Steroid withdrawal in tacrolimus (FK506)-treated pediatric liver transplant recipients
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1Division of Pediatric Surgery, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, MD 21287, USA.
Insights
Steroid withdrawal is feasible in most pediatric liver transplant patients using tacrolimus (FK506) monotherapy. This approach minimizes adverse steroid side effects, improving long-term outcomes for recipients.
Area of Science:
- Pediatric transplantation
- Immunosuppression management
- Graft survival optimization
Background:
- Steroids are standard post-transplant but cause significant adverse effects in children.
- Tacrolimus (FK506) is a key immunosuppressant in pediatric liver transplantation.
- Steroid withdrawal aims to reduce long-term complications in pediatric transplant recipients.
Purpose of the Study:
- To assess the feasibility of discontinuing steroid therapy in pediatric liver transplant recipients.
- To evaluate the safety and efficacy of tacrolimus (FK506) monotherapy after steroid withdrawal.
- To determine the rate of successful steroid cessation and associated complications.
Main Methods:
- Pediatric liver transplant patients on tacrolimus (FK506) for over 6 months were evaluated.
- A structured steroid tapering protocol was implemented, aiming for complete withdrawal at 6 months.
- Tacrolimus (FK506) was the sole immunosuppressant, with steroids reintroduced if rejection or graft dysfunction occurred.
Main Results:
- Twenty-nine patients were assessed; 24 successfully had steroids withdrawn.
- Fifty percent (12/24) remained off steroids long-term (mean 22 months) without sequelae.
- The remaining 12 patients required intermittent steroids for rejection, graft dysfunction, or other conditions; 71% (17/24) were ultimately off steroids.
Conclusions:
- Tacrolimus (FK506) monotherapy enables successful steroid withdrawal in the majority of pediatric liver transplant recipients.
- Steroid cessation can be achieved with minimal adverse events, enhancing patient quality of life.
- This strategy represents a significant advancement in managing immunosuppression for pediatric liver transplant patients.
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. Tweleve (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.