Liver biopsy as the gold standard for diagnosis. Pierre BEDOSSA
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1 Liver biopsy as the gold standard for diagnosis Pierre BEDOSSA 1
2 PATHOLOGY OF NAFLD CONFLICTS OF INTEREST Grants and funding from Genfit, Intercept, Allergan, Inventiva, OWL, Echosens CEO and funding of LIVERPAT 2
3 LIVER BIOPSY in NAFLD Histology of NAFLD : association of a large panel of elementary lesions any possible combinations Liver biopsy allows an integrated evaluation of all tissue damages Histology is central for disease diagnosis, classification and prognosis in NAFLD So far, histology is also central for clinical trials Non invasive biomarkers are still unmet need 3
4 THE CLASSICAL VIEW : A DICHOTOMOUS CLASSIFICATION HISTORICAL LANDMARK Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Ludwig J, et al. Mayo Clin Proc Non Alcoholic Fatty Liver Diseases (NAFLD)
5 NASH : AN ENTITY BASED ON ASSOCIATION OF HISTOLOGICAL PATTERNS (NASH CRN) STEATOSIS + BALLOONING + INFLAMMATION + Perisinusoidal fibrosis + Location in zone 3 5
6 THE NATURAL HISTORY OF NAFLD STEATOSIS (NAFL) STEATOHEPATITIS (NASH) FIBROSIS CIRRHOSIS HCC
7 NAFLD Activity Score (NAS, 0-8) STEATOSIS BALLONING + INFLAMMATION NASH CRN, Hepatology 2005
8 Moving forward The dichtomous approach is an oversimplfication of the reality Many cases do not fall into one of the categories Need for a more flexible approach The European initiative (FLIP, EPOS) 8
9 UNDER THE LENS : THE 3 HISTOLOGICAL COMPONENTS OF NAFLD FLIP consortium, Hepatology 2012, Hepatology 2014 THE MARKER THE DRIVER THE KILLER 9
10 THE MARKER 10
11 THE DRIVER Inflammation Ballooning 11
12 HEPATOCELLULAR BALLOONING: THE HALLMARK OF NASH SHAPE + COLOR + SIZE NORMAL LIVER NORMAL LIVER Ballooning 1 Ballooning 2 12
13 THE KILLER 13
14 LIVER FIBROSIS : MAJOR PROGNOSTIC FACTOR Overal survival according to stage of fibrosis in index biopsy Overal survival according to fibrosis stage and compared to control population Liver Related Mortality Younossi ZM, Stepanova M, Rafiq N, et al.. Hepatology 2011 Ekstedt M, Hagström H, Nasr P et al, Hepatology 2015
15 Stage of Fibrosis (Kleiner et al, Hepatology 2005)
16 The S.A.F. score (Steatosis-Activity-Fibrosis) Steatosis (0-3) as for NASH CRN ACTIVITY (0-4) = BALLOONING (0-2) + LOBULAR INFLAMMATION (0-2) Fibrosis (0 4) as for NASH CRN S 0-3 A 0-4 F 0-4 Histopathological algorithm and scoring system for evaluation of liver lesions in morbidly obese patients. Bedossa P, Poitou C, Veyrie N, Bouillot JL, Basdevant A, Paradis V, Tordjman J, Clement K. Hepatology Nov;56(5):1751-9
17 SAF Score S 1 A 4 F 4 S 3 A 0 F 0 SAF SCORE :. A simple and easy to understand complete evaluation 17
18 MANY SHADES IN NAFLD ACTIVITY FIBROSIS 18
19 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A1F1 19
20 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A1F1 20
21 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A3F1 21
22 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A1F1 A3F1
23 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A1F4 23
24 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A1F1 A3F1 A1F4
25 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A3F4 25
26 MANY SHADES IN NAFLD ACTIVITY FIBROSIS A1F1 A3F1 A1F4 26 A3F4
27 CHANGING THE PARADIGM A MULTIDIMENSIONAL CONTINUOUS SCALING SYSTEM STEATOSIS + A0 A1 A2 A3 A4 F0 A0F0 A1F0 A2F0 A3F0 A4F0 F1 A0F1 A1F1 A2F1 A3F1 A4F1 F2 A0F2 A1F2 A2F2 A3F2 A4F2 F3 A0F3 A1F3 A2F3 A3F3 A4F3 F4 A0F4 A1F4 A2F4 A3F4 A4F4
28 CHANGING THE PARADIGM 1. RELEVANCE FOR BIOMARKER DISCOVERY BIOMARKER OF DISEASE ACTIVITY STEATOSIS + A0 A1 A2 A3 A4 BIOMARKER OF FIBROSIS F0 A0F0 A1F0 A2F0 A3F0 A4F0 F1 A0F1 A1F1 A2F1 A3F1 A4F1 F2 A0F2 A1F2 A2F2 A3F2 A4F2 F3 A0F3 A1F3 A2F3 A3F3 A4F3 F4 A0F4 A1F4 A2F4 A3F4 A4F4
29 CHANGING THE PARADIGM 1. RELEVANCE FOR BIOMARKER DISCOVERY 2. RELEVANCE FOR PATIENT MANAGEMENT & FOLLOW-UP STEATOSIS + A0 A1 A2 A3 A4 F0 A0F0 A1F0 A2F0 A3F0 A4F0 F1 A0F1 A1F1 A2F1 A3F1 A4F1 F2 A0F2 A1F2 A2F2 A3F2 A4F2 F3 A0F3 A1F3 A2F3 A3F3 A4F3 F4 A0F4 A1F4 A2F4 A3F4 A4F4
30 CHANGING THE PARADIGM 1. RELEVANCE FOR BIOMARKER DISCOVERY 2. RELEVANCE FOR PATIENT MANAGEMENT & FOLLOW-UP STEATOSIS + A0 A1 A2 A3 A4 F0 A0F0 A1F0 A2F0 A3F0 A4F0 To release F1 A0F1 A1F1 A2F1 A3F1 A4F1 To follow-up F2 A0F2 A1F2 A2F2 A3F2 A4F2 F3 A0F3 A1F3 A2F3 A3F3 A4F3 To be treated F4 A0F4 A1F4 A2F4 A3F4 A4F4
31 ANTI-FIBROTIC CHANGING THE PARADIGM 1. RELEVANCE FOR BIOMARKER DISCOVERY 2. RELEVANCE FOR PATIENT MANAGEMENT & FOLLOW-UP 3. RELEVANCE FOR PERSONALIZED TREATMENT ANTI-INFLAMMATORY TREATMENT STEATOSIS + A0 A1 A2 A3 A4 F0 A0F0 A1F0 A2F0 A3F0 A4F0 F1 A0F1 A1F1 A2F1 A3F1 A4F1 F2 A0F2 A1F2 A2F2 A3F2 A4F2 F3 A0F3 A1F3 A2F3 A3F3 A4F3 F4 A0F4 A1F4 A2F4 A3F4 A4F4
32 CONCERNS ABOUT LIVER BIOPSY Biopsy is not a safe procedure Patient may refuse liver biopsy There is a risk of sampling error There is a risk variability in assessment between pathologists Non invasive biomarkers to replace liver biopsy Biopsy should be considered only for selected patients because it is still the gold/best standard 32
33 TAKE-HOME MESSAGES Liver biopsy is still the gold standard for diagnosis and clinical trials Non invasive test still an unmet need but strongly needed NOT TO REPLACE LIVER BIOPSY BUT TO SELECT THE SUBGROUP OF PATIENTS WHO WILL BENEFIT FROM A LIVER BIOPSY Liver biopsy will stay in the armamentarium of hepatologist in NAFLD for a while 33
34 THANK YOU FOR YOUR ATTENTION! 34
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