XXXX monotherapy in liver transplantation: one-year results of a prospective, randomized, double-blind, placebo-controlled study.

@entity1 @entity1157 @entity228 @entity134 @entity1140 @entity11636
BACKGROUND: Minimal immunosuppression (IS) is desirable in organ transplantation to reduce side effects and to promote the process of tolerance induction. MATERIAL AND METHODS: Between February 2000 and September 2004, 156 adults (>15 years old) receiving a primary liver graft were enrolled in a prospective, randomized, double-blind, placebo-controlled, investigator-driven single-center study comparing @entity1140 ( @entity11636 )-placebo (PL) and @entity11636 -low-dose, short-term (64 days) @entity134 (ST) IS. There were no exclusion criteria at moment of randomization. All @entity1 had a 12-month follow-up (range, 12-84). RESULTS: Three- and 12-month @entity1 survival rates were 93.6% and 87.2% in the @entity11636 -PL group and 98.7% and 94.7% in @entity11636 -ST group (P = 0.096 and P = 0.093, respectively). Three- and 12-month graft survival rates were 92.3% and 85.9% versus 97.4% and 92.3% (P = 0.14 and 0.13, respectively). By 3 and 12 months, rejection treatment had been given in 20.5% (16 pts) and 23% (18 pts) of @entity11636 -PL @entity1 and in 12.7% (10 pts) and 20.5% (16 pts) of @entity11636 -ST @entity1 (P = 0.20 and 0.54). @entity228 -resistant rejection (CRR) at 3 and 12 months was recorded in 12.8% (10 pts) of @entity11636 -PL @entity1 and 3.8% (3 pts) of @entity11636 -ST @entity1 (P = 0.04). When considering the 145 @entity1 transplanted without artificial organ support (n = 145), CRR at 3 and 12 months was recorded in 8.8% (6/68 pts) of @entity11636 -PL @entity1 and in 3.9% (3/77 pts) of @entity11636 -ST @entity1 (P = 0.22). @entity1157 was diagnosed in 1 (1.2%) @entity11636 -PL @entity1 and 4 (5.1%) @entity11636 -ST @entity1 (P = 0.17). By 1 year, 78.2% (61/78) of @entity11636 -PL @entity1 and 82% (64/78) of @entity11636 -ST @entity1 were on @entity11636 monotherapy (P = 0.54). When considering 67 @entity11636 -PL and 74 @entity11636 -ST survivors, rates of monotherapy were 91% (61 pts) and 86.5% (64 pts) (P = 0.39). At 1 year, 62.5% (42 pts) of @entity11636 -PL survivors and 64.9% (48 pts) of @entity11636 -ST survivors were on low-dosage (<6 ng/mL) @entity11636 monotherapy (P 0.79). CONCLUSION: @entity11636 monotherapy can be achieved safely without compromising graft nor @entity1 survival in a primary, even unselected, adult liver transplant population. The higher incidence of early CRR in the @entity11636 -PL group related to the significantly higher number of @entity1 transplanted while being on artificial organ support. In such condition, this monodrug immunosuppressive strategy needs to be adapted. @entity11636 monotherapy strategy should lay the basis for further large scale minimization studies in liver transplantation.
