Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients.
Vincenti F, Larsen CP, et al.American Journal of Transplantation, 12(1):217-210, 2012.
Aims
To assess the efficacy and safety of belatacept relative to cyclosporine by 3 years after transplantation in kidney transplant recipients.
Interventions
More intensive regimen of belatacept versus less intensive regimen of belatacept versus cyclosporine. All patients received basiliximab induction, mycophenolate mofetil and corticosteroids.
Participants
666 patients who received a kidney transplant from a living or standard criteria deceased donor.
Outcomes
Patient and graft survival, the proportion of patients surviving with a functioning graft, renal function assessed by calculated GFR, the rate of acute rejection and overall safety.
Follow-up
3 years.
CET Conclusions
The results of the BENEFIT trial at 3 years showed no difference in patient or graft survival in patients randomised to a more intensive or a less intensive regimen of belatacept compared to patients receiving cyclosporine. However the mean calculated GFR was approximately 20mls per minute higher in the two belatacept groups versus cyclosporine at year 3. There were no new safety issues with the longer follow up and in particular there were no new PTLD cases after month 18.
Data analysis
Modified intention-to-treat analysis
Quality notes
This is a follow-up study of a previous publication: Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant 2010; 10: 535–546. The methodological quality assessment was based on the previous paper.
Trial registration
NCT00256750 (ClinicalTrials.gov)