Use of low-dose OKT3 as induction therapy in liver transplantation

Background. A pilot study was performed to prospectively evaluate the safety and efficacy of "low-dose" OKT3 induction after liver transplantation. Methods. Sixteen patients received a 5- to 10-day course of OKT3 (2.5 mg i.v. daily) along with azathioprine, prednisone, and the delayed introduction of cyclosporine (Neoral). Results. Patient and graft survival rates at 1 year were 88% and 82%. Five patients (31%) had biopsy-proven rejection; all five were treated successfully with steroids. There were 15 infections in 12 patients, including 5 cytomegalovirus infections. Adverse events attributed to OKT3 consisted of low-grade fever (five patients), transient hypoxemia (three patients), and transient hypotension (two patients). Pharmacy acquisition costs for OKT3 averaged $2,139 less as compared to a group of historical controls receiving full-dose therapy. Conclusions. Low-dose OKT3 induction appears to be a safe and useful method of postoperative immunosuppression after liver transplantation. Its ultimate clinical, immunologic, and economic efficacy awaits determination by randomized trial.