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

Lerut, Jan;Pinheiro, Rafael S;Lai, Quirino;Stouffs, Valentine;Gianello, Pierre;et.al.
(2014) Annals of Surgery — Vol. 260, n° 5, p. 886-892 (2014)

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Authors
  • Lerut, JanUCLouvain
    Author
  • Pinheiro, Rafael S
    Author
  • Lai, Quirino
    Author
  • Stouffs, ValentineUCLouvain
    Author
  • Ciccarelli, OlgaUCLouvain
    Author
  • Sempoux, ChristineUCLouvain
    Author
  • ROGGEN, Francine MUCLouvain
    Author
  • De Reyck , ChantalUCLouvain
    Author
  • Latinne, DominiqueUCLouvain
    Author
  • Gianello, PierreUCLouvain
    Author
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Abstract
OBJECTIVE: To investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT). BACKGROUND: The lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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Lerut, J., Pinheiro, R. S., Lai, Q., Stouffs, V., Orlando, G., Juri, J. M. R., Ciccarelli, O., Sempoux, C., ROGGEN, F. M., De Reyck, C., Latinne, D., & Gianello, P. (2014). 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. Annals of Surgery, 260(5), 886-892. https://doi.org/10.1097/SLA.0000000000000969 (Original work published 2014)