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Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study

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Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. / Klintmalm, G B; Feng, S; Lake, J R; Vargas, H E; Wekerle, T; Agnes, S; Brown, K A; Nashan, B; Rostaing, L; Meadows-Shropshire, S; Agarwal, M; Harler, M B; Garcia-Valdecasas, J-C.

in: AM J TRANSPLANT, Jahrgang 14, Nr. 8, 2014, S. 1817-27.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Klintmalm, GB, Feng, S, Lake, JR, Vargas, HE, Wekerle, T, Agnes, S, Brown, KA, Nashan, B, Rostaing, L, Meadows-Shropshire, S, Agarwal, M, Harler, MB & Garcia-Valdecasas, J-C 2014, 'Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study', AM J TRANSPLANT, Jg. 14, Nr. 8, S. 1817-27. https://doi.org/10.1111/ajt.12810

APA

Klintmalm, G. B., Feng, S., Lake, J. R., Vargas, H. E., Wekerle, T., Agnes, S., Brown, K. A., Nashan, B., Rostaing, L., Meadows-Shropshire, S., Agarwal, M., Harler, M. B., & Garcia-Valdecasas, J-C. (2014). Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. AM J TRANSPLANT, 14(8), 1817-27. https://doi.org/10.1111/ajt.12810

Vancouver

Klintmalm GB, Feng S, Lake JR, Vargas HE, Wekerle T, Agnes S et al. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. AM J TRANSPLANT. 2014;14(8):1817-27. https://doi.org/10.1111/ajt.12810

Bibtex

@article{db7adfd964d94cbaab7738ac19c774e5,
title = "Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study",
abstract = "This exploratory phase II study evaluated the safety and efficacy of belatacept in de novo adult liver transplant recipients. Patients were randomized (N = 260) to one of the following immunosuppressive regimens: (i) basiliximab + belatacept high dose [HD] + mycophenolate mofetil (MMF), (ii) belatacept HD + MMF, (iii) belatacept low dose [LD] + MMF, (iv) tacrolimus + MMF, or (v) tacrolimus alone. All received corticosteroids. Demographic characteristics were similar among groups. The proportion of patients who met the primary end point (composite of acute rejection, graft loss, death by month 6) was higher in the belatacept groups (42–48%) versus tacrolimus groups (15–38%), with the highest number of deaths and grafts losses in the belatacept LD group. By month 12, the proportion surviving with a functioning graft was higher with tacrolimus + MMF (93%) and lower with belatacept LD (67%) versus other groups (90%: basiliximab + belatacept HD; 83%: belatacept HD; 88%: tacrolimus). Mean calculated GFR was 15–34 mL/min higher in belatacept-treated patients at 1 year. Two cases of posttransplant lymphoproliferative disease and one case of progressive multifocal leukoencephalopathy occurred in belatacept-treated patients. Follow-up beyond month 12 revealed an increase in death and graft loss in another belatacept group (belatacept HD), after which the study was terminated.",
keywords = "Adult, Aged, Drug Administration Schedule, Female, Glomerular Filtration Rate, Graft Rejection, Graft Survival, Hepatitis C, Humans, Immunoconjugates, Immunosuppression, Immunosuppressive Agents, Leukoencephalopathies, Liver Failure, Liver Transplantation, Lymphoproliferative Disorders, Male, Middle Aged, Mycophenolic Acid, Recurrence, Tacrolimus, Treatment Outcome",
author = "Klintmalm, {G B} and S Feng and Lake, {J R} and Vargas, {H E} and T Wekerle and S Agnes and Brown, {K A} and B Nashan and L Rostaing and S Meadows-Shropshire and M Agarwal and Harler, {M B} and J-C Garcia-Valdecasas",
year = "2014",
doi = "10.1111/ajt.12810",
language = "English",
volume = "14",
pages = "1817--27",
journal = "AM J TRANSPLANT",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "8",

}

RIS

TY - JOUR

T1 - Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study

AU - Klintmalm, G B

AU - Feng, S

AU - Lake, J R

AU - Vargas, H E

AU - Wekerle, T

AU - Agnes, S

AU - Brown, K A

AU - Nashan, B

AU - Rostaing, L

AU - Meadows-Shropshire, S

AU - Agarwal, M

AU - Harler, M B

AU - Garcia-Valdecasas, J-C

PY - 2014

Y1 - 2014

N2 - This exploratory phase II study evaluated the safety and efficacy of belatacept in de novo adult liver transplant recipients. Patients were randomized (N = 260) to one of the following immunosuppressive regimens: (i) basiliximab + belatacept high dose [HD] + mycophenolate mofetil (MMF), (ii) belatacept HD + MMF, (iii) belatacept low dose [LD] + MMF, (iv) tacrolimus + MMF, or (v) tacrolimus alone. All received corticosteroids. Demographic characteristics were similar among groups. The proportion of patients who met the primary end point (composite of acute rejection, graft loss, death by month 6) was higher in the belatacept groups (42–48%) versus tacrolimus groups (15–38%), with the highest number of deaths and grafts losses in the belatacept LD group. By month 12, the proportion surviving with a functioning graft was higher with tacrolimus + MMF (93%) and lower with belatacept LD (67%) versus other groups (90%: basiliximab + belatacept HD; 83%: belatacept HD; 88%: tacrolimus). Mean calculated GFR was 15–34 mL/min higher in belatacept-treated patients at 1 year. Two cases of posttransplant lymphoproliferative disease and one case of progressive multifocal leukoencephalopathy occurred in belatacept-treated patients. Follow-up beyond month 12 revealed an increase in death and graft loss in another belatacept group (belatacept HD), after which the study was terminated.

AB - This exploratory phase II study evaluated the safety and efficacy of belatacept in de novo adult liver transplant recipients. Patients were randomized (N = 260) to one of the following immunosuppressive regimens: (i) basiliximab + belatacept high dose [HD] + mycophenolate mofetil (MMF), (ii) belatacept HD + MMF, (iii) belatacept low dose [LD] + MMF, (iv) tacrolimus + MMF, or (v) tacrolimus alone. All received corticosteroids. Demographic characteristics were similar among groups. The proportion of patients who met the primary end point (composite of acute rejection, graft loss, death by month 6) was higher in the belatacept groups (42–48%) versus tacrolimus groups (15–38%), with the highest number of deaths and grafts losses in the belatacept LD group. By month 12, the proportion surviving with a functioning graft was higher with tacrolimus + MMF (93%) and lower with belatacept LD (67%) versus other groups (90%: basiliximab + belatacept HD; 83%: belatacept HD; 88%: tacrolimus). Mean calculated GFR was 15–34 mL/min higher in belatacept-treated patients at 1 year. Two cases of posttransplant lymphoproliferative disease and one case of progressive multifocal leukoencephalopathy occurred in belatacept-treated patients. Follow-up beyond month 12 revealed an increase in death and graft loss in another belatacept group (belatacept HD), after which the study was terminated.

KW - Adult

KW - Aged

KW - Drug Administration Schedule

KW - Female

KW - Glomerular Filtration Rate

KW - Graft Rejection

KW - Graft Survival

KW - Hepatitis C

KW - Humans

KW - Immunoconjugates

KW - Immunosuppression

KW - Immunosuppressive Agents

KW - Leukoencephalopathies

KW - Liver Failure

KW - Liver Transplantation

KW - Lymphoproliferative Disorders

KW - Male

KW - Middle Aged

KW - Mycophenolic Acid

KW - Recurrence

KW - Tacrolimus

KW - Treatment Outcome

U2 - 10.1111/ajt.12810

DO - 10.1111/ajt.12810

M3 - SCORING: Journal article

C2 - 25041339

VL - 14

SP - 1817

EP - 1827

JO - AM J TRANSPLANT

JF - AM J TRANSPLANT

SN - 1600-6135

IS - 8

ER -