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Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis

Zakary Warsop Orcid Logo, Nikhil Anand Orcid Logo, Husam Al Maliki, Shuell De Souza Orcid Logo, Arya Kamyab Orcid Logo, Amin Al Hadad, Laith Alrubaiy Orcid Logo

Journal of Personalized Medicine, Volume: 14, Issue: 12, Start page: 1133

Swansea University Author: Laith Alrubaiy Orcid Logo

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DOI (Published version): 10.3390/jpm14121133

Abstract

Background/Objectives: Primary biliary cholangitis (PBC) is an autoimmune chronic cholestatic disease of the liver that symptomatically can present with pruritus and fatigue. Its established first- and second-line therapies are ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) although they pro...

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Published in: Journal of Personalized Medicine
ISSN: 2075-4426
Published: MDPI AG 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa68568
first_indexed 2025-01-09T20:33:50Z
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spelling 2024-12-13T12:35:05.7326505 v2 68568 2024-12-13 Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis 62b59abd526b328bbb125dfaa9bdcd6d 0000-0002-6340-8244 Laith Alrubaiy Laith Alrubaiy true false 2024-12-13 Background/Objectives: Primary biliary cholangitis (PBC) is an autoimmune chronic cholestatic disease of the liver that symptomatically can present with pruritus and fatigue. Its established first- and second-line therapies are ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) although they provide limited symptom management. Liver transplantation offers a potentially curative therapeutic option in refractory cases progressing to cirrhosis. Novel research published after the current guidelines highlights the importance of providing an up-to-date analysis of treatment options available. Methods: In this study, we conducted a literature search using Pubmed, Ovid Medline, and SCOPUS to provide a narrative review of first-line, second-line, and emerging therapies in PBC. Results: UDCA has been well established as a long-term, safe therapy within the literature although it is possible that treatment dosage can be further optimised in refractory patients. It has a favourable side effect profile. Despite improving biochemical markers, histopathological profile, and overall outcomes, up to 30–40% of patients are refractory to it. Age and sex are highlighted as independent indicators of non-responsiveness. This necessitates effective second-line therapies. Future trials could aim to investigate UDCA as a co-first-line therapy. Further supporting results for OCA were found in the interim extension trial of the seminal POISE study. The long-term phase 4 COBOLT trial is still awaiting results to further assess the complications, adherence, and potential adverse effects. It is a viable option in UDCA-refractory patients. The high incidence rate of dose-related pruritis indicates that alternative second-line options are needed. Bezafibrate is an off-label antilipemic agent that shows promise as a prospective second-line therapy option. The landmark BEZURSO trial alleviated some efficacy and safety concerns, but it remains associated with elevated serum creatinine; thus, it should be considered with caution. Other prospective second-line therapies are budesonide, triple therapy, and novel agents such as seladelpar and elafibranor. Conclusions: UDCA should remain the treatment of choice for PBC, though perhaps not as monotherapy. With further investigation, BF shows promise as a new second-line therapy alongside OCA, which it may outperform. Journal Article Journal of Personalized Medicine 14 12 1133 MDPI AG 2075-4426 Primary biliary cholangitis; primary biliary cirrhosis; PBC; ursodeoxycholic acid; obeticholic acid; bezafibrate; fenofibrate 30 11 2024 2024-11-30 10.3390/jpm14121133 COLLEGE NANME COLLEGE CODE Swansea University Another institution paid the OA fee This research received no external funding. 2024-12-13T12:35:05.7326505 2024-12-13T12:29:08.4644633 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Zakary Warsop 0009-0003-7407-941X 1 Nikhil Anand 0000-0002-2670-2145 2 Husam Al Maliki 3 Shuell De Souza 0000-0002-1449-3307 4 Arya Kamyab 0000-0002-7461-4983 5 Amin Al Hadad 6 Laith Alrubaiy 0000-0002-6340-8244 7
title Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
spellingShingle Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
Laith Alrubaiy
title_short Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
title_full Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
title_fullStr Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
title_full_unstemmed Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
title_sort Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis
author_id_str_mv 62b59abd526b328bbb125dfaa9bdcd6d
author_id_fullname_str_mv 62b59abd526b328bbb125dfaa9bdcd6d_***_Laith Alrubaiy
author Laith Alrubaiy
author2 Zakary Warsop
Nikhil Anand
Husam Al Maliki
Shuell De Souza
Arya Kamyab
Amin Al Hadad
Laith Alrubaiy
format Journal article
container_title Journal of Personalized Medicine
container_volume 14
container_issue 12
container_start_page 1133
publishDate 2024
institution Swansea University
issn 2075-4426
doi_str_mv 10.3390/jpm14121133
publisher MDPI AG
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 0
active_str 0
description Background/Objectives: Primary biliary cholangitis (PBC) is an autoimmune chronic cholestatic disease of the liver that symptomatically can present with pruritus and fatigue. Its established first- and second-line therapies are ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) although they provide limited symptom management. Liver transplantation offers a potentially curative therapeutic option in refractory cases progressing to cirrhosis. Novel research published after the current guidelines highlights the importance of providing an up-to-date analysis of treatment options available. Methods: In this study, we conducted a literature search using Pubmed, Ovid Medline, and SCOPUS to provide a narrative review of first-line, second-line, and emerging therapies in PBC. Results: UDCA has been well established as a long-term, safe therapy within the literature although it is possible that treatment dosage can be further optimised in refractory patients. It has a favourable side effect profile. Despite improving biochemical markers, histopathological profile, and overall outcomes, up to 30–40% of patients are refractory to it. Age and sex are highlighted as independent indicators of non-responsiveness. This necessitates effective second-line therapies. Future trials could aim to investigate UDCA as a co-first-line therapy. Further supporting results for OCA were found in the interim extension trial of the seminal POISE study. The long-term phase 4 COBOLT trial is still awaiting results to further assess the complications, adherence, and potential adverse effects. It is a viable option in UDCA-refractory patients. The high incidence rate of dose-related pruritis indicates that alternative second-line options are needed. Bezafibrate is an off-label antilipemic agent that shows promise as a prospective second-line therapy option. The landmark BEZURSO trial alleviated some efficacy and safety concerns, but it remains associated with elevated serum creatinine; thus, it should be considered with caution. Other prospective second-line therapies are budesonide, triple therapy, and novel agents such as seladelpar and elafibranor. Conclusions: UDCA should remain the treatment of choice for PBC, though perhaps not as monotherapy. With further investigation, BF shows promise as a new second-line therapy alongside OCA, which it may outperform.
published_date 2024-11-30T20:36:52Z
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score 11.04748

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