title: Daclizumab induction, tacrolimus, mycophenolate mofetil and steroids as an immunosuppression regimen for primary kidney transplant recipients.
abstract: BACKGROUND
  Recent reports have demonstrated the efficacy of interleukin-2-receptor blockers in lowering the incidence of early acute rejection in cyclosporine-treated kidney recipients when compared to patients not induced with an antibody product. The addition of daclizumab to a tacrolimus-mycophenolate mofetil-based immunosuppressive protocol was tested to evaluate whether there might be an additional reduction of the risk of rejection after renal transplantation.
  
  
  METHODS
  Since March 1998, we studied the effect of daclizumab in a nonrandomized, prospective study of 233 sequential recipients of first renal transplant. They were retrospective compared with a control group of 225 renal transplant recipients receiving a 10-day course of OKT3 induction, and tacrolimus, mycophenolate mofetil, and methylprednisolone maintenance. The study group received the same immunosuppressive regimen with the addition of daclizumab at 1 mg/kg for five doses over 10 weeks in the place of OKT3 therapy. There was at least 1HLA DR antigen compatibility match present between all donors and recipients. Patients were followed for 1 year after renal transplantation for the incidence of biopsy-proven acute rejection, patient and graft survival, and adverse events.
  
  
  RESULTS
  At 12 months, patient and graft survival for the daclizumab was 98 and 96 vs. 96 and 94% for the OKT3 group, respectively, and were not statistically different. Acute rejection rates (<6 months) were lower in the daclizumab group as compared with the OKT3 group, i.e., 5 (2.1%) vs. 16 (7.1%) (P=0.011) respectively. The incidence of infection requiring hospitalization appeared to be lower with daclizumab (7.3 vs. 16%, P<0.0036) with a similar trend with cyclomegalovirus infection, i.e., 1.6 vs. 4%, respectively (P=0.14).
  
  
  CONCLUSIONS
  The combination of daclizumab, tacrolimus, mycophenolate mofetil, and steroids is safe and effective for kidney transplant recipients in lowering the incidence of early acute rejection and without any increase in morbidity when compared to our previous protocol, which may have an eventual impact in long-term graft survival.
authors.affiliation: Department of Surgery, Division of Transplantation, University of Miami School of Medicine, Miami, FL 33101, USA.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Ciancio
authors.forename: George W
authors.initials: GW
authors.lastname: Burke
authors.forename: Kiliana
authors.initials: K
authors.lastname: Suzart
authors.forename: David
authors.initials: D
authors.lastname: Roth
authors.forename: Warren
authors.initials: W
authors.lastname: Kupin
authors.forename: Anne
authors.initials: A
authors.lastname: Rosen
authors.forename: Les
authors.initials: L
authors.lastname: Olson
authors.forename: Violet
authors.initials: V
authors.lastname: Esquenazi
authors.forename: Joshua
authors.initials: J
authors.lastname: Miller
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002648:Child; D002675:Child, Preschool; D000077561:Daclizumab; D003920:Diabetes Mellitus / Q000209:etiology; D006085:Graft Survival; D006801:Humans; D006949:Hyperlipidemias / Q000209:etiology; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016030:Kidney Transplantation / Q000009:adverse effects / Q000401:mortality; D008775:Methylprednisolone / Q000627:therapeutic use*; D008875:Middle Aged; D016853:Muromonab-CD3 / Q000627:therapeutic use; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011446:Prospective Studies; D016559:Tacrolimus / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D016853:Muromonab-CD3; D000077561:Daclizumab; D009173:Mycophenolic Acid; D016559:Tacrolimus; D008775:Methylprednisolone