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| |  Belatacept a Promising Immunosuppressant Therapy for Kidney Transplant Recipients Using Extended-Criteria Donors: Presented at ATC By Cheryl Lathrop BOSTON -- June 2, 2009 -- An immunosuppressant therapy regimen with belatacept demonstrates better renal function with comparable patient/graft survival and acute rejection rates compared with a cyclosporine (CsA)-based regimen in kidney transplant recipients using extended-criteria donors (ECDs), researchers reported here at the 2009 American Transplant Congress (ATC). Belatacept currently is being evaluated as an immunosuppressant in renal allograft recipients to avoid the renal and extra-renal toxicities of calcineurin inhibitors (eg, CsA). Recipients of ECD kidneys are at elevated risk of graft dysfunction and loss, and may benefit from a non-nephrotoxic option such as belatacept. Antoine Durrbach, MD, PhD, Paris-Sud Univ 11, Paris, France, and colleagues conducted a study of belatacept versus CsA in ECD kidney-transplant recipients. The Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial (BENEFIT)-EXT is similar to BENEFIT, with the exception that the donor kidneys are from ECDs. Dr. Durrbach presented findings from the 3-year, randomised, phase 3 BENEFIT-EXT here at a concurrent session on May 31. Five hundred forty-three adult subjects were randomised 1:1:1 to receive a more-intensive regimen of belatacept (n = 184), a less-intensive regimen of belatacept (n = 175), or CsA (n = 184). All patients received basiliximab induction, mycophenolate mofetil, and corticosteroids. The two coprimary endpoints in the trial were composite patient/graft survival at 12 months and composite renal function (measured by glomerular filtration rate [GFR] <60 mL/min/1.73 m2 at month 12 or a decrease in measured GFR 10 mL/min/1.73 m2 from month 3 to month 12). Secondary endpoints included the incidence of acute rejection. The mean age of patients was 56 years; with 75% Caucasian and 75% male. One hundred forty-nine patients discontinued treatment due to adverse events, lack of efficacy, or other reasons. Patient/graft survival with belatacept was noninferior to CsA at month 12 (86% belatacept more-intensive group, 88% belatacept less-intensive group, 85% CsA group). Renal function was superior in the belatacept more-intensive group versus the CsA group, as shown by fewer patients reaching the composite renal endpoint (71% belatacept more-intensive group [P = .002 vs CsA]; 76% belatacept less-intensive group [P = .06 vs CsA]; and 85% CsA group). Renal function was also superior for belatacept as measured by GFR at Month 12 (52 mL/min belatacept more-intensive group [P = .008 vs CsA]; 50 mL/min belatacept less-intensive group [P = .10 vs CsA]; and 45 mL/min CsA). Belatacept was well tolerated as a monthly infusion. The prevalence of acute rejection was 17%, 18%, and 14% in the belatacept more-intensive, belatacept less-intensive, and CsA groups, respectively. The overall rates of infection and malignancy were comparable between groups. In the first 12 months, post-transplant lymphoproliferative disorder was observed in 1 patient from the belatacept more-intensive group, 2 patients in the belatacept less-intensive group, and in 0 CsA patients. [Presentation title: Primary Outcomes From a Randomized, Phase III Study of Belatacept vs Cyclosporine in ECD Kidney Transplants (BENEFIT-EXT Study). Abstract 27]
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