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

OBJECTIVE: most patients with autoimmune hepatitis require long-term treatm ent, but up to 80% of them will develop collateral effects. The aim of this study was to evaluate the efficacy of deflazacort, an oxazolinic derivativ e of prednisolone with fewer effects on bone and glucose metabolism, in the maintenance of remission of type I autoimmune hepatitis in patients treate d previously with conventional immunosuppressive therapy. METHODS: fifteen patients with type I autoimmune hepatitis were included. A ll patients had been treated previously with prednisone with or without aza thioprine until biochemical remission was obtained and the dose could be re duced. Prednisone was then discontinued and deflazacort was started at a do se adjusted to a ratio of 5 mg prednisone per 7.5 mg deflazacort. The bioch emical activity (serum ALT and IgG levels) of liver disease was monitored d uring a follow-up period of 25.8 +/- 7.7 months. RESULTS: prednisone therapy was followed by a statistically significant dec rease in serum ALT (0P: 386 +/- 345 U/L us 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 s econd month of treatment. After changing to deflazacort no alterations in A LT 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 patie nts had normal or slightly increased (less than 50% above normal) ALT level s. The titers of ANA and ASMA remained the same in 82% of the patients, dec reased in 12%, and increased in the remaining 6%. During follow-up no patie nt developed arterial hypertension, diabetes mellitus, or changes in visual acuity. Eight patients, all women, complained of dorsolumbar pain which wa s not related to osteoporosis. CONCLUSIONS: deflazacort seems to be useful in maintaining remission of aut oimmune hepatitis during a prolonged period of follow-up. Future studies sh ould include a histological evaluation of the patients and a prospective co mparative analysis of side-effects.