title: Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation.
abstract: BACKGROUND
  The administration of alemtuzumab (Campath-1H [C1H]; Berlex Laboratories, Montville, NJ) at transplantation prevents a vigorous immune response and is believed to allow a gradual engagement of the host immune system. We report our preliminary experience with C1H and tacrolimus (Tac) immunosuppression in adult liver transplantation.
  
  
  METHODS
  We administered C1H and low-dose Tac to 40 adult recipients of cadaveric liver allografts between December 2001 and April 2003. A control group who met the same eligibility criteria consisted of 50 liver transplant recipients treated with our standard Tac and steroids protocol.
  
  
  RESULTS
  Baseline characteristics and patient and graft survival were similar (P >0.15). The incidence of acute rejection was significantly lower during the first 2 months posttransplantation (P =0.002) and slightly lower overall in the study group versus the control group at 12 months (46% vs. 55%, P =0.12, log-rank test). Median time to rejection among those experiencing rejection was significantly longer in the study group versus control group (2.76 vs. 0.34 months, P =0.0007). The mean Tac dose, 12-hr trough level, and percentage of patients receiving maintenance steroids were significantly lower in the group receiving C1H and Tac (P <0.0001 during the first 3 months, P <0.05 thereafter), as were the mean creatinine levels (P <0.05) and incidence of nephrotoxicity (P =0.004, conversion from Tac to other agents). Finally, in the group receiving C1H/Tac, patients with an average Tac trough level less than 6.5 ng/mL during the first 2 months post-transplantation demonstrated a significantly higher rejection rate beyond that time (P =0.02).
  
  
  CONCLUSIONS
  C1H and low-dose Tac seems to be at least as effective as our standard Tac and steroids regimen in preventing acute rejection in adult liver allotransplantation with less renal toxicity and less use of maintenance steroids.
authors.affiliation: Department of Surgery, Division of Transplantation, University of Miami School of Medicine, Miami, Florida 33136, USA. atzakis@med.miami.edu
authors.forename: Andreas G
authors.initials: AG
authors.lastname: Tzakis
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Tryphonopoulos
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Kato
authors.forename: Seigo
authors.initials: S
authors.lastname: Nishida
authors.forename: David M
authors.initials: DM
authors.lastname: Levi
authors.forename: Juan R
authors.initials: JR
authors.lastname: Madariaga
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Gaynor
authors.forename: Werviston
authors.initials: W
authors.lastname: De Faria
authors.forename: Arie
authors.initials: A
authors.lastname: Regev
authors.forename: Violet
authors.initials: V
authors.lastname: Esquenazi
authors.forename: Debbie
authors.initials: D
authors.lastname: Weppler
authors.forename: Phillip
authors.initials: P
authors.lastname: Ruiz
authors.forename: Joshua
authors.initials: J
authors.lastname: Miller
mesh_terms: D000208:Acute Disease; D000328:Adult; D000074323:Alemtuzumab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007668:Kidney / Q000187:drug effects; D016031:Liver Transplantation / Q000276:immunology*; D008297:Male; D012189:Retrospective Studies; D013256:Steroids / Q000008:administration & dosage / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000912:Antibodies, Neoplasm; D007166:Immunosuppressive Agents; D013256:Steroids; D000074323:Alemtuzumab; D016559:Tacrolimus