Triple therapy with ursodeoxycholic acid, budesonide and mycophenolate mofetil in patients with features of severe primary biliary cirrhosis not responding to ursodeoxycholic acid alone.
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.
Rabahi
N
N
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.
Chrétien
Y
Y
Gaouar
F
F
Wendum
D
D
Serfaty
L
L
Chazouillères
O
O
Corpechot
C
C
Poupon
R
R
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*
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