title: Improvement in renal function in kidney transplant recipients switched from cyclosporine or tacrolimus to belatacept: 2-year results from the long-term extension of a phase II study.
abstract: Kidney transplant recipients who switched from a calcineurin inhibitor (CNI) to belatacept demonstrated higher calculated glomerular filtration rates (cGFRs) at 1 year in a Phase II study. This report addresses whether improvement was sustained at 2 years in the long-term extension (LTE). Patients receiving cyclosporine or tacrolimus were randomized to switch to belatacept or continue CNI. Of 173 randomized patients, 162 completed the 12-month main study and entered the LTE. Two patients (n = 1 each group) had graft loss between Years 1-2. At Year 2, mean cGFR was 62.0 ml/min (belatacept) vs. 55.4 ml/min (CNI). The mean change in cGFR from baseline was +8.8 ml/min (belatacept) and +0.3 ml/min (CNI). Higher cGFR was observed in patients switched from either cyclosporine (+7.8 ml/min) or tacrolimus (+8.9 ml/min). The frequency of acute rejection in the LTE cohort was comparable between the belatacept and CNI groups by Year 2. All acute rejection episodes occurred during Year 1 in the belatacept patients and during Year 2 in the CNI group. There were more non-serious mucocutaneous fungal infections in the belatacept group. Switching to a belatacept-based regimen from a CNI-based regimen resulted in a continued trend toward improved renal function at 2 years after switching.
authors: University Hospital of Bellvitge, Barcelona, Spain. jgrinyo@bellvitgehospital.cat
authors: Josep
authors: J
authors: Grinyo
authors: Josefina
authors: J
authors: Alberu
authors: Fabiana L C
authors: FL
authors: Contieri
authors: Roberto C
authors: RC
authors: Manfro
authors: Guillermo
authors: G
authors: Mondragon
authors: Georgy
authors: G
authors: Nainan
authors: Maria del C
authors: Mdel C
authors: Rial
authors: Steven
authors: S
authors: Steinberg
authors: Flavio
authors: F
authors: Vincenti
authors: Yuping
authors: Y
authors: Dong
authors: Dolca
authors: D
authors: Thomas
authors: Nassim
authors: N
authors: Kamar
mesh_terms: D000069594:Abatacept; D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007668:Kidney / Q000187:drug effects* / Q000502:physiology; D016030:Kidney Transplantation / Q000379:methods*; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D016572:Cyclosporine; D016559:Tacrolimus