autoimmune and cholestatic liver diseases - gastrofoundation€¦ · cholestatic liver diseases...
TRANSCRIPT
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Autoimmune and cholestatic liver diseases
Prof. Tom Hemming KarlsenResearch Institute of Internal Medicine &
Department of Transplantation Medicine
University of Oslo & Oslo University Hospital, Norway
Johannesburg 24th of November 2018
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www.easl.eu
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ous-research.no/nopsc
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A changing landscape of liver research
(Karlsen and Tacke, 2018)
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Viral hepatitis elimination and public health
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How to accomplish HBV cure?
(Lok et al., 2017)
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The race for new NAFLD drugs to market
(Konermann et al., 2017)
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The race for new NAFLD drugs to market
(Konermann et al., 2017)
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Liver oncology and new drugs in HCC
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So what about autoimmune and cholestatic?
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Primary biliary cholangitis
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Barcelona (ALP 40% decrease or normalization) – 39%
Paris (ALP<3ULN, AST<2ULN, bilirubin<1mg/dl) – 39%
Rotterdam (bilirubin and albumin normalization) – 24%
Toronto (ALP <1.67ULN and/or bilirubin <1mg/dl) – 43%
Mayo (ALP<2ULN or bilirubin 1mg/dl) – 52%
New algorithms occurring regularly
Ursodeoxycholic acid in PBC
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UDCA without biochemical improvement?
Harms et al., EASL 2018
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OCA – phase II and phase III studies
Hirschfield et al., 2015
Nevens et al., 2016
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Pruritus and obeticholic acid
Hirschfield et al., 2015
Nevens et al., 2016
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OCA in cirrhosis – FDA (September 2017)
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EMA dosing recommendation (February 2018)
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Tropifexor – non-bile acid FXR agonist
Schramm et al., EASL 2018
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Bezafibrate (pan-PPAR agonist)
Corpechot et al., NEJM 2018
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Bezafibrate (pan-PPAR agonist)
Corpechot et al., NEJM 2018
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Seladelpar (selective PPARδ agonist)
Jones et al., 2017
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Seladelpar (selective PPARδ agonist)
Hirschfield et al., AASLD 2017
Hirschfield et al., AASLD 2018
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Budesonide (GR and PXR agonist)
(Hirschfield et al., EASL 2018)
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Symptoms management in PBC
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Symptoms - patient involvement
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Complications - patient awareness
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Autoimmune hepatitis
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Standard management in AIH
www.easl.eu
*Treatment probably no longer indicated in decompensated, burn-outcirrhosis, unless high inflammatory score on liver biopsy
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Liver cirrhosis at presentation?
Subclinical disease preceding diagnosis
1/3 adults and 1/2 children cirrhosis at diagnosis
Response in cirrhosis similar, but slower?
Decompensated cirrhosis? (consider HAI)
Gronbaek et al., 2014
n=1,318
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Standard management in AIH
www.easl.eu
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Treat to what end-point?
Luth et al., 2008
Dhaliwal et al., 2015
www.easl.eu
Biochemical remission: normalization of IgG and transaminases
Histological remission: normal histology or HAI < 4 or equivalent
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Treatment >3 years and >2 years following biochemical remission
A liver biopsy should be considered prior to treatment withdrawal
In patients with HAI>3, treatment should not be discontinued
Surveillance continued life-long (frequently during first 12 months)
50-90% of the patients relapse (depending on observation time)
If relapse occurs, life-long immunosuppression advisable
Withdrawal of treatment ?
Montano-Loza et al., 2007
www.easl.eu
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„Difficult to treat“ AIH
www.easl.eu
Intolerance to treatment
Azathioprine: Prednisolone monotherapy? Mycophenolate?
Prednisolone: Budesonide?
Referral for individualized therapy
Incomplete response
Consider diagnosis, concomitant liver disease?
Consider compliance (e.g. 6TGN)
Increasing the dose of azathioprine to 2 mg/kg/day?
Referral for individualized therapy (e.g. CNI, infliximab)
Complete response may not be attainable in some patients
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Principles of 2nd line therapy
Hennes et al., 2008
Tolerance ↑ Failure ↓
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Liberal et al., 2017
Survey – 2nd line (IAIHG)
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Liberal et al., 2017
Survey – 2nd line (IAIHG)
Novartis in Phase II: Anti-BAFF (B-cell-activating
factor) monoclonal antibody
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Primary sclerosing cholangitis
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Is ursodeoxycholic acid helpful in PSC?
(Olsson et al., 2005)
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(Lindor et al., 2009)
Is ursodeoxycholic acid harmful in PSC?
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Ursodeoxycholic acid in PSC?
(Karlsen et al., AP&T 2014, IPSCSG survey)
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norUDCA in PSC
Trauner et al., JHEP 2017
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Obeticholic acid in PSC
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Cowdley et al., AASLD
2017
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GS-9674 in PSC (non-steroidal FXR)
Trauner et al., AASLD 2018
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NGM282 in PSC (FGF19 analog)
Hirschfield et al., EASL 2018
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Simtuzumab phase II data
Muir et al., EASL 2017
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Vedolizumab real life data in PSC
Williamson et al., EASL 2018
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Antibiotics in PSC – therapy or proof-of-concept?
(Tabibian et al., 2013)
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Recurrent PSC – role of the colon?
(Alabraba et al. 2009, Ravikumar et al. 2015, Lindström et al. 2018 Joshi, et al., 2011)
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PSC as a model disease for gut-liver interactions
(Hov and Karlsen, Semin Liv Dis 2017)
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Four important Kaplan-Meier plots for PSC
(URQ – Oslo, ULQ – IPSCSG, LRQ – Mendes et al. 2008 , LLQ – Boonstra et al. 2013)
Tra
ns
pla
nt
fre
es
urv
iva
l(O
slo
)
Years after diagnosis of PSC
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Cholangiocarcinoma surveillance
(Karlsen et al., 2017)
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Surveillance for malignancy
(Boonstra et al., 2013)
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From morphology to molecular diagnoses
Bile – methylation markers Urine – peptide/protein markers Blood – microRNA markers
(Karlsen et al. 2017, Eaton et al. 2015, Andresen et al. 2015, Metzger et al. 2013, Bernuzzi et al. 2016)
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Digitial medicine and AI
(Eric Topol, @erictopol)
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A changing landscape of liver research
(Karlsen and Tacke, 2018)
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A changing landscape of liver research
(Manns et al., Nat Rev Dis Prim 2017)
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A changing landscape of liver research
(Manns et al., Nat Rev Dis Prim 2017)
PBC
AIH
PSC
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Take home messages
- Treatment in PBC, AIH and PSC is still “antique”
- Second line therapies in PBC: bezafibrate vs. OCA
- Second line therapy in AIH: expert opinion recommendations only
- PSC signals from antibiotics and bile acid therapeutics
- Surveillance and biomarkers challenging, digital medicine and AI