109
Views
5
CrossRef citations to date
0
Altmetric
Review

Efficacy and safety of basiliximab in kidney transplantation

, , , , , , , , , & show all
Pages 473-490 | Published online: 10 May 2005

Bibliography

  • MURRAY JE, MERILL JP, HARRISON JH: Kidney transplantation between seven pairs of identical twins. Ann. Surg. (1958) 148(3):343–359.
  • DANESI R, MOSCA M, BOGGI U, MOSCA F, DEL TACCA M: Genetics of drug response to immunosuppressive treatment and prospects for personalized therapy. Mol. Med. Today (2000) 6(12):475–482.
  • ••Basis for personalised immunusuppression.
  • KAHAN BD, PONTICELLI C, (Eds): Principles and practice of renal transplantation. Martin Dunitz Ltd, London: (2000).
  • GLOOR J. Kidney transplantation in the hyperimmunized patient. In: Kidney transplantation: strategies to prevent organ rejection. Ronco C, Chiaramonte S, Remuzzi G (Eds), Karger, Basel (Switzerland) (2005) 11–21.
  • CECKA JM: The UNOS scientific renal transplant registry. In: Clinical transplants 1998. Terasaki PI, Cecka JM, (Eds), UCLA Tissue Typing Laboratory, Los Angeles (CA) (1999) 421–436.
  • BIRKELAND SA: Uremia as a state of immune deficiency. Scandj brimunol. (1976) 5(1-2):107–115.
  • DESCAMPS-LATSCHA B, HERBELIN A, NGUYEN AT, ZINGRAFF J, JUGERS P, CHATENOUD L: Immune system dysregulation in uremia. Semin. Nephrol (1994) 14(3):253–260.
  • EHRICH JH, LOIRAT C, BRUNNER FP et al.: Report on management of renal failure in children in Europe, XXII, 1991. Nephrol Dial. Transplant. (1992) 7\(Suppl. 2):36–48
  • FEUCHT HE, OPELZ G: The humoral immune response towards HLA class II determinants in renal transplantation. Kidney (1996) 50(5):1464–1475
  • CARMELLINI M, VISTOLI F, BOGGI U, BELLINI R, MOSCA F: Delayed graft function incidence as predictive variable of survival of kidney grafts retrieved from elderly donors. Transplant. Proc. (2000) 32(1):128–130
  • GRINYO' JM, CRUZADO JM: Steroid or calcineurin inhibitor-sparing immunosuppressive protocols. In: Kidney transplantation: strategies to prevent organ rejection. Ronco C, Chiaramonte S, Remuzzi G (Eds.). Karger, Basel (2005) 31–42.
  • BOGGI U, DANESI R, VISTOLI F et al: A benefit-risk assessment of basiliximab in renal transplantation. Drug Sal: (2004) 27(2):91–106.
  • ••Comprehensive assessment of benefitsand risks of basiliximab in renal transplantation.
  • CHAPMAN TM, KEATING GM: Basiliximab. A review of its use as induction therapy in renal transplantation. Drugs (2003) 63(24):2803–2835.
  • ••Comprehensive assessment of benefitsand risks of basiliximab in renal transplantation.
  • MORRIS JC, WALDMANN TA: Advances in interleukin 2 receptor targeted treatment. Ann. Rheum. Dis. (2000) 59\(Suppl. 1):109–114.
  • GAFFEN SL: Signaling domains of the interleukin 2 receptor. Cytokine (2001) 14(2):63–77.
  • ELLERY JM, NICHOLLS PJ: Possible mechanism for the alpha-subunit of the interleukin-2 receptor (CD25) to influence interleukin-2 receptor signal transduction. Immunol Cell Biol. (2002) 80(4):351–357.
  • GOEBEL J, STEVENS E, FORREST K, ROSZMAN TL, IJZERMANS JM, WEIMAR W: Daclizumab (Zenapax) inhibits early interleukin-2 receptor signal transduction events. Transpl. Immunol (2000) 8(3):153–159.
  • BAAN CC, VAN RIEMSDIJK-OVERBEEKE IC, BOELAARS-VAN HAPEREN MJ et al: Inhibition of the IL-15 pathway in anti-CD25 mAb treated renal allograft recipients. Transpl. Immunol (2002) 10(1):81–87.
  • KOVARIK JM, KAHAN BD, RAJAGOPALAN PR et al: Population pharmacokinetics and exposure-response relationships for basiliximab in kidney transplantation. The United States Simulect Renal Transplant Study Group. Transplantation (1999) 68(9):1288–1294.
  • MENTRE F, KOVARIK J, GERBEAU C: Constructing a prediction interval for time to reach a threshold concentration based on a population pharmacokinetic analysis: an application to basiliximab in renal transplantation. J. Pharmacokinet. Biopharm. (1999) 27(2):213–230.
  • 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) 64(12):1701–1705.
  • KOVARIK JM, MOORE R, WOLF P et al.: Screening for basiliximab exposure-response relationships in renal allotransplantation. Transplant. (1999) 13(1 Pt 1):32–38.
  • KOVARIK JM, PESCOVITZ MD, SOLLINGER HW et al: Differential influence of azathioprine and mycophenolate mofetil on the disposition ofbasiliximab in renal transplant patients. The Simulect Phase IV Study Group. Clin. Transplant. (2001) 15(2): 123–130.
  • KOVARIK JM, NASHAN B, NEUHAUS P et al: A population pharmacokinetic screen to identify demographic-clinical covariates of basiliximab in liver transplantation. Pharmacol Ther. (2001) 69(4):201–209.
  • 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) 74(7):966–971.
  • STREHLAU J, PAPE L, OFFNER G et al:Interleukin-2 receptor antibody-induced alterations of ciclosporin dose requirements in paediatric transplant recipients. Lancet (2000) 356(9238):1327–1328.
  • NASHAN B, MOORE R, AMOLT P et al.: Randomised trial basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. CHIB 201 International Study Group. Lancet (1997) 350(9086):1193–1198.
  • •• Multicentre, randomised, double-blind, placebo-controlled, Phase III trial.
  • KAHAN BD, RAJAGOPALAN PR, HALL M: Reduction of occurrence of acute cellular rejection among renal allograft recipients treated with basiliximab, a chimeric antiterleukin-2-receptor monoclonal antibody. United States Simulect Renal Study Group. Transplantation (1999) 67(2):276–284.
  • •• Multicentre, randomised, double-blind, placebo-controlled, Phase III trial.
  • 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) 33(7-8):3172–3173.
  • SIFONTIS N, BENEDETTI E, VASQUEZ E: Clinically significant drug interaction between basiliximab and tacrolimus in renal transplant recipients. Transplant. Proc. (2002) 34(5):1730–1732.
  • BAUDOUIN V, CRUSIAUX A, HADDAD E et al: Anaphylactic shock caused by immunoglobulin e sensitization after retreatment with chimeric anti-interleukin-2 receptor monoclonal antibody basiliximab. Transplantation (2003) 76(3):459–463.
  • ••Anaphylactic shock following re-exposureto basilbdmab, including pathogenesis and possible preventive measures.
  • BARROS VR, ROCHA V, GARCIA VD, GARCIA CD: Anaphylactic shock after retreatment with basiliximab. Transplant. Proc. (2003) 35(1):579.
  • ••Anaphylactic shock following re-exposureto basiliximab.
  • SHAH MH, BOKHARI MZ, BOKHARI MT, FAROOQ A, YOUSAF SM: Safety and efficacy of basiliximab for the prevention of acute rejection in kidney transplant recipients. Transplant. Proc. (2003) 35(7):2737–2738.
  • PONTICELLI C, YUSSIM A, CAMBI V et al.:A randomized, double-blind trial of basiliximab immunoprophylaxis plus triple therapy in kidney transplant recipients. Simulect Phase IV Study Group. Transplantation (2001) 72(7):1261–1267.
  • •• Multicentre, randomised, double-blind, placebo controlled trial.
  • FOLKMANE I, BICANS J, AMERIKA D, CHAPENKO S, MUROVSKA M, ROSENTALS R: Low rate of acute rejection and cytomegalovirus infection in kidney transplant recipients with basiliximab. Transplant Proc. (2001) 33(7-8):3209–3210.
  • BOGGI U, VISTOLI F, DEL CHIARO M, BARTOLO TV, RIZZO G, MOSCA F: CSA/MMF/steroids versus CSA/AZA/ steroids with and without basiliximab cadaveric kidney transplantation. Transplant. Proc. (2001) 33(7-8):3199–3200.
  • SIWACH V, DHANDA R, AGGARWAL B, SINGH B, JAIN PK, SARIN PK: Early experience with Simulect (basiliximab) induction in living donor renal allografting in India. Transplant. Proc. (2003) 35(1):196–197.
  • 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. Simulect International Study Group. Transplantation (2003); 75(1):37–43.
  • ••Multicentre, randomised, placebocontrolled, double-blind trial.
  • SOLLINGER H, KAPLAN B, PECOVITZ MD et al: Basiliximab versus antithymocyte globulin for prevention of acute renal allograft rejection. Transplantation (2001) 72(12):1915–1919.
  • ••Multicentre, open-label, randomised trial.
  • LEBRANCHU Y, BRIDOUX F, BUEHLER M et al: Immunoprophylaxis with basiliximab compared with antithymocyte globulin renal transplant patients receiving MMF-containing triple therapy. Am. I Transplant. (2002) 2(1):48–56.
  • ••Multicentre, open-label, randomised trial.
  • VINCENTI F, MONACO A, GRINYO J, KINKHABWALA M, ROZA A: Multicenter randomized prospective trial of steroid withdrawal in renal transplant recipients receiving basiliximab, cyclosporine microemulsion and mycophenolate mofetil. Am. J. Transplant. (2003) 3(3):306–311.
  • KODE R, FA K, CHOWDHURY S et al: Basiliximab plus low-dose cyclosporin versus OKT3 for induction immunosuppression following renal transplantation. Clin. Transplant. (2003) 17(4):369–376.
  • BALBONTIN F, KIBERD B, SINGH D et al: Basiliximab widens the therapeutic window for AUC-monitored Neoral therapy early after kidney transplantation. Transplant. Proc. (2003) 35(7):2409–2411.
  • KUNG SC, PARIKH M, FYFE B et al: Simulect induction facilitates Neoral-based steroid-free immunosuppression in primary kidney transplant recipients. Transplant. Proc. (2004) 36(Suppl. 2S):475S–477S.
  • KIBERD BA, LAWEN J, FRASER AD, KEOUGH-RYAN T, BELITSKY P: Early adequate mycophenolic acid exposure is associated with less rejection in kidney transplantation. Am. I Transplant. (2004) 4(7):1079–1083.
  • VITKO S, TEDESCO H, ERIS J et al.: Everolimus with optimized cyclosporine dosing in renal transplant recipients: 6-month safety and efficacy results of two randomized studies. Am. I Transplant. (2004) 4(4):626–635.
  • •Data from two prospective, randomised, parallel group, open-label studies.
  • MARTIN GARCIA D, MARTIN GAGO J, MENDILUCE A, GORDILLO R, BUSTAMENTE J: Tacrolimus-basiliximab versus cyclosporine-basiliximab in renal transplantation 'de nov : acute rejection and complications. Transplant. Proc. (2003) 35(5):1694–1696.
  • LEONARDI G, MESSINA M, GIRAUDI R, PELLU V, FOP F, SEGOLONI GP: 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. (2004) 18(2):113–118.
  • TULLIUS SG, PRATSCHKE J, STROBELT V et al.: ATG versus basiliximab induction therapy in renal allograft recipients receiving a dual immunosuppressive regimen: one-year results. Transplant. Proc. (2003) 35(6):2100–2101.
  • WILAND AM, FINK JC, WEIR MR et al: Should living-unrelated renal transplant recipients receive antibody induction? Results of a clinical experience trial. Transplantation (2004) 77(3):422–425.
  • •Efficacy of basiliximab with concurrent triple immunosuppression based on tacrolimus/mycophenolate mofetil/ steroids.
  • RAHAMIMOV R, YUSSIM A, AFTER T et al: Rejection rate in living donor kidney transplantation wi th and without basiliximab in tacrolimusimycophenolate mofetil-based protocol. Transplant. Proc. (2003) 35(2):653–654.
  • •Efficacy of basiliximab with concurrent triple immunosuppression based on tacrolimus/mycophenolate mofetil/ steroids.
  • THISTLETHWAITE JR JR, NASHAN B, HALL M, CHOD OFF L, LIN TH: Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus. The Global Simulect Study Group. Transplantation (2000) 70(5):784–790.
  • ••Efficacy of basiliximab on diabeticsubgroups in pooled results from two multicentre, double-blind, placebo-controlled, Phase III trials.
  • BOGGI U, VISTOLI F, COPPELLI A, MARCHETTI P, RIZZO G, MOSCA F: Use of basiliximab in conjunction with either NeoraliMMF/steroids or Prograti MMF/steroids in simultaneous pancreas-kidney transplantation. Transplant. Proc. (2001) 33(7-8):3201–3202.
  • CHOW FY, POLKINGHORNE K, SAUNDER A, KERR PG, ATKINS RC, CHADBAN SJ: Historical controlled trial of OKT3 versus basiliximab induction therapy in simultaneous pancreas-renal transplantation. Nephrology (Carlton) (2003) 8(4):212–216.
  • KUMAR MS, KODE RK, PANKEWYCZ et al: Simulect, Neoral, Cellcept and prednisone in kidney recipients with delayed graft function: a prospective controlled study. Transplant. Proc. (2001) 33(7-8):3762–3763.
  • VESTER U, KRANZ B, TESTA G et al: Efficacy and tolerability interleukin-2 receptor blockade with basiliximab in pediatric renal transplant recipients. Pediatr. Transplant. (2001) 5(4):297–301
  • PAPE L, STREHLAU J, HENNE T et al: Single centre experience with basiliximab in paediatric renal transplantation. Nephrol. Dial. Transplant. (2002) 17(2):276–280.
  • CLARK G, WALSH G, DESHPANDE P, KOFFMAN G: Improved efficacy of basiliximab over antilymphocyte globulin induction therapy in paediatric renal transplantation. Nephrol. Dial. Transplant. (2002) 17(7):1304–1309.
  • VESTER U, KRANZ B, TESTA G, PAUL A, BROELSCH CE, HOYER PF: Medical and Surgical Aspects of Pediatric Renal Transplantation Using Living Donors. Transplant. Proc. (2004) 36(5):1308–1310.
  • GARCIA MESEGUER C, VILA LOPEZ A, LUQUE DE PABLOS A, VALLO BOADO A, SIMON JM: Immunoprophylaxis with Simulect (Basiliximab) in pediatric kidney transplant recipients: results from routine clinical practice at 5 kidney transplant units. The Pediatric EOSS Study Group. Transplant. Proc. (2003) 35(5):1697–1698.
  • DUZOVA A, BUYAN N, BAKKALOGLU M et al: Triple immunosuppression with or without basiliximab in pediatric renal transplantation: acute rejection rates at one year. Transplant. Proc. (2003) 35(8):2878–2880.
  • HEISEL 0, HEISEL R, BALSHAW R, KEOWN P: New onset diabetes mellitus in patients receiving calcineurin inhibitors: a systematic review and meta-analysis. Am. J. Transplant. (2004) 4(4):583–595.
  • DE MATTOS AM, OLYAEI AJ, BENNETT WM. Nephrotoxicity of immunosuppressive drugs: long-term consequences and challenges for the future. Am. J. Kidney Dis. (2000) 35(2):333–346.
  • FLECHNER SM, GOLDFARB D, MODLIN C et al.: Kidney transplantation without calcineurin inhibitor drugs: a prospective randomized trial of sirolimus versus cyclosporine. Transplantation (2002) 74(8):1070–1076.
  • PISANI F, BUONUOMO 0, IARIA G et al.: Sirolimus in kidney transplantation from marginal donors. Transplant. Proc. (2004) 36(3):495–496.
  • BAMGBOLA FO, DEL RIO M, KASKEL FJ, FLYNN JT. Non-cardiogenic pulmonary edema during basiliximab induction in three adolescent renal transplant patients. Pediatr. Transplant. (2003) 7(4):315–320.
  • ••Serious adverse event following initialexposure to basiliximab.
  • LO A, STRATTA RJ, ALLOWAY RR et al: Initial clinical experience with interleukin-2 receptor antagonist induction in combination with tacrolimus, mycophenolate mofetil and steroids in simultaneous kidney-pancreas transplantation. Transpl. Int. (2001) 14(6):396–404.
  • SWIATECKA-URBAN A, GARCIA C, FEUERSTEIN D et al.: Basiliximab induction improves the outcome of renal transplants in children and adolescents. Pediatr. Nephrol. (2001) 16(9):693–696
  • CHERIKH WS, KAUFFMAN HM, MCBRIDE MA, MAGHIRANG J, SWINNEN LJ, HANTO DW: Association of the type of induction immunosuppression with posttransplant lymphoproliferative disorder, graft survival, and patient survival after primary kidney transplantation. Transplantation (2003) 76(9):1289–1293
  • ••Detailed analysis of the incidence ofpost-transplant lymphoproliferative disorders based on immunosuppressive management.
  • ABRAMOWICZ D, CRUSIAUX A, GOLDMAN M. Anaphylactic shock after retreatment with OKT3 monoclonal antibody. N Engl. I Med. (1992) 327(10):736.
  • LEONARD PA, WOODSIDE KJ, GUGLIUZZA KK, SUR S, DALLER JA: Safe administration of a humanized murine antibody after anaphylaxis to a chimeric murine antibody. Transplantation (2002) 74(12):1697–1700.
  • ADU D, COCKWELL P, IVES NJ, SHAW J, WHEATLEY K: Interleukin-2 receptor monoclonal antibodies in renal transplantation: meta-analysis of randomised trials. BE Med. J. (2003) 326 (7393):789.
  • •• Meta-analysis.
  • WEBSTER AC, PLAYFORD EG, HIGGINS G, CHAPMAN JR, CRAIG JC: Interleukin 2 receptor anatgonists for renal transplant recipients: a meta-analysis of randomized trials. Transplantation (2004) 77(2):166–176.
  • •• Meta-analysis.
  • KEOWN PA, BALSHAW R, KRUEGER H, BALADI JF: Economic analysis of basiliximab in renal transplantation. Transplantation (2001) 71(11):1573–1579.
  • LORBER MI, FASTENAU J, WILSON D,DI CESARE J, HALL ML: A prospective economic evaluation of basiliximab (Simulect) therapy following renal transplantation. Clin. Transplant. (2000) 14(5):479–485.
  • POLSKY D, WEINFURT KP, KAPLAN B, KIM J, FASTENAU J, SCHULMAN KA: An economic and quality-of-life assessment of basiliximab versus antithymocyte globulin immunoprophylaxis in renal transplantation. Nephrol Transplant. (2001) 16(5):1028–1033.
  • LILLIU H, BRUN-STRANG C, LE PEN C et al.: Cost-minimization study comparing Simulect@ versus Thymoglobulin@ in renal transplant induction. Clin. Transplant. (2004) 18(3):247–253.
  • AALAMIAN Z. Reducing adverse events of immunosuppressive agents in kidney transplanta recipients. Frog. Transplant. (2001); 11(4):271–282.
  • 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.
  • BUSH WW. Overview of transplantation immunology and pharmacotherapy of adult solid organ transplant recipients: focus on immunosuppression. Transplantation (1999) 10(2):253–269.
  • WILDE MI. GOA KL. Muromonab CD3: a reappraisal of its pharmacology and use as prophylaxis of solid organ transplant rejection. Drugs (1996) 51(5):865–894.
  • 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) 60(7):748–756.
  • STERKERS G, BAUDOUIN V, ANSART-PIRENNE H et al. Duration of action of a chimeric interleukin-2 recpetor monoclonal antibody, basiliximab, in pediatric kidney transplant recipients. Transplant. Proc. (2000) 32(8):2757–2759.
  • LINDHOLM A, OHLMAN S, ALBRECHTSEN D, TUFVESON G, PERSSON H, PERSSON NH. The impact of acute rejection episodes on long-term graft function and outcome in 1347 primary renal transplant recipients threated by 3 cyclosporine regimens. Transplantation (1993) 56(2):307–315.
  • MATAS AJ, GILLINGHAM KJ, PAYNE WD, NAJARIAN JS. The impact of an acute rejection episode on long-term renal allograft survival (tl/2). Transplantation (1994) 57(6):857–859
  • BASADONNA GP, MATAS AJ, GILLINGHAM KJ et al. Early versus late acute renal allograft rejection: impact on chronic rejection. Transplantation (1993) 55(5):993–995.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.