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.
RCT Entities:
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.
Authors: Abraham Shaked; Michele R DesMarais; Heather Kopetskie; Sandy Feng; Jeffrey D Punch; Josh Levitsky; Jorge Reyes; Goran B Klintmalm; Anthony J Demetris; Bryna E Burrell; Allison Priore; Nancy D Bridges; Peter H Sayre Journal: Am J Transplant Date: 2018-12-31 Impact factor: 8.086
Authors: Khurram Bari; Shimul A Shah; Tiffany E Kaiser; Robert M Cohen; Nadeem Anwar; David Kleesattel; Kenneth E Sherman Journal: Liver Transpl Date: 2020-08-19 Impact factor: 5.799
Authors: Josh Levitsky; David Goldberg; Abigail R Smith; Sarah A Mansfield; Brenda W Gillespie; Robert M Merion; Anna S F Lok; Gary Levy; Laura Kulik; Michael Abecassis; Abraham Shaked Journal: Clin Gastroenterol Hepatol Date: 2016-08-25 Impact factor: 11.382
Authors: Manuel Rodríguez-Perálvarez; Marta Guerrero-Misas; Douglas Thorburn; Brian R Davidson; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2017-03-31
Authors: Lawrence Mj Best; Jeffrey Leung; Suzanne C Freeman; Alex J Sutton; Nicola J Cooper; Elisabeth Jane Milne; Maxine Cowlin; Anna Payne; Dana Walshaw; Douglas Thorburn; Chavdar S Pavlov; Brian R Davidson; Emmanuel Tsochatzis; Norman R Williams; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2020-01-16