Background and Aims <p>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.</p> Methods <p>In this retrospective review of a prospectively maintained database, treatment-naive AIH patients treated with prednisolone were categorized into high-dose (&gt; 20&#xa0;mg/day) and low-dose (≤ 20&#xa0;mg/day) groups. The primary outcome was the biochemical response, defined as normalization of serum transaminases within 6&#xa0;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.</p> Results <p>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).</p> Conclusion <p>Low-dose (≤ 20&#xa0;mg/day) prednisolone induction results in similar biochemical response and clinical outcomes compared to a high-dose (&gt; 20&#xa0;mg/day) regimen in patients with AIH.</p>

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

  • Arnav Aggarwal,
  • Shekhar Swaroop,
  • Sagnik Biswas,
  • Shubham Mehta,
  • Sarthak Saxena,
  • Rajkumar Bayye,
  • Umang Arora,
  • Ayush Agarwal,
  • Rimlee Dutta,
  • Rajni Yadav,
  • Prasenjit Das,
  • Samagra Agarwal,
  • Deepak Gunjan,
  • Baibaswata Nayak,
  • Shalimar

摘要

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.