Long-Term Belatacept Exposure Maintains Efficacy and Safety at 5 Years: Results From the Long-Term Extension of the BENEFIT Study
| Autor: | Christian P. Larsen, Barbara A. Bresnahan, L. E. Gaite, J. Kothari, L. Pupim, Lionel Rostaing, Flavio Vincenti, Marie-Christine Moal, G. A. Mondragón‐Ramirez, Steven M. Steinberg, Josep M. Grinyó, K. M. Rice, S. Gang |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty Immunoconjugates Time Factors medicine.medical_treatment Urology Renal function Kidney Function Tests Graft loss Belatacept Abatacept Cohort Studies Postoperative Complications medicine Humans Immunology and Allergy Pharmacology (medical) Deceased donor kidney Transplantation business.industry International Agencies Immunosuppression Prognosis Kidney Transplantation Lymphoproliferative Disorders Surgery Safety profile Regimen Cohort Cyclosporine Kidney Failure Chronic Female Safety business Immunosuppressive Agents Follow-Up Studies Glomerular Filtration Rate medicine.drug |
| Zdroj: | American Journal of Transplantation. 13:2875-2883 |
| ISSN: | 1600-6135 |
| Popis: | The Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial randomized patients receiving a living or standard criteria deceased donor kidney transplant to a more (MI) or less intensive (LI) regimen of belatacept or cyclosporine A (CsA). The 5-year results of the long-term extension (LTE) cohort are reported. A total of 456 (68.5% of intent-to-treat) patients entered the LTE at 36 months; 406 patients (89%) completed 60 months. Between Months 36 and 60, death occurred in 2%, 1% and 5% of belatacept MI, belatacept LI and CsA patients, respectively; graft loss occurred in 0% belatacept and 2% of CsA patients. Acute rejection between Months 36 and 60 was rare: zero belatacept MI, one belatacept LI and one CsA. Rates for infections and malignancies for Months 36-60 were generally similar across belatacept groups and CsA, respectively: fungal infections (14%, 15%, 12%), viral infections (21%, 18%, 16%) and malignancies (6%, 6%, 9%). No new posttransplant lymphoproliferative disorder cases occurred after 36 months. Mean calculated GFR (MDRD, mL/min/1.73 m(2) ) at Month 60 was 74 for belatacept MI, 76 for belatacept LI and 53 for CsA. These results show that the renal function benefit and safety profile observed in belatacept-treated patients in the early posttransplant period was sustained through 5 years. |
| Databáze: | OpenAIRE |
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