Woynarowski, Marek and Nemeth, Antal and Baruch, Yaacov and Koletzko, Sibylle and Melter, Michael and Rodeck, Burkhard and Strassburg, Christian P. and Proels, Markus and Wozniak, Magorzata and Manns, Michael P. (2013) Budesonide versus Prednisone with Azathioprine for the Treatment of Autoimmune Hepatitis in Children and Adolescents. JOURNAL OF PEDIATRICS, 163 (5). 1347-+. ISSN 0022-3476, 1097-6833
Full text not available from this repository. (Request a copy)Abstract
Objective To compare the effect of budesonide vs prednisone therapy both in combination with azathioprine in pediatric patients with autoimmune hepatitis (AIH). Study design Forty-six patients with AIH (11 males and 35 females) aged 9-17 years were enrolled in a 6-month, prospective, double-blind, randomized, active-controlled, multicenter phase IIb study evaluating budesonide (n = 19; 3 mg twice or 3 times daily) vs prednisone (n = 27; 40 mg/day tapered to 10 mg/day), both with azathioprine (1-2 mg/kg/day), followed by a further 6 months of open-label budesonide therapy. The primary efficacy endpoint was complete biochemical remission (normal serum alanine aminotransferase and aspartate aminotransferase levels) without predefined steroid-specific side effects. Results We observed no statistically significant difference in the percentage of patients who met the primary endpoint between the budesonide (3 of 19; 16%) and prednisone groups (4 of 27; 15%) after 6 months, nor in the percentage of patients who experienced biochemical remission (budesonide, 6 of 19 [32%]; prednisone, 9 of 27 [33%]), lack of steroid-specific side effects (budesonide, 10 of 19 [53%]; prednisone, 10 of 27 [37%]). The mean weight gain was 1.2 +/- 3.5 kg in the budesonide group and 5.1 +/- 4.9 kg in the prednisone group (P =.006). A total of 42 patients received open-label budesonide treatment for another 6 months. After 12 months, 46% of these patients achieved complete remission. Conclusion Oral budesonide with azathioprine can induce and maintain remission in pediatric patients with AIH and may be considered an alternative therapy to prednisone. The treatment causes fewer side effects and does not lead to weight gain; however, it may be less effective than prednisone in inducing remission.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CHRONIC ACTIVE HEPATITIS; CONTROLLED-TRIAL; REMISSION; CYCLOSPORINE; CHILDHOOD; DIAGNOSIS; THERAPY; DISEASE; EPIDEMIOLOGY; POPULATION; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Kinder- und Jugendmedizin |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Apr 2020 10:44 |
| Last Modified: | 01 Apr 2020 10:44 |
| URI: | https://pred.uni-regensburg.de/id/eprint/15772 |
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