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.
authors.forename: G B
authors.initials: GB
authors.lastname: Klintmalm
authors.forename: S
authors.initials: S
authors.lastname: Feng
authors.forename: J R
authors.initials: JR
authors.lastname: Lake
authors.forename: H E
authors.initials: HE
authors.lastname: Vargas
authors.forename: T
authors.initials: T
authors.lastname: Wekerle
authors.forename: S
authors.initials: S
authors.lastname: Agnes
authors.forename: K A
authors.initials: KA
authors.lastname: Brown
authors.forename: B
authors.initials: B
authors.lastname: Nashan
authors.forename: L
authors.initials: L
authors.lastname: Rostaing
authors.forename: S
authors.initials: S
authors.lastname: Meadows-Shropshire
authors.forename: M
authors.initials: M
authors.lastname: Agarwal
authors.forename: M B
authors.initials: MB
authors.lastname: Harler
authors.forename: J-C
authors.initials: JC
authors.lastname: Garcia-Valdecasas
mesh_terms: D000069594:Abatacept; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D005260:Female; D005919:Glomerular Filtration Rate; D006084:Graft Rejection; D006085:Graft Survival; D006526:Hepatitis C / Q000401:mortality / Q000601:surgery; D006801:Humans; D018796:Immunoconjugates / Q000008:administration & dosage / Q000627:therapeutic use*; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D056784:Leukoencephalopathies / Q000150:complications; D017093:Liver Failure / Q000401:mortality / Q000601:surgery; D016031:Liver Transplantation; D008232:Lymphoproliferative Disorders / Q000150:complications; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D012008:Recurrence; D016559:Tacrolimus / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D009173:Mycophenolic Acid; D016559:Tacrolimus