The efficacy and safety of budesonide combined with azathioprine versus predniso(lo)ne combined with azathioprine for autoimmune hepatitis: A systematic review and meta-analysis - 12/10/25
, Kehu Yang b, c, g, ⁎ Highlights |
• | Limited systematic review and meta-analysis comparing budesonide + azathioprine (AZA) vs. predniso(lo)ne + AZA for autoimmune hepatitis (AIH), incorporating 6 studies (4 RCTs and 2 cohort studies, n = 929 patients). |
• | Superior efficacy in RCTs: Budesonide + AZA showed significantly higher complete biochemical remission (CBR) rates than predniso(lo)ne + AZA (RR = 1.45, 95 % CI: 1.24–1.68), while cohort studies indicated no significant difference (RR = 0.86, 95 % CI: 0.57–1.28). |
• | Improved safety profile: Budesonide + AZA significantly reduced adverse events (AEs) (RCTs: RR = 0.49; cohort: RR = 0.61) and steroid-related AEs (RCTs: RR = 0.51; cohort: RR = 0.64). |
• | Subgroup insights: Budesonide + AZA may benefit patients with milder liver injury (lower ALT/AST), whereas predniso(lo)ne + AZA might be preferable for severe cases. |
• | Clinical implications: Supports budesonide + AZA as a potential preferable alternative for non-cirrhotic AIH, though evidence certainty ranges from low (RCTs) to very low (cohort studies). |
Abstract |
Background and Aim |
The efficacy and safety of budesonide combined with azathioprine (AZA) compared to predniso(lo)ne combined with AZA in the treatment of autoimmune hepatitis (AIH) remain uncertain. This study aimed to compare the efficacy and safety of two combination regimens.
Methods |
A comprehensive literature search was performed in various databases from database inception to July 2023. The primary outcome was complete biochemical remission rate of AIH. A fixed-effects model was employed when heterogeneity was low, with risk ratios (RR) and 95 % confidence intervals (CIs) reported.
Results |
Six studies involving 929 patients were included in the analysis. Among these studies, four were randomized controlled trials (RCTs), while two were cohort studies. The results of the meta-analysis revealed inconsistent findings regarding the complete biochemical remission (CBR) rate between budesonide combined with AZA and predniso(lo)ne combined with AZA in both RCTs and cohort studies. (RCT: RR=1.45, 95 % CI: 1.24 to 1.68; cohort study: RR=0.86, 95 % CI: 0.57 to 1.28). The meta-analysis revealed that the combination of budesonide and AZA was associated with a reduced occurrence of adverse events (AEs) (RCT: RR=0.49, 95 % CI: 0.35 to 0.69; cohort study: RR=0.61, 95 % CI: 0.43 to 0.88) and steroid-related AEs (RCT: RR=0.51, 95 % CI: 0.35 to 0.74; cohort study: RR=0.64, 95 % CI: 0.44 to 0.95).
Conclusion |
The combination of budesonide and AZA may offer potential advantages in terms of efficacy and safety for populations with less severe liver damage or lower ALT/AST levels, although the certainty of evidence is currently low to very low.
Le texte complet de cet article est disponible en PDF.Key Words : Autoimmune hepatitis, Budesonide, Predniso(lo)ne, Azathioprine, Meta-analysis
Plan
Vol 49 - N° 9
Article 102708- novembre 2025 Retour au numéro
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