Abstract:
BACKGROUND:Belatacept is associated with better renal function and an improved cardiovascular/metabolic risk profile versus cyclosporine in kidney transplant recipients. The current analysis examined pooled safety data for belatacept versus cyclosporine used in combination with basiliximab, mycophenolate mofetil, and steroids. METHODS:Patients enrolled in three core studies in de novo kidney transplantation were randomized to a more intensive (MI) or less intensive (LI) regimen of belatacept or cyclosporine. The pooled analysis included 1425 patients (MI: 477; LI: 472; cyclosporine: 476). Median follow-up was approximately 2.4 years. RESULTS:Belatacept was generally well tolerated. The frequency of deaths (MI: 7%; LI: 5%; cyclosporine: 7%) and serious infections (MI: 37%; LI: 32%; cyclosporine: 36%) were lower in the LI group versus cyclosporine. The frequency of malignancies was 10%, 6%, and 7% in the MI, LI, and cyclosporine groups, respectively. Sixteen cases of posttransplant lymphoproliferative disorder (PTLD) occurred (n=8 MI; n=6 LI; n=2 cyclosporine), including nine cases involving the central nervous system (CNS) (n=6 MI; n=3 LI). The risk of CNS PTLD was highest in Epstein-Barr virus(-) recipients; more CNS PTLD cases occurred in the MI group. One case of progressive multifocal leukoencephalopathy was reported in the MI group. CONCLUSIONS:Treatment with belatacept-based regimens was generally safe for a period of at least 2 years. There was a greater risk of PTLD--specifically CNS PTLD--in the belatacept groups versus cyclosporine, especially in Epstein-Barr virus(-) patients and with the MI dose. The number of deaths and serious infections was lower in the LI regimen versus MI and cyclosporine. The overall safety profile favored the LI over the MI regimen.
journal_name
Transplantationjournal_title
Transplantationauthors
Grinyó J,Charpentier B,Pestana JM,Vanrenterghem Y,Vincenti F,Reyes-Acevedo R,Apanovitch AM,Gujrathi S,Agarwal M,Thomas D,Larsen CPdoi
10.1097/TP.0b013e3182007b95subject
Has Abstractpub_date
2010-12-27 00:00:00pages
1521-7issue
12eissn
0041-1337issn
1534-6080journal_volume
90pub_type
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