Budesonide as first-line treatment in patients with autoimmune hepatitis seems inferior to standard predni(so)lone administration

Fecha de publicación: Fecha Ahead of Print:

Autores de IDIVAL

Autores ajenos al IDIVAL

  • Hernández-Guerra M
  • Pérez-Medrano I
  • Sapena V
  • Riveiro-Barciela M
  • Barreira-Díaz A
  • Gómez E
  • Morillas RM
  • Del Barrio M
  • Escudé L
  • Mateos B
  • Horta D
  • Gómez J
  • Conde I
  • Ferre-Aracil C
  • El Hajra I
  • Arencibía A
  • Zamora J
  • Fernández A
  • Salcedo M
  • Molina E
  • Soria A
  • Estévez P
  • López C
  • Álvarez-Navascúes C
  • Retortillo MG
  • Londoño MC
  • ColHai Registry



BACKGROUND 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 RESULTS: This was a retrospective, multicenter study of 105 naïve 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 (IPTW-PS). 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 biochemical response 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 IPTW-PS, 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 <2xULN, 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.

Copyright © 2022 American Association for the Study of Liver Diseases.

Datos de la publicación

0270-9139, 1527-3350

Hepatology  John Wiley & Sons Inc


Citas Recibidas en Web of Science: 7


  • No hay documentos


Filiaciones mostrar / ocultar

Campos de estudio