title: 5-year results of a prospective, randomized, single-center study of alemtuzumab compared with rabbit antithymocyte globulin induction in simultaneous kidney-pancreas transplantation.
abstract: BACKGROUND
  The study purpose was to analyze 5-year outcomes in a prospective, randomized trial of alemtuzumab (ALEM) versus rabbit antithymocyte globulin (rATG) induction in simultaneous kidney-pancreas transplantation (SKPT).
  
  
  METHODS
  From February 2005 through October 2008, a total of 46 SKPTs (45 portal-enteric drainage) were prospectively randomized to receive either single-dose ALEM (30 mg intraoperatively) or multiple-dose rATG antibody induction (starting intraoperatively, minimum of 3 doses administered) with tacrolimus/mycophenolate and/or steroids.
  
  
  RESULTS
  Of 222 kidney transplant patients enrolled in the study, 46 received SKPTs; 28 (61%) received ALEM and 18 (39%) received rATG induction. Follow-up ranged from 54 to 98 months (mean, 69 months). There were no significant differences between the 2 groups in 5-year patient (82% ALEM vs 89% rATG), kidney graft (79% ALEM vs 72% rATG), or pancreas graft (64% ALEM vs 56% rATG) survival rates. Death-censored kidney (90% ALEM vs 75% rATG) and pancreas (71% ALEM vs 56% rATG) graft survival rates were likewise comparable (both, P = NS). Acute rejection (21% ALEM vs 44% rATG; P = .11) and major infection (39% ALEM vs 67% rATG; P = .13) rates were slightly lower in the ALEM group; cytomegalovirus infections were significantly lower (0% ALEM vs 17% rATG; P = .05). The incidence of late acute rejection was low in both groups. There were no differences in early pancreas thromboses (3.6% ALEM vs 11% rATG), postoperative bleeding (11% ALEM vs 0% rATG), other surgical complications, or readmissions between groups. In patients with functioning grafts, 5-year mean serum creatinine (1.4 ALEM vs 1.6 mg/dL rATG), calculated abbreviated Modification of Diet in Renal Disease glomerular filtration rate (55 ALEM vs 52 mL/min/1.73 m(2) rATG), glycosylated hemoglobin (both 5.4%), and C-peptide (2.2 ALEM vs 2.3 ng/mL rATG) levels were similar.
  
  
  CONCLUSIONS
  Single-dose ALEM and multiple dose rATG induction provided similar medium-term patient, kidney, and pancreas graft function and survival rates. ALEM induction may be associated with less acute rejection and major infection over the long term.
authors.affiliation: Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina. Electronic address: rstratta@wakehealth.edu.
authors.forename: R J
authors.initials: RJ
authors.lastname: Stratta
authors.affiliation: Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: J
authors.initials: J
authors.lastname: Rogers
authors.affiliation: Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: G
authors.initials: G
authors.lastname: Orlando
authors.affiliation: Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: U
authors.initials: U
authors.lastname: Farooq
authors.affiliation: Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Y
authors.initials: Y
authors.lastname: Al-Shraideh
authors.affiliation: Department of General Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: A C
authors.initials: AC
authors.lastname: Farney
mesh_terms: D000328:Adult; D000074323:Alemtuzumab; D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000961:Antilymphocyte Serum / Q000008:administration & dosage*; D003586:Cytomegalovirus Infections / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000276:immunology; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D016035:Pancreas Transplantation; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011817:Rabbits
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D000074323:Alemtuzumab