Final Results From the Long-Term Extension (LTE) of the Belatacept Phase 2 Study in Kidney Transplantation.

Abstract

Background: At 5 years post-transplant, data from the Phase 2 IM103-100 LTE study of belatacept in kidney transplantation demonstrated a favorable safety profile and improved renal function vs cyclosporine (CsA) (Vincenti F et al, JASN 2010;21(9):1587-96). The safety and efficacy of belatacept up to study closure (9-11 years follow-up) is reported herein. Methods: 218 patients were randomized to receive a more or less intensive regimen of bela (n=145) or CsA (n=73), with bela patients receiving treatment at 4- or 8-week intervals (5 mg/kg after 6 months). Here we focus on the results of the 44 bela patients who remained in the LTE cohort until study end; too few CsA patients (n=9) remained at the end of the study to make comparisons between groups. Results: The 44 patients remaining in the bela group at study end received treatment for a mean of 9.7 years. From randomization to end of study, 25% of patients missed no infusions, and 21% missed only 1 infusion. There were no deaths or graft losses in this cohort. From randomization to study end, 84% of bela patients had serious AEs, 36% had serious infections, and 23% had malignancies. There were no cases of PTLD in this cohort. In the pooled bela cohort, mean(SD) MDRD cGFR was 70(21) mL/min/1.73m2 at Month 3 and 72(17) mL/min/1.73m2 at the end of the study (Figure). From randomization to study end, there was 1 acute rejection episode (Banff grade IIA), occurring in Year 9 in a patient randomized to the 8-week dosing interval group. Conclusions: Data suggest that the profile of belatacept is consistent over approximately 10 years of treatment: patients maintained renal function with no new safety findings and there was high treatment compliance. However, the sample sizes are limited in this self-selecting cohort, therefore results should be interpreted with caution.Figure: No Caption available.DISCLOSURE:Blancho, G.: Speaker’s Bureau, Novartis, Roche. Jones-Burton, C.: Employee, Bristol-Myers Squibb. Vincenti, F.: Grant/Research Support, Bristol Myers Squibb, Alexion, Pfizer, Astellas, Novartis, Genentech.