Basiliximab Induction and Postoperative Steroid-free Immunosuppression With Tacrolimus in Pediatric Liver Transplantation: A Randomized Clinical Trial

Chong Dong; Zhuolun Song; Chao Sun; Kai Wang; Wei Zhang; Jing Chen; Weiping Zheng; Yang Yang; Zhen Wang; Chao Han; Lijun Jiao; Guofeng Zhang; Enbo Xie; Wei Gao; Zhongyang Shen

doi:10.1097/TP.0000000000004951

Basiliximab Induction and Postoperative Steroid-free Immunosuppression With Tacrolimus in Pediatric Liver Transplantation: A Randomized Clinical Trial

Transplantation. 2024 Feb 29. doi: 10.1097/TP.0000000000004951. Online ahead of print.

Authors

Chong Dong^{1

2}, Zhuolun Song^{1

2}, Chao Sun^{1

2}, Kai Wang^{1

2}, Wei Zhang^{1

2}, Jing Chen^{1

2}, Weiping Zheng^{1

2}, Yang Yang^{1

2}, Zhen Wang^{1

2}, Chao Han^{1

2}, Lijun Jiao^{1

2}, Guofeng Zhang^{1

2}, Enbo Xie^{1

2}, Wei Gao^{1

2}, Zhongyang Shen^{1

2}

Affiliations

¹ Department of Pediatric Transplantation, Tianjin First Central Hospital, Tianjin, China.
² Tianjin Key Laboratory for Organ Transplantation, Tianjin, China.

PMID: 38419149
DOI: 10.1097/TP.0000000000004951

Abstract

Background: Optimizing the immunosuppressive regimen is essential to improve the long-term outcomes of pediatric liver transplant recipients.

Methods: We conducted a prospective, randomized, open-label study to compare the safety and efficacy of 2 treatment approaches during pediatric liver transplantation: tacrolimus monotherapy following basiliximab induction (the study group) and a dual regimen of tacrolimus plus steroids (the control group). A total of 150 patients were enrolled, with 75 patients allocated to each group.

Results: In both groups, recipients achieved graft and recipient overall survival rates exceeding 93%, with no statistically significant differences between them. However, the study group exhibited a significantly lower incidence of acute cellular rejection (ACR), delayed occurrence of ACR, and an improved ACR-free survival rate at 2 y compared with the control group. Notably, the study group also showed a significant reduction in the incidence of de novo donor-specific antibodies at 3-mo and 2-y posttransplant. Furthermore, 6 mo after the transplant, the study group demonstrated significant improvements in weight-for-age Z score and height-for-age Z score. No notable differences were observed in postoperative complications or the incidence of liver fibrosis between the 2 groups.

Conclusions: Basiliximab induction combine with tacrolimus (TAC) monotherapy is a safe and effective immunosuppressive regimen to reduce the episodes of ACR without influencing the development of liver fibrosis and graft and recipient survival rate after pediatric liver transplantation.