title: Immunoprophylaxis with Simulect (basiliximab) in kidney transplantation: results from routine clinical practice at 18 kidney transplant units.
abstract: OBJECTIVE
  The objective of this study is to assess a Simulect (basiliximab) regimen in routine clinical practice in the Spanish kidney transplantation units to evaluate efficacy and safety.
  
  
  METHODS
  In this prospective, observational study, data on demographics, parameters of efficacy, and safety in patients who under with kidney transplantation treated with Simulect (basiliximab) were collected through an on-line collection system.
  
  
  RESULTS
  One hundred sixty three patients at 18 kidney transplant units included 12 months follow-up. The patient mean age was 52 years (DS 13,67) including 96 (58.90%) men and 67 (41.10%) women. Cold ischemia time was 19 hours (DS 6,79). Only 2 patients presented with PRA >50%. For prophylactic immunosuppression, 67.13% of patients received triple therapy with CNI (cyclosporine 49.65% or tacrolimus 17.48%), MMF (66.43%) or AZA (10.49%), and steroids. Incidence of acute rejection (AR) at 12 months was 12.27% (1.84% steroid-resistant). In subgroup analysis, AR was 13.5% in nondiabetics and 4.5% in diabetics, including 3 steroid-resistant episodes (1.84%) in nondiabetics and none in diabetics. In relation to donor age, AR was incidence 10.3% in patients with kidneys from donors aged 50 years or younger and 10.6% when donors were older than 50 years, including 1 (1.73%) and 2 (1.93%) steroid-resistant episodes, respectively. The graft and patient survival rates at 12 months were 90% and 98%, respectively.
  
  
  CONCLUSIONS
  Simulect (basiliximab) used in routine clinical practice provided good prophylaxis against acute rejection in several kidney transplant patient populations, similar to that observed in randomized clinical studies with excellent tolerability and safety.
authors.affiliation: Hospital Gregorio Marañón, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Rengel
authors.forename: A
authors.initials: A
authors.lastname: Fernández Rodriguez
authors.forename: E
authors.initials: E
authors.lastname: Gómez Huertas
authors.forename: J J
authors.initials: JJ
authors.lastname: Plaza
authors.forename: J C
authors.initials: JC
authors.lastname: Ruiz San Millán
authors.forename: F
authors.initials: F
authors.lastname: Oppenheimer
authors.forename: J
authors.initials: J
authors.lastname: Bustamante
authors.forename: D
authors.initials: D
authors.lastname: Checa
authors.forename: J A
authors.initials: JA
authors.lastname: Sanchez Plumed
authors.forename: J
authors.initials: J
authors.lastname: García Pérez
authors.forename: A
authors.initials: A
authors.lastname: Sanz Guajardo
authors.forename: S
authors.initials: S
authors.lastname: Llorente
authors.forename: J A
authors.initials: JA
authors.lastname: Martin Govantes
authors.forename: M A
authors.initials: MA
authors.lastname: Gentil
authors.forename: P
authors.initials: P
authors.lastname: Gomez Ullate
authors.forename: D
authors.initials: D
authors.lastname: Sanchez Guisande
authors.forename: J M
authors.initials: JM
authors.lastname: Puig
authors.forename: C
authors.initials: C
authors.lastname: Fernández
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000367:Age Factors; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077552:Basiliximab; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins; D013030:Spain; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab