Depleting antibody induction in simultaneous pancreas-kidney transplantation: a
prospective single-center comparison of alemtuzumab versus rabbit anti-thymocyte
globulin.
Author(s): Stratta RJ(1), Rogers J, Orlando G, Farooq U, Al-Shraideh Y, Doares W, Kaczmorski
S, Farney AC.
Affiliation(s): Author information:
(1)Wake Forest School of Medicine, Department of General Surgery , Medical Center
Blvd, Winston-Salem, NC 27157 , USA +1 336 716 0548 ; +1 336 713 5055 ;
rstratta@wakehealth.edu.
Publication date & source: 2014, Expert Opin Biol Ther. , 14(12):1723-30
BACKGROUND: The study purpose was to analyze midterm outcomes in a prospective
trial of alemtuzumab (Alem) versus rabbit anti-thymocyte globulin (rATG)
induction in simultaneous pancreas-kidney transplantation (SPKT).
METHODS: From February 2005 to October 2008, 46 SPKTs (45 portal-enteric
drainage) were prospectively randomized as part of a larger kidney transplant
study to receive either single-dose Alem (30 mg intraoperatively) or
multiple-dose rATG antibody induction (starting intraoperatively, minimum three
doses administered) with tacrolimus/mycophenolate ± steroids.
RESULTS: Of 222 kidney transplant patients enrolled in the study, 46 received
SPKTs; 28 (61%) received Alem and 18 (39%) rATG induction. Follow-up ranged from
67 to 111 months (mean 80 months). There were no significant differences between
the two groups in 5 years actual patient (86% Alem vs 89% rATG), kidney (82% Alem
vs 61% rATG, p = 0.17) or pancreas (68% Alem vs 56% rATG) graft survival rates.
Five years death-censored kidney (92% Alem vs 69% rATG, p = 0.09) and pancreas
(76% Alem vs 56% rATG, p = 0.198) graft survival rates were slightly higher in
patients receiving Alem. Acute rejection (21% Alem vs 44% rATG, p = 0.12) and
major infection (39% Alem vs 67% rATG, p = 0.13) rates were slightly lower in the
Alem group; cytomegalovirus infections were significantly lower (0 Alem vs 17%
rATG, p = 0.05). The incidence of late acute rejection was low in both groups.
There were no differences in early pancreas thrombosis (3.6% Alem vs 11% rATG),
postoperative bleeding (11% Alem vs 0 rATG), other surgical complications,
readmissions or freedom from steroids between groups. In patients with
functioning grafts, 5 years mean serum creatinine (1.4 Alem vs 1.6 mg/dl rATG),
calculated abbreviated modification of diet in renal disease glomerular
filtration rate (55 Alem vs 52 ml/min/1.73 m(2) rATG), hemoglobin A1c (both 5.4%)
and C-peptide (2.6 Alem vs 2.3 ng/ml rATG) levels were similar.
CONCLUSIONS: Single-dose Alem and multiple-dose rATG induction provide similar
midterm patient survival and graft functional outcomes with no major differences
in morbidity or resource utilization.
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