Transplant Trial Watch

Outcomes at 7 years post-transplant in black vs nonblack kidney transplant recipients administered belatacept or cyclosporine in BENEFIT and BENEFIT-EXT.

Florman S, Vincenti F, et al.

Clinical Transplantation 2018; 32(4): e13225.


Aims
To conduct a 7-year post-hoc analysis of the BENEFIT* and BENEFIT-EXT** studies to examine the effect of race and treatment in kidney transplant recipients.

Interventions
In BENEFIT and BENEFIT-EXT recipients were randomized to receive either belatacept more intense, belatacept less intense or cyclosporine based immunosuppression. In the present analysis, participants were categorized as black or nonblack (according to self-identification) and efficacy and safety were examined separately according to treatment group (BENEFIT and BENEFIT-EXT).

Participants
666 BENEFIT and 543 BENEFIT- EXT patients who were alive and observable at 84 months postrandomization, or who had died or experienced graft loss by month 84.

Outcomes
Measured outcomes included time to death or graft loss, renal function and graft survival.

Follow-up
Month 84 (7 years)

CET Conclusions
They authors report the 7-year follow of the BENEFIT (living or standard criteria deceased donors) and BENEFIT-EXT (extended criteria donors) trials comparing more intensive and less intensive belatacept with cyclosporine for black versus nonblack recipients. The analyses included all intention to treat patients who were alive and observable at 7 years or who had died or experienced graft loss by 7 years. Data from each trial were analysed separately and hazard ratios were calculated using Cox-regression models. In the BENEFIT study there were 55 black versus 611 nonblack patients and in the BENEFIT-EXT study there were 71 black versus 472 nonblack patients. For both the BENEFIT and BENEFIT-EXT trials, there was no effect of race on time to death or graft loss and there was no interactive effect between treatment and race. Estimated glomerular filtration rates (eGFR) increased for the belatacept groups but decreased for the cyclosporine group for both black and nonblack patients. The authors note that the results should be interpreted with caution because of the small number of black patients.

Jadad score
2

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Quality notes
Previously assessed as *Vincenti F, 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, and **Durrbach A, 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.

Trial registration
ClinicalTrials.gov - NCT00256750 and ClinicalTrials.gov - NCT00114777

Funding source
Industry funded