Autoimmune Hepatitis

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1 Paul J. Pockros,MD Director of Clinical Research, Scripps Translational Science Institute Director, Liver Disease Center and Senior Consultant Scripps Clinic La Jolla, California Thanks to John Vierling,MD for providing many of the slides in this presentation. Response Question #1 Which of the following describe autoimmune hepatitis: 1. Hepatocellular necroinflammation 2. Autoantibodies: non-organ, non-species-specific 3. Hypergammaglobulinemia and/or serum IgG 4. Responsiveness to immunosuppressive medications 5. All of the above 1

2 Definition: Syndrome of progressive hepatitis characterized by loss of tolerance to hepatic autoantigens that results in: Hepatocellular necroinflammation Autoantibodies: non-organ, non-species-specific Hypergammaglobulinemia and/or IgG Non-pathognomic histopathology Responsiveness to immunosuppressive medications Response Question #2 AIH occurs most commonly in females at an age of: yrs yrs yrs yrs 5. 1 and and 4 2

3 Demographics and Epidemiology Uncommon Afflicts 200,000 in U.S.A. Incidence 1.9 per 10 5 per year Prevalence 16.9 per 10 5 Female to male ratio= 4:1 Afflicts both children and adults Bimodal age distribution: vs yrs 6% liver transplants in US 40% mortality in symptomatic patients 6 months if untreated Female Predominant, Bimodal Age Distribution 3

4 Clinical Spectrum Acute Hepatitis 25-30% Usually younger Icteric acute viral hepatitis-like picture Asymptomatic 15-20% Extrahepatic manifestations may be present Fulminant Hepatic Failure 5% Potentially reversible without OLT Czaja AJ: Clin Liver Diseases 2002; 6: Classification Based on Autoantibodies Types: 1 (95-97%) 2 (3-5%) 3 (1-2%) AutoAbs: ANA &/or SMA LKM1 SLA/LP* SLA/LP SLA/LP panca** Absence of unique autoab in putative Type 3 Consensus: 2 types *SLA/LP=Anti-soluble liver antigen/liver-pancreas antibodies **panca=peri-nuclear (protoplasmicstaining) antineutrophil cytoplasmic antibodies 4

5 Differential Diagnostic Dilemmas Autoantibodies Disease ANA/SMA LKM1 LKM2 LKM3 SLA/LP Acute Hepatitis 80% Chronic 20-25% % HCV HBV-HDV % - Alcoholic 75% Hepatitis Wilson Common* Disease *Acute phase reaction normalizes ceruloplasmin concentration!! Test Cu: 24 hour urine (>100 g) & hepatic (250 g/g dry wt) Drug-Induced Drugs Latency Disease Methyldopa Weeks-Months AIH type 1 Minocycline Months-Years AIH type 1 Nitrofurantoin Months-Years AIH type 1 Statins Months AIH type 1 Lie Z-X and Kaplowitz N. Clin Liver Dis. 2002; 6: Alla V et al. J Clin Gastroenterol 2006; 40:

6 Immunology of Drug Metabolism Autoimmune Responses Against CYPs and UGTs UGTs=UDP-glucuronosyltransferase enzymes ; P450s=Cytochrome P450 enzymes AIH Clinical Presentations Extrahepatic Autoimmune Manifestations AIH Type 2 (40%) > AIH Type 1 (10%) Spectrum Thyroid disease (Hashimoto s, Graves) Rheumatoid arthritis Miscellaneous Diabetes mellitus type 1 Sjögren syndrome Vitiligo Addison disease Celiac sprue 6

7 Response Question #3 Histological changes seen in AIH are: 1. Pathognomic 2. May be similar to those seen in viral or drug hepatitis 3. Exclude interface hepatitis 4. All of the above 5. None of the above Requires a Biopsy Compatible, Not Pathognomic Histopathology Interface hepatitis Lymphocytic infiltrates Variable % plasma cells Eosinophils Severe cases Lobular hepatitis Bridging necrosis Similar features: Viral & drug hepatitis Wilson disease PBC stage 3 PSC stage 3 Centrolobular inflammation without portal-interface infiltrates 7

8 Characteristic Feature of Interface Hepatitis = Interface Hepatitis Plasma Cells May or May Not Be Present 8

9 7/24/2012 Immunopathology of CD4 Th1 and CD8 CTL Hepatic Inflammatory Infiltrates Portal tracts CD4>>CD8 T cells Plasma cells Eosinophils Interface Hepatitis CD8>CD4 T cells Indicative of CTL activity No Ig on hepatocytes IgG Secreting B and Plasma Cells IgG IgM Lee H, et al. Am J Clin Pathol 2010; 133:

10 IgG4 Plasma Cell Subtype Watanabe CH, et al Liver Int 2010; 30: Umemura T, et al. J Gastroenterol 2011; 46 (Suppl): AIH HLA Associations Class II III I HLA DP,DO,DQ,DR C B A Class I: A1, B8 Class II: Susceptibility DRB1*0301 DRB1*0401 DRB1*0404 DRB1*0405 DRB1*1301 Protective DRB1*1501 Immunologic diseases: DRB4*0103 Class III: C4AQ0 C 4, C 2, C4AQ0, HSP70,TNF HLA DR Donaldson PT & Czaja AJ: Clin Liver Dis 2002; 6:

11 Class II HLA Associations DR3 44% DR3-DR4 9% Others 15% DR4 32% Czaja AJ et al: Hepatology 18:816, 1993 CP Revised Scoring System of the International Group* Gender Female +2 HLA DR3 or DR4 +1 AP:AST (or ALT) ratio -globulin or IgG level above normal ANA, SMA, or anti- LKM1 titers >3 <1.5 > <1.0 >1:80 1:80 1:40 <1: Immune disease Thyroiditis, colitis, others +2 Other markers Histological features AMA Positive -4 Treatment response Viral markers Drugs Positive Negative Yes No Anti-SLA, actin, LC1, panca Interface hepatitis Plasmacytic Rosettes None of above Biliary changes Other features Complete Relapse Pretreatment aggregate score: Definite diagnosis >15 Probable diagnosis Alcohol <25 g/day >60 g/day +2-2 Post-treatment aggregate score: Definite diagnosis >17 Probable diagnosis *Adapted from Alvarez F, Berg PA, Bianchi FB, et al. J. Hepatology 1999;31:

12 Response Question #4 The goals of treatment for AIH should be to: 1. Normalize ALT to <19 U/L for women or <30 U/L for men 2. Reduce AST and ALT to X ULN 3. Confine inflammation to portal tracts 4. Eliminate portal lymphoplasmacytic inflammation 5. 2 and and AIH Treatment Goals Remission Reduce mortality, symptoms Reduce AST and ALT to X ULN Histology: Confine inflammation to portal tracts Eliminate interface hepatitis Slow progression to cirrhosis Minimize immunosuppression to maintain remission Minimize serious adverse events 12

13 100 Probability of Cirrhosis During Steroid Therapy Percent Probability During treatment During follow-up After treatment Duration of Therapy (Years) Czaja A, AIH Treatment Goals New Concept of Remission Prevent progression and OLT Relieve symptoms Normalize ALT <19 U/L for women <30 U/L for men Histology: Eliminate portal lymphoplasmacytic inflammation Eliminate interface hepatitis Prevent progression to cirrhosis Use combinations of immunosuppressive drugs to inhibit immunopathogenetic mechanisms at multiple sites minimize adverse events 13

14 Indications for Immunosuppression Serum AST>10-fold ULN Absolute Relative None Symptoms (fatigue, arthralgia, jaundice) Asymptomatic with normal or near normal serum AST and γ- globulin levels Serum AST>5-fold ULN and - globulin level>2-fold ULN Bridging necrosis or multiacinar necrosis on histological examination Incapacitating symptoms Serum AST and/or -globulin less than absolute criteria Interface hepatitis Osteopenia, emotional instability, hypertension, diabetes, or cytopenia (white blood cell counts 2.5 x 10 9 /L or platelet counts 50 x 10 9 /L) Inactive cirrhosis or mild portal inflammation (portal hepatitis) Severe cytopenia (white blood cell counts <2.5 x 10 9 /L or platelet counts <50 x 10 9 /L) or known complete deficiency of TPMT activity precludes treatment with azathioprine Vertebral compression, psychosis, brittle diabetes, uncontrolled hypertension, known intolerances to prednisone or azathioprine AASLD Practice Guidelines AIH, 2010 TPMT=Thiopurine methyltransferase Conventional Immunosuppression Monotherapy Prednisone only* (mg/day) Combination Therapy Prednisone* (mg/day) Azathioprine USA (mg/ day) EU (mg/ kg/ day) Week Week Week Week Maintenance until end point Reasons for Preference Cytopenia Thiopurine methyltransferase deficiency Pregnancy Malignancy Short course (<6 mo) Postmenopausal state Osteoporosis Brittle diabetes Obesity Acne Emotional lability Hypertension * Prednisolone can be used in place of prednisone in equivalent doses. AASLD Practice Guidelines AIH,

15 Adverse Effects of Chronic Immunosuppression Corticosteroids Fluid-electrolyte Hypertension Cataracts Glaucoma Osteoporosis Cutaneous atrophy Acne Poor wound healing Glucose intolerance Psychiatric Impotence Amenorrhea Azathioprine Bone marrow suppression Gastrointestinal upset Rash Secondary infections Hepatotoxicity Malignancy Prospective, Double-Blind, Randomized, Controlled Trial Budesonide+Aza vs Prednisone+Aza Manns MP, et al. Gastroenterology 2010; 139:

16 in Pregnancy Fertility due to secondary amenorrhea Treatment not contraindicated Prednisone alone safe Safety of prednisone + azathioprine less clear Risk to fetus Prematurity (30%) Low birth rate (35%) C-section (26%) Complications of PVHTN due to expanded blood volume, intensified hyperdynamic circulation Clinical, Biochemical and Histological Remission During Steroid Therapy Percent Remission % who enter remission do so within 3 years Duration of Therapy (months) Clinical Remission Biochemical Remission Histological Remission Czaja A,

17 Relapse of AIH After Withdrawal of Therapy Increased Probability of Cirrhosis and Need for OLT Montano-Loza AJ et al. Liver Int 2007; 27: Probability of Survival During Steroid Therapy Percent Probability No cirrhosis Cirrhosis during or after therapy Cirrhosis at presentation Duration of Therapy (Years) Czaja A,

18 Risk Factors for Progression and Need for OLT Presentation as acute liver failure Non-response to treatment Isolated ASMA F-actin-specificity (higher -globulin & IgG) HLA haplotype DR3 > DR4; both > DR13 TNF G-308A polymorphism Onset of decompensation in cirrhotics Extrahepatic immunologic diseases Absence Exception Rheumatoid arthritis with anti-cyclic citrullinated peptide autoabs Younger age, type 2 Male gender Response-Guided Therapeutic Options 18

19 Changing Frequency of Remission Using 2002 vs AASLD Guidelines Definitions 27% Remission 73% 74% Remission 26% 2002 AIH Practice Guideline 2010 AIH Practice Guideline Muratori L: Hepatology.2011; 52: 1857 Frequency of Progression After Remission Using Definition in 2010 AASLD Guideline 4% Lack of Progression During Remission 96% Muratori L: Hepatology.2011; 52:

20 Autoimmune Liver Diseases Excellent Survivals Post-OLT UNOS Database Figure 1. Post-OLT Patient Su PBC 12% PSC 8% AILDs 26% AIH 6%* All Other 74% Patient Survival (%) PBC AIH ETOH HCV + HCV ETOH Years Post-OLT Ilyas J, O Mahony C, Vierling. Best Pract Res Clin Gastro; 2011 Allograft Loss After OLT Impact of Recurrent Diseases HCV PSC 10% after 13.7 years AIH Crypto FHF FHF Rowe IA et al. Transplant Int 2008; 21:

21 : Summary Uncommon disease of children and adults Afflicts females predominantly (4:1) Variable clinical presentations challenging IAIHG Validated Diagnostic Scoring Systems Clinical Biochemical HLA DR Histopathology Response to corticosteroids New criteria for remission: Normalization of ALT Stable Disease Therapy to Achieve Remission: Conventional prednisone ± azathioprine ( 30-40%) Alternative immunosuppression required in ( 60-70%) OLT for decompensation with MELD 15 or HCC Excellent Graft and Patient Survivals Recurrent AIH in 22% 21

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