The BENEFIT trial is a seven-year, follow-up, open-label, randomized, comparative, multicenter study that enrolled 666 renal transplant recipients of standard criteria deceased donor (SCD) and living donor kidneys. Patients were randomized to one of three cohorts: FDA-approved Nulojix regimen, a less intensive dose of Nulojix (n=226), or cyclosporine (n=221). The primary endpoints were composite patient and graft survival by 12 months, rate of acute rejection by 12 months, and composite measured GFR <60 at month 12 or a decrease in measured GFR from month 3 to month 12.
At three years, BENEFIT results demonstrated improvement in renal function in kidney transplant recipients treated with Nulojix compared to cyclosporine. Nulojix demonstrated a statistically significant 43% relative risk reduction of death or graft loss (transplant failure) in patients receiving the FDA-approved Nulojix regimen over those receiving a cyclosporine regimen (HR=0.57, P=0.0286). Data also showed that there was a statistically significant survival benefit of 52% relative risk reduction of treatment failure at five years post-transplant (HR=0.477, P=0.0045).
Nulojix is already indicated for organ rejection prophylaxis in adult EBV seropositive patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
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