Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)
The BENEFIT Study was a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, 3-year trial comparing the efficacy and safety of NULOJIX to cyclosporine (CsA) in adult de novo patients receiving a living or standard criteria deceased (SCD) donor kidney transplant.1,2
Patient Population1 |
Adult recipients (N=666) of a kidney allograft from a living or SCD donor
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Dosing Regimen |
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Endpoints1,2 |
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*The median daily corticosteroid dosing at Week 1 was 31.7 mg; at Week 2 it was 25 mg; at Week 4 it was 20 mg; at Week 6 it was 15 mg; and at Month 6 it was 10 mg.
†Histologically confirmed acute rejection by a central pathologist on a biopsy done for any reason, whether or not accompanied by clinical signs of rejection.1
‡GFR was calculated using the MDRD formula.1
§NODAT: Defined as use of an antidiabetic agent for ≥30 days or ≥2 fasting plasma glucose values ≥126 mg/dL (7.0 mmol/L) post-transplantation.1
References
- NULOJIX [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company.
- Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010;10(3):535-546.
- Data on file. NULO 075. Bristol-Myers Squibb Company. Princeton, NJ.
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial— EXTended criteria donors (BENEFIT-EXT)
The BENEFIT-EXT Study was the first large-scale trial that assessed maintenance immunosuppression with adult de novo patients who received a kidney transplant from an extended-criteria deceased (ECD) donor. The BENEFIT-EXT Study was a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, 3-year trial comparing the efficacy and safety of NULOJIX to cyclosporine (CsA) in adults who received a de novo kidney allograft from an extended criteria deceased donor (N=543).1,2
Patient Population1 |
Adult recipients (N=543) of a kidney allograft from an ECD donor:
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Dosing Regimen |
|
Endpoints1,2 |
|
*The median daily corticosteroid dosing at Week 1 was 30 mg; at Week 2 it was 25 mg; at Week 4 it was 20 mg; at Week 6 it was 16.7 mg; and at Month 6 it was 10 mg.
†Histologically confirmed acute rejection by a central pathologist on a biopsy done for any reason, whether or not accompanied by clinical signs of rejection.1
‡GFR was calculated using the MDRD formula.1
§NODAT: Defined as use of an antidiabetic agent for ≥30 days or ≥2 fasting plasma glucose values ≥126 mg/dL (7.0 mmol/L) post-transplantation.1
References
- NULOJIX [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company.
- Durrbach A, Pestana JM, Pearson T, et al. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010;10(3):547-557.
- Data on file. NULO 059. Bristol-Myers Squibb Company. Princeton, NJ.