OUTCOMES AS A FUNCTION OF DONOR:RECIPIENT CHARACTERISTICS FROM A PHASE III STUDY OF BELATACEPT VS CYCLOSPORINE IN KIDNEY TRANSPLANTATION (BENEFIT)

THERAPEUTIC STRATEGIES FOR KIDNEY TRANSPLANTATION

F. Vincenti¹, J.M. Grinyó², B. Charpentier³, J.O.M. Pestana⁴, L. Rostaing⁵, H. De jonge⁶, C. Lin⁷, G. Di russo⁸, C. Larsen^9
1Division Of Nephrology, University of California, San Francisco (UCSF), San Francisco/UNITED STATES OF AMERICA, ²Nephrology, Hospital Universitari de Bellvitge, Barcelona/SPAIN, ³Nephrology And Transplantation Dept, Bicetre Hospital, Paris/FRANCE, ⁴Nephrology, Hospital do Rim e Hipertensão, Sâo Paulo/BRAZIL, ⁵Nephrology, Dialysis And Organ Transplant Department, Toulouse University Hospital, Toulouse/FRANCE, ⁶Nephrology Department, University Hospital Leuven, Leuven/BELGIUM, ⁷, Bristol-Myers Squibb, Hopewell/NJ/UNITED STATES OF AMERICA, ⁸, Bristol-Myers Squibb, Princeton/NJ/UNITED STATES OF AMERICA, ⁹Emory Transplant Center, Emory University School of Medicine, Atlanta/GA/UNITED STATES OF AMERICA

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Introduction: BENEFIT is a 3-year, randomized, phase III study of belatacept vs. cyclosporine in adults receiving a kidney transplant from a living or deceased donor. Belatacept is a first-in-class co-stimulation blocker in development for primary maintenance immunosuppression. In this subgroup analysis, 24-month outcomes as a function of donor: recipient characteristics are assessed.

Methods: Patients were randomized 1:1:1 to a more intensive (MI) or less intensive (LI) regimen of belatacept or CsA; all patients received basiliximab induction, MMF, and corticosteroids. Twenty-four month outcomes including patient /graft survival, measured glomerular filtration rate (mGFR), and protocol-defined acute rejection (AR) as function of donor type and HLA mismatches were assessed. Results: Of the 666 pts comprising the ITT population, 385 patients received living donor kidneys (73% living related and 27% living unrelated) and 281 patients received deceased donor kidneys. Patient/graft survival, GFR and AR as a function of donor type are presented in the table. In the ITT population, Adjudicated graft loss due to acute rejection in the overall ITT population was 0.9% across all treatment arms. Among patients with 0-2, 3-4 and 5 – 6 HLA mismatches, pt/graft survival (%) at 24 months was 98, 93 and 91 for MI, 93, 97 and 94 for LI and 96, 92 and 80 for CsA respectively. AR rates (%) for the same groups were 16, 26 and 31 for MI, 13, 19 and 19 for LI and 4, 10 and 14 for CsA respectively. Mean mGFR was 58, 71 and 65 for MI, 64, 68 and 76 for LI and 50, 52 and 52 for CsA among patients with 0-2, 3-4 and 5 – 6 HLA mismatches, respectively. Twenty Four Month Outcomes as a Function of Donor Type

	ITT			Living Donor			Deceased Donor
	MI (n=219)	LI (n=226)	CsA (n=221)	MI (n=132)	LI (n=129)	CsA (n=124)	MI (n=87)	LI (n=97)	CsA (n=97)
Patient/Graft Survival, %	94	95	91	94	94	92	94	96	89
mean mGFR, ml/min	65	68	51	65	66	50	64	71	51
AR, %	24	17	9	19	18	7	32	17	11

Conclusions: Belatacept compared to CsA maintained excellent patient/graft survival irrespective of donor type. Acute rejection rates were higher with belatacept.GFR was consistently better with belatacept versus CsA overall and was consistent across donor and recipient subgroups.

Disclosure: All authors have declared no conflicts of interest.