New Options and Opportunities for Personalised Treatment of Primary Biliary Cholangitis: Have You Updated Your Approach?
PeerVoice
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Oct 29, 2025
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About This Presentation
David Jones, OBE, MD, PhD and David Jones, OBE, MD, PhD discuss primary biliary cholangitis in this CME activity titled "New Options and Opportunities for Personalised Treatment of Primary Biliary Cholangitis: Have You Updated Your Approach?" For the full presentation, please visit us at w...
Slide Content
PeerVoice
New Options and Opportunities for Personalised Treatment of
Primary Biliary Cholangitis: Have You Updated Your Approach?
Learning Objectives
Describe the contemporary approach to pharmacologic treatment of primary
biliary cholangitis (PBC)
Identify individuals with PBC who may benefit from initiation of second-line
treatment options or a transition in second-line treatment approach
Apply available data to guide the personalisation of second-line treatment
choice for individuals with PBC based on person- and disease-specific
characteristics (eg, presence of moderate-to-severe pruritus or compensated
cirrhosis, prior treatment with fibrates or obeticholic acid [OCA])
PeerVoice is an EBAC* accredited provider since 2022.
This program has been supported by an independent educational grant from Gilead Sciences, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, Perv
New Options and Opportunities for Personalised Treatment of
Primary Biliary Cholangitis: Have You Updated Your Approach?
Learning Objectives
Describe the contemporary approach to pharmacologic treatment of primary
biliary cholangitis (PBC)
Identify individuals with PBC who may benefit from initiation of second-line
treatment options or a transition in second-line treatment approach
Apply available data to guide the personalisation of second-line treatment
choice for individuals with PBC based on person- and disease-specific
characteristics (eg, presence of moderate-to-severe pruritus or compensated
cirrhosis, prior treatment with fibrates or obeticholic acid [OCA])
PeerVoice is an EBAC* accredited provider since 2022.
This program has been supported by an independent educational grant from Gilead Sciences, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, Perv
PeerVoice
Part 1 of 7: Contemporary Considerations for Person-Centered Care of PBC
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
a
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
Part 1 of 7: Contemporary Considerations for Person-Centered Care of PBC
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
a
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Pathophysiology of Primary Biliary Cholangitis (PBC)
Coordinated T- and B-cell—mediated
‘autoimmune cascade with T-cell
mediated BEC injury
Loss of the protective
bicarbonate-rich umbrella
‘around BECs and gradual
loss of bile ducts
Progressive
lammation and
biliary fibrosis
Cholestasis
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Pathophysiology of Primary Biliary Cholangitis (PBC)
Coordinated T- and B-cell—mediated
‘autoimmune cascade with T-cell
mediated BEC injury
Loss of the protective
bicarbonate-rich umbrella
‘around BECs and gradual
loss of bile ducts
Progressive
lammation and
biliary fibrosis
Cholestasis
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
Symptoms of PBC
7 | 23 | | Cognitive
a Pruritus Fatigue & 8
pr symptoms
Dry eyes
and mouth
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Symptoms of PBC
7 | 23 | | Cognitive
a Pruritus Fatigue & 8
pr symptoms
Dry eyes
and mouth
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
PBC: Current Treatment Paradigm
Diagnosis
Initiate UDCA (13-15 mg/kg/day)
At12 months
Assess biochemical response to UDCA
Adequate response
| Inadequate response
Second-line therapy options
y 3 + (OCA)
Continue UDCA Add second-line ||. Elafibranor
indefinitely therap + Seladelpar
+ Fibrates (off-label)
| Assess response — If complete response
Change second-line
treatment or refer
www.peervoice.com/RNT870
patient to a clinical trial
y
Ifno or incomplete
response
Continue second-line
therapı
Copyright © 2010-2025, PeerVoice
PBC: Current Treatment Paradigm
Diagnosis
Initiate UDCA (13-15 mg/kg/day)
At12 months
Assess biochemical response to UDCA
Adequate response
| Inadequate response
Second-line therapy options
y 3 + (OCA)
Continue UDCA Add second-line ||. Elafibranor
indefinitely therap + Seladelpar
+ Fibrates (off-label)
| Assess response — If complete response
Change second-line
treatment or refer
www.peervoice.com/RNT870
patient to a clinical trial
y
Ifno or incomplete
response
Continue second-line
therapı
Copyright © 2010-2025, PeerVoice
PeerVoice
PBC: Association Between Response to UDCA and Outcomes
| Patients treated with UDCA
show a longer
transplantation-free survival
than non-treated patients at
5,10, and 15 years
Monitoring biochemical liver
levels in response to UDCA
treatment is recommended in
clinical practice to monitor
disease progression and
treatment response
Lack of global standard UDCA treatment response endpoint
Rochester 6 ALP 22 x ULN or Mayo score 24.5
Barcelona 12 Decrease in ALP <40% and ALP 21 x ULN
Paris-1 12 ALP 23 x ULN or AST
22 x ULN or bilirubin 21 mg/dL
Rotterdam 12 Bilirubin 21 x ULN and/or albumin <1 x ULN
Toronto 24 ALP >1.67 x ULN
Paris-Il 12 ALP 21.5 x ULN or AST 21.5 x ULN or
: bilirubin >1 mg/dL
Ehime 6 Decrease in GGT <70% and GGT 21 x ULN
All definitions of biochemical response to UDCA were able to
differentiate responders from non-responders with respect to
survival free of liver-related events/death
com/RNTE
Copyright © 2010-2025, PeerVoice
PBC: Association Between Response to UDCA and Outcomes
| Patients treated with UDCA
show a longer
transplantation-free survival
than non-treated patients at
5,10, and 15 years
Monitoring biochemical liver
levels in response to UDCA
treatment is recommended in
clinical practice to monitor
disease progression and
treatment response
Lack of global standard UDCA treatment response endpoint
Rochester 6 ALP 22 x ULN or Mayo score 24.5
Barcelona 12 Decrease in ALP <40% and ALP 21 x ULN
Paris-1 12 ALP 23 x ULN or AST
22 x ULN or bilirubin 21 mg/dL
Rotterdam 12 Bilirubin 21 x ULN and/or albumin <1 x ULN
Toronto 24 ALP >1.67 x ULN
Paris-Il 12 ALP 21.5 x ULN or AST 21.5 x ULN or
: bilirubin >1 mg/dL
Ehime 6 Decrease in GGT <70% and GGT 21 x ULN
All definitions of biochemical response to UDCA were able to
differentiate responders from non-responders with respect to
survival free of liver-related events/death
com/RNTE
Copyright © 2010-2025, PeerVoice
PeerVoice
ELATIVE Study
Outcomes With Elafibranor vs Placebo
Biochemical Response
Eslibranor Placebo
Mans) Minzse)
»
ES
“2
Es
ES
Pm
>
°
uno
Time, wi
ALP Normaistion
bano ice
»
LE
iv»
Es
°
uam
Time, wi
www.peervoice.com/RNT870
Change in Score on the Worst Itch
Numeric Rating Seale (WI-NRS)
Patients With Moderate-to-Severe Prurtus
Po _Teutiranor 7" Pactbo
en The LS mean change did not
differ significantly between
groups (-1.93 vs -115
difference, -0.78
Cl, -1.99 to 0.42; P = 20)
LS mean change
from BL
e 0 4 8 2 620242692 36 40 44 48 82
Time, wk
Most Frequent AEs With Elafibranor vs Placebo
Event, Placebo
% of patients 3)
‘Abdominal pain m 56
Diarrhoea m 94
Nausea m 56
52 Vomiting m 18
Pruritus: 20.4 264
Copyright © 2010-2025, PeerVoice
ELATIVE Study
Outcomes With Elafibranor vs Placebo
Biochemical Response
Eslibranor Placebo
Mans) Minzse)
»
ES
“2
Es
ES
Pm
>
°
uno
Time, wi
ALP Normaistion
bano ice
»
LE
iv»
Es
°
uam
Time, wi
www.peervoice.com/RNT870
Change in Score on the Worst Itch
Numeric Rating Seale (WI-NRS)
Patients With Moderate-to-Severe Prurtus
Po _Teutiranor 7" Pactbo
en The LS mean change did not
differ significantly between
groups (-1.93 vs -115
difference, -0.78
Cl, -1.99 to 0.42; P = 20)
LS mean change
from BL
e 0 4 8 2 620242692 36 40 44 48 82
Time, wk
Most Frequent AEs With Elafibranor vs Placebo
Event, Placebo
% of patients 3)
‘Abdominal pain m 56
Diarrhoea m 94
Nausea m 56
52 Vomiting m 18
Pruritus: 20.4 264
Copyright © 2010-2025, PeerVoice
PeerVoice
RESPONSE Study: Outcomes With Seladelpar vs Placebo
Rates of Biochemical ALP Patients With BL Pruritus NRS Score 24
Response Normalisation =
wo o
23 P<.001 P<.001
ss] — — Los
ar e +
x» 8 16 15
$ so 1 5 ae P—
5 E = 26
E
& 3-3 33
Placebo Seledeiper Placebo Selber
(3/68) sas) (ores) (228) Time, mo
Most Frequent AEs With Seladelpar vs PBO Seladelpar, n = 49
Event, —— Placebo,
% of patients
COVID-19 180
Headache 78
‘Abdominal pain 70
Nausea 6.2
Abdominal distention 62
Pruritus 47
Copyright © 2010-2025,
verVoice
RESPONSE Study: Outcomes With Seladelpar vs Placebo
Rates of Biochemical ALP Patients With BL Pruritus NRS Score 24
Response Normalisation =
wo o
23 P<.001 P<.001
ss] — — Los
ar e +
x» 8 16 15
$ so 1 5 ae P—
5 E = 26
E
& 3-3 33
Placebo Seledeiper Placebo Selber
(3/68) sas) (ores) (228) Time, mo
Most Frequent AEs With Seladelpar vs PBO Seladelpar, n = 49
Event, —— Placebo,
% of patients
COVID-19 180
Headache 78
‘Abdominal pain 70
Nausea 6.2
Abdominal distention 62
Pruritus 47
Copyright © 2010-2025,
verVoice
PeerVoice
Abbreviations and References
Pathophysiology of Primary Biliary Cholangitis (PBC)
Abbreviation(s): BEC: biliary epithelial cells.
Reference(s): Leung KK et al. Aliment Pharmacol Ther. 2020:52:1150-1164.
Symptoms of PBC
Reference(s): Hirschfield GM et al. Gut. 2018;67:1568-1594.
Sivakumar T, Kowdley KV. Hepat Med. 2021;13:83-92.
PBC: Current Treatment Paradigm
Abbreviation(s): OCA: obeticholic acid; UDCA: ursodeoxycholic acid.
Reference(s): Sohal A, Kowdley KV. Hepat Med. 2023;31:63-77.
Trivella J et al. Hepatol Commun. 2023;7:e0179. doi: 101097/HC90000000000000179.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Abbreviations and References
Pathophysiology of Primary Biliary Cholangitis (PBC)
Abbreviation(s): BEC: biliary epithelial cells.
Reference(s): Leung KK et al. Aliment Pharmacol Ther. 2020:52:1150-1164.
Symptoms of PBC
Reference(s): Hirschfield GM et al. Gut. 2018;67:1568-1594.
Sivakumar T, Kowdley KV. Hepat Med. 2021;13:83-92.
PBC: Current Treatment Paradigm
Abbreviation(s): OCA: obeticholic acid; UDCA: ursodeoxycholic acid.
Reference(s): Sohal A, Kowdley KV. Hepat Med. 2023;31:63-77.
Trivella J et al. Hepatol Commun. 2023;7:e0179. doi: 101097/HC90000000000000179.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
Abbreviations and References (Cont'd)
PBC: Association Between Response to UDCA and Outcomes
Abbreviation(s): ALP: alkaline phosphatase; AST: aspartate aminotransferase; GGT: gamma-glutamyl transferase; ULN:
upper limit of normal.
Reference(s): Hirschfield GM et al J. Hepatol. 2017;67:145-172.
Kuiper EM; Dutch PBC Study Group. Gastroenterol, 2009;136:1281-1287.
Lammers WJ; Global PBC Study Group. Gastroenterol, 2015;149:1804-1812e4.
ELATIVE Study: Outcomes With Elafibranor vs Placebo
Abbreviation(s): BL: baseline; LS: least squares.
Reference(s): Kowdley KV; ELATIVE Study Investigators’ Group. N Engl J Med. 2024;390:795-805.
RESPONSE Study: Outcomes With Seladelpar vs Placebo
Abbreviation(s): LSM: least squares mean; NRS: numerical rating scale; PBO: placebo.
Reference(s): Hirschfield GM; RESPONSE Study Group. N Engl J Med. 2024;390:783-794.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Abbreviations and References (Cont'd)
PBC: Association Between Response to UDCA and Outcomes
Abbreviation(s): ALP: alkaline phosphatase; AST: aspartate aminotransferase; GGT: gamma-glutamyl transferase; ULN:
upper limit of normal.
Reference(s): Hirschfield GM et al J. Hepatol. 2017;67:145-172.
Kuiper EM; Dutch PBC Study Group. Gastroenterol, 2009;136:1281-1287.
Lammers WJ; Global PBC Study Group. Gastroenterol, 2015;149:1804-1812e4.
ELATIVE Study: Outcomes With Elafibranor vs Placebo
Abbreviation(s): BL: baseline; LS: least squares.
Reference(s): Kowdley KV; ELATIVE Study Investigators’ Group. N Engl J Med. 2024;390:795-805.
RESPONSE Study: Outcomes With Seladelpar vs Placebo
Abbreviation(s): LSM: least squares mean; NRS: numerical rating scale; PBO: placebo.
Reference(s): Hirschfield GM; RESPONSE Study Group. N Engl J Med. 2024;390:783-794.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
Part 2 of 7: ls Timing Everything?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
a
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-2025, Peervoi
Part 2 of 7: ls Timing Everything?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
a
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-2025, Peervoi
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Nico: 32-Year-Old Male With Fatigue and Pruritu:
Patient Case #1
Presentation Lab tests
+ Long and lasting moderate fatigue LFTs Values Virology tests
+ Moderate pruritus since 2022 ALP (U/L) 455 + Anti-lgG HAV Abs: negative
. . + Anti-igG EBV Abs: negative
Eurer va ved vert erw) | 354 ||. HBV, HCV, HEV, HIV, CMV:
+ No signs or symptoms of decompensated liver disease i
= ALT (U/L) 62 De
+ Nosigns of jaundice =
+ AMAL +++
+ ANA: ++
+ pANCA: negative
+ ASMA: negative
+ Nosigns of cirrhosis PT-INR 10
Medical and family history PLTs: 280 x 10%L
's: 280 x
No previous medical history
Healthy and athletic
IgM: 36 g/L
IgG: 9.3 g/L
Father and aunt were diagnosed with PBC at age 46
and 42 years, respectively
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Nico: 32-Year-Old Male With Fatigue and Pruritu:
Patient Case #1
Presentation Lab tests
+ Long and lasting moderate fatigue LFTs Values Virology tests
+ Moderate pruritus since 2022 ALP (U/L) 455 + Anti-lgG HAV Abs: negative
. . + Anti-igG EBV Abs: negative
Eurer va ved vert erw) | 354 ||. HBV, HCV, HEV, HIV, CMV:
+ No signs or symptoms of decompensated liver disease i
= ALT (U/L) 62 De
+ Nosigns of jaundice =
+ AMAL +++
+ ANA: ++
+ pANCA: negative
+ ASMA: negative
+ Nosigns of cirrhosis PT-INR 10
Medical and family history PLTs: 280 x 10%L
's: 280 x
No previous medical history
Healthy and athletic
IgM: 36 g/L
IgG: 9.3 g/L
Father and aunt were diagnosed with PBC at age 46
and 42 years, respectively
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PeerVoice
Nico: 32-Year-Old Male Diagnosed With PBC
Patient Case #1
Abdominal ultrasound
+ Smooth liver surface with normal parenchyma
+ Spleen size 13.2 cm
+ Normal portal venous flow
+ No bile duct dilatation or stone formation
Imaging
+ TE: 10.2 kPa (F3)
First-line treatment
+ UDCA 15 mg/kg/day
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Nico: 32-Year-Old Male Diagnosed With PBC
Patient Case #1
Abdominal ultrasound
+ Smooth liver surface with normal parenchyma
+ Spleen size 13.2 cm
+ Normal portal venous flow
+ No bile duct dilatation or stone formation
Imaging
+ TE: 10.2 kPa (F3)
First-line treatment
+ UDCA 15 mg/kg/day
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Nico: Reassessment 12 Mo
Patient Case #1
Lab tests
TB
mg/
120
DB
mg/dL.
091
AST
<20 UI!
58
+
<20 UL
62
GGT
<40U
354
P <100
[077
455
‘Glob
g/dl
173
058
076
189
324
152
081
0.87
221
243
074
076
154
294
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
Nico: Reassessment 12 Mo
Patient Case #1
Lab tests
TB
mg/
120
DB
mg/dL.
091
AST
<20 UI!
58
+
<20 UL
62
GGT
<40U
354
P <100
[077
455
‘Glob
g/dl
173
058
076
189
324
152
081
0.87
221
243
074
076
154
294
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
PeerVoice
Young Age as a Prognostic Factor in PBC
Pruritus Severity Fatigue Severity Response to UDCA at 24 Months
_ (VAS)! (PBC-40)2 (Paris | Criteria)?
Ss gu po
E 5
B
a Es 7
8 8 y
A E És
2a Eos ¿
En $ ba
7 2
fo Ê s o
à «80 31- 4041- 5051-6061-70 > 70 «30 31- 4041- 5051-6061-70 > 70 <30 31-4041- 5051-6061-70 >70
Ago at Diagnosis Ago at Diagnosis Ago at Diagnosis
"P €.08:1P « 0001: Chi square = 558; P < 0001
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Young Age as a Prognostic Factor in PBC
Pruritus Severity Fatigue Severity Response to UDCA at 24 Months
_ (VAS)! (PBC-40)2 (Paris | Criteria)?
Ss gu po
E 5
B
a Es 7
8 8 y
A E És
2a Eos ¿
En $ ba
7 2
fo Ê s o
à «80 31- 4041- 5051-6061-70 > 70 «30 31- 4041- 5051-6061-70 > 70 <30 31-4041- 5051-6061-70 >70
Ago at Diagnosis Ago at Diagnosis Ago at Diagnosis
"P €.08:1P « 0001: Chi square = 558; P < 0001
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PeerVoice
Male Sex as a Prognostic Factor in PBC
Liver-Related Death or Transplant in Males vs Females
Diagnostic delays (36 vs 12 months)
Fewer PBC-associated symptoms
e
Less response to treatment
e
ES
More progression to cirrhosis
Higher velocity to cirrhotic decompensation
Probability
o
ES
Higher risk of death or transplant (8.5 vs 3.8 per 100 PY)
More frequency of HCC (0.9 vs 0.3 per 100 PY)
9
o 2 4 6 8 0
jated with more severe liver involvement, an increased risk of developing
d for liver transplantation
prognosis linked to higt
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Male Sex as a Prognostic Factor in PBC
Liver-Related Death or Transplant in Males vs Females
Diagnostic delays (36 vs 12 months)
Fewer PBC-associated symptoms
e
Less response to treatment
e
ES
More progression to cirrhosis
Higher velocity to cirrhotic decompensation
Probability
o
ES
Higher risk of death or transplant (8.5 vs 3.8 per 100 PY)
More frequency of HCC (0.9 vs 0.3 per 100 PY)
9
o 2 4 6 8 0
jated with more severe liver involvement, an increased risk of developing
d for liver transplantation
prognosis linked to higt
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Prognostic Value of LSM in PBC
Mortality or Liver Transplantation (LT)
International multicentre PBC cohort 20:
+ 5323 reliable liver stiffness measurements (LSMs) ©
2 5
+ 2736 UDCA-treated patients ES
E
+ Median follow-up: 41 years 3 2
1
+ Deaths: 145; (liver-related, 62) = 08
+ Liver transplantation: 51
or
LSM aHR 95% Cl C-stati
5 10 15 20 25 30 35 40 as 50
Mortality or LT 1046 | 1033-1060 085 Esta pa)
Linear relation between LSM an
Mortality or liver= = f ortality or LT
related complications | 1941 | 1028-1054 pes z
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Prognostic Value of LSM in PBC
Mortality or Liver Transplantation (LT)
International multicentre PBC cohort 20:
+ 5323 reliable liver stiffness measurements (LSMs) ©
2 5
+ 2736 UDCA-treated patients ES
E
+ Median follow-up: 41 years 3 2
1
+ Deaths: 145; (liver-related, 62) = 08
+ Liver transplantation: 51
or
LSM aHR 95% Cl C-stati
5 10 15 20 25 30 35 40 as 50
Mortality or LT 1046 | 1033-1060 085 Esta pa)
Linear relation between LSM an
Mortality or liver= = f ortality or LT
related complications | 1941 | 1028-1054 pes z
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POISE: Response at 1 Year Stratified by ALP Threshold at 6
Months
ALP at 6 mo and
POISE criteria at 1 y
N=744
6 months
Response
1year 53/50 n = 25/235 (11%)
5-year survival 95.1% 85.6%
ALP, x ULN | — 101(0.80-128) 148 (112-172) 313 (236-431) 215 (199-255)
ALP normalisation 220 (54.2%) 16 (15.5%) 1(0.5%) 0 (0.0%)
Response probability | 0.90 0.73-0.96) 0.75 (0.57-0.89) 0.29 (0.14-0.49) 0.39 (0.21-0.74)
Copyright © 2010-2025, PeerVoice
POISE: Response at 1 Year Stratified by ALP Threshold at 6
Months
ALP at 6 mo and
POISE criteria at 1 y
N=744
6 months
Response
1year 53/50 n = 25/235 (11%)
5-year survival 95.1% 85.6%
ALP, x ULN | — 101(0.80-128) 148 (112-172) 313 (236-431) 215 (199-255)
ALP normalisation 220 (54.2%) 16 (15.5%) 1(0.5%) 0 (0.0%)
Response probability | 0.90 0.73-0.96) 0.75 (0.57-0.89) 0.29 (0.14-0.49) 0.39 (0.21-0.74)
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PBC: Earlier Assessment to UDCA Response
10. 30 = M6 mo overall
en 1 12 mo overall
8 25 eii M6 mo cirrhotics
3 3 20. 100 12 mo cirrhotics
56 > 6 monon-cirhotics
à 4 5 90] |m 12 mo non-cirrhotics | à 20%
ES 8 © 80 206 Pa 69
: = 5 È 200%
o o g 70 Er
BL 6mo ly 2 BL 6mo ty 2 3 aus 2108%
y 2y mo ly 2y 2.5 Pa 10 P=02
Time Time BOO] 498% mn 277%
P06 5
8 50
6 8 &
Eso
5
6 2
z z
34 3 30
55 ES 20
= Sa 0
o o o
BL 6mo ly 2y 6mo ly 2y Toronto POISE
Time
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Time
Copyright © 2010-2025, Peer
PBC: Earlier Assessment to UDCA Response
10. 30 = M6 mo overall
en 1 12 mo overall
8 25 eii M6 mo cirrhotics
3 3 20. 100 12 mo cirrhotics
56 > 6 monon-cirhotics
à 4 5 90] |m 12 mo non-cirrhotics | à 20%
ES 8 © 80 206 Pa 69
: = 5 È 200%
o o g 70 Er
BL 6mo ly 2 BL 6mo ty 2 3 aus 2108%
y 2y mo ly 2y 2.5 Pa 10 P=02
Time Time BOO] 498% mn 277%
P06 5
8 50
6 8 &
Eso
5
6 2
z z
34 3 30
55 ES 20
= Sa 0
o o o
BL 6mo ly 2y 6mo ly 2y Toronto POISE
Time
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Time
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PeerVoice
Abbreviations and References
Nico: 32-Year-Old Male With Fatigue and Pruritus
Abbreviation(s): Abs: antibodies; ALT: alanine transaminase; ALP: alkaline phosphatase; AMA: antimitochondrial
antibodies; ANA: antinuclear antibody; ASMA: anti-smooth muscle antibody; CMV: cytomegalovirus; EBV: Epstein-Barr
virus; GGT: gamma-glutamyl transferase; HAV: hepatitis A virus; HBV: hepatitis 8 virus; HCV: hepatitis C virus; HEV:
hepatitis E virus; HIV: human immunodeficiency virus; immunoglobulit : international normalised rati
function test; PANCA: perinuclear antineutrophil cytoplasmic antibodies; PBC: primary biliary cholangitis; PLT: platelet;
Nico: 32-Year-Old Male Diagnosed With PBC
Abbreviation(s): TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Nico: Reassessment 12 Months Later
Abbreviation(s): ALB: albumin; AST aspartate aminotransferase; BL: baseline; DB: direct bilirubin; y-Glob: gamma
globulin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2026.
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Abbreviations and References
Nico: 32-Year-Old Male With Fatigue and Pruritus
Abbreviation(s): Abs: antibodies; ALT: alanine transaminase; ALP: alkaline phosphatase; AMA: antimitochondrial
antibodies; ANA: antinuclear antibody; ASMA: anti-smooth muscle antibody; CMV: cytomegalovirus; EBV: Epstein-Barr
virus; GGT: gamma-glutamyl transferase; HAV: hepatitis A virus; HBV: hepatitis 8 virus; HCV: hepatitis C virus; HEV:
hepatitis E virus; HIV: human immunodeficiency virus; immunoglobulit : international normalised rati
function test; PANCA: perinuclear antineutrophil cytoplasmic antibodies; PBC: primary biliary cholangitis; PLT: platelet;
Nico: 32-Year-Old Male Diagnosed With PBC
Abbreviation(s): TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Nico: Reassessment 12 Months Later
Abbreviation(s): ALB: albumin; AST aspartate aminotransferase; BL: baseline; DB: direct bilirubin; y-Glob: gamma
globulin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2026.
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Abbreviations and References (Cont'd)
Young Age as a Prognostic Factor in PBC
Abbreviation(s): VAS: visual analogue scale.
Reference(s): Carbone M et al. Gastroenterol. 2013;144:560-569. doi: 10.1053/jgastro.201212.005.
Male Sex as a Prognostic Factor in PBC
Abbreviation(s): HCC: hepatocellular carcinoma; PY: person years.
Reference(s): Abdulkarim M et al. Scand J Gastroenterol. 2019;54:1391-1396.
John BV et al. Hepatol, 2021:74:879-891.
Natarajan Y et al. Dig Dis Sci. 2021,66:2439-2451.
Prognostic Value of LSM in PBC.
Reference(s): Corpechot C et al. J Hepatol. 2021:75(2):5226-S227.
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Abbreviations and References (Cont'd)
Young Age as a Prognostic Factor in PBC
Abbreviation(s): VAS: visual analogue scale.
Reference(s): Carbone M et al. Gastroenterol. 2013;144:560-569. doi: 10.1053/jgastro.201212.005.
Male Sex as a Prognostic Factor in PBC
Abbreviation(s): HCC: hepatocellular carcinoma; PY: person years.
Reference(s): Abdulkarim M et al. Scand J Gastroenterol. 2019;54:1391-1396.
John BV et al. Hepatol, 2021:74:879-891.
Natarajan Y et al. Dig Dis Sci. 2021,66:2439-2451.
Prognostic Value of LSM in PBC.
Reference(s): Corpechot C et al. J Hepatol. 2021:75(2):5226-S227.
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Abbreviations and References (Cont'd)
POISE: Response at 1 Year Stratified by ALP Threshold at 6 Months
Abbreviation(s): ULN: upper limit of normal.
Reference(s): Murillo Perez CF et al. Liver Int. 2023;7:1497-1506.
PBC: Earlier Assessment to UDCA Response
Reference(s): Cangado GGL et al. Dig Dis Sci. 2023;68:514-520.
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Abbreviations and References (Cont'd)
POISE: Response at 1 Year Stratified by ALP Threshold at 6 Months
Abbreviation(s): ULN: upper limit of normal.
Reference(s): Murillo Perez CF et al. Liver Int. 2023;7:1497-1506.
PBC: Earlier Assessment to UDCA Response
Reference(s): Cangado GGL et al. Dig Dis Sci. 2023;68:514-520.
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Part 3 of 7: Where Do We Set the Bar?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
A.
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
Part 3 of 7: Where Do We Set the Bar?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
A.
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
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PeerVoice
Berta: 37-Year-Old Female With Moderate Fatigue and Pruritus
Patient Case #2
Presentation (2023)
+ Moderate fatigue
+ Moderate pruritus
+ No symptoms of decompensated liver disease
Physical examination
+ No signs of jaundice
+ Liver not palpable
+ No signs of cirrhosis
Medical and family history
Acute hepatitis A (1994)
Scleroderma
Occasional use of antihistamines for pruritus
No history of alcohol or drug abuse
Lab tests
LFTs Values
ALP (U/L) 325
GGT (U/L) 165
ALT (U/L) 80
TB (mg/dL) | 21
ALB (g/L) 40
PT-INR 10
Virology tests
+ Anti-igG HAV Abs: positive
+ HBV, HCV, HIV: negative
Additional blood tests
AMA: +++
ANA: ++
PANCA: negative
ASMA: negative
IgM: 19 g/L.
186: 37 g/L
PLTs: 180 x 10°/L
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Berta: 37-Year-Old Female With Moderate Fatigue and Pruritus
Patient Case #2
Presentation (2023)
+ Moderate fatigue
+ Moderate pruritus
+ No symptoms of decompensated liver disease
Physical examination
+ No signs of jaundice
+ Liver not palpable
+ No signs of cirrhosis
Medical and family history
Acute hepatitis A (1994)
Scleroderma
Occasional use of antihistamines for pruritus
No history of alcohol or drug abuse
Lab tests
LFTs Values
ALP (U/L) 325
GGT (U/L) 165
ALT (U/L) 80
TB (mg/dL) | 21
ALB (g/L) 40
PT-INR 10
Virology tests
+ Anti-igG HAV Abs: positive
+ HBV, HCV, HIV: negative
Additional blood tests
AMA: +++
ANA: ++
PANCA: negative
ASMA: negative
IgM: 19 g/L.
186: 37 g/L
PLTs: 180 x 10°/L
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Berta: 37-Year-Old Female Diagnosed With PBC
Patient Case #2
Abdominal ultrasound
Smooth liver surface with normal parenchyma
Normal spleen size
Normal portal venous flow
No bile duct dilatation or stone formation
Imaging
+ TE: 10.2 kPa > advanced fibrosis stage (F3)
First-line treatment
+ UDCA 13 mg/kg/d
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Berta: 37-Year-Old Female Diagnosed With PBC
Patient Case #2
Abdominal ultrasound
Smooth liver surface with normal parenchyma
Normal spleen size
Normal portal venous flow
No bile duct dilatation or stone formation
Imaging
+ TE: 10.2 kPa > advanced fibrosis stage (F3)
First-line treatment
+ UDCA 13 mg/kg/d
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Berta: Reassessment 12 Months Later
Patient Case #2
Imaging
+ TE: 10.6 kPa > advanced fibrosis stage (F3)
Lab tests
BT/DB
mg/dL
1.0/0.3
AST
10 UI/L
61
ALT
<20 UI/L
80
GGT
<40 ui!
165
ALP <100
U/L
325
1.0/0.3
54
57
87
243
1.0/0.3
43
44
76
154
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Berta: Reassessment 12 Months Later
Patient Case #2
Imaging
+ TE: 10.6 kPa > advanced fibrosis stage (F3)
Lab tests
BT/DB
mg/dL
1.0/0.3
AST
10 UI/L
61
ALT
<20 UI/L
80
GGT
<40 ui!
165
ALP <100
U/L
325
1.0/0.3
54
57
87
243
1.0/0.3
43
44
76
154
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PeerVoice
Association of ALP and Bilirubin Values With PBC Outcomes
Survival Estimates in Patients With
Normal and Abnormal Levels of ALP
100
oo; y ALP sI x ULN
100
20
80 60
a ALP 1.67-3.0 x ULN
Survival, %
60
2 Abnormal bilirubin
so
5 3
Follow-Up, y
5 9
Follow-Up, y
Survival Estimates in Patients With
Normal and Abnormal Levels of Bilirubin
Normal bilirubin (<06 x ULN)
Normal bilirubin (>06 = ULN)
liver transplantation or death in patients with PBC
Attaining bilirubin levels <0.6 x ULN or normal ALP is associated with the lowest risk for
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Copyright © 2010-2025, PeerVoice
Association of ALP and Bilirubin Values With PBC Outcomes
Survival Estimates in Patients With
Normal and Abnormal Levels of ALP
100
oo; y ALP sI x ULN
100
20
80 60
a ALP 1.67-3.0 x ULN
Survival, %
60
2 Abnormal bilirubin
so
5 3
Follow-Up, y
5 9
Follow-Up, y
Survival Estimates in Patients With
Normal and Abnormal Levels of Bilirubin
Normal bilirubin (<06 x ULN)
Normal bilirubin (>06 = ULN)
liver transplantation or death in patients with PBC
Attaining bilirubin levels <0.6 x ULN or normal ALP is associated with the lowest risk for
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PeerVoice
In Which Patients With PBC Is Normalisation of ALP Critical?
Complication-Free Survival Functions for Normal-ALP and Abnormal-ALP Groups
Depending on LSM at Entry
3 os
E
5
2 06
5
z
5 04 usm «10 kee À a A
3 — ALP[10;15] x ULN
& 02 LSM 210 kPa { — ARS IG UN
— ALP[10;1.5] x ULN
Patients with advanced
from complete norm:
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In Which Patients With PBC Is Normalisation of ALP Critical?
Complication-Free Survival Functions for Normal-ALP and Abnormal-ALP Groups
Depending on LSM at Entry
3 os
E
5
2 06
5
z
5 04 usm «10 kee À a A
3 — ALP[10;15] x ULN
& 02 LSM 210 kPa { — ARS IG UN
— ALP[10;1.5] x ULN
Patients with advanced
from complete norm:
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Abbreviations and References
Berta: 37-Year-Old Female With Moderate Fatigue and Pruritus
Abbreviation(s): Abs: antibodies; ALB: albumin; ALT: alanine transaminase; ALP: alkaline phosphatase; AMA:
antimitochondrial antibodies; ANA: antinuclear antibody; ASMA: anti-smooth muscle antibody; GGT: gamma-glutamyl
transferase; HAV: hepatitis A virus; HBV: hepatitis B virus; HCV: hepatitis C virus; HIV: human immunodeficiency virus; lg:
immunoglobul ternational normalised rati FT: r function test; pANCA: perinuclear antineutrophil
cytoplasmic antibodies; PLT: platelet; PT: prothrombin time; TB: total bilirubin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Berta: 37-Year-Old Female Diagnosed With PBC.
Abbreviation(s): PBC: primary biliary cholangitis; TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Berta: Reassessment 12 Months Later
Abbreviation(s): AST aspartate aminotransferase; BL: baseline; BT: total bilirubin; DB: direct bilirubin; y-Glob: gamma
globulin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Abbreviations and References
Berta: 37-Year-Old Female With Moderate Fatigue and Pruritus
Abbreviation(s): Abs: antibodies; ALB: albumin; ALT: alanine transaminase; ALP: alkaline phosphatase; AMA:
antimitochondrial antibodies; ANA: antinuclear antibody; ASMA: anti-smooth muscle antibody; GGT: gamma-glutamyl
transferase; HAV: hepatitis A virus; HBV: hepatitis B virus; HCV: hepatitis C virus; HIV: human immunodeficiency virus; lg:
immunoglobul ternational normalised rati FT: r function test; pANCA: perinuclear antineutrophil
cytoplasmic antibodies; PLT: platelet; PT: prothrombin time; TB: total bilirubin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Berta: 37-Year-Old Female Diagnosed With PBC.
Abbreviation(s): PBC: primary biliary cholangitis; TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Berta: Reassessment 12 Months Later
Abbreviation(s): AST aspartate aminotransferase; BL: baseline; BT: total bilirubin; DB: direct bilirubin; y-Glob: gamma
globulin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
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PeerVoice
Abbreviations and References (Cont'd)
Association of ALP and Bilirubin Values With PBC Outcomes
Abbreviation(s): ULN: upper limit of normal.
Reference(s): Murillo Perez CF et al. Am J Gastroenterol. 2020;115:1066-1074.
In Which Patients With PBC Is Normalisation of ALP Critical?
Abbreviation(s): LSM: liver stiffness measurement.
Reference(s): Corpechot C et al. Hepatology. 2024:79:39-48.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Abbreviations and References (Cont'd)
Association of ALP and Bilirubin Values With PBC Outcomes
Abbreviation(s): ULN: upper limit of normal.
Reference(s): Murillo Perez CF et al. Am J Gastroenterol. 2020;115:1066-1074.
In Which Patients With PBC Is Normalisation of ALP Critical?
Abbreviation(s): LSM: liver stiffness measurement.
Reference(s): Corpechot C et al. Hepatology. 2024:79:39-48.
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PeerVoice
Part 4 of 7: What About Symptom Control?
A.
mi
David Jones, OBE, MD, PhD Alejandra Villamil, MD
Professor of Liver Immunology Professor Medicine
Newcastle University Universidad de Buenos Aires
Consultant Hepatologist Director Liver Autoimmunity Unit
Freeman Hospital Hospital Italiano de Buenos Aires
Newcastle upon Tyne, Buenos Aires, Argentina
Tyne & Wear, United Kingdom
Copyright © 2010-202
Part 4 of 7: What About Symptom Control?
A.
mi
David Jones, OBE, MD, PhD Alejandra Villamil, MD
Professor of Liver Immunology Professor Medicine
Newcastle University Universidad de Buenos Aires
Consultant Hepatologist Director Liver Autoimmunity Unit
Freeman Hospital Hospital Italiano de Buenos Aires
Newcastle upon Tyne, Buenos Aires, Argentina
Tyne & Wear, United Kingdom
Copyright © 2010-202
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Freya: 45-Year-Old Female Diagnosed With PBC
Patient Case #3
Presentation Lab tests
e GIO ALT GGT ALP | TB | PLTs
E it (um) (U) (U/L) (mg/dL) (x 10%L)
Severe itch (U/L) ( U/L) (mg/dL) («10 wren
+ Hypothyroid (adequately replaced)
+ Mother has PBC Treatment
+ UDCA at a dose of 15 mg/kg/d
+ Antihistamines from GP for itch
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Freya: 45-Year-Old Female Diagnosed With PBC
Patient Case #3
Presentation Lab tests
e GIO ALT GGT ALP | TB | PLTs
E it (um) (U) (U/L) (mg/dL) (x 10%L)
Severe itch (U/L) ( U/L) (mg/dL) («10 wren
+ Hypothyroid (adequately replaced)
+ Mother has PBC Treatment
+ UDCA at a dose of 15 mg/kg/d
+ Antihistamines from GP for itch
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
PBC-Specific Tools for Measuring Health-Related Quality of Life
PBC-Specific Questionnaires
(Number of questions per domain;
answers are rated from 1-5, where 1 = best possible
answer and 5 = worst possible answer)
Pruritus-Specific Tools
Items / Dimensions
* Questions about dry mouth and dry eyes are included in the
symptom domain.
www.peervoice.com/RNT870
E PBC-40 PBC-10
Domains Go) (CES item; measures | O (no itch) to 10
Pruritus NRS | itch intensity over | (worst imaginable
‘Symptoms | 7 2 24 hr itch)
Dryness | = - item; measures | O (no itch) to 10
TR | 3 1 PBCWINRS | itch intensity over | (worst imaginable
24hr itch)
| i El 5 dimensions O(noitch) to 5
6 1 = (duration, degree, | (worst itch) for 4
| a 5 $-D Itch Scale | direction, disability, | dimensions except
distribution) for distribution
Emotional 3
Copyright © 2010-2025, PeerVoice
PBC-Specific Tools for Measuring Health-Related Quality of Life
PBC-Specific Questionnaires
(Number of questions per domain;
answers are rated from 1-5, where 1 = best possible
answer and 5 = worst possible answer)
Pruritus-Specific Tools
Items / Dimensions
* Questions about dry mouth and dry eyes are included in the
symptom domain.
www.peervoice.com/RNT870
E PBC-40 PBC-10
Domains Go) (CES item; measures | O (no itch) to 10
Pruritus NRS | itch intensity over | (worst imaginable
‘Symptoms | 7 2 24 hr itch)
Dryness | = - item; measures | O (no itch) to 10
TR | 3 1 PBCWINRS | itch intensity over | (worst imaginable
24hr itch)
| i El 5 dimensions O(noitch) to 5
6 1 = (duration, degree, | (worst itch) for 4
| a 5 $-D Itch Scale | direction, disability, | dimensions except
distribution) for distribution
Emotional 3
Copyright © 2010-2025, PeerVoice
PeerVoice
Freya: Reassessment 12 Months Later
Patient Case #3
Presentation
+ No significant improvement in fatigue or itch (pruritus
NRS 6.9 [BL 7.2])
+ Feels socially isolated, which leads to symptoms of
depression
Lab tests
ALT | C ALP TB PLTS
(U/L) (U/L) (U/L) (mg/dL) (x109/L)
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
Freya: Reassessment 12 Months Later
Patient Case #3
Presentation
+ No significant improvement in fatigue or itch (pruritus
NRS 6.9 [BL 7.2])
+ Feels socially isolated, which leads to symptoms of
depression
Lab tests
ALT | C ALP TB PLTS
(U/L) (U/L) (U/L) (mg/dL) (x109/L)
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
PeerVoice
ASSURE OLE Study: Effect of Seladelpar vs PBO on Pruritu
Mean change from baseline in weekly averaged pruritus NRS among patients with
moderate-to-severe baseline pruritus in RESPONSE rollover patients
RESPONSE Rollover Patients
” RESPONSE ASSURE
3 I Placebo
8. I Continuous seladelpar
2
E M Crossover seladelpar
A
2
5
Ê
E
5
H
=
<
at 6 ue 6 ®
Time on Treatment, mo®
"Month 13,1, and 1 indicate ASSURE months 1,3, and 6
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
ASSURE OLE Study: Effect of Seladelpar vs PBO on Pruritu
Mean change from baseline in weekly averaged pruritus NRS among patients with
moderate-to-severe baseline pruritus in RESPONSE rollover patients
RESPONSE Rollover Patients
” RESPONSE ASSURE
3 I Placebo
8. I Continuous seladelpar
2
E M Crossover seladelpar
A
2
5
Ê
E
5
H
=
<
at 6 ue 6 ®
Time on Treatment, mo®
"Month 13,1, and 1 indicate ASSURE months 1,3, and 6
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
ELATIVE Study: Effect of Elafibra
rvs PBO on Pruritu
aa
E
"EE
80% aay
El
À
:
3 |
: LA
Eva
=
‘Baseline Wook 52 Baseline Weck 52
Elafibranor
Proportion of Patients
eer PBO-
improved | 667% | 444%
No change | 238% | 278%
worsened | 9.5% | 278%
NH = LI
em
ze
PA
50%
ne
40%
a 22
208
om
Baceine Wook 52 Baseine Wook 52
Elafibranor Placebo
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
ELATIVE Study: Effect of Elafibra
rvs PBO on Pruritu
aa
E
"EE
80% aay
El
À
:
3 |
: LA
Eva
=
‘Baseline Wook 52 Baseline Weck 52
Elafibranor
Proportion of Patients
eer PBO-
improved | 667% | 444%
No change | 238% | 278%
worsened | 9.5% | 278%
NH = LI
em
ze
PA
50%
ne
40%
a 22
208
om
Baceine Wook 52 Baseine Wook 52
Elafibranor Placebo
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
PeerVoice
Abbreviations and References
Freya: 45-Year-Old Female Diagnosed With PBC
Abbreviation(s): ALT: alanine transaminase; ALP: alkaline phosphatase; BL: baseline; GGT: gamma-glutamyl transferase;
GP: general practitioner; PBC: primary biliary cholangitis; PLT: platelet; TB: total bilirubin; UDCA; ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2026.
PBC-Specific Tools for Measuring Health-Related Quality of Life
Abbreviation(s): NRS: numeric rating scale; WI: worst itch
Reference(s): Ai X et al. Scand J Gastroenterol. 2022;57:333-339,
Alrubaiy L; UK-PBC Research Consortium. Aliment Pharmacol Ther. 2019;50:1223-1231.
Elman S et al. Br J Dermatol. 2010;162:587-593.
Jacoby A et al. Gut. 2005;54:1622-1629.
Montali L; Italian-Japanese PBC Study Group. Dig Liver Dis. 2010;42:718-723,
Schattenberg J et al. J Hepatol. 2023;78:S995.
Freya: Reassessment 12 Months Later
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Abbreviations and References
Freya: 45-Year-Old Female Diagnosed With PBC
Abbreviation(s): ALT: alanine transaminase; ALP: alkaline phosphatase; BL: baseline; GGT: gamma-glutamyl transferase;
GP: general practitioner; PBC: primary biliary cholangitis; PLT: platelet; TB: total bilirubin; UDCA; ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2026.
PBC-Specific Tools for Measuring Health-Related Quality of Life
Abbreviation(s): NRS: numeric rating scale; WI: worst itch
Reference(s): Ai X et al. Scand J Gastroenterol. 2022;57:333-339,
Alrubaiy L; UK-PBC Research Consortium. Aliment Pharmacol Ther. 2019;50:1223-1231.
Elman S et al. Br J Dermatol. 2010;162:587-593.
Jacoby A et al. Gut. 2005;54:1622-1629.
Montali L; Italian-Japanese PBC Study Group. Dig Liver Dis. 2010;42:718-723,
Schattenberg J et al. J Hepatol. 2023;78:S995.
Freya: Reassessment 12 Months Later
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Abbreviations and References (Cont'd)
ASSURE OLE Study: Effect of Seladelpar vs PBO on Pruritus
Abbreviation(s): OLE: open label extension; PBO: placebo.
Reference(s): Levy C et al. Am J Gastroenterol. 2025 Jun 24. [ePub ahead of print]
doi: 1014309/ajg0000000000003603
ELATIVE Study: Effect of Elafibranor vs PBO on Pruritus
Reference(s): Kremer AE et al. European Association for the Study of the Liver Congress 2024 (EASL 2024). Abstract
LBP-028.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Abbreviations and References (Cont'd)
ASSURE OLE Study: Effect of Seladelpar vs PBO on Pruritus
Abbreviation(s): OLE: open label extension; PBO: placebo.
Reference(s): Levy C et al. Am J Gastroenterol. 2025 Jun 24. [ePub ahead of print]
doi: 1014309/ajg0000000000003603
ELATIVE Study: Effect of Elafibranor vs PBO on Pruritus
Reference(s): Kremer AE et al. European Association for the Study of the Liver Congress 2024 (EASL 2024). Abstract
LBP-028.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
Part 5 of 7: Is There More We Can Do?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
a
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-2025, Peervoi
Part 5 of 7: Is There More We Can Do?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
a
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-2025, Peervoi
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Lyla: 57-Year-Old Female Diagnosed With Asymptomatic PBC
Patient Case #4
Presentation Lab tests
+ Diagnosed with PBC after a routine check-up showed ALT GGT ALP TB T=
abnormal LFT values (U/L) (U/L) (USL) (mg/dL) («10°/L)
man [ape [os [aos] o | ze |
+ TE: 10.6 kPa at diagnosis
First-line treatment
+ UDCA at a dose of 13 mg/kg/d
www.peervoice.com/RNT870 Copyright © 2010-2025,
Lyla: 57-Year-Old Female Diagnosed With Asymptomatic PBC
Patient Case #4
Presentation Lab tests
+ Diagnosed with PBC after a routine check-up showed ALT GGT ALP TB T=
abnormal LFT values (U/L) (U/L) (USL) (mg/dL) («10°/L)
man [ape [os [aos] o | ze |
+ TE: 10.6 kPa at diagnosis
First-line treatment
+ UDCA at a dose of 13 mg/kg/d
www.peervoice.com/RNT870 Copyright © 2010-2025,
PeerVoice
Lyla: Reassessment 12 Months Later
Patient Case #4
Lab tests Imaging
Asal REG A ATEN Were ES + TE:9.3 kPa; remained essentially unchanged at 12 mo
(U/L) (U/L) (U/L) (mg/dL) (x109/L) follow-up
UDCA second-line treatment
+ Bezafibrate: 400 mg daily
281 | 10 | 2a |
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Lyla: Reassessment 12 Months Later
Patient Case #4
Lab tests Imaging
Asal REG A ATEN Were ES + TE:9.3 kPa; remained essentially unchanged at 12 mo
(U/L) (U/L) (U/L) (mg/dL) (x109/L) follow-up
UDCA second-line treatment
+ Bezafibrate: 400 mg daily
281 | 10 | 2a |
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Lyla: Reassessment 18 Months After Initial Presentation
Patient Case #4
Lab tests Imaging
+ TE:9.5 kPa; remained unchanged at 18 mo follow-up
voca Next steps?
Bezafibrate
<=
?
u
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Lyla: Reassessment 18 Months After Initial Presentation
Patient Case #4
Lab tests Imaging
+ TE:9.5 kPa; remained unchanged at 18 mo follow-up
voca Next steps?
Bezafibrate
<=
?
u
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
RESPONSE and ASSURE: Composite Biochemical Response by
Prior Treatment Status
Prior Treatment With Fibrates/OCA No Prior Treatment With Fibrates/OCA
100 100
an RESPONSE ASSUR| = RESPONSE ASSURE
833 33<
320 so 39 80
SEX Ste
558 528
< 82 60 <32 co
aT Tr
2885 22885
aoe ¿8%
o o
1369 203050 13692 B 15 B
Time, mo Time, mo
Seladelpar 10 mg m Crossover to 10 mg M Placebo
www.peervoice.com/RNT870 Copyright © 2010-2025,
RESPONSE and ASSURE: Composite Biochemical Response by
Prior Treatment Status
Prior Treatment With Fibrates/OCA No Prior Treatment With Fibrates/OCA
100 100
an RESPONSE ASSUR| = RESPONSE ASSURE
833 33<
320 so 39 80
SEX Ste
558 528
< 82 60 <32 co
aT Tr
2885 22885
aoe ¿8%
o o
1369 203050 13692 B 15 B
Time, mo Time, mo
Seladelpar 10 mg m Crossover to 10 mg M Placebo
www.peervoice.com/RNT870 Copyright © 2010-2025,
PeerVoice
Abbreviations and References
Lyla: 57-Year-Old Female Diagnosed With Asymptomatic PBC
phosphatase; BL: baseline; GGT: gamma-glutamyl transferase;
: total bilirubin; TE: transient elastography; UDCA:
Abbreviation(s): ALT: alanine transaminase; ALP: alkali
LFT: liver function test; PBC: primary biliary cholangitis; PLT: platelet;
ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Lyla: Reassessment 12 Months Later
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025,
Lyla: Reassessment 18 Months After Initial Presentation
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
RESPONSE and ASSURE: Composite Biochemical Response by Prior Treatment Status
Abbreviation(s): OCA: obeticholic acid.
Reference(s): Villamil A et al. European Association for the Study of the Liver Congress 2025 (EASL 2025). Abstract
THU-274.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Abbreviations and References
Lyla: 57-Year-Old Female Diagnosed With Asymptomatic PBC
phosphatase; BL: baseline; GGT: gamma-glutamyl transferase;
: total bilirubin; TE: transient elastography; UDCA:
Abbreviation(s): ALT: alanine transaminase; ALP: alkali
LFT: liver function test; PBC: primary biliary cholangitis; PLT: platelet;
ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Lyla: Reassessment 12 Months Later
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025,
Lyla: Reassessment 18 Months After Initial Presentation
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
RESPONSE and ASSURE: Composite Biochemical Response by Prior Treatment Status
Abbreviation(s): OCA: obeticholic acid.
Reference(s): Villamil A et al. European Association for the Study of the Liver Congress 2025 (EASL 2025). Abstract
THU-274.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Part 6 of 7: Can We Intervene in Compensated Cirrhosis?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
A.
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
Part 6 of 7: Can We Intervene in Compensated Cirrhosis?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
A.
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Amanda: 61-Year-Old Female Diagnosed With PBC
Patient Case #5
Presentation (2022)
+ Peripheral oedema LETS Virology tests
+ Long standing fatigue ALP (U/L) + Anti-IgG HAV, CMV Abs, HBS-
Ag: positive
auth’) 4 + HBV, HCV, HEV, HIV: negative
ALT (U/L) 48
Weight: 58 k
oa 14 IED) 23 Additional blood tests
Height: 163 m AMA
ALB (g/L) 39 ANA ++
A PT-INR 09 PANCA: negative
Liver not palpable ASMA: negative
No collateral circulation PLTS: 149 x 10°/L IgM: 26 g/L
IgG: 9.3 g/L
+ Mild pruritus,
Physical examination
No signs of jaundice
Medical and family history
+ Hypercholesterolaemia managed with eze:
+ No history of drug abuse
+ 1-2 alcoholic drinks/week
www.peervoice.com/RNT870 Copyright © 2010-2025,
erVeice
Amanda: 61-Year-Old Female Diagnosed With PBC
Patient Case #5
Presentation (2022)
+ Peripheral oedema LETS Virology tests
+ Long standing fatigue ALP (U/L) + Anti-IgG HAV, CMV Abs, HBS-
Ag: positive
auth’) 4 + HBV, HCV, HEV, HIV: negative
ALT (U/L) 48
Weight: 58 k
oa 14 IED) 23 Additional blood tests
Height: 163 m AMA
ALB (g/L) 39 ANA ++
A PT-INR 09 PANCA: negative
Liver not palpable ASMA: negative
No collateral circulation PLTS: 149 x 10°/L IgM: 26 g/L
IgG: 9.3 g/L
+ Mild pruritus,
Physical examination
No signs of jaundice
Medical and family history
+ Hypercholesterolaemia managed with eze:
+ No history of drug abuse
+ 1-2 alcoholic drinks/week
www.peervoice.com/RNT870 Copyright © 2010-2025,
erVeice
PeerVoice
manda: 61-Year-Old Female Diagnosed With PBC (Cont'd)
Patient Case #5
Abdominal ultrasound First-line treatment
Nodular hepatic contour, enlarged caudate lobe and + UDCA 13 mg/kg/day
left lobe lateral segment + Diuretics + carvedilol 3.125 mg/day
Spleen size: 17.2 em
Enlarged portal vein
No bile duct dilatation or stone formation
Imaging
+ TE:18.0 kPa > cirrhosis (F4)
+ Gastroscopy: Varices grade Il; mild gastropathy
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
manda: 61-Year-Old Female Diagnosed With PBC (Cont'd)
Patient Case #5
Abdominal ultrasound First-line treatment
Nodular hepatic contour, enlarged caudate lobe and + UDCA 13 mg/kg/day
left lobe lateral segment + Diuretics + carvedilol 3.125 mg/day
Spleen size: 17.2 em
Enlarged portal vein
No bile duct dilatation or stone formation
Imaging
+ TE:18.0 kPa > cirrhosis (F4)
+ Gastroscopy: Varices grade Il; mild gastropathy
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Amanda: Reassessment 12 Months Later
Patient Case #5
Lab tests
<20 UN!
39
GGT
<40 Ul/!
n
LP «100
[0778
241
32
72
189
63
El]
155
Imaging
+ Oedema control
+ — TE:274kPa (previously 18.0 kPa)
+ US:Noascites
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
Amanda: Reassessment 12 Months Later
Patient Case #5
Lab tests
<20 UN!
39
GGT
<40 Ul/!
n
LP «100
[0778
241
32
72
189
63
El]
155
Imaging
+ Oedema control
+ — TE:274kPa (previously 18.0 kPa)
+ US:Noascites
www.peervoice.com/RNT870
Copyright © 2010-2025, PeerVoice
PeerVoice
RESPONSE Study: Outcomes in Patients With or Without
Cirrhosis
www.peervoice.com/RNT870
Patients With Response, %
Composite Biochemical Endpoint at
Month 12 According to Subpopulations
100
so 655
60
222
40
M Seladelpar 10 mg
WM Placebo
20
o
n/N= 2/9 78 1/56 72/10
With Without
Cirrhosis Cirrhosis
n=27 n=166
Copyright © 2010-2025, PeerVoice
RESPONSE Study: Outcomes in Patients With or Without
Cirrhosis
www.peervoice.com/RNT870
Patients With Response, %
Composite Biochemical Endpoint at
Month 12 According to Subpopulations
100
so 655
60
222
40
M Seladelpar 10 mg
WM Placebo
20
o
n/N= 2/9 78 1/56 72/10
With Without
Cirrhosis Cirrhosis
n=27 n=166
Copyright © 2010-2025, PeerVoice
PeerVoice
SPONSE Study: Change From Baseline in ALP
Patients With Cirrhosis Patients Without Cirrhosis
a a
5 5
El E]
zw 23.2 <u
Es sa -18.0
as ag
qe 1214 32 104.8
E E
5 E
£ 2
ö ö
Time, mo
-0- Seladelpar 10 mg —0- Placebo
Rapid
*P<.0001,** P «05.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
SPONSE Study: Change From Baseline in ALP
Patients With Cirrhosis Patients Without Cirrhosis
a a
5 5
El E]
zw 23.2 <u
Es sa -18.0
as ag
qe 1214 32 104.8
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Time, mo
-0- Seladelpar 10 mg —0- Placebo
Rapid
*P<.0001,** P «05.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
y: AEs in Patients With and Without Cirrhosis
Live
AEs, n (%)
With cirrhosis | Seladelpar 10mg | 18 2(1) o o
(n=27) Placebo 9 2 (22) 1m) o
Without cirrhosis | Seladelpar 10 mg | 110 6 (5) 8(7) o
(n=166) Placebo 56 4(7) am o
+ Two patients with cirrhosis receiving seladelpar experienced liver-related AEs (hepatomegaly and
ascites, both Grade 1); the patient with ascites subsequently developed an SAE of oesophageal
varices haemorrhage (Grade 3)
+ Allmuscle-related AEs in the seladelpar group were Grade 1-2 and not associated with creatine
kinase (Ck) changes
+ No renal impairment was observed in patients with or without cirrhosis
Copyright © 2010-2025, PeerVoice
y: AEs in Patients With and Without Cirrhosis
Live
AEs, n (%)
With cirrhosis | Seladelpar 10mg | 18 2(1) o o
(n=27) Placebo 9 2 (22) 1m) o
Without cirrhosis | Seladelpar 10 mg | 110 6 (5) 8(7) o
(n=166) Placebo 56 4(7) am o
+ Two patients with cirrhosis receiving seladelpar experienced liver-related AEs (hepatomegaly and
ascites, both Grade 1); the patient with ascites subsequently developed an SAE of oesophageal
varices haemorrhage (Grade 3)
+ Allmuscle-related AEs in the seladelpar group were Grade 1-2 and not associated with creatine
kinase (Ck) changes
+ No renal impairment was observed in patients with or without cirrhosis
Copyright © 2010-2025, PeerVoice
PeerVoice
ELATIVE Study: Outcomes in Patients With or Without
Advanced Fibrosis
Mean liver stiffness, kPa 107+89 | 101:82
>10 kPa, no (%) 31(80) 17 (80) 48 (31)
Bridging fibrosis or cirrhosis, no (%) 128) 8(50) 20 (43)
19 (50)
r stiffness >10 kPa or bridging fibrosis/cirrhosis (or both), no (%) | 35 (104) (34) (88) 54 (154) (35)
'Percentages are based on evaluable patients with available date (denominators in parentheses).
Subgroup Analysis for the Primary Endpoint
Subgroup
Cirrhotic at BL (No) ——
HU
——
ranor 80 mg >
20 0 2 40 60 80 100
Risk Difference, % (95% Cl)
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
ELATIVE Study: Outcomes in Patients With or Without
Advanced Fibrosis
Mean liver stiffness, kPa 107+89 | 101:82
>10 kPa, no (%) 31(80) 17 (80) 48 (31)
Bridging fibrosis or cirrhosis, no (%) 128) 8(50) 20 (43)
19 (50)
r stiffness >10 kPa or bridging fibrosis/cirrhosis (or both), no (%) | 35 (104) (34) (88) 54 (154) (35)
'Percentages are based on evaluable patients with available date (denominators in parentheses).
Subgroup Analysis for the Primary Endpoint
Subgroup
Cirrhotic at BL (No) ——
HU
——
ranor 80 mg >
20 0 2 40 60 80 100
Risk Difference, % (95% Cl)
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PeerVoice
Abbreviations and References
Amanda: 61- Year-Old Female Diagnosed With PBC
Abbreviation(s): Abs: antibodies; ALB: albumin; ALT: alanine transaminase; ALP: alkaline phosphatase; AMA:
antimitochondrial antibodies; ANA: antinuclear antibody; ASMA; anti-smooth muscle antibody; CMV: cytomegalovirus;
GGT: gamma-glutamyl transferase; HAV: hepatitis A virus; HBS-Ag: hepatitis B surface antigen; HBV: hepatitis B virus;
HCV: hepatitis C virus; HEV: hep: E virus; HIV: human immunodeficiency virus; Ig: immunoglobulin; INR: international
normalised ratio; LFT: liver function test; PANCA: perinuclear antineutrophil cytoplasmic antibodies; PBC: primary biliary
cholangitis; PLT: platelet; PT: prothrombin time; TB: total bilirubin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Amanda: 61-Year-Old Female Diagnosed With PBC (Cont'd)
Abbreviation(s): TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Amanda: Reassessment 12 Months Later
Abbreviation(s): AST aspartate aminotransferase; BL: baseline; BT: total bilirubin; DB: direct bilirubin; y-Glob: gamma
globulin; US: ultrasound; 2L: second-line.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Abbreviations and References
Amanda: 61- Year-Old Female Diagnosed With PBC
Abbreviation(s): Abs: antibodies; ALB: albumin; ALT: alanine transaminase; ALP: alkaline phosphatase; AMA:
antimitochondrial antibodies; ANA: antinuclear antibody; ASMA; anti-smooth muscle antibody; CMV: cytomegalovirus;
GGT: gamma-glutamyl transferase; HAV: hepatitis A virus; HBS-Ag: hepatitis B surface antigen; HBV: hepatitis B virus;
HCV: hepatitis C virus; HEV: hep: E virus; HIV: human immunodeficiency virus; Ig: immunoglobulin; INR: international
normalised ratio; LFT: liver function test; PANCA: perinuclear antineutrophil cytoplasmic antibodies; PBC: primary biliary
cholangitis; PLT: platelet; PT: prothrombin time; TB: total bilirubin.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Amanda: 61-Year-Old Female Diagnosed With PBC (Cont'd)
Abbreviation(s): TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
Amanda: Reassessment 12 Months Later
Abbreviation(s): AST aspartate aminotransferase; BL: baseline; BT: total bilirubin; DB: direct bilirubin; y-Glob: gamma
globulin; US: ultrasound; 2L: second-line.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Abbreviations and References (Cont'd)
RESPONSE Study: Outcomes in Patients With or Without Cirrhosis
Reference(s): Hirschfield GM; RESPONSE Study Group. N Engl J Med. 2024;390:783-794.
RESPONSE Study: Change From Baseline in ALP
Abbreviation(s): LS: least squares; SE: standard error.
Reference(s): Villamil A et al. American Association for the Study of Liver Diseases The Liver Meeting 2024 (AASLD
2024). Presentation 164.
RESPONSE Study: AEs in Patients With and Without Cirrhosis
Abbreviation(s): SAE: serious adverse event.
Reference(s): Villamil A et al. American Association for the Study of Liver Diseases The Liver Meeting 2024 (AASLD
2024). Presentation 164.
ELATIVE Study: Outcomes in Patients With or Without Advanced Fibrosis
Abbreviation(s): PBO: placebo.
Reference(s): Kowdley KV; ELATIVE Study Investigators’ Group. N Engl J Med. 2024;390:795-805.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
Abbreviations and References (Cont'd)
RESPONSE Study: Outcomes in Patients With or Without Cirrhosis
Reference(s): Hirschfield GM; RESPONSE Study Group. N Engl J Med. 2024;390:783-794.
RESPONSE Study: Change From Baseline in ALP
Abbreviation(s): LS: least squares; SE: standard error.
Reference(s): Villamil A et al. American Association for the Study of Liver Diseases The Liver Meeting 2024 (AASLD
2024). Presentation 164.
RESPONSE Study: AEs in Patients With and Without Cirrhosis
Abbreviation(s): SAE: serious adverse event.
Reference(s): Villamil A et al. American Association for the Study of Liver Diseases The Liver Meeting 2024 (AASLD
2024). Presentation 164.
ELATIVE Study: Outcomes in Patients With or Without Advanced Fibrosis
Abbreviation(s): PBO: placebo.
Reference(s): Kowdley KV; ELATIVE Study Investigators’ Group. N Engl J Med. 2024;390:795-805.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Part 7 of 7: Are There Additional Benefits?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
A.
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
Part 7 of 7: Are There Additional Benefits?
David Jones, OBE, MD, PhD
Professor of Liver Immunology
Newcastle University
Consultant Hepatologist
Freeman Hospital
Newcastle upon Tyne,
Tyne & Wear, United Kingdom
A.
mi
Alejandra Villamil, MD
Professor Medicine
Universidad de Buenos Aires
Director Liver Autoimmunity Unit
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Copyright © 2010-202
PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
David Jones, OBE, MD, PhD, has a financial interest/relationship or affiliation in the form of:
Consultant for Advanz Pharma Corp; Ipsen Biopharmaceuticals, Inc.;
and Umecrine Cognition AB.
Grant/Research Support from Intercept Pharmaceuticals, Inc.
j Speakers Bureau participant with Advanz Pharma Corp; Dr. Falk Pharma GmbH; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Advisory Board for Kowa Company, Ltd. and Umecrine Cognition AB.
Speaker or participant in accredited CME/CPD for Advanz Pharma Corp.; GSK plc.;
and Ipsen Biopharmaceuticals, Inc.
Alejandra Villamil, MD, has a financial interest/relationship or affiliation in the form of:
A. Grant/Research Support from Gilead Sciences, Inc.; GSK plc.; Intercept Pharmaceuticals, Inc.;
L Ipsen Biopharmaceuticals, Inc.; and Mirum Pharma.
y Speakers Bureau participant with Gilead Sciences, Inc. and Intercept Pharmaceuticals, Inc.
Advisory Board for Gilead Sciences, Inc.; Intercept Pharmaceuticals, Inc.; and Mirum Pharma.
Speaker or participant in accredited CME/CPD for Gilead Sciences, Inc. and Intercept
Pharmaceuticals, Inc.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVoice
PeerVoice
Ben: 69-Year-Old Male Non-Responder to UDCA
Patient Case #6
Presentation (2022)
+ Asymptomatic PBC diagnosed during a routine check-up
Medical history
+ Hypercholesterolaemia; not on any medication
Imaging
+ TE (2022): 6.5 kPa
+ TE (2028): 8.5 kPa
Treatment
+ 2022: UDCA 15 mg/kg/d
+ 2023: bezafibrate; good response
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Ben: 69-Year-Old Male Non-Responder to UDCA
Patient Case #6
Presentation (2022)
+ Asymptomatic PBC diagnosed during a routine check-up
Medical history
+ Hypercholesterolaemia; not on any medication
Imaging
+ TE (2022): 6.5 kPa
+ TE (2028): 8.5 kPa
Treatment
+ 2022: UDCA 15 mg/kg/d
+ 2023: bezafibrate; good response
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
RESPONSE Study: Lipid Changes in Patients With or Without
Lipid-Modifying Therapies
Total Cholesterol
No Statin Use Statin Use
Change From BL, %,
LS Mean + SE
Change From BL, %,
LS Mean = SE
-0- Seladelpar 10mg —0- Placebo
*P «0001; ** P «05.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
RESPONSE Study: Lipid Changes in Patients With or Without
Lipid-Modifying Therapies
Total Cholesterol
No Statin Use Statin Use
Change From BL, %,
LS Mean + SE
Change From BL, %,
LS Mean = SE
-0- Seladelpar 10mg —0- Placebo
*P «0001; ** P «05.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
PeerVoice
ELATIVE Study: Lipid Changes in Patients With or With
Lipid-Modifying Therapies
Without Lipid-Modifying Therapies
Total Cholesterol, mg/dL.
With Lipid-Modifying Therapies
Total Cholesterol, mg/dL.
25 ER
58 28
08 5 —@- Elafibranor oe
£2 -20 £2
£a —@- Placebo $3
ze % 28 =e
22 -20 (-23.3 to -2.4) 22
Le -227 e E (217003) -22
(-30.1 to -15.3) (-38.6 to 34.2)
n 79 a n 15 6
LS mean difference with PBO:
-9.86 2 to 2.91)
8
www.peervoice.com/RNT870
LS mean difference with PBO:
-2.99 (-45.54 to 39.56)
P=.8837
Copyright © 2010-2025, PeerVoice
ELATIVE Study: Lipid Changes in Patients With or With
Lipid-Modifying Therapies
Without Lipid-Modifying Therapies
Total Cholesterol, mg/dL.
With Lipid-Modifying Therapies
Total Cholesterol, mg/dL.
25 ER
58 28
08 5 —@- Elafibranor oe
£2 -20 £2
£a —@- Placebo $3
ze % 28 =e
22 -20 (-23.3 to -2.4) 22
Le -227 e E (217003) -22
(-30.1 to -15.3) (-38.6 to 34.2)
n 79 a n 15 6
LS mean difference with PBO:
-9.86 2 to 2.91)
8
www.peervoice.com/RNT870
LS mean difference with PBO:
-2.99 (-45.54 to 39.56)
P=.8837
Copyright © 2010-2025, PeerVoice
PeerVoice
Abbreviations and References
Ben: 69-Year-Old Male Non-Responder to UDCA
Abbreviation(s): PBC: primary biliary cholangitis; TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
RESPONSE Study: Lipid Changes in Patients With or Without Lipid-Modifying Therapies
Abbreviation(s): BL: baseline; LS: least squares; SE: standard error.
Reference(s): Bowlus CL et al. American Association for the Study of Liver Diseases The Liver Meeting 2023 (AASLD
2023). Presentation 4342.
ELATIVE Study: Lipid Changes in Patients With or Without Lipid-Modifying Therapies
Abbreviation(s): PBO: placebo.
Reference(s): Mayo MJ et al. European Association for the Study of the Liver Congress 2024 (EASL 2024). Poster P21.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
Abbreviations and References
Ben: 69-Year-Old Male Non-Responder to UDCA
Abbreviation(s): PBC: primary biliary cholangitis; TE: transient elastography; UDCA: ursodeoxycholic acid.
Reference(s): Personal communication: David Jones, OBE, MD, PhD, Alejandra Villamil, MD; October 2025.
RESPONSE Study: Lipid Changes in Patients With or Without Lipid-Modifying Therapies
Abbreviation(s): BL: baseline; LS: least squares; SE: standard error.
Reference(s): Bowlus CL et al. American Association for the Study of Liver Diseases The Liver Meeting 2023 (AASLD
2023). Presentation 4342.
ELATIVE Study: Lipid Changes in Patients With or Without Lipid-Modifying Therapies
Abbreviation(s): PBO: placebo.
Reference(s): Mayo MJ et al. European Association for the Study of the Liver Congress 2024 (EASL 2024). Poster P21.
www.peervoice.com/RNT870 Copyright © 2010-2025, PeerVaice
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