TY - JOUR
T1 - Clinical course and prognostic risk factors of SARS-CoV-2 vaccine-related hepatitis
T2 - differentiating severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury from autoimmune hepatitis
AU - Malino, Donald
AU - Codoni, Greta
AU - Kirchner, Theresa
AU - Engel, Bastian
AU - Villamil, Alejandra Maria
AU - Efe, Cumali
AU - Stattermayer, Albert Friedrich
AU - Weltzsch, Jan Philipp
AU - Sebode, Marcial
AU - Bernsmeier, Christine
AU - Lleo, Ana
AU - Gevers, Tom J. G.
AU - Kupcinskas, Limas
AU - Castiella, Agustin
AU - Pinazo, Jose
AU - De Martin, Eleonora
AU - Bobis, Ingrid
AU - Sandahl, Thomas Damgaard
AU - Pedica, Federica
AU - Invernizzi, Federica
AU - Del Poggio, Paolo
AU - Bruns, Tony
AU - Kolev, Mirjam
AU - Semmo, Nasser
AU - Bessone, Fernando
AU - Giguet, Baptiste
AU - Poggi, Guido
AU - Ueno, Masayuki
AU - Jang, Helena
AU - Elpek, Gulsum Ozlem
AU - Soylu, Nese Karadag
AU - Cerny, Andreas
AU - Wedemeyer, Heiner
AU - Matter, Matthias S.
AU - Uzun, Sarp
AU - Matilla-Cabello, Gonzalo
AU - Vergani, Diego
AU - Mieli-Vergani, Giorgina
AU - Lucena, M. Isabel
AU - Andrade, Raul J.
AU - Zen, Yoh
AU - Taubert, Richard
AU - Beretta-Piccoli, Benedetta Terziroli
PY - 2026/5/1
Y1 - 2026/5/1
N2 - Background and aim – Reported cases of acute liver injury with autoimmune features post-COVID-19 vaccination raise questions about whether this represents vaccine-triggered autoimmune hepatitis (AIH) or self-limiting drug-induced autoimmune-like hepatitis (DI-ALH). We report follow-up data to determine if the disease course is self-limiting or immunosuppression-dependent. Methods – Members of the International AIH Group and the European Reference Network on Hepatological Diseases who contributed cases to our original cohort provide follow-up data at 6 months, 12 months, and at last follow-up. Results – Sixty-two patients (median age 56 years, 35 female) were included (median follow-up: 22.8 months). Fifty-eight (93%) received steroids ± azathioprine/mycophenolate. Four died of non–liver-related causes. Transaminases normalization rates were 71, 92, and 90% at 6 months, 12 months, and last follow-up, respectively. Twenty-four had a DI-ALH-like course, with ALT normalization and no relapse with or without (n = 4) a short (<9 months) immunosuppressive treatment. Nineteen had an AIH-like course, with relapse after discontinuation (n = 11) or persistent ALT elevation despite treatment (n = 8). Nineteen were unclassified. Risk factors for AIH-like progression included a higher revised AIH score, advanced fibrosis, and severe interface hepatitis. Conclusion – Most cases resemble DI-ALH, which we propose naming severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury, but a significant subset requires long-term immunosuppression, resembling classical AIH.
AB - Background and aim – Reported cases of acute liver injury with autoimmune features post-COVID-19 vaccination raise questions about whether this represents vaccine-triggered autoimmune hepatitis (AIH) or self-limiting drug-induced autoimmune-like hepatitis (DI-ALH). We report follow-up data to determine if the disease course is self-limiting or immunosuppression-dependent. Methods – Members of the International AIH Group and the European Reference Network on Hepatological Diseases who contributed cases to our original cohort provide follow-up data at 6 months, 12 months, and at last follow-up. Results – Sixty-two patients (median age 56 years, 35 female) were included (median follow-up: 22.8 months). Fifty-eight (93%) received steroids ± azathioprine/mycophenolate. Four died of non–liver-related causes. Transaminases normalization rates were 71, 92, and 90% at 6 months, 12 months, and last follow-up, respectively. Twenty-four had a DI-ALH-like course, with ALT normalization and no relapse with or without (n = 4) a short (<9 months) immunosuppressive treatment. Nineteen had an AIH-like course, with relapse after discontinuation (n = 11) or persistent ALT elevation despite treatment (n = 8). Nineteen were unclassified. Risk factors for AIH-like progression included a higher revised AIH score, advanced fibrosis, and severe interface hepatitis. Conclusion – Most cases resemble DI-ALH, which we propose naming severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury, but a significant subset requires long-term immunosuppression, resembling classical AIH.
KW - autoimmune hepatitis
KW - COVID-19 vaccines
KW - follow-up
KW - severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury
KW - vaccine-induced hepatitis
KW - DIAGNOSIS
KW - CRITERIA
U2 - 10.1097/MEG.0000000000003142
DO - 10.1097/MEG.0000000000003142
M3 - Article
SN - 0954-691X
VL - 38
SP - 615
EP - 624
JO - European Journal of Gastroenterology & Hepatology
JF - European Journal of Gastroenterology & Hepatology
IS - 5
ER -