Open AccessA DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MONOCLONAL ANTI-INTERLEUKIN-2 RECEPTOR ANTIBODY (BT563) ADMINISTRATION TO PREVENT ACUTE REJECTION AFTER KIDNEY TRANSPLANTATION
Author(s) -
Teun van Gelder,
Robert Zietse,
A. H. L. Mulder,
Jan N.M. Yzermans,
C. J. Hesse,
L. M. B. Vaessen,
Willem Weimar
Publication year - 1995
Publication title -
transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.45
H-Index - 204
eISSN - 1534-6080
pISSN - 0041-1337
DOI - 10.1097/00007890-199508000-00007
Subject(s) - monoclonal antibody , medicine , kidney transplantation , transplantation , placebo , immunology , interleukin 2 , administration (probate law) , receptor , monoclonal , kidney , antibody , pharmacology , cytokine , pathology , political science , alternative medicine , law
In a double-blind, randomized, placebo-controlled trial, BT563, a murine IgG1 anti-IL-2R antibody, was given as a rejection prophylaxis after kidney transplantation. Drug-related side effects were not observed. 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) during placebo treatment. Within the first 4 postoperative weeks, freedom from rejection in the BT563 group and in the placebo group was 96% vs. 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 placebo group was found of 3/27 (11%) vs. 8/29 (28%) patients (P = 0.18). Infectious complications were distributed equally between the 2 groups. CMV disease, found in 3 placebo-treated patients, occurred after rejection treatment (2/3). Within the BT563 group, 1 patient lost his graft due to renal artery thrombosis, 2 grafts were lost as a result of technical failure, and 2 patients had a squamous cell carcinoma that could be treated curatively. We conclude that the use of the anti-IL-2R mAb BT563 effectively prevents rejection after kidney transplantation without increasing infectious complications.