IMMUNOSUPPRESSION Use of Daclizumab in the Immunosuppression of High-Risk Kidney and Kidney/Pancreas Recipients: Warsaw Transplantation Center Experience T. Ba ˛ czkowska, K. Kukula, E. Nowacka-Cieciura, T. Cieciura, D. Lewandowska, R. Ciecierski, T. Grochowiecki, W. Rowinski, J. Szmidt, M. Durlik, and M. Lao D ACLIZUMAB is a humanized monoclonal antibody directed against the alpha (CD-25) subunit of the interleukin-2 receptor (IL-2R), a receptor that is expressed solely on activated T lymphocytes. The antibody may there- fore induce a selective CDR immunosuppressive effect without increasing the risk of infection and malignancy. The humanization process results in the production of a virtually human antibody with mouse complementarity determining regions (CDRs) only. Plasma half-life of the drug is there- fore extended to 20 days. Addition of daclizumab to cyclo- sporine-based immunosuppression significantly reduces acute rejection incidence. 1 Little is known, however, about the efficacy of daclizumab for the treatment of allograft recipients at high risk for rejection; 2 the subject of this report which assesses the frequency of acute rejection episodes, side-effect incidence, and long-term outcomes among kidney (group 1) and kidney/pancreas (group 2) recipients treated with a quadruple immunosuppressive protocol. PATIENTS AND METHODS We examined a population of 31 patients, 14 men and 17 women, undergoing kidney or kidney/pancreas transplantation, deemed to be at high risk for rejection episodes by virtue of a combined kidney/pancreas transplant, PRA above 80%, living unrelated donor kidney recipient, and/or second kidney allograft recipient. The immunosuppressive protocol consisted of daclizumab, cyclo- sporine (CyA) (or tacrolimus in case of one patient), mycopheno- late mofetil (MMF), and prednisone. Daclizumab was adminis- tered three times at a dose of 1.07  0.12 mg/kg on the day of procedure and thereafter on days 14 and 28. Cyclosporine was administered at the dose of 8.03  1.85 mg/kg per 24 hours. The dose of mycophenolate mofetil was 2 g/24 h; in the single case of patient receiving tacrolimus, the mycofenolate dose was 1 g/24 h. The target dose of prednisone was 0.5 mg/kg per 24 hours. The demographic details are presented in Table 1. From the Transplantation Institute, Department of Transplan- tation and Vascular Surgery; Medical University of Warsaw, Warsaw, Poland Address reprint requests to Teresa Ba ˛ czkowska, Transplan- tation Institute, Medical University of Warsaw, 59 Nowogrodzka Street, 02-006 Warsaw, Poland. Table 1. Demographic Data and Rejection Rates in the Studied Groups of Patients Kidney Tx Kidney/ Pancreas Tx F/M 8/11 9/3 Age (y) 42.7  13.5 38  5.3 Duration of HD treatment (mo) 63.7  50.2 37.5  13.3* First kidney Tx 14 (4 living unrelated donors) — Second kidney Tx 5 — No. of HLA mismatches A 1.27  0.5 1.83  0.4* B 1.18  0.8 1.5  0.5 DR 1.0  0.6 1.33  0.8 GS + MMF + CyA 18 12 GS + MMF + FK506 1 0 CIT (h) 28.3  10.1 7.6  3.4* ATN (d) 5.5  9.5 2.0  6* Acute rejection episodes 3 (16%) 1 (8%) Treatment of rejection 3  0.5g MP 3  0.5 MP Time to rejection episodes (d) 38  52 109 Graft loss/death 1/1 4/4 *P  .05. © 2002 by Elsevier Science Inc. 0041-1345/0-2000/$–see front matter 655 Avenue of the Americas, New York, NY 10010 PII S0041-1345(01)02842-1 Transplantation Proceedings, 34, 551–552 (2002) 551