A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MONOCLONAL ANTI-INTERLEUKIN-2 RECEPTOR ANTIBODY (BT563) ADMINISTRATION TO PREVENT ACUTE REJECTION AFTER KIDNEY-TRANSPLANTATION

In a double-blind, randomized, placebo-controlled trial, BT563, a muri ne IgG(1) anti-IL-2R antibody, was given as a rejection prophylaxis af ter kidney transplantation, Drug-related side effects were not observe d. During the 10-day course of BT563, no rejections (0/27) were found, whereas a rejection episode occurred in 7 patients (7/29) (P=0.01) du ring placebo treatment, Within the first 4 postoperative weeks, freedo m from rejection in the BT563 group and in the placebo group was 96% v s. 76% (P=0.05). Due to rejection in the placebo group, 2 grafts were lost. At 3 months, an overall rejection incidence in the BT563 and pla cebo group was found of 3/27 (11%) vs, 8/29 (28%) patients (P=0.18). I nfectious complications were distributed equally between the 2 groups, CMV disease, found in 3 placebo-treated patients, occurred after reje ction treatment (2/3). Within the BT563 group, 1 patient lost his graf t due to renal artery thrombosis, 2 grafts were lost as a result of te chnical failure, and 2 patients had a squamous cell carcinoma that cou ld be treated curatively. We conclude that the use of the anti-IL-2R m Ab BT563 effectively prevents rejection after kidney transplantation w ithout increasing infectious complications.