A randomized clinical trial of prophylactic OKT3 monoclonal antibody in liver allograft recipients
A. B. Cosimi, R. L. Jenkins, R. J. Rohrer, F. L. Delmonico, M. Hoffman and A. P. Monaco
Transplantation Unit, Massachusetts General Hospital, Boston 02114.
Seventy-nine hepatic allograft recipients were randomized to receive either
conventional immunosuppression, including cyclosporine, azathioprine, and
steroids (41 patients), or investigational therapy in which OKT3 replaced
cyclosporine during the first postoperative week (38 patients). Early
rejection occurred in 29 patients (71%) in the conventional group and 15
patients (39%) in the OKT3 group. Posttransplantation renal dysfunction
occurred in 12 patients (29%) in the conventional group and 6 patients
(16%) in the OKT3 group. Mean initial hospital stay was 34.1 +/- 18.8 days
in the conventional group compared with 29.1 +/- 16.8 days in the OKT3
group. Cumulative patient survival (mean follow-up, 17.8 +/- 7.1 months)
was 73.2% (30/41) for the conventional group and 84.2% (32/38) for the OKT3
group. Prophylactic OKT3 is indicated especially for liver allograft
recipients with other complicating conditions that make management of early
rejection unusually difficult.
