PHC, Paris, 30th Jan 2017 PATHOLOGY OF NAFLD. Pierre Bedossa. Departement of Pathology Hôpital Beaujon University Paris-Diderot Paris - FRANCE
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1 PHC, Paris, 30th Jan 2017 PATHOLOGY OF NAFLD Pierre Bedossa Departement of Pathology Hôpital Beaujon University Paris-Diderot Paris - FRANCE 1
2 PATHOLOGY OF NAFLD NAFLD: a chronic liver disease with a wide range of tissue lesions Liver biopsy allows an integrated evaluation of tissue damages related to various pathophysiological mechanisms Histology is central for disease definitions and prognosis in NAFLD Non invasive biomarkers are still unmet need 2
3 OUTLINES CLASSIFICATIONS OF NAFLD : INTEGRATED APPROACH (NASH CRN) ANALYTICAL APPROACH (SAF) HISTOLOGY IN CLINICAL TRIALS 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) STEATOSIS (NAFL) STEATOHEPATI TIS (NASH)
5 THE NATURAL HISTORY OF NAFLD STEATOSIS (NAFL) STEATOHEPATI TIS (NASH) FIBROSIS CIRRHO SIS HCC
6 NASH : ASSOCIATION OF HISTOLOGICAL PATTERNS STEATOSIS (NAFL) STEATOHEPATI TIS (NASH) STEATOSIS + BALLOONING + INFLAMMATION + Perisinusoidal fibrosis + Location in zone 3 FIBROSIS CIRRHO SIS HCC
7 THE LIMIT OF A DICHOTOMOUS CLASSIFICATION BORDERLI NE STEATOSIS (NAFL) STEATOHEPATI TIS (NASH)
8 THE LIMIT OF A DICHOTOMOUS CLASSIFICATION BORDERLI NE STEATOSIS (NAFL) STEATOHEPATI TIS (NASH)
9 NAFLD Activity Score (NAS, 08) STEATOSIS BALLONING 1 2 NASH CRN, Hepatology INFLAMMATION 1 2 3
10 NAFLD Activity Score (NAS, 08) Correlation between NAS and histologic diagnosis of NASH < 3: no NASH 3-4 : GREY ZONE >5 : definitively NASH NAS = Sum of lesions related to different mechanisms and with different clinical relevance (steatosis vs hepatocellular injury) Ballooning (0-2) underweighted vs steatosis (0-3) or inflammation (0-3) NAS has not been shown as a prognostic factor
11 OUTLINES CLASSIFICATIONS OF NAFLD : INTEGRATED APPROACH (NASH CRN) ANALYTICAL APPROACH (SAF) HISTOLOGY IN CLINICAL TRIALS 11
12 UNDER THE LENS : THE 3 HISTOLOGICAL COMPONENTS OF NAFLD FLIP consortium, Hepatology 2012, Hepatology 2014 STEATOSIS ACTIVITY THE MARKER THE DRIVER FIBROSIS THE KILLER 12
13 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 S0-3A0-4F0-4 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
14 STEATO SIS THE MARKER 14
15 ACTIVI TY THE DRIVER Inflammation Ballooning 15
16 HEPATOCELLULAR BALLOONING: THE HALLMARK OF NASH SHAPE + COLOR + SIZE NORMAL LIVER Ballooning 1 CK18 Ballooning 2 16
17 The FLIP algorithm NAFL NAFL NAFL NAFL NASH NASH NAFL NASH NASH 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
18 REPRODUCIBILITY OF DIAGNOSIS OF NASH WITH FLIP ALGORITHM 40 biopsies (Steatosis, NASH) 1st session (unsupervised) 2nd session (with classifier) 0.54 (moderate) 0.66 (substantial) 26/40 (65 %) 34/40 (85 %) 0.35 (fair) 0.70 (substantial) 18/40 (45 %) 34/40 (85 %) Liver Pathologists (n=6) κ score Nbr of biopsies with agreement between all pathologists General Pathologists (n=10) κ score Nbr of biopsies with agreement between all pathologists The FLIP Pathology consortium, Hepatology 2014 The definition of NASH by an association of 3 features and a clear definition of each of them make the diagnosis of NASH strongly reproducible
19 FIBROS THE IS KILLER 19
20 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
21 Stage of Fibrosis (Kleiner et al, Hepatology 2005)
22 STAGE OF FIBROSIS: ROOM FOR IMPROVEMENT
23 STAGE OF FIBROSIS: ROOM FOR IMPROVEMENT STAGE 3 / SEPTAL FIBROSIS 23
24 PATHOLOGY OF NAFLD OUTLINES CLASSIFICATION OF NAFLD : INTEGRATED APPROACH ANALYTICAL APPROACH HISTOLOGY IN CLINICAL TRIALS Histology is a validated surrogate endpoint 24
25 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 25
26 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 26 A0F1
27 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 27
28 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 28 A3F1
29 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 29
30 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 30 A0F4
31 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 31
32 MANY SHADES OF NAFLD ACTIVITY FIBROSIS 32 A3F4
33 MANY SHADES OF NAFLD ACTIVITY A0F1 A3F1 FIBROSIS A0F4 33 A3F4
34 HISTOLOGY IN NAFLD CLINICAL TRIALS STEATOSI S + 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 34
35 HISTOLOGY IN NAFLD CLINICAL TRIALS STEATOSI S + 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 35
36 HISTOLOGY IN NAFLD CLINICAL TRIALS STEATOSI S + 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 36
37 HISTOLOGY IN NAFLD CLINICAL TRIALS STEATOSI S + 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 37
38 ENDPOINT IN CLINICAL TRIALS RESOLUTION OF NASH WITHOUT WORSENING OF FIBROSIS REGRESSION OF FIBROSIS WITHOUT WORSENING OF NASH STEATOSI S + A0 A1 A2 A3 A4 F0 A0F0 A2F0 A3F0 A4F0 F1 A0F1 CU A1F0 RI N G TH A1F1 E D A2F1 A3F1 A4F1 I SE AS E F2 A0F2 A1F2 A2F2 A3F2 A4F2 F3 A0F3 A1F3 A2F3 A3F3 A4F3 F4 A0F4 A1F4 A2F4 A3F4 A4F4 38
39 PATHOLOGY OF NAFLD Take-home messages NAFLD is the combination of several features of variable intensity and of different prognostic values. The dichotomous classification NAFL vs NASH is an oversimplification which is no more relevant in clinical practice. New proposals have been formulated. NASH is defined by histological criteria. Therefore, biopsy is needed if diagnosis and evaluation of severity are required. Histology is the only accepted surrogate marker in clinical trials Non invasive markers are urgently needed
40 THANK YOU FOR YOUR ATTENTION! 40
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