Luigi Muratori, MD, PhD Dipartimento di Scienze Mediche e Chirurgiche Policlinico Sant'Orsola via Massarenti, Bologna

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1 Luigi Muratori, MD, PhD Dipartimento di Scienze Mediche e Chirurgiche Policlinico Sant'Orsola via Massarenti, Bologna Il sottoscritto dichiara di non aver avuto negli ultimi 12 mesi conflitto d interesse in relazione a questa presentazione e che la presentazione non contiene discussione di farmaci in studio o ad uso off-label

2 MONOTEMATICA AISF 2013 Pisa Ottobre 2013 Personalizzazione della Cura in Epatologia Prototipi di Pazienti con Epatite Autoimmune Luigi Muratori, MD, PhD Department of Medical and Surgical Sciences Alma Mater Studiorum - University of Bologna Bologna, Italy

3 : an unresolving inflammation of the liver of unknown cause 1. interface hepatitis 2. hypergammaglobulinemia 3. non organ-specific autoantibodies

4

5 Age distribution at diagnosis/onset patients I II III IV V VI VII VIII IX Decade

6 Age distribution at diagnosis/onset adult pts II III IV V VI VII VIII IX Decade

7 Sex distribution at diagnosis/onset adult pts 60 f/m ratio: 3.6/1 female male II III IV V VI VII VIII IX Decade

8 Serology at diagnosis/onset adult pts ANA 62.7% SMA 60.2% panca/panna 38.8% anti-dsdna 27.3% anti-sla 15.6% LKM1 10.8% LC1 2.9%

9 Serology at diagnosis/onset adult pts ANA 62.7% SMA 60.2% panca/panna 38.8% anti-dsdna 27.3% anti-sla 15.6% LKM1 10.8% LC1 2.9%

10 Serology at diagnosis/onset adult pts ANA 62.7% SMA 60.2% panca/panna 38.8% anti-dsdna 27.3% anti-sla 15.6% LKM1 10.8% LC1 2.9%

11 Serology at diagnosis/onset adult pts 60 type 1 type II III IV V VI VII VIII IX Decade

12 PROTOTYPES of Autoimmune Hepatitis at onset/diagnosis: ACUTE: acute icteric hepatitis INSIDIOUS: vague and non-specific symptoms, such as fatigue, arthralgia, malaise, anorexia, nausea, abdominal pain, itching ASYMPTOMATIC: altered liver function tests occasionally found

13 Onset/Diagnosis adult patients 30% 23% 47% ACUTE INSIDIOUS ASYMPTOMATIC

14 Onset/Diagnosis adult patients 30% 23% 47% ACUTE INSIDIOUS ASYMPTOMATIC

15 Onset/Diagnosis adult patients ACUTE INSIDIOUS ASYMPTOMATIC Male/Female 26/92 15/45 14/62 Age (yrs) 42±16 43±17 42±16 AST (Xunl) 30±19 15±14 7±8 gammagt (Xunl) 4±3.4 4± ±3.5 Alkaline Phos (Xunl) 1.7± ± ±0.8 Bilirubin (mg/dl) 11.7± ± ±1.5 Albumin (g/l) 39±9 40±8 41±7 IgG (Xunl) 1.5± ± ±0.5 Cholesterol (mg/dl) 160±53 179±54 173±49

16 Onset/Diagnosis adult patients ACUTE INSIDIOUS ASYMPTOMATIC Male/Female 26/92 15/45 14/62 Age (yrs) 42±16 43±17 42±16 AST (Xunl) 30±19 15±14 7±8 gammagt (Xunl) 4±3.4 4± ±3.5 Alkaline Phos (Xunl) 1.7± ± ±0.8 Bilirubin (mg/dl) 11.7± ± ±1.5 Albumin (g/l) 39±9 40±8 41±7 IgG (Xunl) 1.5± ± ±0.5 Cholesterol (mg/dl) 160±53 179±54 173±49

17 Onset/Diagnosis adult patients ACUTE INSIDIOUS ASYMPTOMATIC Male/Female 26/92 15/45 14/62 Age (yrs) 42±16 43±17 42±16 AST (Xunl) 30±19 15±14 7±8 gammagt (Xunl) 4±3.4 4± ±3.5 Alkaline Phos (Xunl) 1.7± ± ±0.8 Bilirubin (mg/dl) 11.7± ± ±1.5 Albumin (g/l) 39±9 40±8 41±7 IgG (Xunl) 1.5± ± ±0.5 Cholesterol (mg/dl) 160±53 179±54 173±49

18 Onset/Diagnosis adult patients Acute Insidious Asymptomatic HLA DRB1* % 36% 35% HLA DRB1* % 30% 24% HLA A1-B8-DR3 22% 22% 18.5% Associated Autoimm Dis 33% 29% 45% Florid Histology 74% 63% 42% Cirrhosis 9% 28% 16% Type 1/Type 2 109/9 56/4 64/12 ANA 65% 66% 55% SMA 60% 61% 53% LKM1 9% 4% 21% SLA 10.5% 14% 22%

19 Onset/Diagnosis adult patients Acute Insidious Asymptomatic HLA DRB1* % 36% 35% HLA DRB1* % 30% 24% HLA A1-B8-DR3 22% 22% 18.5% Associated Autoimm Dis 33% 29% 45% Florid Histology 74% 63% 42% Cirrhosis 9% 28% 16% Type 1/Type 2 109/9 56/4 64/12 ANA 65% 66% 55% SMA 60% 61% 53% LKM1 9% 4% 21% SLA 10.5% 14% 22%

20 Onset/Diagnosis adult patients Acute Insidious Asymptomatic HLA DRB1* % 36% 35% HLA DRB1* % 30% 24% HLA A1-B8-DR3 22% 22% 18.5% Associated Autoimm Dis 33% 29% 45% Florid Histology 74% 63% 42% Cirrhosis 9% 28% 16% Type 1/Type 2 109/9 56/4 64/12 ANA 65% 66% 55% SMA 60% 61% 53% LKM1 9% 4% 21% SLA 10.5% 14% 22%

21 Onset/Diagnosis adult patients Acute Insidious Asymptomatic HLA DRB1* % 36% 35% HLA DRB1* % 30% 24% HLA A1-B8-DR3 22% 22% 18.5% Associated Autoimm Dis 33% 29% 45% Florid Histology 74% 63% 42% Cirrhosis 9% 28% 16% Type 1/Type 2 109/9 56/4 64/12 ANA 65% 66% 55% SMA 60% 61% 53% LKM1 9% 4% 21% SLA 10.5% 14% 22%

22 : standard treatments for adults AASLD Practice Guidelines on AIH, 2002

23 Hepatology 2010;51: Endpoints of Initial Immunosuppressive Treatment in Autoimmune Hepatitis Remission Disappearance of symptoms, normal serum aminotransferases, bilirubin and gammaglobulin levels, normal hepatic tissue or inactive cirrhosis. Incomplete response Some or no improvement in clinical, laboratory, and histological features despite compliance with therapy after 2-3 years. No worsening of condition. Treatment failure Worsening clinical, laboratory, and histological features despite compliance with therapy. Development of jaundice, ascites or hepatic encephalopathy. Drug toxicity Development of intolerable cosmetic changes, symptomatic osteopenia, emotional instability, poorly controlled hypertension, brittle diabetes or progressive cytopenia.

24 Onset Remission

25 Treatment Response adult patients 16% 22% 62% Remission Incomplete Response No Response

26 Evolving Liver Disease according to Treatment Response (226 adult patients) Remission 6% Incomplete Response 24% No Response 76%

27 Treatment Response adult patients Acute Insidious Asymptomatic Remission 69% 48% 65% Incomplete Response 10% 27% 18% No Response 21% 25% 17% Evolving Liver Disease (226 pts) 9% 34% 29% Follow-up (mo.) 86±80 88±60 82±70

28 Treatment Response adult patients Acute Insidious Asymptomatic Remission 69% 48% 65% Incomplete Response 10% 27% 18% No Response 21% 25% 17% Evolving Liver Disease (226 pts) 9% 34% 29% Follow-up (mo.) 86±80 88±60 82±70

29 Treatment Response adult patients Acute Insidious Asymptomatic Remission 69% 48% 65% Incomplete Response 10% 27% 18% No Response 21% 25% 17% Evolving Liver Disease (226 pts) 9% 34% 29% Follow-up (mo.) 86±80 88±60 82±70

30 TAKE HOME MESSAGES Acute hepatitis is the most common AIH prototype The insidious prototype of AIH is more frequently associated with liver cirrhosis and its remission rate is the lowest The insidious and the asymptomatic prototypes are the most likely to evolve and progress

31 Luigi Muratori Department of Medical and Surgical Sciences Policlinico Sant'Orsola (Pavillon 11) via Massarenti, Bologna tel fax

32 Stop Press!!! Centro per lo Studio e la Cura delle Malattie Autoimmuni del Fegato Francesco B. Bianchi Dott. Fabio Cassani Prof. Marco Lenzi Dott. Luigi Muratori Dott. Paolo Muratori Dott. Alessandro Granito (UO MI Bolondi) Dott. Giorgio Pappas (UO MI Bernardi)... Policlinico Sant Orsola-Malpighi Padiglione 11 via Massarenti, Bologna

33 Luigi Muratori Department of Medical and Surgical Sciences Policlinico Sant'Orsola (Pavillon 11) via Massarenti, Bologna tel fax

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