A PROSPECTIVE RANDOMIZED TRIAL COMPARING INTERLEUKIN-8 RECEPTOR ANTIBODY VERSUS ANTITHYMOCYTE GLOBULIN AS PART OF A QUADRUPLE IMMUNOSUPPRESSIVE INDUCTION THERAPY FOLLOWING ORTHOTOPIC LIVER-TRANSPLANTATION

Background. Quadruple immunosuppressive induction therapy has been sho wn to markedly reduce the incidence of acute rejection episodes withou t increasing the incidence of infectious complications after liver tra nsplantation. However, the use of polyclonal antibody preparations (e. g. antithymocyte globulin [ATG]) is associated with side effects such as fever and tachycardia. To evaluate the efficacy and the safety of a monoclonal antibody directed against the interleukin-2 receptor (BT56 3) in comparison with ATG as part of a quadruple induction regimen, a prospective, randomized study was conducted. Methods. Eighty consecuti ve adult recipients of primary orthotopic liver transplants were rando mized to receive either BT563 (10 mg/day; days 0-12; n=39) or ATG (5 m g/kg/day; days 0-6; n=41) in addition to the standard immunosuppressiv e protocol consisting of cyclosporine, and prednisolone, and azathiopr ine. Results. Patients treated with BT563 had a significantly lower in cidence of steroid-sensitive rejection episodes (3 vs. 11; P<0.025) an d also significantly fewer drug-related side effects (4 vs. 18, P < 0. 038) when compared with patients treated with ATG. The incidence of in fectious complications was not different between the two groups, Patie nt survival did not differ significantly between the two groups (84.6% at 1, 2, and 3 years in the BT563 group and 90.2% at 1 year and 87.8% at 2 and 3 years for the ATG group). Analysis of graft function showe d an advantage for the BT563 group in terms of postoperative bilirubin levels. However, no differences were observed in long-term follow-up between the two groups. Conclusions. Our results indicate that treatme nt with anti-interleukin-a receptor antibody as part of quadruple indu ction therapy after orthotopic liver transplantation is safe and effec tive and shows fewer steroid-sensitive rejection episodes as well as f ewer side effects when compared with quadruple induction therapy inclu ding ATG.