Effectiveness of treatments for autoimmune hepatitis across all age groups: an umbrella review protocol

This umbrella review will synthesize evidence on the effectiveness and safety of pharmacological treatments for autoimmune hepatitis across all age groups, including patients with refractory disease.

Autoimmune hepatitis is a chronic, immune-mediated liver disease that affects all ages. It is more common in women and is characterized by persistent hepatocellular inflammation and interface hepatitis, elevated transaminases, and increased immunoglobulin G and autoantibodies. Although prednisolone and/or azathioprine is the standard treatment, over 20% of patients do not respond or tolerate this treatment.

This review will consider systematic reviews and meta-analyses that evaluate any first- or second-line pharmacological treatment for autoimmune hepatitis, administered to pediatric, adult, or older adult populations.

This review will follow the JBI methodology for umbrella reviews. Searches will be conducted in CINAHL (EBSCOhost), Cochrane Library, Embase (Ovid), LILACS, PubMed, and Scopus. Title/abstract, full-text screening, and data extraction will be performed independently by 2 reviewers, with a predefined procedure in place to resolve disagreements. The quality of the systematic reviews will be appraised using the JBI critical appraisal checklist for systematic reviews, and the certainty of the evidence will be judged using a GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach modified for umbrella reviews. The findings will be presented in tables and figures, with a narrative synthesis and primary stratification by age group and treatment response (eg, treatment-naïve vs. refractory patients). Subgroup and sensitivity analyses are pre-specified.

PROSPERO CRD420251072878.