Julien Lemaire, Pierre Goffette, Vincent Van Thuyne, Olga Ciccarelli, Dominique Latinne, Jules Mathijs, Michele Zuckermann, Jacques Rahier, Pierre Gianello, Hervé Bazin, Jan Lerut, J Hope, Anne Cornet, Francine Roggen, and Stephanie Talpe
Blockade of costimulation and adhesion signaling is an attractive approach to interfere with graft rejectionBetween 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).At day 7, histological rejection expressed by mean Banff scores (2.3+/-1.6 vs. 5.4+/-1.6 in the TAC group; P0.0001) and incidence of moderate to severe rejection (scoreor=6) (0 vs. 10 [50%] in the TAC group; P0.001) 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.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.