Seven year follow up of Nulojix (belatacept)in kidney transplant patients- BMS

BMS announced results from a 7-year, long-term follow-up from a prospective, randomized Phase III trial (BENEFIT) in kidney transplant patients, which demonstrated a statistically significant 43% relative risk reduction of death or graft loss (transplant failure) in patients receiving the Nulojix (belatacept) FDA-approved dosing regimen over those receiving a cyclosporine regimen (hazard ratio=0.57, p=0.0286). Data also showed that there was a statistically significant survival benefit of 52% relative risk reduction of death or graft loss at 5 years post-transplant (hazard ratio=0.477, p=0.0045). In the long-term follow-up (years 3-7) on BENEFIT participants, the safety profile of the Nulojix regimen was similar to the cyclosporine regimen.

Nulojix is the first selective T-cell costimulation blocker indicated in combination with basiliximab induction, mycophenolate mofetil (MMF) and corticosteroids for the prophylaxis of organ rejection in adult Epstein-Barr Virus (EBV) seropositive patients receiving a kidney transplant. The 7-year BENEFIT results were presented in the plenary session at the 2015 American Transplant Congress (ATC) in Philadelphia.