Efficacy and Safety Outcomes of Extended Criteria Donor Kidneys by Subtype: Subgroup Analysis of BENEFIT-EXT at 7 Years After Transplant.
Florman S, Becker T, et al.American Journal of Transplantation 2017; 17(1): 180-190.
Aims
To conduct a post-hoc analysis of the previous Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial–Extended Criteria Donors (BENEFIT-EXT) trial* to determine the efficacy and safety of belatacept at 7 years according to donor kidney subtype.
Interventions
All patients received basiliximab induction, mycophenolate mofetil and corticosteroids and were randomized to one of three groups and received either more intensive or less intensive belatacept-based immunosuppression, or CsA-based immunosuppression. Outcomes were assessed according to three donor subtypes, donation after cardiac death (DCD), expanded criteria donor (ECD) or anticipated cold ischemia time (CIT) ≥ 24 hours.
Participants
543 de novo kidney transplant recipients aged ≥18 years who participated in the BENEFIT-EXT trial beyond 3 years.
Outcomes
Measured outcomes included patient and graft survival, renal function, acute rejection, donor-specific antibodies, and safety outcomes including adverse events, infections and malignancies.
Follow-up
7 years (84 months)
CET Conclusions
In this post-hoc analysis of the BENEFIT-EXT trial, participants are split by donor subtype (ECD, DCD or anticipated CIT > 24 hours). The benefits in GFR of belatacept over cyclosporine A are maintained in all 3 subgroups. It is not really clear what the rationale for the subgroup analysis presented here is – the authors do not speculate as to why they would expect belatacept to have a differential effect in the 3 subgroups. Given that the subgroups are quite small (only 55 patients in the DCD group) the findings are not that surprising, and this paper adds little to the current literature.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed as *Durrbach A, et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (benefit-ext study). American Journal of Transplantation. 2010;10(3):547-557.
Trial registration
ClinicalTrials.gov - NCT00114777