Deflazacort for long-term maintenance of remission in type I autoimmune hepatitis.

OBJECTIVE

most patients with autoimmune hepatitis require long-term treatment, but up to 80% of them will develop collateral effects. The aim of this study was to evaluate the efficacy of deflazacort, an oxazolinic derivative of prednisolone with fewer effects on bone and glucose metabolism, in the maintenance of remission of type I autoimmune hepatitis in patients treated previously with conventional immunosuppressive therapy.

METHODS

fifteen patients with type I autoimmune hepatitis were included. All patients had been treated previously with prednisone with or without azathioprine until biochemical remission was obtained and the dose could be reduced. Prednisone was then discontinued and deflazacort was started at a dose adjusted to a ratio of 5 mg prednisone per 7.5 mg deflazacort. The biochemical activity (serum ALT and IgG levels) of liver disease was monitored during a follow-up period of 25.8 +/- 7. 7 months.

RESULTS

prednisone therapy was followed by a statistically significant decrease in serum ALT (0P: 386 +/- 345 U/L vs 2M 80 +/- 22 U/L, p < 0.02) and IgG (0P 3029 +/- 1934 mg/dL vs 2M 2064 +/- 933 mg/dL, p < 0.05), from the second month of treatment. After changing to deflazacort no alterations in ALT and IgG serum levels were detected except for a mild, transient increase in serum IgG during the first 3 months. During follow-up, 94% of the patients had normal or slightly increased (less than 50% above normal) ALT levels. The titers of ANA and ASMA remained the same in 82% of the patients, decreased in 12%, and increased in the remaining 6%. During follow-up no patient developed arterial hypertension, diabetes mellitus, or changes in visual acuity. Eight patients, all women, complained of dorsolumbar pain which was not related to osteoporosis.

CONCLUSIONS

deflazacort seems to be useful in maintaining remission of autoimmune hepatitis during a prolonged period of follow-up. Future studies should include a histological evaluation of the patients and a prospective comparative analysis of side-effects.