Good 3-year graft and patient survival with belatacept

Three-year follow-up results show continued high rates of patient and graft survival in kidney transplant recipients treated with belatacept, reports a study in the American Journal of Transplantation.

The researchers present final results from the Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT) study. A total of 666 kidney transplant recipients were randomly assigned to receive the selective costimulation blocker belatacept in either a more-intensive (MI) or a less-intensive (LI) regimen, or standard treatment with cyclosporine. Previous results have shown similar rates of patient and graft survival but with better renal function and improved cardiovascular and metabolic risk profiles in the belatacept groups. Belatacept was associated with an increased rate of posttransplant lymphoproliferative disorder, particularly of the central nervous system.

Four hundred seventy-one patients completed at least 3 years of treatment. The rates of survival with a functional graft were 92 percent with belatacept, both MI and LI, and 89 percent with cyclosporine. At 3 years, the mean calculated GFR was higher (approximately 21 mL/min/1.73 m2) in the belatacept groups, compared with the cyclosporine group. The calculated GFR increased by 1.0 mL/min/1.73 m2 per year with belatacept MI and 1.2 mL/min/1.73 m2 per year with belatacept LI, compared with a decrease of 2.0 mL/min/1.73 m2 per year with cyclosporine.

There was one case of acute rejection in the cyclosporine group during the third year of follow-up. No new cases of posttransplant lymphoproliferative disorder occurred after 18 months, and there were no new safety signals.

The new report extends the benefits of belatacept through 3 years of follow-up. The rates of patient and graft survival are similar to those of cyclosporine, and kidney function is better. The BENEFIT investigators conclude “the totality of data suggests that belatacept offers an important therapeutic advance in the care of renal transplant recipients” [Vincenti F, et al. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transpl 2012; 12:210–217].