Browse by author
Lookup NU author(s): Dr Jess Dyson, Dr April Phaw, Dr Vinod Hegade, Dr George Mells, Professor David Jones
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 2023 The Authors. 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.
Author(s): Abbas N, Culver EL, Thorburn D, Halliday N, Crothers H, Dyson JK, Phaw A, Aspinall R, Khakoo SI, Kallis Y, Smith B, Patanwala I, McCune A, Chimakurthi CR, Hegade V, Orrell M, Jones R, Mells G, Thain C, Thain R-M, Jones D, Hirschfield G, Trivedi PJ
Publication type: Article
Publication status: Published
Journal: Clinical Gastroenterology and Hepatology
Year: 2023
Volume: 21
Issue: 6
Pages: 1561-1570.e13
Print publication date: 01/06/2023
Online publication date: 09/08/2022
Acceptance date: 02/04/2018
Date deposited: 18/09/2024
ISSN (print): 1542-3565
ISSN (electronic): 1542-7714
Publisher: W.B. Saunders
URL: https://doi.org/10.1016/j.cgh.2022.07.038
DOI: 10.1016/j.cgh.2022.07.038
PubMed id: 35961518
Altmetrics provided by Altmetric
