Efficacy, Safety and Long-Term Clinical Outcomes of Low-Dose Versus High-Dose Prednisolone Induction in Autoimmune Hepatitis: A Propensity Score-Matched Analysis.

Abstract

Background and aims: Multiple corticosteroid dosing regimens are used in managing autoimmune hepatitis (AIH). We aimed to compare the efficacy of a low- versus high-dose prednisolone induction regimen in achieving a biochemical response in AIH.

Methods: In this retrospective review of a prospectively maintained database, treatment-naive AIH patients treated with prednisolone were categorized into high-dose (> 20 mg/day) and low-dose (≤ 20 mg/day) groups. The primary outcome was the biochemical response, defined as normalization of serum transaminases within 6 months of treatment. Propensity score matching was applied in a 1:1 ratio. Kaplan-Meier survival analysis was used to compare index or further decompensation, and mortality.

Results: Of 121 patients, 47 received low-dose and 74 high-dose prednisolone. After matching 45 patients remained in each group: 92.2% received concomitant azathioprine or mycophenolate mofetil, whereas the remaining received prednisolone monotherapy. Six-month biochemical response rates were similar between low- and high-dose groups (62.2% vs. 60.0%; p = 0.829). Patients with cirrhosis had lower response rates than those without cirrhosis, with no difference between low- and high-dose prednisolone in either group. Index decompensation among compensated patients (HR, 1.17; 95% CI 0.26-5.37; p = 0.838), further decompensation among previously decompensated patients (HR, 1.41; 95% CI 0.54-3.71; p = 0.480) were also comparable in the 2 groups. Mortality rates were also similar. There was a trend toward fewer steroid-related side effects in the low-dose group (27.7% vs. 43.2%; p = 0.084).

Conclusion: Low-dose (≤ 20 mg/day) prednisolone induction results in similar biochemical response and clinical outcomes compared to a high-dose (> 20 mg/day) regimen in patients with AIH.