2004TransplantationRequires access

THE CLINICAL STUDY OF TWO-DOSE BASILIXIMAB COMPARED WITH TWO-DOSE DACLIZUMAB IN RENAL TRANSPLANTATION

Ming‐Hsien Lin, An Ming, Ming‐Hui Zhao

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Abstract

P756 Aims: To evaluate the efficacy and safety of two-dose Basiliximab for the prevention of acute rejection and immunosuppressive induction in contrast to two-dose Daclizumab. Methods: 58 patients were randomized and controlled into two groups: Basiliximab group (n=30) and Daclizumab (n =28) group. All the patients received the triple therapy including cyclosporine microemulsion (Neoral®) mycophenolate mofetil and prednisolone (CsA+MMF+Pred). Basiliximab group received two-dose Basiliximab (20mg) on day 0 (2 hours before operation) and on day 4 post-transplant, while Daclizumab group also received two-dose Daclizumab (1mg/kg) on day 1 and on day 14 days post-transplant. Clinical outcomes were observed till 12 months in all patients. CD25+ T cell was tested by Beckman Coulter flow cytometer every week in 2 months after transplantation. Results: During six-month follow-up, the number of AR episodes were 5 in Daclizumab group and no one in Basiliximab group (p<0.05). The numbers of CD25+ T cell decreased rapidly in two groups and maintained for first 4-6 weeks. Then CD25+ T cell recovered slowly to normal at week 8 only in Basiliximab group. During the first 12 months after post-transplantation, there were 2 cases of bacterial infection in every group, 2 cases of CMV infection in Daclizumab group and 1 case in Basiliximab group. All patients were alive. There was only 1 case of lost graft in every group. Conclusions: Two-dose Basiliximab in the prevention of AR are more effective than two-dose Daclizumab. Both are safe.

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What this paper is about

P756 Aims: To evaluate the efficacy and safety of two-dose Basiliximab for the prevention of acute rejection and immunosuppressive induction in contrast to two-dose Daclizumab. Methods: 58 patients were randomized and controlled into two groups: Basiliximab group (n=30) and Daclizumab (n =28) group. All the patients received the triple therapy including cyclosporine microemulsion (Neoral®) mycophenolate mofetil and prednisolone (CsA+MMF+Pred). Basiliximab group received two-dose Basiliximab (20mg) on day 0 (2 hours before operation) and on day 4 post-transplant, while Daclizumab group also received two-dose Daclizumab (1mg/kg) on day 1 and on day 14 days post-transplant. Clinical outcomes were observed till 12 months in all patients. CD25+ T cell was tested by Beckman Coulter flow cytometer every week in 2 months after transplantation. Results: During six-month follow-up, the number of AR episodes were 5 in Daclizumab group and no one in Basiliximab group (p<0.05). The numbers of CD25+ T cell decreased rapidly in two groups and maintained for first 4-6 weeks. Then CD25+ T cell recovered slowly to normal at week 8 only in Basiliximab group. During the first 12 months after post-transplantation, there were 2 cases of bacterial infection in every group, 2 cases of CMV infection in Daclizumab group and 1 case in Basiliximab group. All patients were alive. There was only 1 case of lost graft in every group. Conclusions: Two-dose Basiliximab in the prevention of AR are more effective than two-dose Daclizumab. Both are safe.

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Available abstract

P756 Aims: To evaluate the efficacy and safety of two-dose Basiliximab for the prevention of acute rejection and immunosuppressive induction in contrast to two-dose Daclizumab. Methods: 58 patients were randomized and controlled into two groups: Basiliximab group (n=30) and Daclizumab (n =28) group. All the patients received the triple therapy including cyclosporine microemulsion (Neoral®) mycophenolate mofetil and prednisolone (CsA+MMF+Pred). Basiliximab group received two-dose Basiliximab (20mg) on day 0 (2 hours before operation) and on day 4 post-transplant, while Daclizumab group also received two-dose Daclizumab (1mg/kg) on day 1 and on day 14 days post-transplant. Clinical outcomes were observed till 12 months in all patients. CD25+ T cell was tested by Beckman Coulter flow cytometer every week in 2 months after transplantation. Results: During six-month follow-up, the number of AR episodes were 5 in Daclizumab group and no one in Basiliximab group (p<0.05). The numbers of CD25+ T cell decreased rapidly in two groups and maintained for first 4-6 weeks. Then CD25+ T cell recovered slowly to normal at week 8 only in Basiliximab group. During the first 12 months after post-transplantation, there were 2 cases of bacterial infection in every group, 2 cases of CMV infection in Daclizumab group and 1 case in Basiliximab group. All patients were alive. There was only 1 case of lost graft in every group. Conclusions: Two-dose Basiliximab in the prevention of AR are more effective than two-dose Daclizumab. Both are safe.

Key concepts: Daclizumab, Basiliximab, Medicine, Transplantation, IL-2 receptor, Gastroenterology, Urology, Internal medicine

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