LONG TERM FOLLOW-UP (10 YEARS) OF A PROSPECTIVE TRIAL ASSAY COMPARING LO-TACT-1 ANTIBODY VERSUS ANTI-THYMOCYTE GLOBULIN INDUCTION THERAPY IN KIDNEY TRANSPLANTATION.

Abstract

P760 Aims: To evaluate the long term graft survival, acute and chronic rejections, infectious diseases and malignancies following an induction therapy with a rat interleukin 2 receptor monoclonal antibody Lo-Tact-1 versus anti-thymocyte globulin (ATG). Patients and Methods: Forty recipients of primary renal transplantation were prospectively randomised between May 1990 and June 1991. Twenty recipients were treated with Lo-Tact-1 IV 10 mg daily (group I) and twenty with ATG 15 ml/day (group II) during the first 14 days of transplantation. All patients were treated with azathioprine, steroids, cyclosporine. Creatinemia, proteinuria and clinical events were collected during ten years. Results: Median age was 42.1 years in group I and 39.3 years in group II. There was no difference between the two group for sex ratio, rate of anti-HLA antibodies, HLA A, B, DR mismatches, cold ischemia time. Six recipients died within 10 years of follow-up (n=5 in group I, n=1 in group II). All of them had a functional graft. At 10 years the graft loss was 35 % in group I and 45 % in group II (p=ns). Nine acute rejections occurred in group I and 10 in group II (p=ns). All were cortico-sensitive. Chronic allograft rejection was significantly higher in group II (n=9) than in group I (n=3), p<0.05. Six patients had a nephropathy due to cyclosporine toxicity (n=4 in group I, n=2 in group II, p=ns). Viral infectious diseases including cytomegalovirus, herpes virus and zoster virus diseases were significantly higher in group II (n=8) than in group I (n=2), p < 0.05. Bacterial infectious including pneumonia, pyelonephritis, airways infections, septicaemia were significantly higher in group II (n = 16) than in group I (n=10), p<0.05. At ten years three patients had malignancies (cutaneous lymphoma n=1 in group II, epidermoidis carcinoma n=1 and cervical uterus carcinoma n=1 in group I). Conclusions: Although both Lo-tact-1 and ATG were effective and safety induction therapy in kidney transplantation, less bacterial and viral infections and chronic allograft rejection were noted in Lo-tact-1-treated patient after a long follow-up.