title: Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients.
abstract: The clinical profile of belatacept in kidney transplant recipients was evaluated to determine if earlier results in the BENEFIT study were sustained at 3 years. BENEFIT is a randomized 3 year, phase III study in adults receiving a kidney transplant from a living or standard criteria deceased donor. Patients were randomized to a more (MI) or less intensive (LI) regimen of belatacept, or cyclosporine. 471/666 patients completed ≥3 years of therapy. A total of 92% (MI), 92% (LI), and 89% (cyclosporine) of patients survived with a functioning graft. The mean calculated GFR (cGFR) was ∼21 mL/min/1.73 m(2)  higher in the belatacept groups versus cyclosporine at year 3. From month 3 to month 36, the mean cGFR increased in the belatacept groups by +1.0 mL/min/1.73 m(2) /year (MI) and +1.2 mL/min/1.73 m(2) /year (LI) versus a decline of -2.0 mL/min/1.73 m(2) /year (cyclosporine). One cyclosporine-treated patient experienced acute rejection between year 2 and year 3. There were no new safety signals and no new posttransplant lymphoproliferative disorder (PTLD) cases after month 18. Belatacept-treated patients maintained a high rate of patient and graft survival that was comparable to cyclosporine-treated patients, despite an early increased occurrence of acute rejection and PTLD.
authors: University of California, San Francisco, Kidney Transplant Service, San Francisco, CA, USA. Flavio.Vincenti@ucsfmedctr.org
authors: F
authors: F
authors: Vincenti
authors: C P
authors: CP
authors: Larsen
authors: J
authors: J
authors: Alberu
authors: B
authors: B
authors: Bresnahan
authors: V D
authors: VD
authors: Garcia
authors: J
authors: J
authors: Kothari
authors: P
authors: P
authors: Lang
authors: E Mancilla
authors: EM
authors: Urrea
authors: P
authors: P
authors: Massari
authors: G
authors: G
authors: Mondragon-Ramirez
authors: R
authors: R
authors: Reyes-Acevedo
authors: K
authors: K
authors: Rice
authors: L
authors: L
authors: Rostaing
authors: S
authors: S
authors: Steinberg
authors: J
authors: J
authors: Xing
authors: M
authors: M
authors: Agarwal
authors: M B
authors: MB
authors: Harler
authors: B
authors: B
authors: Charpentier
mesh_terms: D000069594:Abatacept; D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate; D006085:Graft Survival; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D016896:Treatment Outcome
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine