Combination of Obeticholic Acid with Bezafibrate, with Or without Ursodeoxycholic Acid
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Jones A.
Kallis, Y.
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2025
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Article
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Treatment goals of Primary biliary cholangitis (PBC) are to prevent end stage liver disease and to manage disease related symptoms. Additive triple therapy, wherein patients are prescribed Ursodeoxycholic acid (UDCA), Obeticholic acid (OCA), and Bezafibrate (BZA), has shown biochemical benefit in patients with inadequate response to dual therapy. This study aims to add to this evidence base to further understanding of the efficacy and safety of this combination in PBC patients. A retrospective service evaluation of patients treated with triple therapy, or combination second line therapy- OCA and BZA without UDCA, since 2020 at Barts Health NHS Trust. All patients prescribed one of these treatment regimes were included, as well as those for whom it had been discontinued. Liver stiffness measurements (LSM), alkaline phosphatase (ALP), alanine aminotransferase (ALT), bilirubin and creatinine prior and following initiation of combination therapy was documented. Changes to pruritus status, and discontinuation reasons were also recorded. In total, 17 patients were included with 15 patients prescribed triple therapy (UDCA, OCA, BZA) and 2 patients with UDCA intolerance receiving dual second line therapies (OCA, BZA). 4 patients had compensated cirrhosis prior to combination therapy initiation. In all patients OCA was initiated first, and BZA was added afterwards. Mean duration of combination therapy was 34 months (+/- 15.5). 4 patients discontinued triple therapy, the median duration of triple therapy prior to discontinuation was 8.5 months. Discontinuation reasons were rising bilirubin, worsening dizziness and fatigue, poor medication adherence and hepatic decompensation, respectively. No elevations in creatinine kinase (CK) were recorded. Mean LSM prior to combination therapy was 11.1 kPa (+/- 8.7), n=17. Mean LSM once established on triple therapy was 12.1 kPa (+/- 11.3), n=15 data not available in two patients. Table 1 shows the biochemical response rates. 7 (41%) patients achieved long term normalisation of ALP levels and 7 (41%) achieved reduction in pruritus symptom severity. Combination therapy in PBC can lead to further reductions in biochemical markers of disease activity and can normalise ALP in some patients. Triple therapy can also have a positive impact on pruritus management in patients unresponsive to other therapies. In this single centre retrospective study, combination therapy appeared to be safe with minimal adverse effects and high patient acceptance rates. Further studies are needed to develop the evidence base for this treatment and to identify longer term outcomes and potential risks. (Table presented).
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Gut