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Long‐Term Outcomes in Belatacept‐ Versus Cyclosporine‐Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT‐EXT, a Phase III Randomized Study
| Content Provider | Semantic Scholar |
|---|---|
| Author | Durrbach, Antoine Pestana, José Osmar Medina Florman, Sandy Rial, Maria Del Carmen Rostaing, Lionel Kuypers, Dirk Matas, Arthur J. Wekerle, Th. Polinsky, Martin Meier-Kriesche, Herwig-Ulf Munier, Stéphane Grinyo, Josep María |
| Copyright Year | 2016 |
| Abstract | In the Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial-Extended Criteria Donors (BENEFIT-EXT), extended criteria donor kidney recipients were randomized to receive belatacept-based (more intense [MI] or less intense [LI]) or cyclosporine-based immunosuppression. In prior analyses, belatacept was associated with significantly better renal function compared with cyclosporine. In this prospective analysis of the intent-to-treat population, efficacy and safety were compared across regimens at 7 years after transplant. Overall, 128 of 184 belatacept MI-treated, 138 of 175 belatacept LI-treated and 108 of 184 cyclosporine-treated patients contributed data to these analyses. Hazard ratios (HRs) comparing time to death or graft loss were 0.915 (95% confidence interval [CI] 0.625-1.339; p = 0.65) for belatacept MI versus cyclosporine and 0.927 (95% CI 0.634-1.356; p = 0.70) for belatacept LI versus cyclosporine. Mean estimated GFR (eGFR) plus or minus standard error at 7 years was 53.9 ± 1.9, 54.2 ± 1.9, and 35.3 ± 2.0 mL/min per 1.73 m2 for belatacept MI, belatacept LI and cyclosporine, respectively (p < 0.001 for overall treatment effect). HRs comparing freedom from death, graft loss or eGFR <20 mL/min per 1.73 m2 were 0.754 (95% CI 0.536-1.061; p = 0.10) for belatacept MI versus cyclosporine and 0.706 (95% CI 0.499-0.998; p = 0.05) for belatacept LI versus cyclosporine. Acute rejection rates and safety profiles of belatacept- and cyclosporine-based treatment were similar. De novo donor-specific antibody incidence was lower for belatacept (p ≤ 0.0001). Relative to cyclosporine, belatacept was associated with similar death and graft loss and improved renal function at 7 years after transplant and had a safety profile consistent with previous reports. |
| Starting Page | 3192 |
| Ending Page | 3201 |
| Page Count | 10 |
| File Format | PDF HTM / HTML |
| DOI | 10.1111/ajt.13830 |
| PubMed reference number | 27130868 |
| Journal | Medline |
| Volume Number | 16 |
| Alternate Webpage(s) | https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0f/4c/AJT-16-3192.PMC5516151.pdf |
| Alternate Webpage(s) | https://doi.org/10.1111/ajt.13830 |
| Journal | American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
