Standard treatment
Untreated autoimmune hepatitis (AIH) has a poor prognosis, with a 5-year survival rate of 50% and 10-year survival rate of 10%.[45]Strassburg CP, Manns MP. Treatment of autoimmune hepatitis. Semin Liver Dis. 2009 Aug;29(3):273-85.
http://www.ncbi.nlm.nih.gov/pubmed/19676000?tool=bestpractice.com
Immunosuppressive therapy significantly improves survival.[63]Abhyankar A, Tapper E, Bonder A. Immunosuppressive therapy in immune-mediated liver disease in the non-transplanted patient. Pharmaceuticals (Basel). 2013 Dec 30;7(1):18-28.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3915192
http://www.ncbi.nlm.nih.gov/pubmed/24380894?tool=bestpractice.com
The majority of patients with moderate to severe AIH respond to treatment within 2 weeks and achieve remission, with serum aminotransferases falling into the normal range after 12 or more months of treatment.[36]Gleeson D, Heneghan MA; British Society of Gastroenterology. British Society of Gastroenterology (BSG) guidelines for management of autoimmune hepatitis. Gut. 2011 Dec;60(12):1611-29.
https://gut.bmj.com/content/60/12/1611.long
http://www.ncbi.nlm.nih.gov/pubmed/21757447?tool=bestpractice.com
[64]Hoeroldt B, McFarlane E, Dube A, et al. Long-term outcomes of patients with autoimmune hepatitis managed at a nontransplant center. Gastroenterology. 2011 Jun;140(7):1980-9.
https://www.gastrojournal.org/article/S0016-5085(11)00280-0/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/21396370?tool=bestpractice.com
[65]Czaja AJ. Rapidity of treatment response and outcome in type 1 autoimmune hepatitis. J Hepatol. 2009 Jul;51(1):161-7.
http://www.ncbi.nlm.nih.gov/pubmed/19446908?tool=bestpractice.com
The aim of treatment is for patients to achieve sustained remission without the need for medication. Guidance recommends an attempt at withdrawal of treatment for patients who have been in remission for at least 24 months.[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
However, sustained remission without treatment is only achieved in a minority of patients, and 50% to 90% of patients who achieve remission relapse within 12 months of drug withdrawal.[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
[36]Gleeson D, Heneghan MA; British Society of Gastroenterology. British Society of Gastroenterology (BSG) guidelines for management of autoimmune hepatitis. Gut. 2011 Dec;60(12):1611-29.
https://gut.bmj.com/content/60/12/1611.long
http://www.ncbi.nlm.nih.gov/pubmed/21757447?tool=bestpractice.com
The risk of relapse can be predicted based on histological findings prior to withdrawing treatment. The American Association for the Study of Liver Diseases suggests that a liver tissue examination (via biopsy) prior to drug withdrawal is useful.[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 overall 10‐ and 20‐year survival rates of treated AIH in a non-transplant centre are 91% and 70%, respectively. The standardised mortality ratio is 1.63 for all-cause death and 1.86 after inclusion of liver transplant as ‘death’.[64]Hoeroldt B, McFarlane E, Dube A, et al. Long-term outcomes of patients with autoimmune hepatitis managed at a nontransplant center. Gastroenterology. 2011 Jun;140(7):1980-9.
https://www.gastrojournal.org/article/S0016-5085(11)00280-0/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/21396370?tool=bestpractice.com
AIH should not be treated when risks clearly outweigh the benefits or in those with chronic cirrhosis in the absence of an inflammatory component.[45]Strassburg CP, Manns MP. Treatment of autoimmune hepatitis. Semin Liver Dis. 2009 Aug;29(3):273-85.
http://www.ncbi.nlm.nih.gov/pubmed/19676000?tool=bestpractice.com
Liver transplantation
The 5-year patient and graft survival rate is approximately 75% to 90%.[66]Sucher E, Sucher R, Gradistanac T, et al. Autoimmune hepatitis-immunologically triggered liver pathogenesis-diagnostic and therapeutic strategies. J Immunol Res. 2019 Nov 25;2019:9437043.
https://www.hindawi.com/journals/jir/2019/9437043
http://www.ncbi.nlm.nih.gov/pubmed/31886312?tool=bestpractice.com
The 10-year survival rate is approximately 75%.[66]Sucher E, Sucher R, Gradistanac T, et al. Autoimmune hepatitis-immunologically triggered liver pathogenesis-diagnostic and therapeutic strategies. J Immunol Res. 2019 Nov 25;2019:9437043.
https://www.hindawi.com/journals/jir/2019/9437043
http://www.ncbi.nlm.nih.gov/pubmed/31886312?tool=bestpractice.com
Immunosuppression post-liver transplant has usually consisted of tacrolimus alone or with mycophenolate or azathioprine. The use of corticosteroids remains controversial.
Recurrent AIH is a challenge post-transplant and may be related to greater disease severity in the recipient liver before transplantation, as well as the type of immunosuppression used, or the human leukocyte antigen (HLA) status of the donor. Some reports implicate weaning of patients off corticosteroids. Successful management of recurrent disease relies on early detection with liver biopsy. In most cases, increased immunosuppression is successful. The 5-year survival in this population still approaches >78%.[54]Molmenti EP, Netto GJ, Murray NG, et al. Incidence and recurrence of autoimmune/alloimmune hepatitis in liver transplant recipients. Liver Transpl. 2002 Jun;8(6):519-26.
https://aasldpubs.onlinelibrary.wiley.com/doi/abs/10.1053/jlts.2002.32981
http://www.ncbi.nlm.nih.gov/pubmed/12037782?tool=bestpractice.com
De novo AIH can arise in patients who have received a transplant for other liver diseases and may be a form of late cellular rejection. This generally responds to modification of immunosuppression.[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
Special clinical challenges in the prognosis of AIH
AIH can present in a variety of ways. This diversity of presentation can impede the diagnosis. For example, serological markers can be variably expressed in some patients. In addition, different ethnic groups can have non-classical clinical presentations, and sex may affect treatment response and outcome. Debate remains regarding therapy in asymptomatic patients, older patients, and pregnant women.[67]Czaja AJ. Special clinical challenges in autoimmune hepatitis: the elderly, males,
pregnancy, mild disease, fulminant onset, and nonwhite patients. Semin Liver Dis. 2009 Aug;29(3):315-30.
http://www.ncbi.nlm.nih.gov/pubmed/19676004?tool=bestpractice.com
Older patients
Twenty percent of adults develop AIH after 60 years of age and generally have a greater degree of hepatic fibrosis, ascites, and cirrhosis, indicating that they have an aggressive disease.[68]Czaja AJ, Carpenter HA. Distinctive clinical phenotype and treatment outcome of type 1 autoimmune hepatitis in the elderly. Hepatology. 2006 Mar;43(3):532-8.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.21074
http://www.ncbi.nlm.nih.gov/pubmed/16496338?tool=bestpractice.com
[69]Miyake T, Miyaoka H, Abe M, et al. Clinical characteristics of autoimmune hepatitis in older aged patients. Hepatol Res. 2006 Oct;36(2):139-42.
http://www.ncbi.nlm.nih.gov/pubmed/16872893?tool=bestpractice.com
The frequency of comorbidities such as osteoporosis, hypertension, diabetes, and active malignancy may preclude the use of corticosteroids.
Post-menopausal women were found not to have a statistically different frequency of drug-related adverse effects compared with pre-menopausal women.[67]Czaja AJ. Special clinical challenges in autoimmune hepatitis: the elderly, males,
pregnancy, mild disease, fulminant onset, and nonwhite patients. Semin Liver Dis. 2009 Aug;29(3):315-30.
http://www.ncbi.nlm.nih.gov/pubmed/19676004?tool=bestpractice.com
However, older patients can be managed successfully with a combination of prednisone and azathioprine, and may respond more quickly than younger counterparts and fail treatment less often. Initial therapy has been shown to be well tolerated. Re-treatment after relapse, however, was associated with a higher cumulative frequency of drug-related complications such as vertebral compression in the post-menopausal group. Bone maintenance and densitometry monitoring regimens can reduce complications.
Older patients should not be denied liver transplantation simply on the basis of age because the 5-year survival rates after liver transplantation in this age group have been shown to be the same as those in younger adults, and older patients had lower rates of acute rejection.[70]Cross TJ, Antoniades CG, Muiesan P, et al. Liver transplantation in patients over 60 and 65 years: an evaluation of long-term outcomes and survival. Liver Transpl. 2007 Oct;13(10):1382-8.
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/lt.21181
http://www.ncbi.nlm.nih.gov/pubmed/17902123?tool=bestpractice.com
Males
Because AIH is rare in males, the diagnosis might be delayed or missed. Men tend to be younger than women at presentation, relapse more commonly after treatment withdrawal, and more frequently express the HLA-A1-D8-DRB1*03 allele.
Men have a better long-term survival rate than women, which may be related to the fact that women often have other autoimmune disorders concomitantly.[71]Al-Chalabi T, Underhill JA, Portmann BC, et al. Impact of gender on the long-term outcome and survival of patients with autoimmune hepatitis. J Hepatol. 2008 Jan;48(1):140-7.
http://www.ncbi.nlm.nih.gov/pubmed/18023911?tool=bestpractice.com
Pregnancy
AIH during pregnancy is a complicated clinical state. However, experience indicates that both pregnancy and liver disease can be successfully managed when they co-exist. The major risk of pregnancy in these cases is premature delivery of the fetus, which has been estimated to occur in 16% to 20% of pregnancies.[72]Sharma R, Simon TG, Stephansson O, et al. Pregnancy outcomes in women with autoimmune hepatitis - a nationwide population-based cohort study with histopathology. Clin Gastroenterol Hepatol. 2023 Jan;21(1):103-14.e10.
https://www.cghjournal.org/article/S1542-3565(21)01348-3/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/34954339?tool=bestpractice.com
[73]Westbrook RH, Yeoman AD, Kriese S, et al. Outcomes of pregnancy in women with autoimmune hepatitis. J Autoimmun. 2012 May;38(2-3):J239-44.
http://www.ncbi.nlm.nih.gov/pubmed/22261501?tool=bestpractice.com
The fetal loss and stillbirth rate of 27% is higher than that for the general population (7% to 15%) but similar to that for women with chronic disease (24% to 29%).[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
[73]Westbrook RH, Yeoman AD, Kriese S, et al. Outcomes of pregnancy in women with autoimmune hepatitis. J Autoimmun. 2012 May;38(2-3):J239-44.
http://www.ncbi.nlm.nih.gov/pubmed/22261501?tool=bestpractice.com
Antiphospholipid antibodies are strongly associated with AIH, and may be a separate, but related, cause of preterm delivery.[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
AIH may improve during pregnancy because oestrogen mediates a cytokine shift from a T-helper type 1 (Th1) to a T-helper type 2 (Th2) anti-inflammatory profile. Unfortunately, AIH is frequently exacerbated after delivery, when oestrogen levels can fall dramatically.[74]Bozward AG, Wootton GE, Podstawka O, et al. Autoimmune hepatitis: tolerogenic immunological state during pregnancy and immune escape in post-partum. Front Immunol. 2020 Sep 24;11:591380.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7541906
http://www.ncbi.nlm.nih.gov/pubmed/33072138?tool=bestpractice.com
Azathioprine and mercaptopurine appear to be relatively safe in prospective cohort studies and retrospective reviews of pregnant patients with inflammatory bowel disease.[75]Francella A, Dyan A, Bodian C, et al. The safety of 6-mercaptopurine for childbearing patients with inflammatory bowel disease: a retrospective cohort study. Gastroenterology. 2003 Jan;124(1):9-17.
https://www.gastrojournal.org/article/S0016-5085(03)50013-0/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/12512024?tool=bestpractice.com
[76]Natekar A, Pupco A, Bozzo P, et al. Safety of azathioprine use during pregnancy. Can Fam Physician. 2011 Dec;57(12):1401-2.
https://www.cfp.ca/content/57/12/1401.long
http://www.ncbi.nlm.nih.gov/pubmed/22170192?tool=bestpractice.com
[77]Akbari M, Shah S, Velayos FS, et al. Systematic review and meta-analysis on the effects of thiopurines on birth outcomes from female and male patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013 Jan;19(1):15-22.
http://www.ncbi.nlm.nih.gov/pubmed/22434610?tool=bestpractice.com
US and European guidance states that azathioprine can be continued throughout pregnancy.[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
Acute, severe, or fulminant AIH presentation
Acute, severe, or fulminant AIH is rare. Overall, the reported response to corticosteroids in severe AIH has fluctuated from 36% to 100%.[78]Mendizabal M, Marciano S, Videla MG, et al. Fulminant presentation of autoimmune hepatitis: clinical features and early predictors of corticosteroid treatment failure. Eur J Gastroenterol Hepatol. 2015 Jun;27(6):644-8.
http://www.ncbi.nlm.nih.gov/pubmed/25923939?tool=bestpractice.com
One study found that Model for End-stage Liver Disease (MELD) scores of >12 at presentation had sensitivity of 97% and specificity of 68% for treatment failure; MELD scores may therefore be a useful tool in identifying patients who warrant more urgent consideration for liver transplantation.[79]Montano-Loza AJ, Carpenter HA, Czaja AJ. Features associated with treatment failure in type 1 autoimmune hepatitis and predictive value of the model of end-stage liver disease. Hepatology. 2007 Oct;46(4):1138-45.
http://www.ncbi.nlm.nih.gov/pubmed/17668882?tool=bestpractice.com
Non-white patients
Black North American patients more commonly have cirrhosis at presentation than white North American patients, whereas Japanese patients typically have mild, late-onset disease. South American patients are more frequently younger than white North American counterparts and have less severe laboratory abnormalities at presentation. Alaskan natives have icteric disease more frequently than non-native patients, while African, Asian, and Arab patients have a higher frequency of cholestatic features and greater occurrence of biliary changes on histology than white Northern European patients.[67]Czaja AJ. Special clinical challenges in autoimmune hepatitis: the elderly, males,
pregnancy, mild disease, fulminant onset, and nonwhite patients. Semin Liver Dis. 2009 Aug;29(3):315-30.
http://www.ncbi.nlm.nih.gov/pubmed/19676004?tool=bestpractice.com
The variations in these phenotypes indicate that genetic background and geographical location may affect presentation and occurrence of the disease.[67]Czaja AJ. Special clinical challenges in autoimmune hepatitis: the elderly, males,
pregnancy, mild disease, fulminant onset, and nonwhite patients. Semin Liver Dis. 2009 Aug;29(3):315-30.
http://www.ncbi.nlm.nih.gov/pubmed/19676004?tool=bestpractice.com