An Integrated Safety Profile Analysis of Belatacept in Kidney Transplant Recipients

Grinyó, Josep M.; Charpentier, B; Pestana, José Medina; Vanrenterghem, Yves; Vincenti, Flavio; Reyes‐Acevedo, Rafael; Apanovitch, Anne Marie; Gujrathi, Sheila; Agarwal, Mamta; Thomas, Dolca; Larsen, Christian

doi:10.1097/tp.0b013e3182007b95

Cited by 109 publications

(86 citation statements)

References 22 publications

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“…Two belatacept dosing regimens, more intense (MI) and less intense (LI) regimens, were assessed in BENEFIT and BENEFIT-EXT. The belatacept MI and LI regimens had similar efficacy, and the LI regimen had fewer deaths and serious infections than the MI regimen (18), supporting a more favorable benefit/ risk profile for the LI regimen.…”

Section: Introductionmentioning

confidence: 79%

“…Clinical data from the BENEFIT and BENEFIT-EXT studies have indicated that the belatacept LI regimen is associated with a more favorable safety profile, supporting it as the recommended regimen moving forward (18). Thus, to investigate the safety of belatacept in the RTR-PD subpopulation, patients treated with the LI regimen were compared with patients treated with cyclosporine.…”

Section: Discussionmentioning

confidence: 99%

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Belatacept-versus Cyclosporine-Based Immunosuppression in Renal Transplant Recipients with Pre-existing Diabetes

Rostaing¹,

Neumayer

Reyes‐Acevedo³

et al. 2011

Clinical Journal of the American Society of Nephrology

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SummaryBackground and objectives Renal transplant recipients with pre-existing diabetes (PD) have reduced graft survival and increased risk of mortality and ischemic heart disease compared with nondiabetic transplant recipients. To assess the effect of belatacept in this high-risk group, we evaluated outcomes of the subpopulation with PD from previously published BENEFIT and BENEFIT-EXT trials. ConclusionsIn post hoc analysis of patients with PD, patient/graft survival and renal function at 12 months were numerically higher with belatacept versus cyclosporine, but not statistically significant. Further study is necessary to confirm the benefits belatacept may provide in these patients.

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Section: Introductionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Belatacept-versus Cyclosporine-Based Immunosuppression in Renal Transplant Recipients with Pre-existing Diabetes

Rostaing¹,

Neumayer

Reyes‐Acevedo³

et al. 2011

Clinical Journal of the American Society of Nephrology

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“…The Food and Drug Administration (FDA) recently approved use of Belatacept in renal transplantation. Initial results are promising but infectious and malignancy complications appear concerning (10,11). Advancements in pharmacogenomics can help elucidate the pharmacokinetics of maintenance immunosuppression.…”

Section: Immunosuppressionmentioning

confidence: 99%

The future of cardiac transplantation

Koomalsingh¹,

Kobashigawa²

2018

Ann. Cardiothorac. Surg.

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The first human-to-human heart transplant was performed 50 years ago in 1967. Heart transplantation has now entered an era of tremendous growth and innovation. The future of heart transplantation is bright with the advent of newer immunosuppressive medications and strategies that may even result in tolerance.Much of this progress in heart transplant medicine is predicated on a better understanding of acute and chronic rejection pathways through basic science studies. The future will also include personalized medicine where genomics and molecular science will dictate customized treatment for optimal outcomes. The introduction of mechanical circulatory support (MCS) devices has changed the landscape for patients with severe heart failure to stabilize the most ill patient and make them better candidates for heart transplant.As ex vivo preservation takes hold, we may witness an expansion of the donor pool through the use of donation after cardiac death (DCD) donors. In addition, further geographical donor heart sharing through ex vivo preservation may further decrease waitlist mortality by enabling longer distance donor hearts to be allocated for the sickest waitlist patient. It is no doubt an exciting time to be involved in the field of heart transplantation. In this perspective, we will summarize the present state of heart transplantation and discuss various innovations that are being pursued.

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“…Tizenkét hónappal a vesetranszplantáció után vizsgálva a belatacepttel kezelt betegeket, a kreatinin clearance és vérnyomásértékek tekintetében szignifi kánsan jobb eredmények születtek a kontrollcsoporttal, azaz a kalcineurin inhibitort tartalmazó kezeltekkel szemben, továbbá 50%-kal alacsonyabb arányban alakult ki cukorháztartási zavar is [15,16,17]. Hasonló eredményeket a kétéves prospektív vizsgálatok is mutattak [18,19]. A vizsgálatok során CNI-vel történt összehasonlításban a belatacept esetében nagyobb arányban észleltek akut rejekciót.…”

Section: A Kostimuláció Gátlásán Keresztül Ható Immunszuppresszánsokunclassified

“…Összességében kisebb rizikót jelentett a klinikai vizsgálatban a nagyobb arányú PTLD előfordulása, mint a vesetoxicitás, cardiovascularis és diabetogen mellékhatások összessége. A PTLD és PML kialakulása kivédhető az EBV-szeronegatív betegek kizárásával, mert az EBV-re nem immunizált betegekben a PTLD előfordulása jóval nagyobbnak bizonyult [15, 18,19].…”

Section: A Kostimuláció Gátlásán Keresztül Ható Immunszuppresszánsokunclassified

Recent options in drug therapy after solid organ transplantation

2012

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A szervtranszplantáció ötvenéves történetében az immunszuppresszív terápia fejlődésének köszönhetően egyre jobb szerv-és betegtúlélési eredményekről számoltak be világszerte, azonban a bázisgyógyszereknek minősülő kalcineurin inhibitorok káros mellékhatásait, elsősorban a nephrotoxicitast mellőző vegyületek kifejlesztése csak az elmúlt két évtizedben zajlott. A gazdaszervezet számára idegennek minősülő implantált szerv a recipiensből komplex immunválaszt vált ki. A dolgozatban az immunválasz vázlatos áttekintését követően a szerzők bemutatják az új, eltérő tá-madáspontokon ható gyógyszereket. Ezek vagy már gyakorlati alkalmazásban lévő, vagy rövid időn belül esetlegesen forgalomba kerülő vegyületek, amelyek távlati lehetőségeket nyújtanak a kalcineurin inhibitorok leváltására. Kiemelt hangsúlyt kap a kostimulációs blokádon keresztül ható belatacept és az elmúlt években egyre nagyobb kutatási teret nyerő toleranciaindukció, mint jövőbeli lehetőség. Orv. Hetil., 2012Hetil., , 153, 1294Hetil., -1301. Kulcsszavak: szervátültetés, immunszuppresszió, kalcineurin inhibitor, kostimulációs blokád, toleranciaindukció Recent options in drug therapy after solid organ transplantationSolid organ transplantation has shown improvement in patient and graft survival rates due to the development of immunosuppression in the last fi fty years; however only the last two decades led to the development of new, baseline immunosuppressive drugs that avoid the unlikely side effects of calcineurin inhibitors, especially nephrotoxicity. The transplanted organ is foreign to the host and, therefore, it induces a complex immune response of the recipient. In this review, a brief outline of immune response is given, followed by the introduction of new immunosuppressive drugs acting via variant pathways. These are compounds which are already in use or becoming shortly available and are potential future alternatives for the calcineurin inhibitors. This paper highlights the role of co-stimulation blockade with belatacept and the recently even more intensively studied fi eld of tolerance induction. Orv. Hetil., 2012, 153, 1294-1301 Keywords: organ transplantation, immunosuppression, calcineurin inhibitor, co-stimulation blockade, tolerance induction (Beérkezett: 2012. február 12.; elfogadva: 2012. június 17.) Rövidítések APC = (antigen presenting cell) antigén-bemutató sejt; BKV = BK-vírus; CD = (cluster of differentiation) sejtfelszíni fehérjék jelölése; CMV = cytomegalovirus; CNI = kalcineurin inhibitor; CTLA4 = citotoxikus T-lymphocyta-antigén-4; DC = dentritikus sejt; EBV = Epstein-Barr-vírus; FDA = Food and Drug Administration; FKBP12 = (FK-binding protein 12) FK-kötő fehérje 12; FOXP3 = forkhead boksz p3, egyike a transzkripciós regulátor fehérjéknek; γ-IFN = gamma-interferon; GVH = graft versus host; HUS = hemolitikus urémiás szindróma; IDO = indolamin-2,3-dioxigenáz; IL = interleukin; IL-2R = interleukin-2-receptor; JAK3 = Janus activated kinase 3, citokinreceptorokhoz kötődő tirozinkinázok egyike; LFA-1 = limphocytafunkció-asszociált anti...

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An Integrated Safety Profile Analysis of Belatacept in Kidney Transplant Recipients

Cited by 109 publications

References 22 publications

Belatacept-versus Cyclosporine-Based Immunosuppression in Renal Transplant Recipients with Pre-existing Diabetes

Belatacept-versus Cyclosporine-Based Immunosuppression in Renal Transplant Recipients with Pre-existing Diabetes

The future of cardiac transplantation

Recent options in drug therapy after solid organ transplantation

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