An Integrated Safety Profile Analysis of Belatacept in Kidney Transplant Recipients

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dc.contributor.authorGrinyo, Josep
dc.contributor.authorCharpentier, Bernard
dc.contributor.authorPestana, Jose Medina [UNIFESP]
dc.contributor.authorVanrenterghem, Yves
dc.contributor.authorVincenti, Flavio
dc.contributor.authorReyes-Acevedo, Rafael
dc.contributor.authorApanovitch, Anne Marie
dc.contributor.authorGujrathi, Sheila
dc.contributor.authorAgarwal, Mamta
dc.contributor.authorThomas, Dolca
dc.contributor.authorLarsen, Christian P.
dc.contributor.institutionUniv Barcelona
dc.contributor.institutionHop Bicetre
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionUniv Hosp Leuven
dc.contributor.institutionUniv Calif San Francisco
dc.contributor.institutionHosp Miguel Hidalgo Aguascalientes
dc.contributor.institutionBristol Myers Squibb Co
dc.contributor.institutionEmory Transplant Ctr
dc.contributor.institutionUniv Transplant Ctr
dc.date.accessioned2016-01-24T14:05:50Z
dc.date.available2016-01-24T14:05:50Z
dc.date.issued2010-12-27
dc.description.abstractBackground. Belatacept is associated with better renal function and an improved cardiovascular/metabolic risk profile versus cyclosporine in kidney transplant recipients. the current analysis examined pooled safety data for belatacept versus cyclosporine used in combination with basiliximab, mycophenolate mofetil, and steroids.Methods. Patients enrolled in three core studies in de novo kidney transplantation were randomized to a more intensive (MI) or less intensive (LI) regimen of belatacept or cyclosporine. the pooled analysis included 1425 patients (MI: 477; LI: 472; cyclosporine: 476). Median follow-up was approximately 2.4 years.Results. Belatacept was generally well tolerated. the frequency of deaths (MI: 7%; LI: 5%; cyclosporine: 7%) and serious infections (MI: 37%; LI: 32%; cyclosporine: 36%) were lower in the LI group versus cyclosporine. the frequency of malignancies was 10%, 6%, and 7% in the MI, LI, and cyclosporine groups, respectively. Sixteen cases of posttransplant lymphoproliferative disorder (PTLD) occurred (n = 8 MI; n = 6 LI; n = 2 cyclosporine), including nine cases involving the central nervous system (CNS) (n = 6 MI; n = 3 LI). the risk of CNS PTLD was highest in Epstein-Barr virus(-) recipients; more CNS PTLD cases occurred in the MI group. One case of progressive multifocal leukoenceph-alopathy was reported in the MI group.Conclusions. Treatment with belatacept-based regimens was generally safe for a period of at least 2 years. There was a greater risk of PTLD-specifically CNS PTLD-in the belatacept groups versus cyclosporine, especially in Epstein-Barr virus(-) patients and with the MI dose. the number of deaths and serious infections was lower in the LI regimen versus MI and cyclosporine. the overall safety profile favored the LI over the MI regimen.en
dc.description.affiliationUniv Barcelona, Dept Nephrol, Univ Hosp Bellvitge, Div Nephrol, Barcelona 08907, Spain
dc.description.affiliationHop Bicetre, Dept Nephrol, Le Kremlin Bicetre, France
dc.description.affiliationHosp Rim & Hipertensao Unifesp, Dept Med, Div Nephrol, São Paulo, Brazil
dc.description.affiliationUniv Hosp Leuven, Dept Nephrol, Louvain, Belgium
dc.description.affiliationUniv Calif San Francisco, Dept Med, Div Nephrol, Kidney Transplant Serv, San Francisco, CA USA
dc.description.affiliationHosp Miguel Hidalgo Aguascalientes, Dept Surg, Aguascalientes, Mexico
dc.description.affiliationBristol Myers Squibb Co, Princeton, NJ USA
dc.description.affiliationEmory Transplant Ctr, Atlanta, GA USA
dc.description.affiliationUniv Transplant Ctr, Dept Surg, Atlanta, GA USA
dc.description.affiliationUnifespHosp Rim & Hipertensao Unifesp, Dept Med, Div Nephrol, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipBristol-Myers Squibb
dc.description.sponsorshipPfizer
dc.description.sponsorshipNovartis
dc.description.sponsorshipAstellas Pharma
dc.description.sponsorshipGenzyme
dc.description.sponsorshipGenentech
dc.description.sponsorshipRoche
dc.description.sponsorshipInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
dc.format.extent1521-1527
dc.identifierhttp://dx.doi.org/10.1097/TP.0b013e3182007b95
dc.identifier.citationTransplantation. Philadelphia: Lippincott Williams & Wilkins, v. 90, n. 12, p. 1521-1527, 2010.
dc.identifier.doi10.1097/TP.0b013e3182007b95
dc.identifier.issn0041-1337
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/33175
dc.identifier.wosWOS:000285377100043
dc.language.isoeng
dc.publisherLippincott Williams & Wilkins
dc.relation.ispartofTransplantation
dc.rightsAcesso restrito
dc.subjectBelatacepten
dc.subjectCyclosporineen
dc.subjectKidney transplanten
dc.subjectSafetyen
dc.subjectPosttransplant lymphoproliferative disorderen
dc.titleAn Integrated Safety Profile Analysis of Belatacept in Kidney Transplant Recipientsen
dc.typeArtigo
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