Is Minimal, [Almost] Steroid-Free Immunosuppression a Safe Approach in Adult Liver Transplantation? Long-term Outcome of a Prospective, Double Blind, Placebo-Controlled, Randomized, Investigator-Driven Study

Is Minimal, [Almost] Steroid-Free Immunosuppression a Safe Approach in Adult Liver Transplantation? Long-term Outcome of a Prospective, Double Blind, Placebo-Controlled, Randomized, Investigator-Driven Study

To investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT). The lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT. Between February 2000 and September 2004, 156 adults were enrolled in a prospective, randomized, d...

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Published in:Annals of surgery Vol. 260; no. 5; pp. 886 - 892
Main Authors: Lerut, Jan P., Pinheiro, Rafael S., Lai, Quirino, Stouffs, Valentine, Orlando, Giuseppe, Juri, Juan Manuel Rico, Ciccarelli, Olga, Sempoux, Christine, Roggen, Francine M., De Reyck, Chantal, Latinne, Dominique, Gianello, Pierre
Format: Journal Article
Language:English
Published: United States by Lippincott Williams & Wilkins 01-11-2014
Subjects:
Adult
Biopsy
Double-Blind Method
Female
Graft Survival
Humans
Immunosuppression - methods
Immunosuppressive Agents - administration & dosage
Liver Function Tests
Liver Transplantation
Male
Placebos
Prospective Studies
Recurrence
Steroids - administration & dosage
Survival Rate
Tacrolimus - administration & dosage
Treatment Outcome
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Summary:To investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT). The lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT. Between February 2000 and September 2004, 156 adults were enrolled in a prospective, randomized, double-blind, placebo-controlled minimization trial comparing tacrolimus placebo (TAC-PLAC) and TAC short-term steroid (TAC-STER) IS. All patients had a minimum clinical, biochemical, and histological follow-up of 5 years. Five-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were 78.1% and 82.1% (P=0.89) and 74.2% and 76.9% (P=0.90), respectively. Five-year biopsies were available in 112 (89.6%) of 125 survivors. Twelve patients refused a biopsy because of their excellent evolution; tissue material was insufficient in 1 patient; 11 had normal liver tests; and 2 patients had developed alcoholic and secondary biliary cirrhosis. Histology was normal in 44 (39.3%) patients; 35 (31.3%) had disease recurrence. The remaining biopsies showed nonspecific chronic hepatitis (14.3%), mild inflammatory infiltrates (10.7%), and steatosis (3.5%). All findings were equally distributed between both groups. In each group, 3 patients (4.8%) presented with acute cellular rejection after the first year and only 1 (0.9%) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis. Arterial hypertension, diabetes mellitus, renal insufficiency, hypercholesterolemia, gout, and obesity were equally low in both groups. Excellent long-term results can be obtained under minimal IS and absence of steroids. TAC-based monotherapy is feasible in most adult liver recipients until 5 years of follow-up.
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ISSN:0003-4932
1528-1140
DOI:10.1097/SLA.0000000000000969