title: Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study.
abstract: The Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial randomized patients receiving a living or standard criteria deceased donor kidney transplant to a more (MI) or less intensive (LI) regimen of belatacept or cyclosporine A (CsA). The 5-year results of the long-term extension (LTE) cohort are reported. A total of 456 (68.5% of intent-to-treat) patients entered the LTE at 36 months; 406 patients (89%) completed 60 months. Between Months 36 and 60, death occurred in 2%, 1% and 5% of belatacept MI, belatacept LI and CsA patients, respectively; graft loss occurred in 0% belatacept and 2% of CsA patients. Acute rejection between Months 36 and 60 was rare: zero belatacept MI, one belatacept LI and one CsA. Rates for infections and malignancies for Months 36-60 were generally similar across belatacept groups and CsA, respectively: fungal infections (14%, 15%, 12%), viral infections (21%, 18%, 16%) and malignancies (6%, 6%, 9%). No new posttransplant lymphoproliferative disorder cases occurred after 36 months. Mean calculated GFR (MDRD, mL/min/1.73 m(2) ) at Month 60 was 74 for belatacept MI, 76 for belatacept LI and 53 for CsA. These results show that the renal function benefit and safety profile observed in belatacept-treated patients in the early posttransplant period was sustained through 5 years.
authors.affiliation: University Hospital, Toulouse, France; INSERM U563, IFR-BMT, Toulouse, France.
authors.forename: L
authors.initials: L
authors.lastname: Rostaing
authors.forename: F
authors.initials: F
authors.lastname: Vincenti
authors.forename: J
authors.initials: J
authors.lastname: Grinyó
authors.forename: K M
authors.initials: KM
authors.lastname: Rice
authors.forename: B
authors.initials: B
authors.lastname: Bresnahan
authors.forename: S
authors.initials: S
authors.lastname: Steinberg
authors.forename: S
authors.initials: S
authors.lastname: Gang
authors.forename: L E
authors.initials: LE
authors.lastname: Gaite
authors.forename: M-C
authors.initials: MC
authors.lastname: Moal
authors.forename: G A
authors.initials: GA
authors.lastname: Mondragón-Ramirez
authors.forename: J
authors.initials: J
authors.lastname: Kothari
authors.forename: L
authors.initials: L
authors.lastname: Pupim
authors.forename: C P
authors.initials: CP
authors.lastname: Larsen
mesh_terms: D000069594:Abatacept; D000328:Adult; D015331:Cohort Studies; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007390:International Agencies; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008232:Lymphoproliferative Disorders / Q000517:prevention & control; D008297:Male; D011183:Postoperative Complications / Q000517:prevention & control; D011379:Prognosis; D012449:Safety; D013997:Time Factors
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine
keywords: Belatacept; cyclosporine A; kidney; renal function