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027 USE OF BUDESONIDE IN AUTOIMMUNE HEPATITIS: AN INTERIM ANALYSIS OF THE CASL EXPERIENCE I Zandieh1, V Wong2, C Wang3, J Howard2, L Worobetz4, G Minuk5, H Witt-Sullivan6, F Habal3, E Yoshida1 BACKGROUND: Autoimmune hepatitis (AIH) is a chronic inflammatory disease that is successfully treated in 70-75% of patients with prednisone/azathioprine immunosuppressive therapy. The remaining patients are intolerant or refractory to these standard medications. Budesonide, a synthetic glucocorticoid, undergoes a high degree of first pass metabolism, reducing its systemic bioavailability and has a 58 fold greater affinity for the glucocorticoid receptor compared to prednisone. Budesonide may be a potentially useful systemic steroid-sparing immunosuppressive agent in the treatment of AIH.
1Divisions of Gastroenterology, University of British Columbia, Vancouver, British Columbia; 2University of Western Ontario, London, Ontario; 3University of Toronto, Toronto, Ontario; 4University of Saskatchewan, Saskatoon, Saskatchewan; 5University of Manitoba, Winnipeg, Manitoba; 6McMaster University, Hamilton, Ontario
AIM: To review the Canadian experience with the use of budesonide in the treatment of AIH.
METHODS: Patients with AIH currently or previously treated with budesonide were identified through the CASL membership. Data was collected regarding their clinical and treatment history.
RESULTS: A total of 7 patients have been identified to date. All patients are female with an average age of 39 years (12-66 years). The indication for budesonide was adverse side effects related to prednisone and azathioprine in 3 patients, and an intolerance to azathioprine resulting in prednisone dependence in the remaining 4 patients. Patients were treated in doses ranging from 9mg daily to 3mg every other day, for a duration of therapy ranging from 24 weeks to 8 years. Five of the seven patients had a complete response, defined as sustained normalization of the aminotransferases. The remaining 2 patients were classified as non-responders (<50% reduction in pre-treatment aminotransferases). Two of the 4 patients deemed prednisone dependent tolerated complete prednisone withdrawal following budesonide introduction. A third patient's post-budesonide predisone dose was 25% of its original dose.
CONCLUSIONS: Budesonide has been successfully used in 5 of 7 patients in Canada with autoimmune hepatitis intolerant to prednisone and azathioprine or prednisone dependent. No adverse effects were reported with budesonide. Budesonide is a systemic steroid sparing immunosuppressive agent that is potentially of value in the treatment of AIH patients refractory/intolerant of standard therapy and is deserving of further clinical study in this area.