A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study)
Autor(a) principal: | |
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Data de Publicação: | 2010 |
Outros Autores: | , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNIFESP |
Texto Completo: | http://repositorio.unifesp.br/handle/11600/32295 http://dx.doi.org/10.1111/j.1600-6143.2010.03016.x |
Resumo: | Recipients of extended criteria donor (ECD) kidneys are at increased risk for graft dysfunction/loss, and may benefit from immunosuppression that avoids calcineurin inhibitor (CNI) nephrotoxicity. Belatacept, a selective costimulation blocker, may preserve renal function and improve long-term outcomes versus CNIs. BENEFIT-EXT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-EXTended criteria donors) is a 3-year, Phase III study that assessed a more (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in adult ECD kidney transplant recipients. the coprimary endpoints at 12 months were composite patient/graft survival and a composite renal impairment endpoint. Patient/graft survival with belatacept was similar to cyclosporine (86% MI, 89% LI, 85% cyclosporine) at 12 months. Fewer belatacept patients reached the composite renal impairment endpoint versus cyclosporine (71% MI, 77% LI, 85% cyclosporine; p = 0.002 MI vs. cyclosporine; p = 0.06 LI vs. cyclosporine). the mean measured glomerular filtration rate was 4-7 mL/min higher on belatacept versus cyclosporine (p = 0.008 MI vs. cyclosporine; p = 0.1039 LI vs. cyclosporine), and the overall cardiovascular/metabolic profile was better on belatacept versus cyclosporine. the incidence of acute rejection was similar across groups (18% MI; 18% LI; 14% cyclosporine). Overall rates of infection and malignancy were similar between groups; however, more cases of posttransplant lymphoproliferative disorder (PTLD) occurred in the CNS on belatacept. ECD kidney transplant recipients treated with belatacept-based immunosuppression achieved similar patient/graft survival, better renal function, had an increased incidence of PTLD, and exhibited improvement in the cardiovascular/metabolic risk profile versus cyclosporine-treated patients. |
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Durrbach, A.Pestana, Jose Osmar Medina [UNIFESP]Pearson, T.Vincenti, F.Garcia, V. D.Campistol, J.del Carmen Rial, M.Florman, S.Block, A.Di Russo, G.Xing, J.Garg, P.Grinyo, J.Univ Paris 11Universidade Federal de São Paulo (UNIFESP)Emory UnivUniv Calif San FranciscoComplexo Hosp Santa CasaUniv BarcelonaInst NefrolTulane Sch MedBristol Myers Squibb CoUniv Hosp Bellvitge2016-01-24T13:59:21Z2016-01-24T13:59:21Z2010-03-01American Journal of Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 10, n. 3, p. 547-557, 2010.1600-6135http://repositorio.unifesp.br/handle/11600/32295http://dx.doi.org/10.1111/j.1600-6143.2010.03016.x10.1111/j.1600-6143.2010.03016.xWOS:000274621200016Recipients of extended criteria donor (ECD) kidneys are at increased risk for graft dysfunction/loss, and may benefit from immunosuppression that avoids calcineurin inhibitor (CNI) nephrotoxicity. Belatacept, a selective costimulation blocker, may preserve renal function and improve long-term outcomes versus CNIs. BENEFIT-EXT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-EXTended criteria donors) is a 3-year, Phase III study that assessed a more (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in adult ECD kidney transplant recipients. the coprimary endpoints at 12 months were composite patient/graft survival and a composite renal impairment endpoint. Patient/graft survival with belatacept was similar to cyclosporine (86% MI, 89% LI, 85% cyclosporine) at 12 months. Fewer belatacept patients reached the composite renal impairment endpoint versus cyclosporine (71% MI, 77% LI, 85% cyclosporine; p = 0.002 MI vs. cyclosporine; p = 0.06 LI vs. cyclosporine). the mean measured glomerular filtration rate was 4-7 mL/min higher on belatacept versus cyclosporine (p = 0.008 MI vs. cyclosporine; p = 0.1039 LI vs. cyclosporine), and the overall cardiovascular/metabolic profile was better on belatacept versus cyclosporine. the incidence of acute rejection was similar across groups (18% MI; 18% LI; 14% cyclosporine). Overall rates of infection and malignancy were similar between groups; however, more cases of posttransplant lymphoproliferative disorder (PTLD) occurred in the CNS on belatacept. ECD kidney transplant recipients treated with belatacept-based immunosuppression achieved similar patient/graft survival, better renal function, had an increased incidence of PTLD, and exhibited improvement in the cardiovascular/metabolic risk profile versus cyclosporine-treated patients.Bristol- Myers SquibbRochePfizerNovartisAstellasGenzymeGenentechUniv Paris 11, IFRNT, Bicetre Hosp, Paris, FranceHosp Rim & Hipertensao Unifesp, São Paulo, BrazilEmory Univ, Transplant Ctr, Atlanta, GA 30322 USAUniv Calif San Francisco, Kidney Transplant Serv, San Francisco, CA 94143 USAComplexo Hosp Santa Casa, Hosp Dom Vicente Scherer, Porto Alegre, RS, BrazilUniv Barcelona, Renal Transplantat Unit, Hosp Clin & Prov, Barcelona, SpainInst Nefrol, Buenos Aires, DF, ArgentinaTulane Sch Med, New Orleans, LA USABristol Myers Squibb Co, Princeton, NJ USAUniv Hosp Bellvitge, Barcelona, SpainHosp Rim & Hipertensao Unifesp, São Paulo, BrazilWeb of Science547-557engWiley-BlackwellAmerican Journal of Transplantationhttp://olabout.wiley.com/WileyCDA/Section/id-406071.htmlinfo:eu-repo/semantics/openAccessBelataceptcyclosporineextended criteria donorkidneyrenal functionA Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlereponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP11600/322952022-11-04 15:08:28.676metadata only accessoai:repositorio.unifesp.br:11600/32295Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestopendoar:34652022-11-04T18:08:28Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
dc.title.en.fl_str_mv |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
title |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
spellingShingle |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) Durrbach, A. Belatacept cyclosporine extended criteria donor kidney renal function |
title_short |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
title_full |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
title_fullStr |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
title_full_unstemmed |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
title_sort |
A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study) |
author |
Durrbach, A. |
author_facet |
Durrbach, A. Pestana, Jose Osmar Medina [UNIFESP] Pearson, T. Vincenti, F. Garcia, V. D. Campistol, J. del Carmen Rial, M. Florman, S. Block, A. Di Russo, G. Xing, J. Garg, P. Grinyo, J. |
author_role |
author |
author2 |
Pestana, Jose Osmar Medina [UNIFESP] Pearson, T. Vincenti, F. Garcia, V. D. Campistol, J. del Carmen Rial, M. Florman, S. Block, A. Di Russo, G. Xing, J. Garg, P. Grinyo, J. |
author2_role |
author author author author author author author author author author author author |
dc.contributor.institution.none.fl_str_mv |
Univ Paris 11 Universidade Federal de São Paulo (UNIFESP) Emory Univ Univ Calif San Francisco Complexo Hosp Santa Casa Univ Barcelona Inst Nefrol Tulane Sch Med Bristol Myers Squibb Co Univ Hosp Bellvitge |
dc.contributor.author.fl_str_mv |
Durrbach, A. Pestana, Jose Osmar Medina [UNIFESP] Pearson, T. Vincenti, F. Garcia, V. D. Campistol, J. del Carmen Rial, M. Florman, S. Block, A. Di Russo, G. Xing, J. Garg, P. Grinyo, J. |
dc.subject.eng.fl_str_mv |
Belatacept cyclosporine extended criteria donor kidney renal function |
topic |
Belatacept cyclosporine extended criteria donor kidney renal function |
description |
Recipients of extended criteria donor (ECD) kidneys are at increased risk for graft dysfunction/loss, and may benefit from immunosuppression that avoids calcineurin inhibitor (CNI) nephrotoxicity. Belatacept, a selective costimulation blocker, may preserve renal function and improve long-term outcomes versus CNIs. BENEFIT-EXT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-EXTended criteria donors) is a 3-year, Phase III study that assessed a more (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in adult ECD kidney transplant recipients. the coprimary endpoints at 12 months were composite patient/graft survival and a composite renal impairment endpoint. Patient/graft survival with belatacept was similar to cyclosporine (86% MI, 89% LI, 85% cyclosporine) at 12 months. Fewer belatacept patients reached the composite renal impairment endpoint versus cyclosporine (71% MI, 77% LI, 85% cyclosporine; p = 0.002 MI vs. cyclosporine; p = 0.06 LI vs. cyclosporine). the mean measured glomerular filtration rate was 4-7 mL/min higher on belatacept versus cyclosporine (p = 0.008 MI vs. cyclosporine; p = 0.1039 LI vs. cyclosporine), and the overall cardiovascular/metabolic profile was better on belatacept versus cyclosporine. the incidence of acute rejection was similar across groups (18% MI; 18% LI; 14% cyclosporine). Overall rates of infection and malignancy were similar between groups; however, more cases of posttransplant lymphoproliferative disorder (PTLD) occurred in the CNS on belatacept. ECD kidney transplant recipients treated with belatacept-based immunosuppression achieved similar patient/graft survival, better renal function, had an increased incidence of PTLD, and exhibited improvement in the cardiovascular/metabolic risk profile versus cyclosporine-treated patients. |
publishDate |
2010 |
dc.date.issued.fl_str_mv |
2010-03-01 |
dc.date.accessioned.fl_str_mv |
2016-01-24T13:59:21Z |
dc.date.available.fl_str_mv |
2016-01-24T13:59:21Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
American Journal of Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 10, n. 3, p. 547-557, 2010. |
dc.identifier.uri.fl_str_mv |
http://repositorio.unifesp.br/handle/11600/32295 http://dx.doi.org/10.1111/j.1600-6143.2010.03016.x |
dc.identifier.issn.none.fl_str_mv |
1600-6135 |
dc.identifier.doi.none.fl_str_mv |
10.1111/j.1600-6143.2010.03016.x |
dc.identifier.wos.none.fl_str_mv |
WOS:000274621200016 |
identifier_str_mv |
American Journal of Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 10, n. 3, p. 547-557, 2010. 1600-6135 10.1111/j.1600-6143.2010.03016.x WOS:000274621200016 |
url |
http://repositorio.unifesp.br/handle/11600/32295 http://dx.doi.org/10.1111/j.1600-6143.2010.03016.x |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.none.fl_str_mv |
American Journal of Transplantation |
dc.rights.driver.fl_str_mv |
http://olabout.wiley.com/WileyCDA/Section/id-406071.html info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
http://olabout.wiley.com/WileyCDA/Section/id-406071.html |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
547-557 |
dc.publisher.none.fl_str_mv |
Wiley-Blackwell |
publisher.none.fl_str_mv |
Wiley-Blackwell |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
instname_str |
Universidade Federal de São Paulo (UNIFESP) |
instacron_str |
UNIFESP |
institution |
UNIFESP |
reponame_str |
Repositório Institucional da UNIFESP |
collection |
Repositório Institucional da UNIFESP |
repository.name.fl_str_mv |
Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP) |
repository.mail.fl_str_mv |
|
_version_ |
1802764184284299264 |