A randomised controlled trial comparing two steroid avoidance regimes was conducted in our centre from December 2006 to November 2010. Alemtuzumab induction followed by tacrolimus (TAC) monotherapy was compared to basiliximab induction followed by tacrolimus / mycophenolate (MMF) maintenance. We present three year follow up data from the trial.
At the time of renal transplantation, 116 adult patients were recruited and randomised to either the control group – basiliximab (BAS) followed by TAC and MMF, standard in our institution at the time, or induction with alemtuzumab (ALEM) and TAC monotherapy. At three years, the two groups were compared considering patient and graft survival, renal function, rates of infective, malignany and cardiovascular complications and rates of acute rejection.
Data was available for 111 patients at 3 years. Patient survival was 92.6% vs. 94.7% in the alemtuzumab and basiliximab groups respectively (p=0.64). Graft survival was 83.3% vs 87.7% (ALEM vs BAS, p=0.51). Renal function at three years was comparable between the two groups with mean creatinine 138±51Μmol/L (ALEM) vs. 151±55Μmol/L (BAS, p=0.25); mean eGFR 53±18ml/min (ALEM) vs. 50±19ml/min (BAS, p=0.45). No differences were seen in urinary protein/creatinine ratios, haemoglobin, total white cell count, lymphocyte count or platelet count at 3 years. CMV disease was seen in two patients in each group over the three year follow up period. One case of BK nephropathy occured – in the basiliximab group. Four cases of post-transplant proliferative disorder were seen – two in each group. Rates of significant cardiovascular events were comparable. Latest follow up eGFRs are 56±22ml/min (ALEM) vs. 50±21ml/min (BAS, p=0.15), with median time to latest follow up of 4.3 years.
Steroid avoidance with alemtuzumab induction and tacrolimus monotherapy yeilds similar outcomes at 3 years to induction with basiliximab followed by tacrolimus / mycophenolate maintenance.
To cite this abstract in AMA style:Smith MWelberry, Cherukuri A, Newstead C, Lewington A, Ahmad N, Menon K, Pollard S, Prasad P, Tibble S, Giddings E, Baker R. Steroid Avoidance with Alemtuzumab Induction and Tacrolimus Monotherapy Gives Similar Outcomes to Basiliximab Induction with Tacrolimus / Mycophenolate Maintenance at Three Years [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/steroid-avoidance-with-alemtuzumab-induction-and-tacrolimus-monotherapy-gives-similar-outcomes-to-basiliximab-induction-with-tacrolimus-mycophenolate-maintenance-at-three-years/. Accessed February 25, 2021.
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