Prednisone, prednisolone dose for AIH remission less relevant than assumed

In autoimmune hepatitis (AIH) patients receiving induction therapy with prednisone or prednisolone, the dose to induce remission may be lowered without compromising efficacy, as reported in a recent study. Specifically, 0.50 mg/kg/day is enough and hence reduces unnecessary exposure to the drugs in this population.

Researchers performed a retrospective cohort study using a comparative effectiveness design. They examined the medical records of 451 adults with AIH who initiated treatment with either prednisone or prednisolone from 1978 through 2017 at different centres in five European countries. Of the patients, 281 were exposed to high doses (initial dose ≥0.50 mg/kg/day) and 170 to low doses (<0.50 mg/kg/day).

At 6 months following treatment initiation, the primary outcome of rate of transaminases normalization did not significantly differ between the high- and low-dose groups (70.5 percent vs 64.7 percent; p=0.20). Logistic regression analysis confirmed this finding (odds ratio, 1.21, 95 percent CI, 0.78–1.87; p=0.38).

Patients started on a higher dose of prednisone/prednisolone had higher drug exposure over time than who were given an initial lower dose (median doses over 6 months, 3,780 vs 2,573 mg; p<0.01).

The incidence of steroid-related side effects (diabetes, osteopaenia, osteoporosis and hypertension) was similar in the low- and high-dose prednisone/prednisolone groups (during the first year of treatment, 18.8 percent vs 21.3 percent; p=0.56).

Current guidelines recommend a prednisone/prednisolone dose range of 0.50–1 mg/kg/day in the treatment of AIH, and the findings suggest that physicians may safely prescribe lower dosages, the researchers said.