Steroid withdrawal in tacrolimus (FK506)-treated pediatric liver transplant recipients

Purpose: The use of steroids in pediatric transplant recipients is associated with significant adverse side effects. The authors examined the feasibility of steroid withdrawal in patients who underwent immunosuppression with tacrolimus (FK506; FK). Methods: All pediatric liver transplant recipients on FK greater than 6 months were evaluated for steroid withdrawal, FK was administered 0.3 mg/kg/d in two divided doses. Steroids were tapered as tolerated with goals of 0.2 to 0.3 mg/kg/d at 6 weeks, 0.2 to 0.3 mg/kg every other day at 3 months, and complete withdrawal after 6 months. Steroid bolus and taper were instituted for enzyme elevation or rejection during biopsy. Results: Twenty-nine patients underwent evaluation for steroid withdrawal. Five patients could not be placed on FK506 monotherapy (chronic, recurrent rejection or LPD). The remaining 24 had steroids withdrawn. Twelve (50%) had no sequelae and continue on FK monotherapy (mean, 22 months off steroids). The other 12 required intermittent steroid therapy for presumed or biopsy-proven rejection (n = 7), graft dysfunction (FK toxicity, n = 2), lymphoproliferative disease necessitating reduction in FK (n = 2) or exacerbations of asthma (n = 1). Five of these 12 patients are now on FK monotherapy (mean, 6 months) for a total of 17 of the 24 (71%) currently off steroids. Conclusion: FK monotherapy can be successfully used to withdraw steroid therapy in the majority of pediatric liver transplant recipients with few sequelae.