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Completely steroid-free immunosuppression in liver transplantation: a randomized study.
Department of Surgery Faculty Papers
  • Carlo B. Ramirez, MD, Department of Surgery, Thomas Jefferson University
  • Cataldo Doria, MD, PhD, Jefferson Medical College - Thomas Jefferson University Hospital
  • Adam M. Frank, MD, Thomas Jefferson University
  • Stephen T. Armenti, New York University School of Medicine
  • Ignazio R. Marino, MD, Jefferson Medical College and Thomas Jefferson University Hospital, Philadelphia
Document Type
Publication Date

This article has been peer reviewed. It is the authors' final version prior to publication in Clinical Transplanation.

Volume 27, Issue 3, May 2013, Pages 463-471.

The published version is available at DOI: 10.1111/ctr.12119. Copyright ©



INTRODUCTION: Corticosteroids (CS) have been standard immunosuppression to prevent and treat rejection. However, CS are associated with increased risk of infection, obesity, hypertension, hyperlipidemia, diabetes, and accelerated hepatitis C virus (HCV) recurrence post-orthotopic liver transplantation (OLT). This study assesses the safety and efficacy of CS-free immunosuppressive regimen in adult OLT.

METHODS: A two-yr, prospective, randomized study of CS with delayed withdrawal (CS) or CS-free regimen with basiliximab, tacrolimus, and enteric-coated mycophenolate sodium (EC-MPS) was performed in 39 patients (CS=20; CS-free=19). CS group received intra-operative methylprednisolone weaned by six months. HCV patients had HCV PCR pre-OLT and 0.5, one, three, and six months post-OLT. Protocol liver biopsies were performed at OLT, 2 and 24 wk post-OLT or when indicated.

RESULTS: Rejection occurred in two patients. Patient survival at one yr (100% vs. 95%), three yr (85% vs. 63%), and five yr (80% vs. 63%) post-OLT were similar between CS and CS-free group, respectively. Death-censored graft survival at one yr (100% vs. 95%), three yr (85% vs. 63%), and five yr (75% vs. 63%) were also similar. The risk of new-onset DM, hypertension, hypercholesterolemia, and weight gain was similar between groups.

CONCLUSION: CS avoidance with basiliximab, calcineurin inhibitor, and EC-MPS is safe and effective as CS- containing immunosuppression in adult OLT.

PubMed ID
Citation Information
Carlo B. Ramirez, MD, Cataldo Doria, MD, PhD, Adam M. Frank, MD, Stephen T. Armenti, et al.. "Completely steroid-free immunosuppression in liver transplantation: a randomized study." (2013)
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