Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.
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Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids. / Offner, Gisela; Toenshoff, Burkhard; Höcker, Britta; Krauss, Manuela; Bulla, Monika; Cochat, Pierre; Fehrenbach, Henry; Fischer, Wolfgang; Foulard, Michel; Hoppe, Bernd; Hoyer, Peter F; Jungraithmayr, Therese C; Klaus, Günter; Latta, Kay; Leichter, Heinz; Mihatsch, Michael J; Misselwitz, Joachim; Montoya, Carmen; Müller-Wiefel, Dirk E.; Neuhaus, Thomas J; Pape, Lars; Querfeld, Uwe; Plank, Christian; Schwarke, Dieter; Wygoda, Simone; Zimmerhackl, Lothar B.
in: TRANSPLANTATION, Jahrgang 86, Nr. 9, 9, 2008, S. 1241-1248.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.
AU - Offner, Gisela
AU - Toenshoff, Burkhard
AU - Höcker, Britta
AU - Krauss, Manuela
AU - Bulla, Monika
AU - Cochat, Pierre
AU - Fehrenbach, Henry
AU - Fischer, Wolfgang
AU - Foulard, Michel
AU - Hoppe, Bernd
AU - Hoyer, Peter F
AU - Jungraithmayr, Therese C
AU - Klaus, Günter
AU - Latta, Kay
AU - Leichter, Heinz
AU - Mihatsch, Michael J
AU - Misselwitz, Joachim
AU - Montoya, Carmen
AU - Müller-Wiefel, Dirk E.
AU - Neuhaus, Thomas J
AU - Pape, Lars
AU - Querfeld, Uwe
AU - Plank, Christian
AU - Schwarke, Dieter
AU - Wygoda, Simone
AU - Zimmerhackl, Lothar B
PY - 2008
Y1 - 2008
N2 - BACKGROUND: Basiliximab, a monoclonal CD25 antibody has proofed effective in reducing acute rejection episodes in adults in various immunosuppressive regimens. The effect of basiliximab in the pediatric population is controversial. METHODS: In a 12-month, double-blind, placebo-controlled trial, renal transplant patients aged 1 to 18 years were randomized to basiliximab or placebo with cyclosporine microemulsion, mycophenolate mofetil, and corticosteroids. The intent-to-treat population comprised 192 patients (100 basiliximab and 92 placebo). RESULTS: The primary efficacy endpoint, time to first biopsy-proven acute rejection episode, or treatment failure by month 6, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients (Kaplan-Meier estimates; hazard ratio 0.72, two-sided 90% confidence interval 0.416-1.26, n.s.). The rate and severity of subclinical rejections in protocol biopsies performed at 6 months posttransplant was higher in the basiliximab group (25.0%) than in the placebo group (11.7%). Patient and death-censored graft survival at 12 months was 97% and 99%, respectively, in the basiliximab cohort, and 100% and 99% among placebo-treated patients (n.s.). Renal function was similar in both treatment groups, and there were no significant between-treatment differences in the incidence of adverse events or infections. CONCLUSIONS: Addition of basiliximab induction to a regimen of cyclosporine microemulsion, mycophenolate mofetil, and steroids resulted in a numerically lower but not significant incidence of biopsy-proven acute rejection versus placebo and excellent graft and patient survival at 1 year in pediatric renal transplant recipients. Whether this numerical difference is a true therapeutic benefit in view of the higher rate and severity of subclinical rejections in the basiliximab group in the protocol biopsy will be investigated in a long-term follow-up study.
AB - BACKGROUND: Basiliximab, a monoclonal CD25 antibody has proofed effective in reducing acute rejection episodes in adults in various immunosuppressive regimens. The effect of basiliximab in the pediatric population is controversial. METHODS: In a 12-month, double-blind, placebo-controlled trial, renal transplant patients aged 1 to 18 years were randomized to basiliximab or placebo with cyclosporine microemulsion, mycophenolate mofetil, and corticosteroids. The intent-to-treat population comprised 192 patients (100 basiliximab and 92 placebo). RESULTS: The primary efficacy endpoint, time to first biopsy-proven acute rejection episode, or treatment failure by month 6, occurred in 16.7% of basiliximab-treated patients and 21.7% of placebo-treated patients (Kaplan-Meier estimates; hazard ratio 0.72, two-sided 90% confidence interval 0.416-1.26, n.s.). The rate and severity of subclinical rejections in protocol biopsies performed at 6 months posttransplant was higher in the basiliximab group (25.0%) than in the placebo group (11.7%). Patient and death-censored graft survival at 12 months was 97% and 99%, respectively, in the basiliximab cohort, and 100% and 99% among placebo-treated patients (n.s.). Renal function was similar in both treatment groups, and there were no significant between-treatment differences in the incidence of adverse events or infections. CONCLUSIONS: Addition of basiliximab induction to a regimen of cyclosporine microemulsion, mycophenolate mofetil, and steroids resulted in a numerically lower but not significant incidence of biopsy-proven acute rejection versus placebo and excellent graft and patient survival at 1 year in pediatric renal transplant recipients. Whether this numerical difference is a true therapeutic benefit in view of the higher rate and severity of subclinical rejections in the basiliximab group in the protocol biopsy will be investigated in a long-term follow-up study.
M3 - SCORING: Zeitschriftenaufsatz
VL - 86
SP - 1241
EP - 1248
JO - TRANSPLANTATION
JF - TRANSPLANTATION
SN - 0041-1337
IS - 9
M1 - 9
ER -
