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Acute Rejection Does Not Have an Impact on the Relative Renal Immunosuppressive Benefits of Belatacept Versus Cyclosporine: Presented at ATC By Cheryl Lathrop BOSTON -- June 2, 2009 -- The relative benefit of belatacept-based immunosuppressive regimens versus cyclosporine (CsA) on renal function was maintained in kidney transplant recipients, despite higher rates and grades of acute rejection, according to research presented here at the 2009 American Transplant Congress (ATC). Chris Larsen, MD, DPhil, Emory University School of Medicine, Atlanta, Georgia, and colleagues described acute rejection and its impact on the 1-year outcomes from the 3-year, randomised, phase 3 Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial (BENEFIT). The researchers presented the 12-month findings of BENEFIT here in a concurrent session on May 31. Patients in BENEFIT -- all adults not receiving an extended-criteria donor (ECD) kidney transplant -- were randomised into 3 groups: a more-intensive regimen of belatacept, a less-intensive regimen of belatacept, or CsA. All patients received basiliximab induction, mycophenolate mofetil, and corticosteroids. The definition of acute rejection included the following for the purposes of this trial: prespecified criteria for clinical suspicion (eg, unexplained rise of 25% or greater from baseline in serum creatinine), histological confirmation, and a decision to treat rejection based on local reading. Additional assessments included frequency and timing, grade and treatment, incidence of donor-specific antibodies, and functional consequences. The belatacept regimens demonstrated comparable patient/graft survival, superior renal function, better cardiovascular/metabolic profile, and general safety and tolerability compared with the CsA regimen. The belatacept regimens also demonstrated a higher rate and grade of acute rejection. In the intent-to-treat analysis at 12 months, acute rejection was exhibited in 22% of patients in the more-intensive belatacept group, 17% in the less-intensive belatacept group, and 7% in the CsA group. A Banff grade of IIb or less for acute rejection (defined as mild to moderate grades) was seen in 10% of patients in the more-intensive belatacept group, 5% of patients in the less-intensive belatacept group, and 1% of patients in the CsA group. Most acute rejections occurred within the first 3 months. The most common treatment for acute rejection was corticosteroids. Initial T-cell depletion was also undertaken. Of the patients with acute rejection, 94% of patients in the more-intensive belatacept group, 92% of patients in the less-intensive belatacept group, and 94% of patients in the CsA group survived with a functioning graft, compared with 96% of patients in the more-intensive belatacept group, 97% of patients in the less-intensive belatacept group, and 93% of patients in the CsA group without acute rejection. Among patients with acute rejection at month 12, measured glomerular filtration rate (GFR) was 62 mL/min/1.73 m2 in the more-intensive belatacept group, 61 mL/min/1.73 m2 in the less-intensive belatacept group, and 48 mL/min/1.73 m2 in the CsA group. For patients without acute rejection, measured GFR was 66 mL/min/1.73 m2 in the more-intensive belatacept group, 65 mL/min/1.73 m2 in the less-intensive belatacept group, and 51 mL/min/1.73 m2 in the CsA group. Few patients were adjudicated to have graft loss due to acute rejection -- 1 in the more-intensive belatacept group, 2 in the less-intensive belatacept group, and 2 in the CsA group. Approximately 50% of patients with acute rejection in the belatacept groups remained on belatacept. The impact of acute rejection on graft function and survival at 12 months was limited, the authors noted, and the longer-term effects of acute rejection will continue to be assessed over the 3-year life of the trial. Long-term patient/graft survival has not improved in kidney transplantation over the last decade, despite declines in acute rejection rates, and there is a need for improved immunosuppressive regimens, Dr. Larsen concluded. [Presentation title: Renal Benefit of Belatacept vs Cyclosporine in Kidney Transplant Patients Is Not Impacted by Acute Rejection (BENEFIT Study). Abstract 100] E-mail this page to a friend or colleague! To print, use this version