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Practical strategies for pruritus management in the obeticholic acid-treated patient with PBC: proceedings from the 2018 expert panel
  1. Jennifer Pate1,
  2. Juilo A Gutierrez2,
  3. Catherine T Frenette3,
  4. Aparna Goel4,
  5. Sonal Kumar5,
  6. Richard A Manch6,
  7. Edward A Mena7,
  8. Paul J Pockros8,
  9. Sanjaya K Satapathy9,
  10. Kidist K Yimam10,
  11. Robert G Gish4
  1. 1 Baylor St Luke’s Medical Center, Houston, Texas, USA
  2. 2 Transplant and Hepatopancreatobiliary Institute, Verity Medical Foundation, San Jose, California, USA
  3. 3 Division of Organ Transplantation, Scripps Clinic/Scripps Green Hospital, La Jolla, California, USA
  4. 4 Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA
  5. 5 Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City, New York, USA
  6. 6 Institute for Liver Health, Phoenix, Arizona, USA
  7. 7 Pasadena Liver Center, Pasadena, California, USA
  8. 8 Division of Gastroenterology and Hepatology, Scripps Clinic/Scripps Translational Science Institute, La Jolla, California, USA
  9. 9 Division of Transplant Surgery, Methodist University Hospital Transplant Institute, University of Tennessee Health Science Center, Memphis, Tennessee, USA
  10. 10 Autoimmune Liver Disease Program, California Pacific Medical Center, San Francisco, California, USA
  1. Correspondence to Dr Robert G Gish; asimonis{at}cpeducate.com

Abstract

Background and aims This article provides expert guidance on the management of pruritus symptoms in patients receiving obeticholic acid (OCA) as treatment for primary biliary cholangitis (PBC). PBC is a chronic, autoimmune cholestatic liver disease that affects intrahepatic bile ducts. If not adequately treated, PBC can lead to cholestasis and end-stage liver disease, which may require transplant. Timely treatment is therefore vital to patient health. Pruritus is a common symptom in patients with PBC. Additionally, the use of OCA to treat PBC can contribute to increased pruritus severity in some patients, adding to patient discomfort, decreasing patient quality of life (QoL), and potentially affecting patient adherence to OCA treatment.

Methods In May 2018, a group of physician experts from the fields of gastroenterology, hepatology, and psychiatry met to discuss the management of pruritus in OCA-treated patients with PBC. Recognizing the importance of optimizing treatment for PBC, these experts developed recommendations for managing pruritus symptoms in the OCA-treated PBC patient based on their experience in clinical practice.

Results These recommendations include a comprehensive list of management strategies (including over-the-counter, prescription, and alternative therapies), guidance on titration of OCA to minimize pruritus severity, and an algorithm that outlines a practical approach to follow up with patients receiving OCA, to better assess and manage pruritus symptoms.

Conclusions Pruritus associated with OCA therapy is dose dependent and often manageable, and with the proper education and tools, most pruritus cases can be effectively managed to minimize treatment discontinuation.

  • primary biliary cholangitis
  • obeticholic acid
  • pruritus
  • cholestatic liver disease
  • liver

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JP, JAG, CTF, AG, SK, RAM, EAM, PJP, SKS, KKY and RGG participated in an Advisory Board Meeting in May 2018 and contributed significant efforts to develop and present patient case studies highlighting successes and challenges associated with the management of OCA-induced pruritus. These case studies and the Advisory Board discourse became the basis for this manuscript. All authors contributed to the development of the article, revised the manuscript critically for important intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the article. All authors had full access to all data and had sole discretion in the data interpretation, writing of the manuscript, review and approval prior to submission, and decision to submit for publication.

  • Funding Support for the roundtable panel discussion was provided by Intercept Pharmaceuticals.

  • Competing interests JP received honoraria as an advisory board member from Intercept Pharmaceuticals and served on the speaker’s bureau for Intercept Pharmaceuticals. JAG received honoraria as an advisory board member from Intercept Pharmaceuticals; and performed as a consultant and advisor for AbbVie, Alexion Pharmaceuticals, Dova Pharmaceuticals, Gilead Sciences, Grifols, Intercept Pharmaceuticals, MediciNova, Merck, and Novartis. He is a speaker for AbbVie, Alexion Pharmaceuticals, Dova Pharmaceuticals, Gilead Sciences, Intercept Pharmaceuticals, and Merck. CTF received honoraria as an advisory board member from Intercept Pharmaceuticals; is a consultant for Conatus Pharmaceuticals, Gilead Sciences, and Wako Chemicals USA; provides research support for GENFIT; served on advisory boards for Eisai, Gilead Sciences, and Wako Chemicals USA; and served on speaker’s bureaus for AbbVie, Dova Pharmaceuticals, Gilead Sciences, Merck, and Salix Pharmaceuticals. AG received honoraria as an advisory board member from Intercept Pharmaceuticals. SK received honoraria as an advisory board member from Intercept Pharmaceuticals. RAM received honoraria as an advisory board member from Intercept Pharmaceuticals. EAM received honoraria as an advisory board member from Intercept Pharmaceuticals. PJP received honoraria as an advisory board member from Intercept Pharmaceuticals, and Scripps Health has received research support from Intercept Pharmaceuticals for trials where PJP is the principal investigator. SKS received honoraria as an advisory board member from Intercept Pharmaceuticals; served on speaker’s panels for Alexion Pharmaceuticals and Dova Pharmaceuticals; served on advisory boards for AbbVie, Bayer Pharmaceuticals, and Gilead Sciences; and received grant funding from Conatus Pharmaceuticals, Dova Pharmaceuticals, GENFIT, Gilead Sciences, and Shire. KKY received honoraria as an advisory board member from Intercept Pharmaceuticals. RGG received honoraria as an advisory board member from Intercept Pharmaceuticals; performed as a consultant and/or advisor for Abbott, AbbVie, Alexion Pharmaceuticals, Arrowhead Pharmaceuticals, Bayer Pharmaceuticals, Bristol-Myers Squibb Company, ContraVir Pharmaceuticals, Eiger BioPharmaceuticals, ENYO Pharma, eStudySite, Genentech, Gilead Sciences, HepaTx, Hoffmann-La Roche, Intellia Therapeutics, Ionis Pharmaceuticals, Janssen Pharmaceuticals, MedImmune, Merck, and Shionogi; served on advisory boards for AbbVie, Arrowhead Pharmaceuticals, Bayer Pharmaceuticals, ContraVir Pharmaceuticals, Dova Pharmaceuticals, Eiger BioPharmaceuticals, ENYO Pharma, Janssen Pharmaceuticals, MedImmune, Merck, Novira/Janssen/Johnson & Johnson, Shionogi, and Spring Bank Pharmaceuticals; served as a clinical trial advisor for eStudySite; chaired an advisory board for Arrowhead Pharmaceuticals; is a consultant for BioCollections, Prometheus Laboratories, Quest Diagnostics, and Theranos; served on the Data Safety Monitoring Boards for Ionis Pharmaceuticals, Transgene, and TRImaran Pharma; and is contracted to lead promotional talks for AbbVie, Alexion Pharmaceuticals, Bayer Pharmaceuticals, Bristol-Myers Squibb Company, Gilead Sciences, and Merck.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

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