Failure of budesonide in a pilot study of treatment-dependent autoimmune hepatitis.
OBJECTIVE
Budesonide has a high hepatic first-pass clearance and metabolites virtually devoid of glucocorticoid activity. Our goals were to assess budesonide in patients with treatment-dependent autoimmune hepatitis and to determine if efficacy and safety justified a controlled trial.


METHODS
Ten patients who were dependent on continuous treatment to prevent exacerbation of their disease were treated with budesonide, 3 mg thrice daily.


RESULTS
Laboratory indices did not improve significantly during 5 +/- 1 months of therapy (range, 2-12 months). Three patients entered clinical and biochemical remission; 2 of them achieved histologic remission. Seven patients either deteriorated during therapy or became drug intolerant. Withdrawal symptoms complicated conversion from prednisone to budesonide treatment, and every patient developed at least 1 side effect. Lumbar spine density decreased in 2 patients, and femur density decreased in 2 patients, including 1 with lumbar spine changes. However, mean bone densities actually increased slightly in the entire group.


CONCLUSIONS
Budesonide therapy was associated with a low frequency of remission and high occurrence of treatment failure and side effects in treatment-dependent autoimmune hepatitis. Findings did not support the need for a controlled treatment trial in this select population.
Czaja
A J
AJ
Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. czaja.albert@mayo.edu
Lindor
K D
KD
D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005269:Femur / Q000187:drug effects / Q000378:metabolism; D019693:Hepatitis, Autoimmune / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011241:Prednisone / Q000627:therapeutic use; D019233:Retreatment; D013131:Spine / Q000187:drug effects / Q000378:metabolism; D017211:Treatment Failure; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use
D000893:Anti-Inflammatory Agents; D019819:Budesonide; D014580:Ursodeoxycholic Acid; D001379:Azathioprine; D011241:Prednisone