Clinical features of patients with new onset of autoimmune hepatitis following SARS-CoV-2 vaccination

Abstract

Introduction: Autoimmune hepatitis (AIH) is a relatively rare chronic immune-mediated liver disease, which develops in genetically predisposed individuals following an environmental trigger. A few cases of AIH have been recently reported after the SARS-CoV-2 vaccination. Aims: The aim of this study was to describe clinical-epidemiological profile of a series of adult patients who experienced AIH onset following SARS-CoV-2 vaccination. Materials and Methods: This multicentric observational study collected clinical data of adult patients who had received SARS-CoV-2 vaccination and thereafter were diagnosed with AIH between 03/2021 and 10/2021 in Italy, using an online survey among members of the Italian Association for the study of the Liver (AISF). Results: Among the 12 patients included: 50% were females, median age 62 years (range 32-80), 6 (50%) had preexisting extrahepatic autoimmune disease (3 thyroiditis, 2 rheumatoid arthritis, 1 systemic lupus erythematosus), 7 patients have received Comirnaty (BioNTech/Pfizer) vaccine, 2 Spikevax (Moderna Biotech) and 3 Vaxzevria (AstraZeneca). Ten patients (83%) had acute onset of AIH with transaminase levels ≥10 times the upper limit of normal (ULN, range 13-77 x ULN), 8 (67%) with jaundice (total bilirubin 3.5-18.6 x ULN). At AIH diagnosis (median time from first and second vaccine dose: 48 and 10 days, respectively) median AST was 18 x ULN (range 5-85), ALT 23.8 x ULN (range 7-83), total bilirubin 3.8 x ULN (range 0.6-18.6), alkaline phosphatase 1.3 x ULN (range 0.8-7.1), immunoglobulin G 1.2 x ULN (median 0.8-1.5). Eight (67%) patients had autoantibodies: 6 ANA, 1 SMA, 1 LKM-1. Liver biopsy was typical for AIH in 8 and compatible in 3 patients. After 3 months 58% achieved complete biochemical response to standard immunosuppressive treatment. Conclusion: While intensive vaccination against SARS-CoV-2 continues, the diagnosis of AIH secondary to vaccines should be included in the differential diagnosis in cases of acute hepatitis of unexplained aetiology.