Lack of differences in safety and effectivity among three induction immunosuppression protocols during the first-year post-liver transplantation in pediatric patients. A multicenter study.
Alejandro Costaguta1, Guillermo Costaguta5, Daniel D'Agostino2, Gabriel Gondolesi3, María Belén Pallitto2, Carolina Rumbo3, Oscar Bottasso4, Fernando Alvarez5.
1Gastroenterology and Hepatology, Sanatorio de Niños, Rosario, Argentina; 2Pediatric Gastroenterology and Hepatology, Hospital Italiano, Buenos Aires, Argentina; 3Hepatology and Liver Transplant Unit, Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina; 4IDICER, CONICET, Rosario, Argentina; 5Pediatrie, CHU Sainte Justine, Montreal, QC, Canada
Introduction: Immunosuppression practice varies among centers. Very few comparative studies are published to define the best approach on an evidence-based background. Pediatric patients are ideal to explore potential differences due to their lower rate of comorbidities, being also a more homogeneous population (@50% suffering from Biliary Atresia).
Methods: A retrospective, observational study of all patients receiving first liver transplantation in the four participating centers during a 5-year period (01/01/2015 to 12/31/2019) was conducted. Based on the type of immunosuppression administered on the immediate posttransplant setting, patients were classified as Group A (Basiliximab + Steroids + Tacrolimus), B (same as A + Thymoglobulin), and C (Steroids + Tacrolimus). Those patients with other schemes were excluded. Main analyzed variables were incidence of acute/chronic rejection, CMV/EBV or other viral/bacterial infections and first-year patient and graft survivals. A sub-set analysis on Biliary Atresia patients was also carried out in order to assess a more homogeneous population. GraphPad software was used for statistical analysis; a p-value of 0.05 was considered significant.
Results: 97 patients from 4 centers were recruited (Group A n= 52, Group B n= 25, Group C n= 20). Proportion of living donors were similar among groups (p=0.93). There were no differences in frequency of rejection (p=0.12), active CMV (p=0.10) or EBV (p=0.12) replication or development of other viral or bacterial infections (p=0.96) among groups, as were for patient (p=0.12) or graft (p=0.30) survival. Considering the 48 patients with Biliary Atresia (Group A n=26, Group B n=16, Group C n=6), frequency of rejection (p=0.64), EBV replication (p=0.92), and other infections (p=0.30) were similar; only CMV replication was more frequent in group B if compared to Group C (p=0.04). First year patient (p=0.61) and graft survival (100% in all groups) were similar as well.
Conclusion: Results during the first-year post-liver transplantation are comparable regardless of the immunosuppression protocol employed in this series, either in the whole group or in the more uniform sample of those with Biliary Atresia. Since our study has been retrospective, a multicenter prospective properly powered study would be required to validate this conclusion.
