Basiliximab: A Review of its Use as Induction Therapy in Renal Transplantation

Drugs

Volumn 63, Issue 24, 2003, Pages 2803-2835

  Chapman, Therese M ^a   Keating, Gillian M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Basiliximab; Immunosuppression; Induction therapy; Pharmacodynamics; Pharmacokinetics; Renal transplant; Therapeutic use

Indexed keywords

ANTIIDIOTYPIC ANTIBODY; AZATHIOPRINE; BASILIXIMAB; CALCINEURIN INHIBITOR; CORTICOSTEROID; CYCLOSPORIN A; DACLIZUMAB; IMMUNOSUPPRESSIVE AGENT; INTERLEUKIN 2 RECEPTOR; INTERLEUKIN 2 RECEPTOR ALPHA; INTERLEUKIN 2 RECEPTOR ALPHA ANTAGONIST; LYMPHOCYTE ANTIBODY; MONOCLONAL ANTIBODY; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OKT 3; PLACEBO; THYMOCYTE ANTIBODY; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ANTIBODY RESPONSE; BOLUS INJECTION; CANCER; CANCER INCIDENCE; CELL PROLIFERATION; CELL SURFACE; COMPARATIVE STUDY; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DRUG EFFICACY; DRUG MECHANISM; DRUG RECEPTOR BINDING; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; FEVER; GASTROINTESTINAL DISEASE; GRAFT REJECTION; GRAFT SURVIVAL; HEALTH CARE COST; HIGH RISK PATIENT; HUMAN; HYPERSENSITIVITY; HYPERSENSITIVITY REACTION; IMMUNOGENICITY; IMMUNOTHERAPY; INFECTION; INFUSION; INSULIN DEPENDENT DIABETES MELLITUS; KIDNEY TRANSPLANTATION; LEUKOPENIA; LYMPHOCYTE DEPLETION; LYMPHOPROLIFERATIVE DISEASE; MONONUCLEAR CELL; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PAIN; PERIPHERAL EDEMA; PHARMACOECONOMICS; PROPHYLAXIS; QUALITY OF LIFE; RETROSPECTIVE STUDY; REVIEW; SURVIVAL RATE; T LYMPHOCYTE; T LYMPHOCYTE ACTIVATION; TREATMENT INDICATION; URINARY TRACT INFECTION; VOMITING;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; AREA UNDER CURVE; CHILD; ECONOMICS, PHARMACEUTICAL; GRAFT REJECTION; HALF-LIFE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; RANDOMIZED CONTROLLED TRIALS; RECOMBINANT FUSION PROTEINS; TISSUE DISTRIBUTION; TRANSPLANTATION IMMUNOLOGY;

CUCUMBER MOSAIC VIRUS; CYTOMEGALOVIRUS; EQUIDAE; MURINAE; ORYCTOLAGUS CUNICULUS;

EID: 0347359176     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-200363240-00009     Document Type: Review

References (85)

1. Breza J, Navratil P. Renal transplantation in adults. BJU Int 1999 Jul; 84 (2): 216-23
2. Moore R. Simulect: redefining immunosuppressive strategies. Transplant Proc 2000 Nov; 32 (7): 1460-2
3. Cibrik DM, Kaplan B, Meier-Kriesche H-U. Role of anti-interleukin-2 receptor antibodies in kidney transplantation. Biodrugs 2001; 15 (10): 655-66
4. Bush WW. Overview of transplantation immunology and the pharmacotherapy of adult solid organ transplant recipients: focus on immunosuppression. Transplantation 1999 May; 10 (2): 253-69
5. Pharmacia Corporation. Atgam®: lymphocyte immune globulin, anti-thymocyte globulin [equine] sterile solution: prescribing information [online]. Available from URL: http:// www.pfizer.com/download/uspi_atgam.pdf [Accessed 2003 Nov 13]
6. Ortho Biotech. Orthoclone OKT3® sterile solution (muromonab CD3): prescribing information [online]. Available from URL: http://www.orthobiotech. com/pdfs/okt3.pdf [Accessed 2003 Nov 13]
7. SangStat Medical Corporation. Thymoglobulin®: anti-thymocyte globulin (rabbit): prescribing information [online]. Available from URL: http://www.sangstat.com/docs/0402pi.pdf [Accessed 2003 Nov 13]
8. Nashan B. The IL2 pathway in clinical immunosuppression. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3072-4
9. Vincenti F. Potential of daclizumab in solid organ transplantation. Biodrugs 1999 May; 11 (5): 333-41
10. Shidban H. Induction therapy in renal transplantation. Curr Opin Transplant 2001; 6 (4): 320-6
11. Amlot PL, Rawlings E, Fernando ON, et al. Prolonged action of a chimeric interleukin-2 receptor (CD25) monoclonal antibody used in cadaveric renal transplantation. Transplantation 1995 Oct 15; 60 (7): 748-56
12. Novartis Pharmaceutical Corporation. Simulect® (basiliximab): prescribing information [online]. Available from URL: http:// www.pharma.us.novartis.com/product/pi.jsp [Accessed 2003 Nov 13]
13. Novartis Pharmaceutical Corporation. Simulect® (basiliximab): product monograph. Novartis Pharmaceutical Corporation (Data on File), 1998
14. Graul A, Leeson P. Basiliximab. Drugs Future 1998; 23 (7): 697-701
15. Novartis Pharmaceutical Corporation. Simulect® (basiliximab): summary of product characteristics [online]. Available from URL: http://www.eudra.org/humandocs/PDFs/EPAR/ Simulect/150298en4.pdf [Accessed 2003 Nov 13]
16. Baan CC, van Riemsdijk-Overbeeke IC, Boelaars-van Haperen MJAM, et al. Inhibition of the IL-15 pathway in anti-CD25 mAb treated renal allograft recipients. Transpl Immunol 2002 Jun; 10 (1): 81-7
17. Kovarik J, Wolf P, Cisterne JM, et al. Disposition of basiliximab, an interleukin-2 receptor monoclonal antibody, in recipients of mismatched cadaver renal allografts. Transplantation 1997 Dec 27; 64 (12): 1701-5
18. Sterkers G, Baudouin V, Ansart-Pirenne H, et al. Duration of action of a chimeric interleukin-2 receptor monoclonal antibody, basiliximab, in pediatric kidney transplant recipients. Transplant Proc 2000 Dec; 32 (8): 2757-9
19. Kovarik JM, Kahan BD, Rajagopalan PR, et al. Population pharmacokinetics and exposure-response relationships for basiliximab in kidney transplantation. Transplantation 1999 Nov 15; 68 (9): 1288-94
20. Kovarik JM, Moore R, Wolf P, et al. Screening for basiliximab exposure-response relationships in renal allotransplantation. Clin Transplant 1999 Feb; 13 (1): 32-8
21. Haba T, Uchida K, Katayama A, et al. Pharmacokinetics and pharmacodynamics of a chimeric interleukin-2 receptor monoclonal antibody, basiliximab, in renal transplantation: a comparison between Japanese and non-Japanese patients. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3174-5
22. Kovarik JM, Pescovitz MD, Sollinger HW, et al. Differential influence of azathioprine and mycophenolate mofetil on the disposition of basiliximab in renal transplant patients. Clin Transplant 2001 Apr; 15 (2): 123-30
23. Kovarik JM, Offner G, Broyer M, et al. A rational dosing algorithm for basiliximab (simulect) in pediatric renal transplantation based on pharmacokinetic-dynamic evaluations. Transplantation 2002 Oct 15; 74 (7): 966-71
24. Kovarik JM, Korn A, Chodoff L. Within-patient controlled assessment of the influence of basiliximab on cyclosporine in pediatric de novo renal transplant recipients. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3172-3
25. Kovarik JM, Rawlings E, Sweny P, et al. Prolonged immunosuppressive effect and minimal immunogenicity from chimeric (CD25) monoclonal antibody SDZ CHI 621 in renal transplantation. Transplant Proc 1996 Apr; 28 (2): 913-4
26. Strehlau J, Pape L, Offner G, et al. Interleukin-2 receptor antibody-induced alterations of ciclosporin dose requirements in paediatric transplant recipients [letter]. Lancet 2000 Oct 14; 356 (9238): 1327-8
27. Sifontis NM, Benedetti E, Vasquez EM. Clinically significant drug interaction between basiliximab and tacrolimus in renal transplant recipients. Transplant Proc 2002 Aug; 34 (5): 1730-2
28. Kahan BD, Rajagopalan PR, Hall M. 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 Jan 27; 67 (2): 276-84
29. Nashan B, Moore R, Amlot P, et al. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients [published erratum appears in Lancet 1997 Nov 15; 350 (9089): 1484]. Lancet 1997 Oct 25; 350 (9086): 1193-8
30. de Boccardo G. Latin American study of the efficacy and safety of simulect in kidney transplant recipients [abstract no. 2333]. Transplantation 2002 Aug 27; 74 (4): 467
31. 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 Oct 15; 72 (7): 1261-7
32. 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 Jan 15; 75 (1): 37-43
33. Sheashaa HA, Bakr MA, Ismail AM, et al. Basiliximab reduces the incidence of acute cellular rejection in live-related-donor kidney transplantation: a three-year prospective randomized trial. J Nephrol 2003; 16: 393-8
34. Sollinger H, Kaplan B, Pescovitz MD, et al. Basiliximab versus antithymocyte globulin for prevention of acute renal allograft rejection. Transplantation 2001 Dec 27; 72 (12): 1915-9
35. Lebranchu Y, Bridoux F, Büchler M, et al. Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy. Am J Transplant 2002 Jan; 2 (1): 48-56
36. Brennan DC. Thymoglobulin versus simulect for induction immunosuppression in cadaveric renal transplant recipients: expanded results from a prospective, randomized, multicenter trial [abstract no. 1121]. Am J Transplant 2003; 3 Suppl. 5: 438-9
37. Nair MP, Nampoory MRN, Johny KV, et al. Induction immunosuppression with interleukin-2 receptor antibodies (basiliximab and daclizumab) in renal transplant recipients. Transplant Proc 2001 Aug; 33 (5): 2767-9
38. Chowdhury S, Kode RK, Ranganna K, et al. Induction strategy using basiliximab combined with mycophenolate MMF and immediate low-dose cyclosporin is steroid sparing and more effective than OKT3. Transplant Proc 2001 Feb-Mar; 33 (1-2): 1057-8
39. Kumar AMS, Fa K, Vankawala R, et al. 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 2001 Nov-Dec; 33 (7-8): 3195-6
40. Pelletier RP, Davies EA, Elkhammas EA, et al. Improved outcome in renal transplant recipients treated with simulect versus OKT3 induction [abstract no. 170]. Transplantation 2000 Apr 27; 69 (8): S157
41. Kode RK, Kumar AMS, Pankewycz O, et al. Simulect induction is safer and more effective than OKT3 in kidney recipients older than 60 years [abstract no. 168]. Transplantation 2000 Apr 27; 69 (8): S157
42. Swiatecka-Urban A, García C, Feuerstein D, et al. Basiliximab induction improves the outcome of renal transplants in children and adolescents. Pediatr Nephrol 2001 Sep; 16 (9): 693-6
43. Pape L, Strehlau J, Henne T, et al. Single centre experience with basiliximab in paediatric renal transplantation. Nephrol Dial Transplant 2002 Feb; 17 (2): 276-80
44. Clark G, Walsh G, Deshpande P, et al. Improved efficacy of basiliximab over antilymphocyte globulin induction therapy in paediatric renal transplantation. Nephrol Dial Transplant 2002 Jul; 17 (7): 1304-9
45. Acott PD, Lawen J, Lee S, et al. Basiliximab versus ATG/ALG induction in pediatric renal transplants: comparison of herpes virus profile and rejection rates. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3180-3
46. Hong JC, Kahan BD. A calcineurin antagonist-free induction strategy for immunosuppression in cadaveric kidney transplant recipients at risk for delayed graft function. Transplantation 2001 May 15; 71 (9): 1320-8
47. Vincenti F, Monaco A, Grinyo J, et al. Multicenter randomized prospective trial of steroid withdrawal in renal transplant recipients receiving basiliximab, cyclosporine microemulsion and mycophenolate mofetil. Am J Transplant 2003; 3: 306-11
48. Vitko S, Klinger M, Salmela K, et al. Comparison of two steroid-free regimens - basiliximab/tacrolimus and tacrolimus/ MMF - with tacrolimus/MMF/steroid therapy after renal transplantation [abstract no. 626]. Am J Transplant 2003; 3 Suppl. 5: 312
49. Xiao SG, Lee D, Fyfe B, et al. 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 [abstract no. 1127]. Am J Transplant 2003; 3 Suppl. 5: 440
50. Solez K, Axelsen RA, Benediktsson H, et al. International standardization of criteria for the histologic diagnosis of renal allograft rejection: the Banff working classification of kidney transplant pathology. Kidney Int 1993; 44: 411-22
51. Racusen LC, Solez K, Colvin RB, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999; 55: 713-23
52. Novartis Pharmaceutical Corporation. Data on File. 2003
53. Garcia-Meseguer C, Roldan M, Melgosa M, et al. Efficacy and safety of basiliximab in pediatric renal transplantation. Transplant Proc 2002 Feb; 34 (1): 102-3
54. Inston NG, Cockwell P, Ready AR. Basiliximab reduces acute allograft rejection in high risk renal transplant recipients [abstract no. 1033]. Am J Transplant 2002; 2 Suppl. 3: 398
55. Kandus A, Kovač D, Buturović-Ponikvar J, et al. Absence of acute rejection using basiliximab with triple immunosuppression in cadaveric kidney recipients in first three months. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3207-8
56. Kumar MSA, Kode RK, Pankewycz OG, et al. Simulect, neoral, cellcept, and prednisone in kidney recipients with delayed graft function: a prospective controlled study. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3762-3
57. Offner G, Broyer M, Niaudet P, et al. A multicenter, open-label, pharmacokinetic/pharmacodynamic safety, and tolerability study of basiliximab (simulect) in pediatric de novo renal transplant recipients. Transplantation 2002 Oct 15; 74 (7): 961-6
58. Tsai MK, Chu SH, Hu RH, et al. Renal transplantation with simulect (basiliximab) plus sandimmune neoral-based immunosuppression: a report of 41 cases in Taiwan. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3194
59. Vester U, Kranz B, Testa G, et al. Efficacy and tolerability of interleukin-2 receptor blockade with basiliximab in pediatric renal transplant recipients. Pediatr Transplant 2001 Aug; 5 (4): 297-301
60. Vilalta R, Vila A, Nieto J, et al. Experience with basiliximab in pediatric renal transplantation. Transplant Proc 2002 Feb; 34 (1): 100-1
61. Knight RJ, Van Buren CT, Katz SM, et al. Induction immunosuppression for cadaveric renal transplantation utilizing sirolimus, basiliximab and delayed introduction of cyclosporine [abstract no. 564]. Am J Transplantation 2001; 1 Suppl. 1: 277
62. Henry ML, Pelletier RP, Elkhammas EA, et al. A single center experience with basiliximab induction therapy in renal transplantation. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3178-9
63. Langer RM, Hong DM, Katz SM, et al. Basiliximab-sirolimus-prednisone induction regimen followed by delayed low-dose cyclosporine in renal transplant recipients of living donors. Transplant Proc 2002 Dec; 34 (8): 3162-4
64. Woodle ES, Vincenti F, Lorber M, et al. A multicenter, open label pilot study of early (5 day) corticosteroid cessation in de novo renal transplant recipients under simulect, tacrolimus and sirolimus therapy: interim analysis [abstract no. 1128]. Am J Transplant 2003; 3 Suppl. 5: 440
65. Kode RK, Pankewycz O, Ranganna K, et al. Rapid steroid reduction in kidney transplant recipients with simulect, neoral and cellcept [abstract no. 427]. Transplantation 2000 Apr 27; 69 (8): S224
66. Adu D, Cockwell P, Ives NJ, et al. Interleukin-2 receptor monoclonal antibodies in renal transplantation: meta-analysis of randomised trials. BMJ 2003 Apr 12; 326: 789-93
67. Keown PA, Balshaw R, Khorasheh S, et al. Meta-analysis of basiliximab for immunoprophylaxis in renal transplantation. Biodrugs 2003; 17 (4): 271-9
68. Mulloy LL, Wright F, Hall ML, et al. Simulect (basiliximab) reduces acute cellular rejection in renal allografts from cadaveric and living donors. Transplant Proc 1999 Feb-Mar; 31 (1-2): 1210-3
69. SangStat Medical Corporation. SangStat transplant study closed early due to significantly fewer kidney rejections seen with thymoglobulin [media release; online]. Available from URL: http://www.sangstat.com/press/2002/02-07. asp [Accessed 2003 Nov 13]
70. Vincenti F. Is complete avoidance of calcineurin inhibitors or steroids now possible? Importance of patient selection and choice of regimen. Transplant Proc 2001 Jun; 33 (4): 11S-8S
71. Thistlethwaite Jr JR, Nashan B, Hall M, et al. Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus. Transplantation 2000 Sep 15; 70 (5): 784-90
72. Chilcott JB, Holmes MW, Walters S, et al. The economics of basiliximab (simulect) in preventing acute rejection in renal transplantation. Transpl Int 2002 Oct; 15 (9-10): 486-93
73. Lorber MI, Fastenau J, Wilson D, et al. A prospective economic evaluation of basiliximab (simulect®) therapy following renal transplantation. Clin Transplant 2000 Oct; 14 (5): 479-85
74. Walters SJ, Whitfield M, Akehurst RL, et al. Pharmacoeconomic evaluation of simulect prophylaxis in renal transplant recipients. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3187-91
75. Keown PA, Balshaw R, Krueger H, et al. Economic analysis of basiliximab in renal transplantation. Transplantation 2001 Jun 15; 71 (11): 1573-9
76. Hasegawa T, Imai H, Miki S. Cost evaluation of basiliximab treatment for renal transplant patients in Japan. Pharmacoeconomics 2003; 21 (11): 791-806
77. Shin GP, Johnson N, Vasquez E, et al. Cost-effectiveness of basiliximab, daclizumab, and OKT3 as induction agents in kidney transplantation [abstract no. PRN2]. Value Health 2000 Mar-Apr; 3 (2): 140
78. Lilliu H, Brun C, Le Pen C, et al. Cost-minimization study comparing simulect versus thymoglobulin in renal transplant induction. Transplant Proc 2001 Nov-Dec; 33 (7-8): 3197-8
79. Polsky D, Weinfurt KP, Kaplan B, et al. An economic and quality-of-life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation. Nephrol Dial Transplant 2001 May; 16 (5): 1028-33
80. 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 Mar 2; 342 (9): 605-12
81. Aalamian Z. Reducing adverse effects of immunosuppressive agents in kidney transplant recipients. Prog Transplant 2001 Dec; 11 (4): 271-82
82. Perico N, Remuzzi G. Prevention of transplant rejection: current treatment guidelines and future developments. Drugs 1997 Oct; 54 (4): 533-70
83. European Renal Association and European Dialysis and Transplant Association. SECTION III: the transplant recipient from initial transplant hospitalization to 1 year post transplant. Nephrol Dial Transplant 2000; 15 Suppl. 7: 52-85
84. Wilde MI, Goa KL. Muromonab CD3: a reappraisal of its pharmacology and use as prophylaxis of solid organ transplant rejection. Drugs 1996 May; 51 (5): 865-94
85. Carswell CI, Plosker GL, Wagstaff AJ. Daclizumab: a review of its use in the management of organ transplantation. Biodrugs 2001; 15 (11): 745-73