Anti-CD2 monoclonal antibody and tacrolimus in adult liver transplantation.
BACKGROUND
Blockade of costimulation and adhesion signaling is an attractive approach to interfere with graft rejection


METHODS
Between January 1997 and May 1999, forty adults having benign liver diseases were included in a prospective, randomized study comparing tacrolimus plus low-dose short-term steroids without (n=20, TAC group) or with a 10-day course of antihuman CD2 monoclonal antibody (n=20, BTI group).


RESULTS
At day 7, histological rejection expressed by mean Banff scores (2.3+/-1.6 vs. 5.4+/-1.6 in the TAC group; P<0.0001) and incidence of moderate to severe rejection (score>or=6) (0 vs. 10 [50%] in the TAC group; P<0.001) were significantly lower in the BTI group. Rejection was treated in 10% (two patients) of BTI patients during the first 3 months and in 15% during the whole follow-up and in 25% (five patients) of TAC patients (P=NS). None of the BTI-patients presented with an adverse event. Three-month, 1-year, and 5-year actual patient survival rates were 100%, 95%, and 95% in the BTI group and 100%, 100%, and 85% in the TAC group. Graft survival rates were 100%, 90%, and 90% in the BTI group and 95%, 95%, and 80% in the TAC group (P=NS). The mAb had no negative impact on infectious or tumor events.


CONCLUSIONS
Antihuman CD2 monoclonal antibody is a safe immunosuppressive drug which has a favorable impact on early immunological follow-up of liver transplanted patients. The antibody had no impact on late patient and graft survival.
Lerut
Jan
J
Liver Transplant Unit, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. lerut@lchir.ucl.ac.be
Van Thuyne
Vincent
V
Mathijs
Jules
J
Lemaire
Julien
J
Talpe
Stéphanie
S
Roggen
Francine
F
Ciccarelli
Olga
O
Zuckermann
Michele
M
Goffette
Pierre
P
Hope
James
J
Gianello
Pierre
P
Bazin
Hervé
H
Cornet
Anne
A
Rahier
Jacques
J
Latinne
Dominique
D
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018801:CD2 Antigens / Q000276:immunology*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D015994:Incidence; D007239:Infections / Q000150:complications; D017093:Liver Failure / Q000150:complications / Q000601:surgery; D016031:Liver Transplantation / Q000276:immunology*; D018655:Lymphocyte Count; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D011184:Postoperative Period; D013256:Steroids / Q000008:administration & dosage / Q000627:therapeutic use; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D018801:CD2 Antigens; D007166:Immunosuppressive Agents; D013256:Steroids; D016559:Tacrolimus