Aim: To compare the early biochemical response and rate of adverse effects in patients who received prednisolone (PRED)/azathioprine (AZA) and those who received budesonide (BUD)/AZA as the first-line treatment for autoimmune hepatitis.
Methods: The study involved 25 patients receiving PRED 30 mg/day + AZA 50 mg/day and 25 patients receiving BUD 9 mg/day + AZA 50 mg/day from February 2015 to February 2018. Biochemical and hemogram data at baseline and after 6 months of treatment, and adverse effects observed in the follow-up, were compared.
Results: There was no difference between the groups in biochemical response (17 patients receiving PRED/AZA and 18 receiving BUD/AZA) and the rate of adverse effects (9 patients receiving PRED/AZA and 5 receiving BUD/AZA). The total number of adverse effects in the BUD/AZA group was lower (15 vs 7) and the treatment was discontinued in 2 (8%) patients in PRED/AZA group, while no treatment discontinuation was observed in BUD/AZA group.
Conclusions: This study showed no differences in biochemical response between the groups. Lower, although not significantly, rate of adverse effects and lower total number of adverse effects indicate that BUD/AZA may potentially be used as the first-line treatment of choice, especially in patients with obesity, diabetes, resistant hypertension, glaucoma, or osteoporosis.