@entity3446 Use in Liver Transplant Recipients With XXXX : A Randomized, Multicenter, Open-Label Phase 3 Trial.

@entity3446 @entity157 @entity1 @entity1349
BACKGROUND: We investigated whether @entity3446 -based immunosuppression improves outcomes in liver transplantation (LTx) candidates with @entity157 ( @entity157 ). METHODS: In a prospective-randomized open-label international trial, 525 LTx recipients with @entity157 initially receiving @entity1 target of @entity3446 inhibitor-free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on @entity1 target of @entity3446 inhibitor-free immunosuppression (group A: 264 @entity1 ) or a group incorporating @entity3446 (group B: 261). The primary endpoint was @entity1349 ( @entity1349 ); intention-to-treat (ITT) analysis was conducted after 8 years. @entity1349 ( @entity1349 ) was a secondary endpoint. RESULTS: Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (P = 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of @entity1349 rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, @entity1349 (P = 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, @entity1 benefited most from @entity3446 ; furthermore, younger recipients (age  <=60) also benefited, as well @entity3446 monotherapy @entity1 . Serious adverse event numbers were alike in groups A (860) and B (874). CONCLUSIONS: @entity3446 in LTx recipients with @entity157 does not improve long-term @entity1349 beyond 5 years. However, a @entity1349 and @entity1349 benefit is evident in the first 3 to 5 years, especially in low-risk @entity1 . This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with @entity157 .
