29 Jan Belacept Found Superior to Cyclosporin For Kidney Transplantation
MedicalResearch.com Interview with:
Dr. Flavio Vincenti
Dr. Flavio Vincenti, M.D
Clinical Professor of Medicine and Surgery
Departments of Medicine and Surgery
Endowed Chair in Kidney Transplantation
University of California, San Francisco
San Francisco, CA 94143
Medical Research: What is the background for this study? What are the main findings?
Dr. Vincenti: This is a phase 3 study of belacept immunosuppression as compared to cyclosporine based immunosuppression in renal transplant recipients randomly assigned to 2 treatments arms of belatacept and a controlled arm consisting of cyclosporine. The main finding of this study is that Belatacept, a fusion receptor protein that blocks co-stimulation and is administered intravenously on the maintenance of a 4 weekly maintenance therapy, had superior outcomes at 5 and 7 years as compared to patients on a CsA-based regimen. The 7 year data show that patients on either arm of belatacept had a 43 percent risk reduction of deaths or grafts loss as compared to patients treated with cyclosporine. In addition, belatcept patients had significantly better preservation of renal function throughout the 7 years of follow up and had lower incidence of donor specific antibodies. Nephrotoxicity from cyclosporine and donor specific antibodies are important causes of late graft loss.
Medical Research: What should clinicians and patients take away from your report?
Dr. Vincenti: A calcineurin inhibitor free regimen consisting of belatacept (the lower intensity regimen is FDA approved therapy in EBV positive patients) provides better long term outcome than cyclosporine, although it may be associated early after transplantation with higher acute rejection rates. An additional benefit of belatacept is that it does not share the worsening of cardiovascular risk factors associated with cyclosporine or tacrolimus.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Vincenti: One important area of research is to determine the best regimen for belatacept to reduce the early acute rejection rate. In the phase 3 trial, the induction that was used was basiliximab while several studies have shown lower rejection rate when depleting antibodies have been used. Also it would be of interest to compare belatacept to tacrolimus since tacrolimus is the preferred calcineurin inhibitor.
Medical Research: Is there anything else you would like to add?
Dr. Vincenti: Belatacept is potentially a transformational drug in transplantation because of its beneficial effects on renal function, its inhibition of donor specific antibodies, and the potential of increasing the life of the graft.
Citation:
Belatacept and Long-Term Outcomes in Kidney Transplantation
N Engl J Med 2016; 374:333-343
January 28, 2016
[wysija_form id=”5″]
Last Updated on January 29, 2016 by Marie Benz MD FAAD