The investigators identified polyreactive immunoglobulin G (pIgG) in adults (published in Hepatology: https://doi.org/10.1002/hep.32134) and children (in preparation). Quantification of these pIgG using a "home-made" ELISA facilitates the diagnosis of autoimmune hepatitis (AIH) as compared to non-AIH liver diseases and healthy controls. Positivity for pIgG was independent from ANA/SMA positivity and equally diagnostic for AIH even when conventional autoantibodies (ANA/SMA/SLA/LKM) were negative. Additionally, the frequency of pIgG was lower than conventional autoantibodies (ANA, SMA) in vaccinia/drug associated severe liver injury in a retrospective multicenter study after Covid-19 vaccination (https://doi.org/10.1016/j.jhepr.2022.100605). Aims of the study The study aims to evaluate the diagnostic capacity of pIgG to predict AIH in comparison to other liver diseases prospectively. To avoid diagnostic inaccuracy between AIH with long-term need for an immunosuppression and drug induced liver injury with autoimmune features, which can be indistinguishable from AIH at baseline and which has a very low relapse rate after a short steroid course, a follow-up after six months is obligatory for inclusion. Therefore, the investigators will collect one serum sample from every patient (without immunosuppressive treatment) that presents to the respective hospital for evaluation of liver disease by liver biopsy within one year after initiation of the study and that provided written informed consent. Follow-up for evaluation of steroid dependency at six months after diagnosis is obligatory.
Study Type
OBSERVATIONAL
Enrollment
400
Polyreactive immunoglobulin G will be tested centralized in Hannover as published (Taubert, Engel et al., Hepatology, 2022). The current standard diagnostic autoantibodies (e.g. ANA, anti-SMA, anti-LKM, anti-LC1, anti-SLA/L) will be tested centrally in Hannover according to current guidelines.
RWTH Aachen
Aachen, Germany
NOT_YET_RECRUITINGUniversity Medical Center Hamburg-Eppendorf
Hamburg, Germany
NOT_YET_RECRUITINGHannover Medical School
Hanover, Germany
RECRUITINGUniversity Medical Center Heidelberg
Heidelberg, Germany
NOT_YET_RECRUITINGUniversity Hospital Schleswig-Holstein, Location Lübeck
Lübeck, Germany
NOT_YET_RECRUITINGRostock University Medical Centre
Rostock, Germany
NOT_YET_RECRUITINGSensitivity of new simplified pIgG AIH Score
Autoimmune serology will be substituted by pIgG in the 2021 simplified AIH Score. Sensitivity of the new score will be compared to the old score, primarily for non-inferiority and second for superiority if non-inferiority was met.
Time frame: Assessment of steroid dependency at six months after enrollment
Specificty of pIgG simplified AIH Score
Autoimmune serology will be substituted by pIgG in the 2021 simplified AIH Score. Sensitivity of the new score will be compared to the old score, primarily for non-inferiority and second for superiority if non-inferiority was met.
Time frame: Assessment at baseline
Diagnostic discrimination between AIH and DILI by polyreactive IgG
Time frame: At enrollment
Prediction of steroid dependent hepatitis by any other autoantibody
Prediction of steroid dependent hepatitis by any other elevated conventional autoantibody according to current guidelines (European Association for the study of the liver: EASL, American Association for the Study of Liver Diseases: AASLD)
Time frame: Assessment of steroid dependency at six months after enrollment
Age-dependency of autoantibodies
Presence of autoantibodies will be descriptively evaluated with regard to age of the patients as currently it is proposed that lower antibody titers/levels are diagnostic in children (dependent on age) than in adults
Time frame: Assessment of autoantibodies at baseline
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