title: A multicenter, prospective, randomized, double-blind trial of basiliximab in heart transplantation.
abstract: BACKGROUND
  The role and pharmacokinetics of interleukin-2 (IL-2) monoclonal antibodies (mAbs) in heart transplantation remain unclear. This 1-year double-blind, randomized, placebo-controlled study evaluated safety, tolerability, and pharmacokinetics of the IL-2 mAb basiliximab with cyclosporine, mycophenolate mofetil, and steroids in adult de novo heart transplant recipients.
  
  
  METHODS
  Fifty-six patients received either basiliximab (20 mg) or placebo on Days 0 and 4 post-transplantation. Safety assessments included adverse events, serious adverse events, and infections. The time to and severity of biopsy-proven acute rejection (BPAR) were also assessed.
  
  
  RESULTS
  Basiliximab was generally well tolerated. There were no significant differences between treatment groups with respect to adverse event profiles, serious adverse events (84.0% vs 61.3%), or infections (84% vs 74.2%). The mean number of days to first BPAR was longer with basiliximab (73.7 +/- 59.68) than placebo (40.6 +/- 53.30) at 6 months, but not statistically significant (trend). The duration that basiliximab concentrations exceeded the CD25 saturation threshold averaged 38 +/- 13 days. Patients with rejection did not clear basiliximab faster or have shorter durations of saturation than rejection-free patients. None of the patients screened had detectable anti-idiotype antibodies.
  
  
  CONCLUSIONS
  These pilot results describe the pharmacokinetics of basiliximab and show that basiliximab appears to be tolerated with a similar safety profile to placebo in adult de novo heart transplant recipients. Larger scale clinical trials are feasible and warranted.
authors.affiliation: Cardiomyopathy and Heart Transplant Center, Ochsner Clinic Foundation, New Orleans, Louisiana, USA. mmehra@ochsner.org
authors.forename: Mandeep R
authors.initials: MR
authors.lastname: Mehra
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Zucker
authors.forename: Lynne
authors.initials: L
authors.lastname: Wagoner
authors.forename: Robert
authors.initials: R
authors.lastname: Michler
authors.forename: John
authors.initials: J
authors.lastname: Boehmer
authors.forename: John
authors.initials: J
authors.lastname: Kovarik
authors.forename: Arthur
authors.initials: A
authors.lastname: Vasquez
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D000077552:Basiliximab; D016572:Cyclosporine / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D016027:Heart Transplantation / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D007239:Infections / Q000453:epidemiology; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011184:Postoperative Period; D015375:Receptors, Interleukin-2 / Q000037:antagonists & inhibitors*; D011993:Recombinant Fusion Proteins / Q000494:pharmacology / Q000627:therapeutic use*; D014481:United States
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D015375:Receptors, Interleukin-2; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D009173:Mycophenolic Acid; D008775:Methylprednisolone