Abstract
BackgroundThe efficacy and safety of minimisation of immunosuppression including early steroid withdrawal in kidney transplant recipients treated with Basiliximab induction remains unclear.MethodsThis retrospective cohort study reports the outcomes from 298 consecutive renal transplants performed since 1st July 2010–June 2013 treated with Basiliximab induction and early steroid withdrawal in low immunological risk patients using a simple immunological risk stratification and 3-month protocol biopsy to optimise therapy. The cohort comprised 225 low-risk patients (first transplant or HLA antibody calculated reaction frequency (CRF ≤50% with no donor specific HLA antibodies) who underwent basiliximab induction, steroid withdrawal on day 7 and maintenance with tacrolimus and mycophenolate mofetil (MMF), and 73 high-risk patients who received tacrolimus, MMF and prednisolone for the first 3 months followed by long term maintenance immunosuppression with tacrolimus and prednisolone. High-risk patients not undergoing 3-month protocol biopsy were continued on triple immunosuppression.ResultsSteroid withdrawal could be safely achieved in low immunological risk recipients with IL2 receptor antibody induction. The incidence of biopsy-proven acute rejection was 15.1% in the low-risk and 13.9% in the high-risk group (including sub-clinical rejection detected at protocol biopsy). One- year graft survival was 93.3% and patient survival 98.5% in the low-risk group, and 97.3 and 100% respectively in the high-risk group. Graft function was similar in each group at 1 year (mean eGFR 61.2 ± 23.4 mL/min low-risk and 64.6 ± 19.2 mL/min high-risk).ConclusionsImmunosuppression regimen comprising basiliximab induction, tacrolimus, MMF and prednisolone with early steroid withdrawal in low risk patients and MMF withdrawal in high risk patients following a normal 3-month protocol biopsy is effective in limiting acute rejection episodes and produces excellent rates of patient survival, graft function and complications.
Highlights
The efficacy and safety of minimisation of immunosuppression including early steroid withdrawal in kidney transplant recipients treated with Basiliximab induction remains unclear
Maintenance immunosuppression without corticosteroids is usually only considered if the induction agent is a lymphocyte depleting antibody such as anti-thymocyte globulin (ATG) or Alemtuzumab (Campath)
One-year overall graft survival was 93.8% (95.1% censored for death) in the low-risk group and 98.6% (98.6% censored for death) in the high-risk group
Summary
The efficacy and safety of minimisation of immunosuppression including early steroid withdrawal in kidney transplant recipients treated with Basiliximab induction remains unclear. The ELITE-Symphony trial, which combined low dose tacrolimus with anti-IL-2 receptor antibody induction and mycophenolate mofetil (MMF) maintenance, defined the current standard of treatment This combination achieved superior outcomes in terms of graft function, survival and biopsy-proven acute rejection (BPAR) at 1 year which was maintained at 3 years compared to ciclosporin or sirolimus based regimens [10, 11]. The ATLAS studies have indicated that steroid-free tacrolimus based regimens can achieve good long term outcomes [12,13,14] Lymphocyte depleting antibodies such as anti-thymocyte globulin (ATG) and Alemtuzumab (Campath) have been used to achieve steroid avoidance/ early withdrawal but use of these drugs carry a risk of over-immunosuppression [6, 15,16,17]. For recipients at higher immunological risk, there are still major challenges to overcome such as higher rates of acute rejection and poor graft survival [18,19,20]
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