title: 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.
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, placebo-controlled, 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, biopsy-confirmed 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.
authors.affiliation: Queen Elizabeth Health Science Center, Halifax, Nova Scotia, Canada. joseph.lawen@dal.ca.
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Lawen
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Davies
authors.forename: Georges
authors.initials: G
authors.lastname: Mourad
authors.forename: Frederic
authors.initials: F
authors.lastname: Oppenheimer
authors.forename: Miguel Gonzalez
authors.initials: MG
authors.lastname: Molina
authors.forename: Lionel
authors.initials: L
authors.lastname: Rostaing
authors.forename: Alan H
authors.initials: AH
authors.lastname: Wilkinson
authors.forename: Laura L
authors.initials: LL
authors.lastname: Mulloy
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Bourbigot
authors.forename: Hans
authors.initials: H
authors.lastname: Prestele
authors.forename: Alexander
authors.initials: A
authors.lastname: Korn
authors.forename: Danièle
authors.initials: D
authors.lastname: Girault
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D000077552:Basiliximab; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D011993:Recombinant Fusion Proteins
chemical_list: D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D009173:Mycophenolic Acid