Is Budesonide effective as first-line therapy in autoimmune hepatitis?

In a new study, Álvaro Díaz-González and team found that budesonide is rarely used as a first-line therapy and is often only given to individuals who have symptoms that are thought to be less severe. The findings of this study were published in Hepatology.

Clinical practice guidelines advise the indiscriminate use of prednisone or budesonide in patients with non-severe acute or chronic autoimmune hepatitis (AIH) without cirrhosis. Budesonide is seldom ever used in clinical practice, nevertheless. The purpose of this study was to describe its use and evaluate its effectiveness and safety in comparison to prednisone as first-line treatment choices.

Budesonide was administered as the first-line medication to 105 individuals with naïve AIH in this retrospective, multicenter research. 276 patients who received prednisone treatments made up the control group. Inverse likelihood of treatment weighted propensity score was used to validate effectiveness after logistic regression was used to evaluate it. Patients receiving budesonide had a median time to biochemical response (BR) of 3.1 months, whereas those receiving prednisone had a median time to BR of 4.9 months.

The key findings of this study were:

1. Prednisone patients had a considerably greater BR rate (87% vs. 49% of patients receiving budesonide, p = 0.001) than those receiving budesonide.

2. At any point throughout follow-up as well as at 6 and 12 months after treatment began, the chance of obtaining BR, as measured by the inverse probability of treatment weighted propensity score, was considerably lower in the budesonide group.

3. In individuals with transaminases 2 upper limit of normality (ULN), BR was comparable across the two therapy groups.

4. A greater risk of adverse events was substantially related with prednisone administration (24.2% vs. 15.9%, p = 0.047).

A decreased incidence of adverse events was linked to budesonide. Although there was no baseline predictor of response found, prednisone-treated individuals had a greater likelihood of BR when their alanine aminotransferase (ALT) or ALT + aspartate aminotransferase (AST) levels dropped quickly. Low transaminase levels at diagnosis (2 ULN) patients had comparable BR with both corticosteroid therapies and may benefit from the less adverse events (AEs) linked to budesonide therapy.

Reference:

Díaz-González, Á., Hernández-Guerra, M., Pérez-Medrano, I., Sapena, V., Riveiro-Barciela, M., Barreira-Díaz, A., Gómez, E., Morillas, R. M., Del Barrio, M., Escudé, L., Mateos, B., Arencibía, A., Zamora, J., … Fernández, A. (2023). Budesonide as first-line treatment in patients with autoimmune hepatitis seems inferior to standard predniso(lo)ne administration. In Hepatology (Vol. 77, Issue 4, pp. 1095–1105). Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/hep.0000000000000018