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document
Long-term exposure to belatacept in recipients of extended criteria donor kidneys . Patients in the BENEFIT-EXT study received extended criteria donor kidneys and a more intensive ( MI ) or less intensive ( LI ) belatacept immunosuppression regimen , or cyclosporine A ( CsA ) . Patients who remained on assigned therapy through year 3 were eligible to enter a long-term extension ( LTE ) study . Three hundred four patients entered the LTE ( n = 104 MI ; n = 113 LI ; n = 87 CsA ) , and 260 continued treatment through year 5 ( n = 91 MI ; n = 100 LI ; n = 69 CsA ) . Twenty patients died during the LTE ( n = 5 MI ; n = 9 LI ; n = 6 CsA ) , and eight experienced graft loss ( n = 2 MI ; n = 1 LI ; n = 5 CsA ) . Three patients experienced an acute rejection episode ( n = 2 MI ; n = 1 LI ) . The incidence rate of serious adverse events , viral infections and fungal infections was similar across groups during the LTE . There were four cases of posttransplant lymphoproliferative disorder ( PTLD ) from the beginning of the LTE to year 5 ( n = 3 LI ; n = 1 CsA ) ; two of three PTLD cases in the LI group were in patients who were seronegative for Epstein-Barr virus ( EBV ( - ) ) at transplantation . Mean ± SD calculated GFR at year 5 was 55.9 ± 17.5 ( MI ) , 59.0 ± 29.1 ( LI ) and 44.6 ± 16.4 ( CsA ) mL/min/1.73 m ( 2 ) . Continued treatment with belatacept was associated with a consistent safety profile and sustained improvement in renal function versus CsA over time .
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Intervention_Other
MI
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Intervention_Other
less intensive ( LI
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Intervention_Control
belatacept immunosuppression regimen
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Intervention_Pharmacological
cyclosporine A ( CsA )
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Outcome_Adverse-effects
episode
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Outcome_Adverse-effects
serious
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Participant_Condition
Patients who remained on assigned therapy through year 3 were eligible to enter a long-term extension ( LTE ) study .