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

Joseph G. Lawen, Elizabeth A. Davies, Georges Mourad, Frederic Oppenheimer, Miguel Gonzalez Molina, Lionel Rostaing, Alan H. Wilkinson, Laura L Mulloy, Bernard J. Bourbigot, Hans Prestele, Alexander Korn, Daniéle Girault

Research output: Contribution to journalArticle

115 Citations (Scopus)

Abstract

Background. Acute rejection remains a major problem in renal transplantation. Immunoprophylaxis with basiliximab (Simulect) has achieved significant reductions in acute rejection episodes in renal allograft recipients receiving dual immunosuppression. This study explored the tolerability and cumulative benefit of combining basiliximab with triple-drug therapy-cyclosporine (USP Modified, Neoral), mycophenolate mofetil, and steroids. Methods. In a randomized, double-blind, placebocontrolled, multicenter study, 123 kidney transplant recipients received either basiliximab at 20 mg before transplantation (day 0) and 20 mg on day 4 (n=59), or placebo (n=64). All received triple-drug immunosuppression and were followed for 6 months. Results. Tolerability of basiliximab was equivalent to placebo, with no increase in serious adverse events, infection, malignancy, or posttransplant lymphoproliferative disorder. At 6 months, there were trends in favor of basiliximab over placebo in the incidences of first biopsy-confirmed acute rejection (15.3% vs. 26.6%, P=NS) and of acute rejection treated with antibody (5.1% vs. 15.6%, P=NS). Kaplan-Meier estimates at 4 weeks and 6 months were significantly in favor of basiliximab treatment for first acute rejection, biopsyconfirmed rejection, rejection episodes treated with antibody therapy, and treatment failure. Renal function improved more rapidly in the basiliximab group, with mean creatinine clearance at week 2 being 54.7 mL/min versus 43.2 mL/min for placebo (P=0.034). At 12 months, patient survival was 100% in both groups; graft survival was 94.9% with basiliximab and 92.2% with placebo. Conclusions. Basiliximab immunoprophylaxis is safe, well tolerated, and shows a trend toward reduction in number of acute rejection episodes in renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.

Original languageEnglish (US)
Pages (from-to)37-43
Number of pages7
JournalTransplantation
Volume75
Issue number1
DOIs
StatePublished - Jan 15 2003

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Mycophenolic Acid
Interleukin-2 Receptors
Double-Blind Method
Kidney Transplantation
Monoclonal Antibodies
Placebos
Cyclosporine
Kidney
Therapeutics
Immunosuppression
Steroids
basiliximab
Lymphoproliferative Disorders
Antibodies
Kaplan-Meier Estimate
Graft Survival
Treatment Failure
Multicenter Studies
Allografts
Creatinine

ASJC Scopus subject areas

  • Transplantation

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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. / Lawen, Joseph G.; Davies, Elizabeth A.; Mourad, Georges; Oppenheimer, Frederic; Molina, Miguel Gonzalez; Rostaing, Lionel; Wilkinson, Alan H.; Mulloy, Laura L; Bourbigot, Bernard J.; Prestele, Hans; Korn, Alexander; Girault, Daniéle.

In: Transplantation, Vol. 75, No. 1, 15.01.2003, p. 37-43.

Research output: Contribution to journalArticle

Lawen, Joseph G. ; Davies, Elizabeth A. ; Mourad, Georges ; Oppenheimer, Frederic ; Molina, Miguel Gonzalez ; Rostaing, Lionel ; Wilkinson, Alan H. ; Mulloy, Laura L ; Bourbigot, Bernard J. ; Prestele, Hans ; Korn, Alexander ; Girault, Daniéle. / 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. In: Transplantation. 2003 ; Vol. 75, No. 1. pp. 37-43.
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abstract = "Background. Acute rejection remains a major problem in renal transplantation. Immunoprophylaxis with basiliximab (Simulect) has achieved significant reductions in acute rejection episodes in renal allograft recipients receiving dual immunosuppression. This study explored the tolerability and cumulative benefit of combining basiliximab with triple-drug therapy-cyclosporine (USP Modified, Neoral), mycophenolate mofetil, and steroids. Methods. In a randomized, double-blind, placebocontrolled, multicenter study, 123 kidney transplant recipients received either basiliximab at 20 mg before transplantation (day 0) and 20 mg on day 4 (n=59), or placebo (n=64). All received triple-drug immunosuppression and were followed for 6 months. Results. Tolerability of basiliximab was equivalent to placebo, with no increase in serious adverse events, infection, malignancy, or posttransplant lymphoproliferative disorder. At 6 months, there were trends in favor of basiliximab over placebo in the incidences of first biopsy-confirmed acute rejection (15.3{\%} vs. 26.6{\%}, P=NS) and of acute rejection treated with antibody (5.1{\%} vs. 15.6{\%}, P=NS). Kaplan-Meier estimates at 4 weeks and 6 months were significantly in favor of basiliximab treatment for first acute rejection, biopsyconfirmed rejection, rejection episodes treated with antibody therapy, and treatment failure. Renal function improved more rapidly in the basiliximab group, with mean creatinine clearance at week 2 being 54.7 mL/min versus 43.2 mL/min for placebo (P=0.034). At 12 months, patient survival was 100{\%} in both groups; graft survival was 94.9{\%} with basiliximab and 92.2{\%} with placebo. Conclusions. Basiliximab immunoprophylaxis is safe, well tolerated, and shows a trend toward reduction in number of acute rejection episodes in renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.",
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AU - Lawen, Joseph G.

AU - Davies, Elizabeth A.

AU - Mourad, Georges

AU - Oppenheimer, Frederic

AU - Molina, Miguel Gonzalez

AU - Rostaing, Lionel

AU - Wilkinson, Alan H.

AU - Mulloy, Laura L

AU - Bourbigot, Bernard J.

AU - Prestele, Hans

AU - Korn, Alexander

AU - Girault, Daniéle

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N2 - Background. Acute rejection remains a major problem in renal transplantation. Immunoprophylaxis with basiliximab (Simulect) has achieved significant reductions in acute rejection episodes in renal allograft recipients receiving dual immunosuppression. This study explored the tolerability and cumulative benefit of combining basiliximab with triple-drug therapy-cyclosporine (USP Modified, Neoral), mycophenolate mofetil, and steroids. Methods. In a randomized, double-blind, placebocontrolled, multicenter study, 123 kidney transplant recipients received either basiliximab at 20 mg before transplantation (day 0) and 20 mg on day 4 (n=59), or placebo (n=64). All received triple-drug immunosuppression and were followed for 6 months. Results. Tolerability of basiliximab was equivalent to placebo, with no increase in serious adverse events, infection, malignancy, or posttransplant lymphoproliferative disorder. At 6 months, there were trends in favor of basiliximab over placebo in the incidences of first biopsy-confirmed acute rejection (15.3% vs. 26.6%, P=NS) and of acute rejection treated with antibody (5.1% vs. 15.6%, P=NS). Kaplan-Meier estimates at 4 weeks and 6 months were significantly in favor of basiliximab treatment for first acute rejection, biopsyconfirmed rejection, rejection episodes treated with antibody therapy, and treatment failure. Renal function improved more rapidly in the basiliximab group, with mean creatinine clearance at week 2 being 54.7 mL/min versus 43.2 mL/min for placebo (P=0.034). At 12 months, patient survival was 100% in both groups; graft survival was 94.9% with basiliximab and 92.2% with placebo. Conclusions. Basiliximab immunoprophylaxis is safe, well tolerated, and shows a trend toward reduction in number of acute rejection episodes in renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.

AB - Background. Acute rejection remains a major problem in renal transplantation. Immunoprophylaxis with basiliximab (Simulect) has achieved significant reductions in acute rejection episodes in renal allograft recipients receiving dual immunosuppression. This study explored the tolerability and cumulative benefit of combining basiliximab with triple-drug therapy-cyclosporine (USP Modified, Neoral), mycophenolate mofetil, and steroids. Methods. In a randomized, double-blind, placebocontrolled, multicenter study, 123 kidney transplant recipients received either basiliximab at 20 mg before transplantation (day 0) and 20 mg on day 4 (n=59), or placebo (n=64). All received triple-drug immunosuppression and were followed for 6 months. Results. Tolerability of basiliximab was equivalent to placebo, with no increase in serious adverse events, infection, malignancy, or posttransplant lymphoproliferative disorder. At 6 months, there were trends in favor of basiliximab over placebo in the incidences of first biopsy-confirmed acute rejection (15.3% vs. 26.6%, P=NS) and of acute rejection treated with antibody (5.1% vs. 15.6%, P=NS). Kaplan-Meier estimates at 4 weeks and 6 months were significantly in favor of basiliximab treatment for first acute rejection, biopsyconfirmed rejection, rejection episodes treated with antibody therapy, and treatment failure. Renal function improved more rapidly in the basiliximab group, with mean creatinine clearance at week 2 being 54.7 mL/min versus 43.2 mL/min for placebo (P=0.034). At 12 months, patient survival was 100% in both groups; graft survival was 94.9% with basiliximab and 92.2% with placebo. Conclusions. Basiliximab immunoprophylaxis is safe, well tolerated, and shows a trend toward reduction in number of acute rejection episodes in renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.

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