Nulojix (belatacept) is indicated for use in combination with corticosteroids and mycophenolate to prevent graft rejection in renal transplantation.
Belatacept is a soluble fusion protein consisting of a modified segment of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to a portion of a human immunoglobulin G1. By selectively blocking T cell co-stimulation, belatacept helps protect renal allografts from immunological rejection.
Two studies evaluated the safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation. Two dosage regimens (one more and one less intensive) were compared with ciclosporin, with all patients receiving basiliximab, mycophenolate and corticosteroids. Efficacy was the same for both regimens but the overall safety and tolerability was better for the lower intensity regimen; consequently, it is the lower dosage regimen that is licensed.
Patient and graft survival were similar for the lower intensity regimen and ciclosporin in both studies but fewer patients treated with belatacept met the composite renal impairment endpoint. Additionally, the mean GFR was higher in patients treated with belatacept than in those who received ciclosporin.