Randomized Trial of Basiliximab Induction versus Steroid Therapy in Pediatric Liver Allograft Recipients Under Tacrolimus Immunosuppression

Abstract

Avoidance of corticosteroids could be beneficial after pediatric liver transplantation (LTx). To test this hypothesis, we performed a randomized prospective study to compare immunosuppression with tacrolimus (TAC) and steroids versus TAC and basiliximab (BAS) after pediatric LTx. Seventy-two patients were recruited, 36 receiving TAC and steroids and 36 TAC and BAS. The primary endpoint was the occurrence of the first rejection episode. Secondary endpoints were the cumulative incidence and severity of rejection, patient and graft survival, and incidence of adverse events. Overall 1-year patient and graft survival rates were 91.4% and 85.5% in the steroid group, and 88.6% and 80% in the BAS group (p = NS). Patients free from rejection were 87.7% in the BAS group and 67.7% in the steroid group (p = 0.036). The use of BAS was associated with a 63.6% reduction in incidence of acute rejection episodes. Overall incidence of infection was 72.3% in the steroid group and 50% in the BAS group (p = 0.035). We conclude that the combination of TAC with BAS is an alternative to TAC and steroid immunosuppression in pediatric LTx, which allows for a significant reduction in the incidence of acute rejection and infectious complications.

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

“…Table 22 summarizes adverse reactions reported with basiliximab. [252][253][254][255][256][257][258][259][260][261][262][263] Table 23 summarizes the use of basiliximab in two studies of lung transplant patients . 265,266 Table 24 summarizes 16 studies in which the drug was administered for nonpulmonary indications.…”

“…265,266 Table 24 summarizes 16 studies in which the drug was administered for nonpulmonary indications. [252][253][254][255][256][257][258][259][260][261][262][263][267][268][269][270] These studies were included in the table because they provided signifi cant information regarding toxicity.…”

“…261,263 Toxic nephropathy (14.1% vs 4.3%) and abdominal pain (11.1% vs 2.2%) were noted at signifi cantly greater rates in the basiliximab group. 261 An open-label pharmacokinetic/pharmacodynamic safety study evaluating basiliximab in 41 pediatric renal transplant patients aged 1 to 17 years has been published.…”

268 Pediatric Liver Transplantation

“…Twelve-month rejection-free survival was similar in the steroid-free group compared with the corticosteroid group. The authors performed the first prospective, controlled, randomized study designed for children undergoing liver transplantation to test the possibility of avoiding the use of corticosteroids under baseline tacrolimus immunosuppression plus basiliximab induction, which confirmed no harmful effect of steroid avoidance on graft acceptance [120] . Corticosteroid withdrawal or avoidance can be difficult in patients with autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis.…”

“…IL-2 receptor antibodies have been used primarily in children as induction agents in double or triple immunosuppression protocols. Preliminary experience in pediatric liver recipients is encouraging: pooled data from the available papers from the literature encompassed 79 patients treated with daclizumab, 165 with basiliximab, and 209 no-induction controls; incidence of acute rejection was lower in the induction groups [119,120,[167][168][169][170][171][172] (Table 10). A multicenter trial studied basiliximab pharmacokinetics and pharmacodynamics in children.…”