The presenting clinical picture of autoimmune hepatitis (AIH) may look similar to many other liver diseases. Characteristic features of AIH include the presence of other autoimmune diseases, elevated aminotransferase levels, the presence of specific autoantibodies, and interface hepatitis on liver biopsy.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
[20]Wang Q, Yang F, Miao Q, et al. The clinical phenotypes of autoimmune hepatitis: a comprehensive review. J Autoimmun. 2016 Jan;66:98-107.
http://www.ncbi.nlm.nih.gov/pubmed/26614611?tool=bestpractice.com
Medical history
Clinical manifestations are variable, ranging from an asymptomatic condition to fulminant hepatic failure. Common symptoms include:[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Rarely, patients may present with fever, oligomenorrhea, encephalopathy, and gastrointestinal bleeding associated with portal hypertension.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
[21]Potts JR, Verma S. Optimizing management in autoimmune hepatitis with liver failure at initial presentation. World J Gastroenterol. 2011 Apr 28;17(16):2070-5.
https://www.wjgnet.com/1007-9327/full/v17/i16/2070.htm
http://www.ncbi.nlm.nih.gov/pubmed/21547124?tool=bestpractice.com
[22]Braga AC, Vasconcelos C, Braga J. Pregnancy with autoimmune hepatitis. Gastroenterol Hepatol Bed Bench. 2016 Summer;9(3):220-4.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947137
http://www.ncbi.nlm.nih.gov/pubmed/27458515?tool=bestpractice.com
A history of other autoimmune diseases may be present such as thyroiditis, type 1 diabetes, celiac disease, and ulcerative colitis.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
[3]Krawitt EL. Autoimmune hepatitis. N Engl J Med. 2006 Jan 5;354(1):54-66.
http://www.ncbi.nlm.nih.gov/pubmed/16394302?tool=bestpractice.com
Physical exam
Physical signs are usually absent in patients with AIH.
Signs of advanced chronic liver disease (e.g., spider nevi, caput medusa, splenomegaly, ascites, palmar erythema) or manifestations of extrahepatic autoimmune disease may be seen (e.g., vitiligo, inflammatory bowel disease).[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Laboratory evaluation
Liver function tests (LFTs) are performed on all patients who present with the described symptoms and signs. In patients with AIH, they will be abnormal at presentation.
Aminotransferase (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) levels are more strikingly elevated than those of bilirubin and alkaline phosphatase (ALP), with values averaging 200 to 300 international units/L, although values of several thousands are sometimes found in patients with an acute (fulminant) course.[23]Al-Chalabi T, Underhill JA, Portmann BC, et al. Effects of serum aspartate aminotransferase levels in patients with autoimmune hepatitis influence disease course and outcome. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1389-95.
https://www.cghjournal.org/article/S1542-3565(08)00844-6/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/18840547?tool=bestpractice.com
Bilirubin and ALP levels are mildly to moderately increased in most patients. However, AIH can sometimes present with a cholestatic picture marked by high levels of conjugated bilirubin and ALP.[14]Mieli-Vergani G, Vergani D, Czaja AJ, et al. Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017.
http://www.ncbi.nlm.nih.gov/pubmed/29644994?tool=bestpractice.com
Elevated serum gamma globulins, particularly immunoglobulin (Ig) G, is another characteristic laboratory feature.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Serum albumin levels may be reduced and prothrombin time prolonged.[24]Komori A. Recent updates on the management of autoimmune hepatitis. Clin Mol Hepatol. 2021 Jan;27(1):58-69.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820207
http://www.ncbi.nlm.nih.gov/pubmed/33291862?tool=bestpractice.com
[25]Yang F, Wang Q, Bian Z, et al. Autoimmune hepatitis: east meets west. J Gastroenterol Hepatol. 2015 Aug;30(8):1230-6.
https://onlinelibrary.wiley.com/doi/10.1111/jgh.12952
http://www.ncbi.nlm.nih.gov/pubmed/25765710?tool=bestpractice.com
Patients whose LFTs are abnormal are then tested for serum autoantibodies to further determine whether they have AIH and, if so, what type. Patients of all ages are usually routinely tested for all the autoantibodies available.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Serologic categorization of AIH
Type 1 AIH
Characterized by the detection of antinuclear antibodies (ANAs) and/or smooth muscle antibodies (SMAs)/anti-actin antibodies.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
ANAs are found in 43% of patients with type 1 AIH and are the traditional markers of the disease, although they are not disease-specific.[26]European Association for the Study of the Liver. EASL clinical practice guidelines: autoimmune hepatitis. J Hepatol. 2015 Oct;63(4):971-1004.
http://www.ncbi.nlm.nih.gov/pubmed/26341719?tool=bestpractice.com
They are directed against diverse nuclear antigens, including centromeres, ribonucleoproteins, and ribonucleoprotein complexes.[2]Zachou K, Rigopoulou E, Dalekos GN. Autoantibodies and autoantigens in autoimmune hepatitis: important tools in clinical practice and to study pathogenesis of the disease. J Autoimmune Dis. 2004 Oct 15;1(1):2.
https://jautoimdis.biomedcentral.com/articles/10.1186/1740-2557-1-2
http://www.ncbi.nlm.nih.gov/pubmed/15679907?tool=bestpractice.com
Patients with ANA-positive type 1 AIH may also have antibodies directed against single-stranded DNA (anti-ssDNA) and double-stranded DNA (anti-dsDNA).[27]Sebode M, Weiler-Normann C, Liwinski T, et al. Autoantibodies in autoimmune liver disease-clinical and diagnostic relevance. Front Immunol. 2018 Mar 27;9:609.
https://www.frontiersin.org/articles/10.3389/fimmu.2018.00609/full
http://www.ncbi.nlm.nih.gov/pubmed/29636752?tool=bestpractice.com
SMAs are directed against actin and nonactin components, including tubulin, vimentin, desmin, and skeletin, and are also standard markers of AIH.[2]Zachou K, Rigopoulou E, Dalekos GN. Autoantibodies and autoantigens in autoimmune hepatitis: important tools in clinical practice and to study pathogenesis of the disease. J Autoimmune Dis. 2004 Oct 15;1(1):2.
https://jautoimdis.biomedcentral.com/articles/10.1186/1740-2557-1-2
http://www.ncbi.nlm.nih.gov/pubmed/15679907?tool=bestpractice.com
Anti-actin antibodies are found in 41% of patients with type 1 AIH.[26]European Association for the Study of the Liver. EASL clinical practice guidelines: autoimmune hepatitis. J Hepatol. 2015 Oct;63(4):971-1004.
http://www.ncbi.nlm.nih.gov/pubmed/26341719?tool=bestpractice.com
Type 2 AIH
Type 2 AIH is characterized by antibodies to liver kidney microsome type 1 (anti-LKM-1), usually in the absence of ANA and SMA.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Antibodies to liver cytosol type 1 (anti-LC1) are present in 32% of patients with anti-LKM-1, occurring mainly in children with severe disease.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Neither anti-LKM-1 nor anti-LC1 are disease specific, as they have also been identified in a small proportion (5% to 10%) of adult and pediatric patients with chronic hepatitis C infection.[3]Krawitt EL. Autoimmune hepatitis. N Engl J Med. 2006 Jan 5;354(1):54-66.
http://www.ncbi.nlm.nih.gov/pubmed/16394302?tool=bestpractice.com
Anti-LKM-3 antibodies are present in 17% of patients with type 2 AIH, and may be useful in assessing otherwise seronegative patients.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Antibodies against soluble liver antigen/liver pancreas (anti-SLA/LP) are found in approximately 10% to 30% of all patients with AIH.[28]Zeman MV, Hirschfield GM. Autoantibodies and liver disease: uses and abuses. Can J Gastroenterol. 2010 Apr;24(4):225-31.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2864616
http://www.ncbi.nlm.nih.gov/pubmed/20431809?tool=bestpractice.com
[29]Manns MP. Antibodies to soluble liver antigen: specific marker of autoimmune hepatitis. J Hepatol. 2000 Aug;33(2):326-8.
https://www.journal-of-hepatology.eu/article/S0168-8278(00)80375-X/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/10952252?tool=bestpractice.com
Anti-SLA/LP is the only disease-specific autoantibody and therefore has high diagnostic value. This has led to the development of reliable commercial assays for anti-SLA/LP detection (enzyme-linked immunosorbent assay [ELISA] and dot-blot).[26]European Association for the Study of the Liver. EASL clinical practice guidelines: autoimmune hepatitis. J Hepatol. 2015 Oct;63(4):971-1004.
http://www.ncbi.nlm.nih.gov/pubmed/26341719?tool=bestpractice.com
Patients seronegative for ANA/SMA or anti-SLA/LP
In patients who are seronegative for ANA/SMA or anti-SLA/LP, it is useful to test for atypical perinuclear antineutrophil cytoplasmic autoantibodies (pANCA) and antibodies against the asialoglycoprotein receptor (anti-ASGP-R) to determine if they have AIH.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
The prevalence of pANCA, traditionally associated with primary sclerosing cholangitis and inflammatory bowel disease, is 40% to 95% among patients with type 1 AIH.[2]Zachou K, Rigopoulou E, Dalekos GN. Autoantibodies and autoantigens in autoimmune hepatitis: important tools in clinical practice and to study pathogenesis of the disease. J Autoimmune Dis. 2004 Oct 15;1(1):2.
https://jautoimdis.biomedcentral.com/articles/10.1186/1740-2557-1-2
http://www.ncbi.nlm.nih.gov/pubmed/15679907?tool=bestpractice.com
[3]Krawitt EL. Autoimmune hepatitis. N Engl J Med. 2006 Jan 5;354(1):54-66.
http://www.ncbi.nlm.nih.gov/pubmed/16394302?tool=bestpractice.com
Anti-ASGP-R are targeted against a transmembrane glycoprotein on the hepatocyte surface (ASGP-R) and seem to correlate with histologic activity.[2]Zachou K, Rigopoulou E, Dalekos GN. Autoantibodies and autoantigens in autoimmune hepatitis: important tools in clinical practice and to study pathogenesis of the disease. J Autoimmune Dis. 2004 Oct 15;1(1):2.
https://jautoimdis.biomedcentral.com/articles/10.1186/1740-2557-1-2
http://www.ncbi.nlm.nih.gov/pubmed/15679907?tool=bestpractice.com
Patients with primary biliary cirrhosis
Patients with primary biliary cirrhosis will test positive for antimitochondrial antibodies (AMA), but it is worth remembering that they can be seen in AIH as well (overlap syndrome).[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Other tests to exclude differential diagnoses
The differential diagnosis includes alcoholic hepatitis, viral hepatitides, drug induced liver injury, Wilson disease, alpha-1 antitrypsin deficiency, and metabolic dysfunction-associated steatohepatitis (formerly known as nonalcoholic steatohepatitis). The following tests are ordered to help exclude some of these differential diagnoses:[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
IgM antibodies to hepatitis A virus (IgM anti-HAV)
hepatitis B surface antigen (HBsAg)
antibodies to hepatitis B core antigen (anti-HBc)
hepatitis C antibody and hepatitis C viral RNA (viral hepatitis)
plasma ceruloplasmin (Wilson disease)
alpha-1 antitrypsin level (alpha-1 antitrypsin deficiency)
serum iron and total iron-binding capacity (genetic hemochromatosis).
Diagnostic scoring systems
The diagnostic scoring system of the International Autoimmune Hepatitis Group (IAIHG) was created in 1993, revised in 1999, and simplified in 2008 (see Criteria).[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
The revised scoring system may be helpful for those patients who do not present with features characteristic of AIH.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Validation of the revised original and simplified scoring systems in prospective studies is required.
Once the diagnosis has been determined, and before treatment, it is recommended that patients are tested for thiopurine methyltransferase (TPMT) activity. In patients with TPMT deficiency, azathioprine is contraindicated.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
Imaging studies
Most patients who have elevated liver enzymes will have an abdominal ultrasound. There are no characteristic imaging features for AIH; however, ultrasound can evaluate for extrahepatic biliary obstruction, abnormalities in liver morphology, and changes associated with portal hypertension such as splenomegaly.[30]Expert Panel on Gastrointestinal Imaging, Arif-Tiwari H, Porter KK, et al. ACR appropriateness criteria® abnormal liver function tests. J Am Coll Radiol. 2023 Nov;20(11s):S302-14.
https://www.jacr.org/article/S1546-1440(23)00620-8/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/38040457?tool=bestpractice.com
[31]Dong Y, Potthoff A, Klinger C, et al. Ultrasound findings in autoimmune hepatitis. World J Gastroenterol. 2018 Apr 21;24(15):1583-90.
https://www.wjgnet.com/1007-9327/full/v24/i15/1583.htm
http://www.ncbi.nlm.nih.gov/pubmed/29686465?tool=bestpractice.com
Liver histology
Unless contraindicated, a liver biopsy should be performed to determine the diagnosis and evaluate the liver status prior to treatment, as therapy can alter the histologic findings.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
[26]European Association for the Study of the Liver. EASL clinical practice guidelines: autoimmune hepatitis. J Hepatol. 2015 Oct;63(4):971-1004.
http://www.ncbi.nlm.nih.gov/pubmed/26341719?tool=bestpractice.com
The percutaneous route is generally not considered safe if the international normalized ratio (INR) is more than 1.5 or the platelet count is less than 50,000/mm³. The transjugular route is preferred in patients with coagulopathy, severe thrombocytopenia, or ascites.[32]Sue MJ, Lee EW, Saab S, et al. Transjugular liver biopsy: safe even in patients with severe coagulopathies and multiple biopsies. Clin Transl Gastroenterol. 2019 Jul;10(7):e00063.
https://journals.lww.com/ctg/Fulltext/2019/07000/Transjugular_Liver_Biopsy__Safe_Even_in_Patients.6.aspx
http://www.ncbi.nlm.nih.gov/pubmed/31259750?tool=bestpractice.com
Possible complications include bleeding, bowel perforation, and pneumothorax. Risk of mortality is very low (0.01%).[33]Thomaides-Brears HB, Alkhouri N, Allende D, et al. Incidence of complications from percutaneous biopsy in chronic liver disease: a systematic review and meta-analysis. Dig Dis Sci. 2022 Jul;67(7):3366-94.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9237012
http://www.ncbi.nlm.nih.gov/pubmed/34129125?tool=bestpractice.com
AIH is characterized by a periportal lesion or interface hepatitis (a portal mononuclear and plasma cell infiltrate). The diagnosis is dependent on the presence of abundant plasma cells. Some degree of fibrosis is almost invariably present. Other histologic features include panacinar (lobular) hepatitis and centrilobular (Rappaport zone 3) necrosis, which are thought to be early histologic manifestations of AIH.
Fibrosis may be absent in the mildest forms of the disease and extensive in advanced disease, connecting portal and central areas (bridging) and leading to architectural distortion of lobules, appearance of regenerating nodules, and cirrhosis.
Bile duct changes may be present in approximately 25% of patients, but are usually mild. Prominent biliary changes are suggestive of an alternate disease process and should raise suspicion of primary sclerosing cholangitis or overlap syndromes.
A plasma cell infiltrate, rosettes of hepatocytes, and multinucleated giant cells may be seen.[1]Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31065
http://www.ncbi.nlm.nih.gov/pubmed/31863477?tool=bestpractice.com
[34]Tiniakos DG, Brain JG, Bury YA. Role of histopathology in autoimmune hepatitis. Dig Dis. 2015;33 Suppl 2:53-64.
https://karger.com/ddi/article/33/Suppl.%202/53/96287/Role-of-Histopathology-in-Autoimmune-Hepatitis
http://www.ncbi.nlm.nih.gov/pubmed/26642062?tool=bestpractice.com