MULTICENTER RETROSPECTIVE ANALYSIS OF SIMULTANEOUS KIDNEY PANCREAS TRANSPLANT RECIPIENTS RECEIVING DACLIZUMAB INDUCTION

Abstract

3 With the emergence of new immunosuppressants, the quest for the optimal immunosuppressive regimen has gained momentum. In an attempt to study the safety and efficacy of daclizumab in combination with tacrolimus (TAC), mycophenolate mofetil (MMF), and steroids, we report our experience with 71 simultaneous kidney-pancreas transplant (SKPT) recipients transplanted from 12/97-11/98. Mean(±SD) follow-up time was 5.9±2.5 months (range 0.5-11). Outcomes evaluated were: patient and graft survival, rejection, infection, daclizumab dosing and adverse events. The study population included 47(66%)M: 24(34%)F with a mean age of 40±8 years. The mean pretransplant duration of diabetes and dialysis were 25±8yrs and 1.5±0.9yrs (HD=34, PD=16), respectively. Mean HLA match was 1.2±1.5, with one patient receiving a second transplant. The mean CIT for the kidney/pancreas was 15±5/16±4hrs. Six month patient, kidney, and pancreas survival, and 6 month rejection rates are shown for the entire group (n= 71) and stratified according to the number of daclizumab doses >3 (n=44) or ≤3 (n=27). (Table)Table2 deaths occurred (fungal and cardiac). 3 kidney graft losses occurred: 2-rejection, 1-death with function. 5 pancreas graft losses occurred: 2-infection, 1-rejection, 1-thrombosis, 1-death. 62 (87%) patients had immediate renal allograft function with 1 and 6 month SrCr (mg/dl) of 1.4±0.9 and 1.4±0.4, respectively. 68 (96%) patients had good initial pancreas allograft function with 1 and 6 month serum glucose (mg/dl) of 99±26 and 93±15, respectively. Of 21 patients with rejection, 19 had a single rejection episode. Although more patients receiving ≤3 doses had rejection, there was no dose response relationship between total number of doses or total mg/kg and time to rejection [88d (≤3) vs. 100d (>3)]. Antilymphocyte therapy for rejection was greater in the ≤3 dose group (8 vs. 3), however immunologic graft losses in each group were rare (1 kidney in ≤3 vs. 1-kidney, 1-pancreas in >3). There were six cases of CMV, 3 fungal, 18 bacterial infections, and 1 PTLD. No major adverse events were attributed to daclizumab use. Conclusions: This preliminary experience suggests that excellent outcomes can be achieved with the use of daclizumab in combination with TAC, MMF, and prednisone in SKPT recipients.