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Tutorial

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Poll

What more is needed to optimize management of PBC?

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More first-line treatment options
   
Additional treatment options in the second-line
   
Therapies with greater antipruritic effect
   
More data on new therapies to guide decision-making
   

Tutorial

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Poll

What investigational class do you think may impact future treatment of PBC the most?

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Ileal bile acid transporter (IBAT) inhibitors
   
NADPH oxidase (NOX) 1 and 4 inhibitors
   
Peroxisome proliferator-activated receptor (PPAR) agonists
   
Another class
   

Tutorial

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Poll

What do you find most challenging when risk-stratifying patients with PBC?

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Timely access to required investigations
   
Interpreting and integrating results from multiple investigations
   
Objective symptom assessment
   
Determining risk group thresholds
   
 
Expert Interviews
Liver Disorders CE/CME accredited

touchEXPERT OPINIONS
Experts answer questions with in-depth advice on the current clinical landscape and how new therapies and guidance might impact regional clinical practice. Useful tips below will show how to navigate the activity. Close

Primary biliary cholangitis: Appraising the changing therapeutic landscape

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Dr Mitchell L Shiffman is the director of the Liver Institute of Virginia at Bon Secours Mercy Health, Richmond, VA, USA, which he founded in 2010. read more

He graduated from the State University of New York Upstate Medical Center in Syracuse before completing residency training in internal medicine and a fellowship training in gastroenterology and hepatology at the Medical College of Virginia in Richmond. From 1990 to 2009, Dr Shiffman was chief of the Hepatology Section and medical director of the Liver Transplant Program at the Virginia Commonwealth University Medical Center in Richmond.

Dr Shiffman has published over 350 articles in peer- reviewed medical journals, invited reviews and/or book chapters; has edited three textbooks on liver disease; and has been the guest editor for two issues of Clinics in Liver Disease.

He is a fellow of the American Association for the Study of Liver Diseases (AASLD), was a member of the board of trustees of the American College of Gastroenterology (ACG) from 2004 to 2010, and has been recognized as a Master Physician of the ACG.

Dr Mitchell L Shiffman discloses: Advisory board or panel fees from CymaBay, Exelixis, Gilead, HepQuant, Intercept, Ipsen and Mirum. Grants/research support from 89 Bio, Akero, Altimmune, Camurus, Durect, Galectin, Genentech, Gilead, HepQuant, Hamni, High Tide, Intercept, Inventiva, Ipsen, Madrigal, Mirum, Novo Nordisk, Oncoustics, Pliant, Salix, Viking Therapeutics and Zydus. Speaker Bureau fees from Genentech, Gilead, Intercept, Ipsen, Madrigal and Mallinckrodt.

Take CE/CME Test

Dr Mitchell L Shiffman is the director of the Liver Institute of Virginia at Bon Secours Mercy Health, Richmond, VA, USA, which he founded in 2010. read more

He graduated from the State University of New York Upstate Medical Center in Syracuse before completing residency training in internal medicine and a fellowship training in gastroenterology and hepatology at the Medical College of Virginia in Richmond. From 1990 to 2009, Dr Shiffman was chief of the Hepatology Section and medical director of the Liver Transplant Program at the Virginia Commonwealth University Medical Center in Richmond.

Dr Shiffman has published over 350 articles in peer- reviewed medical journals, invited reviews and/or book chapters; has edited three textbooks on liver disease; and has been the guest editor for two issues of Clinics in Liver Disease.

He is a fellow of the American Association for the Study of Liver Diseases (AASLD), was a member of the board of trustees of the American College of Gastroenterology (ACG) from 2004 to 2010, and has been recognized as a Master Physician of the ACG.

Dr Mitchell L Shiffman discloses: Advisory board or panel fees from CymaBay, Exelixis, Gilead, HepQuant, Intercept, Ipsen and Mirum. Grants/research support from 89 Bio, Akero, Altimmune, Camurus, Durect, Galectin, Genentech, Gilead, HepQuant, Hamni, High Tide, Intercept, Inventiva, Ipsen, Madrigal, Mirum, Novo Nordisk, Oncoustics, Pliant, Salix, Viking Therapeutics and Zydus. Speaker Bureau fees from Genentech, Gilead, Intercept, Ipsen, Madrigal and Mallinckrodt.

Take CE/CME Test

Dr Mitchell L Shiffman is the director of the Liver Institute of Virginia at Bon Secours Mercy Health, Richmond, VA, USA, which he founded in 2010. read more

He graduated from the State University of New York Upstate Medical Center in Syracuse before completing residency training in internal medicine and a fellowship training in gastroenterology and hepatology at the Medical College of Virginia in Richmond. From 1990 to 2009, Dr Shiffman was chief of the Hepatology Section and medical director of the Liver Transplant Program at the Virginia Commonwealth University Medical Center in Richmond.

Dr Shiffman has published over 350 articles in peer- reviewed medical journals, invited reviews and/or book chapters; has edited three textbooks on liver disease; and has been the guest editor for two issues of Clinics in Liver Disease.

He is a fellow of the American Association for the Study of Liver Diseases (AASLD), was a member of the board of trustees of the American College of Gastroenterology (ACG) from 2004 to 2010, and has been recognized as a Master Physician of the ACG.

Dr Mitchell L Shiffman discloses: Advisory board or panel fees from CymaBay, Exelixis, Gilead, HepQuant, Intercept, Ipsen and Mirum. Grants/research support from 89 Bio, Akero, Altimmune, Camurus, Durect, Galectin, Genentech, Gilead, HepQuant, Hamni, High Tide, Intercept, Inventiva, Ipsen, Madrigal, Mirum, Novo Nordisk, Oncoustics, Pliant, Salix, Viking Therapeutics and Zydus. Speaker Bureau fees from Genentech, Gilead, Intercept, Ipsen, Madrigal and Mallinckrodt.

Take CE/CME Test
  • Select in the video player controls bar to choose subtitle language. Subtitles available in English, Spanish.
  • A practice aid is available for this activity in the Toolkit
  • Downloads including slides are available for this activity in the Toolkit
Learning Objectives

After watching this activity, participants should be better able to:

  • Describe the objectives of PBC treatment in the first line and how patients are risk stratified
  • Discuss treatment sequencing approaches to optimize outcomes in patients with PBC
  • Recall the latest data for new and emerging treatments for PBC
Overview

A renowned expert in hepatology, Dr Mitchell L Shiffman, explores the current and future management of primary biliary cholangitis, including approaches to risk stratification and first-line therapy, treatment sequencing to optimize patient outcomes, and the latest on emerging therapies.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

Hepatologists, gastroenterologists, nurses, nurse practitioners and primary care physicians involved in the management of primary biliary cholangitis.

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty

Dr Mitchell L Shiffman discloses: Advisory board or panel fees from CymaBay, Exelixis, Gilead, HepQuant, Intercept, Ipsen and Mirum. Grants/research support from 89 Bio, Akero, Altimmune, Camurus, Durect, Galectin, Genentech, Gilead, HepQuant, Hamni, High Tide, Intercept, Inventiva, Ipsen, Madrigal, Mirum, Novo Nordisk, Oncoustics, Pliant, Salix, Viking Therapeutics and Zydus. Speaker Bureau fees from Genentech, Gilead, Intercept, Ipsen, Madrigal and Mallinckrodt.

Content reviewer

Danielle Walker, DNP, APRN, AGNP-C, nurse reviewer and planner, has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Contributors

Sola Neunie has no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu

Accreditations

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Nurses

USF Health is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

A maximum of 0.75 contact hours may be earned by learners who successfully complete this continuing professional development activity. USF Health, the accredited provider, acknowledges touchIME as the joint provider in the planning and execution of this CNE activity.

This activity is awarded 0.75 ANCC pharmacotherapeutic contact hour.

Date of original release: 21 November 2024. Date credits expire: 21 November 2025.

If you have any questions regarding credit, please contact cpdsupport@usf.edu

This activity is CE/CME accredited

To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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  • Select in the video player controls bar to choose subtitle language. Subtitles available in English, Spanish.
  • A practice aid is available for this activity in the Toolkit
  • Downloads including slides are available for this activity in the Toolkit

Topics covered in this activity

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touchEXPERT OPINIONS
Primary biliary cholangitis: Appraising the changing therapeutic landscape
0.75 CE/CME credit

Question 1/4
When assessing patients with newly diagnosed PBC to determine their pre-treatment risk of disease progression before initiating first-line treatment with UDCA, which of the following factors, in addition to an ALP >1.5x ULN, would further support stratifying a patient as intermediate-to-high risk?

ALP, alkaline phosphatase; AMA, antimitochondrial antibody; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

Baseline clinical assessment should be carried out alongside
treatment initiation in patients newly diagnosed with PBC. Patients with an intermediate-to-high risk of disease progression will have one or more of the following criteria: abnormal bilirubin; age at diagnosis <45 years; ALP >1.5x ULN; low albumin; or advanced fibrosis/early cirrhosis (Child-Pugh class A).

Abbreviations
ALP, alkaline phosphatase; PBC, primary biliary cholangitis; ULN, upper limit of normal.

Reference
Hirschfield GM, et al. Expert Rev Gastroenterol Hepatol. 2021;15:929–39.

Question 2/4
Your 57-year-old male patient with newly diagnosed PBC and severe pruritus is about to initiate first-line treatment. Based on baseline clinical assessment, the patient has decompensated liver cirrhosis (Child-Pugh class C) and bilirubin >2x ULN. Which of the following would you consider next in the management of this patient?

IBAT, ileal bile acid transporter; PBC, primary biliary cholangitis; PPAR, peroxisome proliferator-activated receptor; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

In patients with PBC, pre-treatment risk of disease progression should be determined and patients deemed at the highest risk should be considered for close monitoring and/or early referral for specialist assessment. Specialist input at a tertiary care centre, including assessment for potential transplantation, is important; notably, in Child-Pugh B and C liver disease, where liver transplant may be indicated. Any one of the following should be considered an indicator of high risk: decompensated cirrhosis (Child-Pugh B or C) i.e. ascites, variceal bleeding; compensated cirrhosis with evidence of clinically significant portal hypertension; bilirubin >2x ULN; or severe pruritus.

Abbreviations
PBC, primary biliary cholangitis; ULN, upper limit of normal.

Reference
Hirschfield GM, et al. Expert Rev Gastroenterol Hepatol. 2021;15:929–39.

Question 3/4
Your patient is a 53-year-old female with PBC who has been receiving first-line therapy with UDCA. At her 6-month follow-up, your patient explained that after starting UDCA, they developed diarrhoea, which was affecting their work and social life. Laboratory tests showed an elevated ALP at 1.7x ULN and normal bilirubin levels. UDCA was stopped and the diarrhoea resolved, but at her latest follow-up, tests show a further increase in ALP to 2x ULN. Which of the following would you consider next in the management of this patient?

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

Second-line monotherapy with obeticholic acid, elafibranor or seladelpar is indicated in adults with PBC who are unable to tolerate UDCA therapy, or in combination with UDCA if there is an inadequate response to UDCA alone.1–3

Abbreviations
PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid.

References

  1. FDA. Obeticholic acid PI. 2022. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2022/207999s008lbl.pdf (accessed 5 November 2024).
  2. FDA. Elafibranor PI. 2024. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2024/218860s000lbl.pdf (accessed 5 November 2024).
  3. FDA. Seladelpar PI. 2024. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf (accessed 5 November 2024).
Question 4/4
At their latest follow-up, your patient with PBC asks you about linerixibat therapy, as they have been reading about an ongoing clinical trial of this agent on an online patient forum. Based on data from the GLIMMER phase IIb trial of linerixibat in PBC, how might you advise your patient on the known efficacy of this agent in relation to itch?

ALP, alkaline phosphatase; PBC, primary biliary cholangitis.

The 12-week dose-finding phase IIb GLIMMER dose-ranging study evaluated linerixibat in patients with PBC and pruritus (N=147). In a post hoc analysis, there were significant differences in change in monthly itch score from baseline between placebo and linerixibat 180 mg once daily (p=0.0424), 40 mg twice daily (p=0.0105), and 90 mg twice daily (p=0.0370).

Abbreviation
PBC, primary biliary cholangitis.

Reference
Levy C, et al. Clin Gastroenterol Hepatol. 2023;21:1902–12.

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