Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study.
Rostaing L, Vincenti F, et al.American Journal of Transplantation 2013; 13(11): 2875-2883.
Aims
To assess the 5-year results of the BENEFIT study which investigated the efficacy and safety of belatacept versus cyclosporine A (CsA) in patients with kidney transplant from living donors or standard criteria deceased donors.
Interventions
Patients were randomised to one of two regimens of belatacept (more intensive or less intensive) or CsA for primary maintenance for immunosuppression. All patients received basiliximab induction, mycophenolate mofetil, and corticosteroids.
Participants
66 living or standard criteria deceased kidney donor recipients.
Outcomes
The primary outcome was to assess the long-term safety and tolerability of belatacept. The other outcomes included the proportion of patients surviving with a functioning graft, renal allograft function and acute rejection rates.
Follow-up
5 years.
CET Conclusions
This paper describes the 5 year follow up from the BENEFIT study (Belatacept versus Cyclosporine in renal transplantation). Patients eligible for this analysis were those that had completed 36 months of their assigned therapy. After 5 years of follow up the calculated GFR (MDRD) was better in both the moderate intensity Belatacept and the low intensity Belatacept arms than the Cyclosporine arm. The difference in mean calculated GFR was approximately 20 ml/minute. The Belatacept arms also saw a greater decrease in serum cholesterol, HDL and triglycerides and a lower mean diastolic blood pressure. There was no difference in graft loss or patient death. It should be noted that there was the same low number of acute rejection episodes from 3-5 years follow up in all arms. This was in contrast to the early follow up where more acute rejections were experienced by the Belatacept arms in the first year.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed in Vincenti et al. A Phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). American Journal of Transplantation 2010; 10: 535-546
Trial registration
ClinicalTrials.gov – NCT00256750