Original ArticleBudesonide versus Prednisone with Azathioprine for the Treatment of Autoimmune Hepatitis in Children and Adolescents
Section snippets
Methods
Patients with AIH aged 9-17 years were included in this analysis. The diagnosis of AIH was established according to the criteria of the International Autoimmune Hepatitis Group.25 Patients enrolled in the study had either a first diagnosis of acute AIH or had experienced a relapse of previously diagnosed AIH based on liver biopsy analysis performed within 12 months before screening. Patients had serum alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) levels at least
Results
Of the 208 patients enrolled in the study, 46 completed segment A and were evaluable (the intention to treat analysis group). This group comprised 11 males and 35 females, aged 9-17 years at screening (mean ± SD, 13.8 ± 2.2 years) and at age 4-14 years at diagnosis of AIH (mean, 11.8 ± 2.7 years). Segment B was completed by 18 of 19 patients in the budesonide group and by 24 of 27 patients in the prednisone group.
The proportion of females was lower in the budesonide group compared with the
Discussion
For decades, the management of AIH was based on prednisone alone or in combination with azathioprine in adults26, 27, 28, 29 and children.30 The definition of AIH remission varies among studies, and may involve clinical, biochemical, immunologic, and histological status assessment. Alvarez et al14 defined AIH remission as normal serum ALT, and Cuarterolo et al15 defined it as normal ALT in the absence of clinical symptoms. The outcome measure used by Aw et al18 was normalized serum AST
References (33)
- et al.
Clinical features and biochemical data of Caucasian children at diagnosis of autoimmune hepatitis
J Autoimmun
(2005) - et al.
Therapy of autoimmune hepatitis
Best Pract Res Clin Gastroenterol
(2011) - et al.
Treatment options for autoimmune hepatitis: a systematic review of randomized controlled trials
J Hepatol
(2010) - et al.
Short-term cyclosporine induces a remission of autoimmune hepatitis in children
J Hepatol
(1999) - et al.
Mycophenolate mofetil as rescue treatment for autoimmune liver disease in children: a 5-year follow-up
J Hepatol
(2009) - et al.
Failure of budesonide in a pilot study of treatment-dependent autoimmune hepatitis
Gastroenterology
(2000) - et al.
Budesonide induces remission more effectively than prednisone in a controlled trial of patients with autoimmune hepatitis
Gastroenterology
(2010) - et al.
International Autoimmune Hepatitis Group report: review of criteria for diagnosis of autoimmune hepatitis
J Hepatol
(1999) - et al.
Clinical, biochemical, and histological remission of severe chronic active liver disease: a controlled study of treatments and early prognosis
Gastroenterology
(1972) - et al.
Controlled trial of prednisone and azathioprine in active chronic hepatitis
Lancet
(1973)
Treatment of autoimmune chronic active hepatitis in childhood
J Pediatr
Classification of chronic hepatitis: diagnosis, grading and staging
Hepatology
Autoimmune hepatitis
Nat Rev Gastroenterol Hepatol
Epidemiology and the initial presentation of autoimmune hepatitis in Sweden: a nationwide study
Scand J Gastroenterol
Incidence and prevalence of primary biliary cirrhosis, primary sclerosing cholangitis, and autoimmune hepatitis in a Norwegian population
Scand J Gastroenterol
Population-based epidemiology study of autoimmune hepatitis: a disease of older women?
J Gastroenterol Hepatol
Cited by (0)
Supported by Dr Falk Pharma (BUC-38/AIH). M.P. is employed by Dr Falk Pharma. M.M. is a consultant to Dr Falk Pharma and receives grant support and lecture fees. The other authors declare no conflicts of interest.
Registered with ClinicalTrials.gov: NCT 00838214.
- ∗
A list of members of European AIH-Budesonide Study Group is available at www.jpeds.com (Appendix).