Recent data in adults indicate that budesonide may be more effective than prednisone for treating autoimmune hepatitis (AIH) (Gastroenterol 2010; 139: 1198-206). Is this true in pediatrics? A small study and an associated editorial indicate that budesonide may be inferior (J Pediatr 2013; 163: 1347-53 & editorial 1246).
The study consisted of 46 pediatric patients with AIH (35 females) who were enrolled in a prospective double-blind, randomized, active-controlled trial with budesonide at a dose of 3 mg TID or prednisone (starting at 40 mg and tapered to 10 mg); all patients received concomitant treatment with azathioprine (1-2 mg/kg/day). After the initial 6 months, a further 6-month open-label treatment with budesonide (n=42) followed. Approximately 70% of the patients had type 1 AIH.
- Normalization of aminotransferases occurred in only 16% of budesonide group and 15% of prednisone group after 6 months.
- At 12 months, 46% of those on budesonide had biochemical remission
The editorial explains why these results are unlikely to affect current management and provides succinct summary of AIH management.
- “The juvenile form of AIH is particularly aggressive…between 40% and 80% of children are reported to have cirrhosis at diagnosis”
- Standard treatment for juvenile AIH: Prednisone 2 mg/kg/day (max 60 mg) which is tapered over 4-8 weeks with the decline of aminotransferase levels to a maintenance dose of 2.5-5 mg/day. 80% of the improvement (in ALT values) occurs within the first two months. Typically, azathioprine is added after some improvement in aminotransferases. In the absence of toxicity, the dose is increased to 2-2.5 mg/kg/day.
- Remission is defined as complete normalization of aminotransferases along with normalization of serum immunoglobulin G levles, negative or very low autoantibody titer, and histologic resolution of inflammation.
- Histologic remission lags biochemical response, “though 95% of patients have a marked histologic improvement after a mean duration of 4 years of effective therapy.”
- Budesonide is not used in the presence of cirrhosis
- Problems with current study are detailed in the editorial. The design likely contributed to remission rates which were significantly lower than reported with standard prednisone/azathioprine.
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Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) and specific medical management interventions should be confirmed by prescribing physician. Application of the information in a particular situation remains the professional responsibility of the practitioner.