A Randomized Clinical Trial of OKT3 Monoclonal Antibody for Acute Rejection of Cadaveric Renal Transplants

TLDR

Murine monoclonal antibody OKT3 binds human T cells and blocks their function. The study investigated the effectiveness of OKT3 in treating T‑cell‑mediated rejection of renal allografts. A prospective randomized multicenter trial enrolled 123 patients with acute rejection of cadaveric renal transplants, assigning them to daily OKT3 for 14 days with reduced other immunosuppressants or to high‑dose steroids. OKT3 achieved a 94 % reversal rate of acute rejection—significantly higher than the 75 % rate with steroids (P = 0.009)—and improved one‑year graft survival to 62 % versus 45 % (P = 0.029), demonstrating its effectiveness.

Abstract

Since the murine monoclonal antibody OKT3 reacts with human T cells and blocks their function, we explored its effectiveness in treating T-cell-mediated rejection of renal allografts. In a prospective randomized multicenter trial, 123 patients undergoing acute rejection of cadaveric renal transplants were treated either with OKT3 daily for a mean of 14 days, with concomitant lowering of the dosage of other immunosuppressive drugs (63 patients), or with conventional high-dose steroids (60 patients). OKT3 reversed 94 per cent of the rejections--a figure that was significantly better (P = 0.009) than the 75 per cent reversal rate obtained with conventional steroid treatment. This superior reversal rate with OKT3 was reflected in an improved one-year graft survival of 62 per cent for the OKT3-treated group, as compared with 45 per cent for the steroid-treated group (P = 0.029), in patients who were all selected by virtue of having had acute rejection. We conclude that treatment with OKT3 (with concomitant lowering of the dosage of other immunosuppressive drugs) is an effective approach for acute renal-allograft rejection.