UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

UK-Wide Multicenter Evaluation of Second-line Therapies in Primary Biliary Cholangitis

Abbas, N; Culver, EL; Thorburn, D; Halliday, N; Crothers, H; Dyson, JK; Phaw, A; ... Trivedi, PJ; + view all (2022) UK-Wide Multicenter Evaluation of Second-line Therapies in Primary Biliary Cholangitis. Clinical Gastroenterology and Hepatology 10.1016/j.cgh.2022.07.038. (In press). Green open access

[thumbnail of 1-s2.0-S1542356522007388-main.pdf]
Preview
Text
1-s2.0-S1542356522007388-main.pdf - Published Version

Download (2MB) | Preview

Abstract

Background & Aims: Thirty-to-forty percent of patients with primary biliary cholangitis inadequately respond to ursodeoxycholic acid. Our aim was to assemble national, real-world data on the effectiveness of obeticholic acid (OCA) as a second-line treatment, alongside non-licensed therapy with fibric acid derivatives (bezafibrate or fenofibrate). Methods: This was a nationwide observational cohort study conducted from August 2017 until June 2021. Results: We accrued data from 457 patients; 349 treated with OCA and 108 with fibric acid derivatives. At baseline/pre-treatment, individuals in the OCA group manifest higher risk features compared with those taking fibric acid derivatives, evidenced by more elevated alkaline phosphatase values, and a larger proportion of individuals with cirrhosis, abnormal bilirubin, prior non-response to ursodeoxycholic acid, and elastography readings >9.6kPa (P <.05 for all). Overall, 259 patients (OCA) and 80 patients (fibric acid derivatives) completed 12 months of second-line therapy, yielding a dropout rate of 25.7% and 25.9%, respectively. At 12 months, the magnitude of alkaline phosphatase reduction was 29.5% and 56.7% in OCA and fibric acid groups (P <.001). Conversely, 55.9% and 36.4% of patients normalized serum alanine transaminase and bilirubin in the OCA group (P <.001). The proportion with normal alanine transaminase or bilirubin values in the fibric acid group was no different at 12 months compared with baseline. Twelve-month biochemical response rates were 70.6% with OCA and 80% under fibric acid treatment (P =.121). Response rates between treatment groups were no different on propensity-score matching or on sub-analysis of high-risk groups defined at baseline. Conclusion: Across the population of patients with primary biliary cholangitis in the United Kingdom, rates of biochemical response and drug discontinuation appear similar under fibric acid and OCA treatment.

Type: Article
Title: UK-Wide Multicenter Evaluation of Second-line Therapies in Primary Biliary Cholangitis
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.cgh.2022.07.038
Publisher version: https://doi.org/10.1016/j.cgh.2022.07.038
Language: English
Additional information: © 2022 by the AGA Institute. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Keywords: Bezafibrate, Cholestasis, Cirrhosis, Farnesoid-X-receptor (FXR), Fenofibrate, Fibrates, Fibric Acid, Obeticholic Acid, Peroxisome Proliferator Activated Receptor (PPAR)
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inst for Liver and Digestive Hlth
URI: https://discovery.ucl.ac.uk/id/eprint/10159355
Downloads since deposit
32Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item