A J Czaja1, K D Lindor. 1. Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. czaja.albert@mayo.edu
Abstract
BACKGROUND & AIMS: 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.
BACKGROUND & AIMS: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.