Abbas, N; Culver, EL; Thorburn, D; Halliday, N; Crothers, H; Dyson, JK; Phaw, A; ... Trivedi, PJ; + view all 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, RM; Jones, D; Hirschfield, G; Trivedi, PJ; - view fewer (2023) UK-Wide Multicenter Evaluation of Second-line Therapies in Primary Biliary Cholangitis. Clinical Gastroenterology and Hepatology , 21 (6) pp. 1561-1570. 10.1016/j.cgh.2022.07.038.

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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.

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