BACKGROUND: At 1 year, belatacept was associated with similar patient/graft survival, better renal function, and an improved cardiovascular/metabolic risk profile versus cyclosporine A (CsA) in the Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial (BENEFIT) and Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial-EXTended criteria donors (BENEFIT-EXT) studies. Acute rejection was more frequent with belatacept in BENEFIT. Posttransplant lymphoproliferative disorder (PTLD)--specifically central nervous system PTLD--was observed more frequently in belatacept-treated patients. This analysis assesses outcomes from BENEFIT and BENEFIT-EXT after 2 years of treatment. METHODS: Patients received a more intensive (MI) or a less intensive (LI) regimen of belatacept or a CsA-based regimen. RESULTS: Four hundred ninety-three of 666 patients (74%) in BENEFIT and 347 of 543 (64%) in BENEFIT-EXT completed 2 years of treatment. The proportion of patients who survived with a functioning graft was similar across groups (BENEFIT: 94% MI, 95% LI, and 91% CsA; BENEFIT-EXT: 83% MI, 84% LI, and 83% CsA). Belatacept's renal benefits were sustained, as evidenced by a 16 to 17 mL/min (BENEFIT) and an 8 to 10 mL/min (BENEFIT-EXT) higher calculated glomerular filtration rate in the belatacept groups versus CsA. There were few new acute rejection episodes in either study between years 1 and 2. Because PTLD risk was highest in Epstein-Barr virus (EBV) (-) patients, an efficacy analysis of EBV (+) patients was performed and was consistent with the overall population results. There were two previously reported cases of PTLD in each study between years 1 and 2 in the belatacept groups. The overall balance of safety and efficacy favored the LI over the MI regimen. CONCLUSIONS: At 2 years, belatacept-based regimens sustained better renal function, similar patient/graft survival, and an improved cardiovascular/metabolic risk profile versus CsA; outcomes that were maintained in EBV (+) patients. No new safety signals emerged.
BACKGROUND: At 1 year, belatacept was associated with similar patient/graft survival, better renal function, and an improved cardiovascular/metabolic risk profile versus cyclosporine A (CsA) in the Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial (BENEFIT) and Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial-EXTended criteria donors (BENEFIT-EXT) studies. Acute rejection was more frequent with belatacept in BENEFIT. Posttransplant lymphoproliferative disorder (PTLD)--specifically central nervous system PTLD--was observed more frequently in belatacept-treated patients. This analysis assesses outcomes from BENEFIT and BENEFIT-EXT after 2 years of treatment. METHODS:Patients received a more intensive (MI) or a less intensive (LI) regimen of belatacept or a CsA-based regimen. RESULTS: Four hundred ninety-three of 666 patients (74%) in BENEFIT and 347 of 543 (64%) in BENEFIT-EXT completed 2 years of treatment. The proportion of patients who survived with a functioning graft was similar across groups (BENEFIT: 94% MI, 95% LI, and 91% CsA; BENEFIT-EXT: 83% MI, 84% LI, and 83% CsA). Belatacept's renal benefits were sustained, as evidenced by a 16 to 17 mL/min (BENEFIT) and an 8 to 10 mL/min (BENEFIT-EXT) higher calculated glomerular filtration rate in the belatacept groups versus CsA. There were few new acute rejection episodes in either study between years 1 and 2. Because PTLD risk was highest in Epstein-Barr virus (EBV) (-) patients, an efficacy analysis of EBV (+) patients was performed and was consistent with the overall population results. There were two previously reported cases of PTLD in each study between years 1 and 2 in the belatacept groups. The overall balance of safety and efficacy favored the LI over the MI regimen. CONCLUSIONS: At 2 years, belatacept-based regimens sustained better renal function, similar patient/graft survival, and an improved cardiovascular/metabolic risk profile versus CsA; outcomes that were maintained in EBV (+) patients. No new safety signals emerged.
Authors: Daniel R Getts; Sushma Shankar; Emily M L Chastain; Aaron Martin; Meghann Teague Getts; Kathryn Wood; Stephen D Miller Journal: Immunotherapy Date: 2011-07 Impact factor: 4.196
Authors: M Cortes-Cerisuelo; S J Laurie; D V Mathews; P D Winterberg; C P Larsen; A B Adams; M L Ford Journal: Am J Transplant Date: 2017-06-30 Impact factor: 8.086
Authors: María José Pérez-Sáez; Núria Montero; Dolores Redondo-Pachón; Marta Crespo; Julio Pascual Journal: Transplantation Date: 2017-04 Impact factor: 4.939
Authors: Stuart J Knechtle; Julia M Shaw; Bernhard J Hering; Kristy Kraemer; Joren C Madsen Journal: Sci Transl Med Date: 2019-07-10 Impact factor: 17.956
Authors: S C Kim; W Wakwe; L B Higginbotham; D V Mathews; C P Breeden; A C Stephenson; J Jenkins; E Strobert; K Price; L Price; R Kuhn; H Wang; A Yamniuk; S Suchard; A B Farris; T C Pearson; C P Larsen; M L Ford; A Suri; S Nadler; A B Adams Journal: Am J Transplant Date: 2017-02-25 Impact factor: 8.086
Authors: M Lowe; I R Badell; P Thompson; B Martin; F Leopardi; E Strobert; A A Price; H S Abdulkerim; R Wang; N N Iwakoshi; A B Adams; A D Kirk; C P Larsen; K A Reimann Journal: Am J Transplant Date: 2012-05-08 Impact factor: 8.086