Comparative trial of immunoprophylaxis with RATG versus OKT3

Abstract

A randomized trial of rabbit antithymocyte globulin (polyclonal) versus OKT3 monoclonal antibody prophylaxis was carried out in 82 heart transplant recipients, who, in addition, received baseline immunosuppression with cyclosporine, azathioprine, and prednisone. One-year actuarial survival was comparable between groups (95% to 98%), but the likelihood of histologic rejection within the first 30 days of transplant was more than seven times greater in OKT3 patients (0.58/patient vs 0.08/patient). Patients receiving OKT3 were more likely to have repeated episodes of rejection, and the mean time to rejection for patients receiving OKT3 was shorter (33 days) than for patients receiving rabbit antithymocyte globulin (67 days). At 120 days, while 52% of patients receiving rabbit antithymocyte globulin were free of rejection, versus 37% of the OKT3 patients, the difference was not significant. There was no difference in the incidence of major or minor bacterial or viral infection between groups, but significant hemodynamic side effects were seen after the first dose of OKT3, and aseptic meningitis developed in two OKT3 patients.