New Therapeutics in Primary Biliary Cholangitis

Learning Objectives

1. Apply diagnostic criteria for PBC, including AMA and PBC-specific ANA serology and the limited role of liver biopsy, and describe the immune-initiated, cholestasis-driven disease model that informs therapeutic targets.

2. Apply risk stratification and biochemical response criteria (ALP thresholds, POISE criteria, and loss of response over time) to decide when to add a second-line PPAR agonist to UDCA.

3. Select therapy for cholestatic pruritus, identify symptom burden that persists despite biochemical response, and interpret the surrogate endpoints and the accelerated versus full approval pathway for new PBC therapeutics.

Financial Support

This activity is supported by independent medical education grants from Intercept Pharmaceuticals, Inc., and Zenas BioPharma.

Target Audience

Transplant hepatologists, gastroenterologists, hepatologists, transplant surgeons, physicians, and other healthcare professionals involved in the care of patients with chronic liver disease and liver transplantation.

Credit Information

In support of improving patient care, this activity has been planned and implemented by INEDSYS Inc. and CME Outfitters, LLC. CME Outfitters, LLC, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physicians (ACCME): CME Outfitters, LLC, designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Note to Nurse Practitioners: Nurse practitioners can apply for AMA PRA Category 1 Credit(s)™ through the American Academy of Nurse Practitioners (AANP). AANP will accept AMA PRA Category 1 Credit(s)™ from Jointly Accredited organizations. Nurse practitioners can also apply for credit through their state boards.

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Disclosure Declaration

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CME/CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CME/CE activity. CME Outfitters, LLC, has evaluated, identified, and attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. Relevant financial relationships exist between the following individuals and commercial interests:

Faculty Disclosures

Raj Vuppalanchi, MD, has nothing to disclose.

Planning Committee Disclosures

Iman Fawzy Montasser, MD (Session Chair) has nothing to disclose.

Sanjaya Satapathy, MD, FACG, FASGE, AGAF, FAASLD, discloses the following relevant financial relationships: Advisory Board: Mirum Pharmaceuticals, Bausch Health; Research Support: Intercept Pharmaceuticals, Durect, Boehringer Ingelheim, Akero Therapeutics, Gilead Sciences, Madrigal, Zydus, Novartis, Fibronostics, CymaBay, Pfizer, Ipsen, Bausch Health; Speakers Bureau: Mirum Pharmaceuticals, Bausch Health.

Prasun K. Jalal, MD (Associate Course Director), discloses the following relevant financial relationships: Advisory Board: Ipsen, Gilead, Mirum, Bausch Health; Consultant: Madrigal; Research Support: Madrigal, Ipsen, Gilead, GSK, Bausch Health; Speakers Bureau: Madrigal, Ipsen.

Jiang Liu, MD, has nothing to disclose.

Benedict Maliakkal, MD, has nothing to disclose.

Kenan Moral has nothing to disclose.

Daniela Jones, MA, has nothing to disclose.

Content Reviewer Disclosures

Andrea Perseghin, EdD, has nothing to disclose.

*All relevant financial relationships have been mitigated.

Unlabeled Use Disclosure

Faculty of this CME/CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices. CME Outfitters, LLC, the faculty, and INEDSYS Inc. do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use.

Credit Claiming Process: This enduring material requires completion of the online post-test (with a passing score) and the activity evaluation to claim credit. Visit myportal.cmeoutfitters.com (free account activation required) to complete the post-test and evaluation. Your certificate is available to download immediately upon successful completion.

Questions about this activity? Contact INEDSYS Inc.

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