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Role of Budesonide for the Treatment of Rejection in Pediatric Liver Transplantation.

INTRODUCTION
Corticosteroids are an integral part of liver transplant (LT) immunosuppression regimens but are often accompanied by many adverse effects. Budesonide is an oral corticosteroid with extensive (80-90%) hepatic first-pass metabolism and minimal systemic absorption. The aim of this study was to examine the safety and efficacy of budesonide for management of acute cellular rejection (ACR) in pediatric LT recipients.


METHODS
A retrospective descriptive analysis was performed for all pediatric patients who underwent LT at our center and were prescribed oral budesonide for the treatment of ACR. Alanine aminotransferase (ALT) values and documented adverse effects were reviewed.


RESULTS
Twenty-nine patients were prescribed budesonide for the treatment of ACR; 65.5% with biopsy proven acute rejection (BPAR) and 34.5% with presumed ACR. There was a significant decrease in ALT noted from the time of rejection when compared to 1 month (p = 0.0011), 3 month (p = 0.0003), and 6 month (p = 0.0001) values following treatment with budesonide. There was no difference noted between patient baseline ALT levels prior to rejection when compared to 1, 3, and 6 month post-treatment values suggesting resolution of rejection. Three patients required conversion from budesonide to systemic steroids. There were no discontinuations of budesonide secondary to adverse effects.


CONCLUSION
Oral budesonide may be a promising alternative to systemic corticosteroids for the management of mild/moderate ACR and for empiric treatment of ACR in select pediatric LT recipients. Data from this study may provide the foundation for larger, prospective, multicenter trials to assess the effectiveness of budesonide in the treatment of ACR.