TY - JOUR
T1 - A randomized, double-blinded comparison of thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients
AU - Brennan, Daniel C.
AU - Flavin, Karen
AU - Lowell, Jeffrey A.
AU - Howard, Todd K.
AU - Shenoy, Surendra
AU - Burgess, Sandra
AU - Dolan, Sara
AU - Kano, Jennifer M.
AU - Mahon, Mitchell
AU - Schnitzler, Mark A.
AU - Woodward, Robert
AU - Irish, William
AU - Singer, Gary G.
PY - 1999/4/15
Y1 - 1999/4/15
N2 - Background. The aim of this study was to compare the efficacy and safety of Thymoglobulin (a rabbit-derived polyclonal antibody) to Atgam (a horse- derived polyclonal antibody) for induction in adult renal transplant recipients. Methods. Transplant recipients (n=72) were randomized 2:1 in a double-blinded fashion to receive Thymoglobulin (n=48) at 1.5 mg/kg intravenously or Atgam (n=24) at 15 mg/kg intravenously, intraoperatively, then daily for at least 6 days. Recipients were observed for at least 1 year of follow-up. Results. By 1 year after transplantation, 4% of Thymoglobulin- treated patients experienced acute rejection compared with 25% of Atgam- treated patients (P=0.014). The rate of acute rejection was lower with Thymoglobulin than Atgam (relative risk=0.09; P=0.009). Rejection was less severe with Thymoglobulin than Atgam (P=0.02). No recurrent rejection occurred with Thymoglobulin compared with 33% with Atgam (P=NS). Patient survival was not different, but the composite end point of freedom from death, graft loss, or rejection, the 'event-free survival,' was superior with Thymoglobulin (94%) compared with Atgam (63%; P=0.0905). Fewer adverse events occurred with Thymoglobulin (P=0.013). Leukopenia was more common with Thymoglobulin than Atgam (56% vs. 4%; P<0.0001) during induction. The mean absolute lymphocyte count remained below baseline with Thymoglobulin throughout the study (P<0.007), but with Atgam, significant lymphocyte reductions occurred only at day 7. The incidence of cytomegalovirus disease was less with Thymoglobulin than Atgam at 6 months (10% vs. 33%; P=0.025). Conclusions. Brief (7-day) induction with Thymoglobulin resulted in less frequent and less severe rejection, a better event-free survival, less cytomegalovirus disease, fewer serious adverse events, but more frequent early leukopenia than induction with Atgam. These results may in fact be explained by a more profound and durable beneficial lymphopenia.
AB - Background. The aim of this study was to compare the efficacy and safety of Thymoglobulin (a rabbit-derived polyclonal antibody) to Atgam (a horse- derived polyclonal antibody) for induction in adult renal transplant recipients. Methods. Transplant recipients (n=72) were randomized 2:1 in a double-blinded fashion to receive Thymoglobulin (n=48) at 1.5 mg/kg intravenously or Atgam (n=24) at 15 mg/kg intravenously, intraoperatively, then daily for at least 6 days. Recipients were observed for at least 1 year of follow-up. Results. By 1 year after transplantation, 4% of Thymoglobulin- treated patients experienced acute rejection compared with 25% of Atgam- treated patients (P=0.014). The rate of acute rejection was lower with Thymoglobulin than Atgam (relative risk=0.09; P=0.009). Rejection was less severe with Thymoglobulin than Atgam (P=0.02). No recurrent rejection occurred with Thymoglobulin compared with 33% with Atgam (P=NS). Patient survival was not different, but the composite end point of freedom from death, graft loss, or rejection, the 'event-free survival,' was superior with Thymoglobulin (94%) compared with Atgam (63%; P=0.0905). Fewer adverse events occurred with Thymoglobulin (P=0.013). Leukopenia was more common with Thymoglobulin than Atgam (56% vs. 4%; P<0.0001) during induction. The mean absolute lymphocyte count remained below baseline with Thymoglobulin throughout the study (P<0.007), but with Atgam, significant lymphocyte reductions occurred only at day 7. The incidence of cytomegalovirus disease was less with Thymoglobulin than Atgam at 6 months (10% vs. 33%; P=0.025). Conclusions. Brief (7-day) induction with Thymoglobulin resulted in less frequent and less severe rejection, a better event-free survival, less cytomegalovirus disease, fewer serious adverse events, but more frequent early leukopenia than induction with Atgam. These results may in fact be explained by a more profound and durable beneficial lymphopenia.
UR - http://www.scopus.com/inward/record.url?scp=0033561405&partnerID=8YFLogxK
U2 - 10.1097/00007890-199904150-00013
DO - 10.1097/00007890-199904150-00013
M3 - Article
C2 - 10221486
AN - SCOPUS:0033561405
SN - 0041-1337
VL - 67
SP - 1011
EP - 1018
JO - Transplantation
JF - Transplantation
IS - 7
ER -