Budesonide as first-line treatment in patients with autoimmune hepatitis seems inferior to standard predniso(lo)ne administration.

Abstract

BACKGROUND AND AIMS:

In patients with non-severe acute or chronic autoimmune hepatitis (AIH) without cirrhosis, clinical practice guidelines recommend indistinct use of prednisone or budesonide. However, budesonide is infrequently used in clinical practice. We aimed to describe its use and compare its efficacy and safety with prednisone as first-line options.

APPROACH AND RESULTS:

This was a retrospective, multicenter study of 105 naive AIH patients treated with budesonide as the first-line drug. The control group included 276 patients treated with prednisone. Efficacy was assessed using logistic regression and validated using inverse probability of treatment weighting propensity score. The median time to biochemical response (BR) was 3.1 months in patients treated with budesonide and 4.9 months in those with prednisone. The BR rate was significantly higher in patients treated with prednisone (87% vs. 49% of patients with budesonide, p < 0.001). The probability of achieving BR, assessed using the inverse probability of treatment weighting propensity score, was significantly lower in the budesonide group (OR = 0.20; 95% CI: 0.11-0.38) at any time during follow-up, and at 6 (OR = 0.51; 95% CI: 0.29-0.89) and 12 months after starting treatment (0.41; 95% CI: 0.23-0.73). In patients with transaminases <2 × upper limit of normal, BR was similar in both treatment groups. Prednisone treatment was significantly associated with a higher risk of adverse events (24.2% vs. 15.9%, p = 0.047).

CONCLUSIONS:

In the real-life setting, the use of budesonide as first-line treatment is low, and it is generally prescribed to patients with perceived less disease activity. Budesonide was inferior to prednisone as a first-line drug but was associated with fewer side effects.

• Authors: Álvaro Díaz-González, Manuel Hernández-Guerra, Indhira Pérez-Medrano, Víctor Sapena, Mar Riveiro-Barciela, Ana Barreira-Díaz, Elena Gómez, Rosa M Morillas, María Del Barrio, Laia Escudé, Beatriz Mateos, Diana Horta, Judith Gómez, Isabel Conde, Carlos Ferre-Aracil, Ismael El Hajra, Ana Arencibía, Javier Zamora, Ainhoa Fernández, Magdalena Salcedo, Esther Molina, Anna Soria, Pamela Estévez, Carmen López, Carmen Álvarez-Navascúes, Montserrat García-Retortillo, Javier Crespo, María-Carlota Londoño, ColHai Registry
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 77 Issue 4 Pg. 1095-1105 (04 01 2023) ISSN: 1527-3350 [Electronic] United States
• PMID: 36626622 (Publication Type: Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2023 American Association for the Study of Liver Diseases.

Chemical References

• Budesonide
• Prednisone
• Glucocorticoids

Topics

• Humans
• Budesonide (adverse effects)
• Prednisone (therapeutic use)
• Hepatitis, Autoimmune (drug therapy)
• Retrospective Studies
• Glucocorticoids (adverse effects)