What is the role of steroid-free regimens for immunosuppression after solid organ transplantation?

Updated: Mar 01, 2021
  • Author: Bethany Pellegrino, MD; Chief Editor: Mary C Mancini, MD, PhD, MMM  more...
  • Print


The known toxicity of long-term steroid exposure has prompted the development of steroid-free immunosuppressive regimens. Benefits of the withdrawal or avoidance of steroids include normal growth in children, improved lipid profiles, improved blood pressures, better glycemic control, and lower risk of bone disease.

The development of cyclosporine prompted attempts to develop steroid-free protocols. Initially, patients were doing well with cyclosporine monotherapy. Over time, 50% of these patients required steroids, usually for acute rejection. More recently, a follow-up study of 100 patients in Denmark who underwent transplantation on steroid-free protocols showed a 1-year graft survival rate of 97% and a 4-year rate of 82%. Strong randomized studies are undoubtedly needed to prove both efficacy and safety of these protocols. [10]

Steroid withdrawal has been used as a strategy to avoid adverse steroid effects in transplantation patients. Recent data show the risk of rejection is higher in patients withdrawn from steroids on a cyclosporine-based protocol. After tacrolimus became available, protocols with this drug showed that withdrawal of steroids after 6 months was successful 80% of the time. More recently, studies involving rapid steroid withdrawal (over 1-2 wk) in patients taking tacrolimus show similar graft survival rates compared with patients withdrawn after 3-6 months.

In African American patients, the risk of acute rejection is high; therefore, steroid-tapering regimens are prohibited. The use of sirolimus with tacrolimus followed by a steroid taper at 3 months has resulted in acceptable rejection rates in African Americans in one early study. [12] The role of sirolimus and mycophenolate mofetil in steroid-free protocols has yet to be definitively determined, although the future looks promising for greater use of steroid-free protocols.

Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!