title: Triple therapy with ursodeoxycholic acid, budesonide and mycophenolate mofetil in patients with features of severe primary biliary cirrhosis not responding to ursodeoxycholic acid alone.
abstract: OBJECTIVE
  To assess the benefit of the UDCA-budesonide combination in association with mycophenolate mofetil (MMF) in patients with primary biliary cirrhosis (PBC) at high risk of developing cirrhosis or liver failure.
  
  
  METHODS
  Inclusion criteria for this three-year open study were: 1) suboptimal biochemical response to one-year UDCA therapy at 13-15 mg/kg/d; 2) significant interface hepatitis without cirrhosis at liver biopsy. Treatment regimen included UDCA (13-15 mg/kg/d), budesonide (6 mg/d) and MMF (1.5 g/d). All patients underwent a control biopsy at three years.
  
  
  RESULTS
  Fifteen patients fulfilled the inclusion criteria. Six patients (41%) normalized biochemistries and seven (47%) had a partial but significant biochemical response, as defined by a serum bilirubin less than 17 micromol/L, alanine aminotransferase less than 70 UI/L and alkaline phosphatase less than 250 UI/L. Histological activity and fibrosis were markedly improved. Side effects were minimal or absent.
  
  
  CONCLUSIONS
  Triple therapy with UDCA, budesonide and MMF may provide benefit in non-cirrhotic PBC patients with features of severe disease not responding to UDCA.
authors.affiliation: Service d'Hépatologie, Centre de Référence des Maladies Inflammatoires des Voies Biliaires, Hôpital Saint-Antoine, AP-HP, 184, rue du Faubourg-Saint-Antoine, 75571 Paris cedex 12, France.
authors.forename: N
authors.initials: N
authors.lastname: Rabahi
authors.forename: Y
authors.initials: Y
authors.lastname: Chrétien
authors.forename: F
authors.initials: F
authors.lastname: Gaouar
authors.forename: D
authors.initials: D
authors.lastname: Wendum
authors.forename: L
authors.initials: L
authors.lastname: Serfaty
authors.forename: O
authors.initials: O
authors.lastname: Chazouillères
authors.forename: C
authors.initials: C
authors.lastname: Corpechot
authors.forename: R
authors.initials: R
authors.lastname: Poupon
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D019819:Budesonide / Q000627:therapeutic use*; D002756:Cholagogues and Choleretics / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000517:prevention & control; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy*; D017093:Liver Failure / Q000517:prevention & control; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012720:Severity of Illness Index; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D002756:Cholagogues and Choleretics; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D019819:Budesonide; D014580:Ursodeoxycholic Acid; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D009173:Mycophenolic Acid; D001663:Bilirubin