Three-Year Outcomes From BENEFIT-EXT: A Phase III Study of Belatacept Versus Cyclosporine in Recipients of Extended Criteria Donor Kidneys.
Pestana JO, Grinyo JM, et al.American Journal of Transplantation, 12(3): 630-639, 2012.
Aims
To evaluate the long term safety and efficacy of belatacept compared to cyclosporine in de novo recipients who had extended criteria donor kidneys.
Interventions
More intensive or less intensive belatacept regimen versus cyclosporine.
Participants
578 recipients of de novo extended criteria donor kidneys.
Outcomes
Outcomes included the proportion of patients surviving with a functioning graft, renal allograft function measured as calculated glomerular filtration rate (GFR), acute rejection, patient and graft survival, graft loss and death, renal function, lymphoproliferative disorder (PTLD) occurrence, incidence of biopsy-proven and protocol-defined acute rejection. Cardiovascular outcomes included systolic and diastolic blood pressure, cholesterol and triglyceride levels. Safety assessment included the frequency of (serious) adverse events, and overall rate of malignancies and infections.
Follow-up
3 years
CET Conclusions
In this three year follow-up of the trial of less intensive or more intensive belatacept compared to cyclosporine in patients given extended criteria kidneys, there was a significant better renal function in patients receiving belatacept. Furthermore, more patients receiving cyclosporine had a GFR less than 30mls per minute at 3 years. However PTLD was higher in the belatacept treated patients as was tuberculosis. These were the two principal safety findings associated with the use of belatacept and this has to be weighed against the significant improvement in renal function.
Data analysis
Modified intention-to-treat analysis
Quality notes
This is a sub-analysis of a previous publication of the same RCT (BENEFIT-EXT study: Durrbach A, Pestana JM, Pearson T, et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant 2010; 10: 547–557. The methodological quality assessment was based on the previous publication.
Trial registration
NCT00114777 (ClinicalTrials.gov)