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, Vol. 14, No. 8, 2014, p. 1817-27.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -