title: Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids.
abstract: 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.
authors.affiliation: Kinderklinik der Medizinischen Hochschule, Carl-Neuberg-Str 1, Hannover, Germany.
authors.forename: Gisela
authors.initials: G
authors.lastname: Offner
authors.forename: Burkhard
authors.initials: B
authors.lastname: Toenshoff
authors.forename: Britta
authors.initials: B
authors.lastname: Höcker
authors.forename: Manuela
authors.initials: M
authors.lastname: Krauss
authors.forename: Monika
authors.initials: M
authors.lastname: Bulla
authors.forename: Pierre
authors.initials: P
authors.lastname: Cochat
authors.forename: Henry
authors.initials: H
authors.lastname: Fehrenbach
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Fischer
authors.forename: Michel
authors.initials: M
authors.lastname: Foulard
authors.forename: Bernd
authors.initials: B
authors.lastname: Hoppe
authors.forename: Peter F
authors.initials: PF
authors.lastname: Hoyer
authors.forename: Therese C
authors.initials: TC
authors.lastname: Jungraithmayr
authors.forename: Günter
authors.initials: G
authors.lastname: Klaus
authors.forename: Kay
authors.initials: K
authors.lastname: Latta
authors.forename: Heinz
authors.initials: H
authors.lastname: Leichter
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mihatsch
authors.forename: Joachim
authors.initials: J
authors.lastname: Misselwitz
authors.forename: Carmen
authors.initials: C
authors.lastname: Montoya
authors.forename: Dirk E
authors.initials: DE
authors.lastname: Müller-Wiefel
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Neuhaus
authors.forename: Lars
authors.initials: L
authors.lastname: Pape
authors.forename: Uwe
authors.initials: U
authors.lastname: Querfeld
authors.forename: Christian
authors.initials: C
authors.lastname: Plank
authors.forename: Dieter
authors.initials: D
authors.lastname: Schwarke
authors.forename: Simone
authors.initials: S
authors.lastname: Wygoda
authors.forename: Lothar B
authors.initials: LB
authors.lastname: Zimmerhackl
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000473:pathology; D016030:Kidney Transplantation / Q000276:immunology*; D008137:Longitudinal Studies; D008297:Male; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D009173:Mycophenolic Acid