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
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2022, Gastroenterologia y HepatologiaCitation Excerpt :A few years later, a similar trial was carried out in the pediatric population. The authors did not identify differences in the emergence of AEs in budesonide and prednisone cohorts either at 6 or 12 months after treatment initiation.19 The data about AEs emergence in the different published studies is summarized in Table 2.
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2020, Journal of HepatologyCitation Excerpt :While being an option for remission induction, budesonide is more difficult to taper due to its short half-life and limited dose availability on the market. Both prednisolone and budesonide can cause considerable long-term side effects, and in view of the better long-term effectiveness of systemic immunosuppressants, steroids should in any case not be the mainstay of therapy in AIH.27,57,58 Nonetheless, in patients intolerant to azathioprine, and also intolerant to MMF, steroid monotherapy may be a valid treatment alternative, if bone mineral density is good and remains good, and if the prednisolone dose required can be kept at a maximum of 10 mg/day (in children probably at a maximum of 2.5–5 mg/day).
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.
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A list of members of European AIH-Budesonide Study Group is available at www.jpeds.com (Appendix).