Abstract
The phase III Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial-Extended Criteria Donors Trial
(BENEFIT-EXT) study compared more or less intensive belatacept-based immunosuppression with cyclosporine (CsA)-based immunosuppression in recipients of extended criteria donor kidneys. In this post hoc analysis, patient outcomes were assessed according to donor kidney subtype. In total, 68.9% of patients received an expanded criteria donor
CET Conclusion
Reviewer: Mr Simon Knight, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
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
Expert Review
Reviewer: Professor Teun van Gelder, Erasmus Medical Center Rotterdam, Netherlands.
Conflicts of interest: Teun van Gelder has received lecture fees from Roche, Chiesi and Astellas Pharma, and consulting fees from Astellas, Novartis, Teva and Sandoz.
Following the publication of the seven-year outcome results of the Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT) trial [1] Florman et al have now also published the (post-hoc) 7 year follow-up results of the BENEFIT-EXT trial, that included extended (EXT) criteria donors [2]. The authors conclude that although time to death or graft loss was similar
Methodological quality
Jadad score ⓘ : 2
Allocation concealment ⓘ : YES
Data analysis ⓘ : MODIFIED INTENTION TO TREAT
Score based on ⓘ : 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
Study details
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)
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