
91. Vincenti F, Schena FP, Paraskevas S, et al. 2006. Metabolic effects of steroid avoidance or early steroid withdrawal: 12-month results of a randomized trial in de novo renal transplant patients receiving cyclosporine, enteric-coated mycophenolate sodium (EC-MPS) and basiliximab. Transplantation, 82(Suppl 3):483.
92. Vìtko S, Klinger M, Salmela K, et al. 2005. Two corticosteroid-free regimens- tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil - in comparison with a standard triple regimen in renal transplantation: results of the Atlas Study. Transplantation, 80:1734-41.
93. Walters SJ, Whitfield M, Akehurst RL, et al. 2003. Economic implications of the use of basiliximab in addition to triple immunosuppressive therapy in renal allograft recipients: a UK perspective. Pharmacoeconomics, 21:129-38.
94. Webster AC, Playford EG, Higgins G, et al. 2004. Interleukin 2 receptor antagonists for renal transplant recipients: a meta-analysis of randomized trials. Transplantation, 77:166-76.
95. Woodle ES, Vincenti F, Lorber MI, et al. 2005. A multicenter pilot study of early (4-day) steroid cessation in renal transplant recipients under Simulect, tacrolimus and sirolimus. Am J Transplant, 5:157-66.
96. Xiao SG, Lee D, Fyfe B, et al. 2003. Two-year patient and graft survival, graft function and chronic allograft nephropathy with steroid-free Neoral based immunosuppression in kidney transplant recipients - a controlled study. Am J Transplant, 5(3 Suppl):440.