Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis

Harms, Maren H.; Hirschfield, Gideon; Floreani, Annarosa; Mayo, Marlyn J.; Parés, Albert; Liberman, Alexander; Malecha, Elizabeth Smoot; Pencek, Richard; MacConell, Leigh; Hansen, Bettina E.

doi:10.1016/j.jhepr.2020.100191

Cited by 11 publications

(7 citation statements)

References 17 publications

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“…As one of the FXR agonists, obeticholic acid (OCA) significantly reduces alkaline phosphatase (ALP), gamma glutamyltranspeptidase (GGT), and alanine aminotransferase (ALT) levels in patients with primary biliary cirrhosis who do not respond to ursodeoxycholic acid [270] . Long-term OCA treatment in patients with primary biliary cholangitis (PBC) shows improvements or stabilizations of disease features, including ductular injury, fibrosis, and collagen morphometry [271][272][273][274][275] .…”

Section: Supervised Pep Anti-fibrosis Anti-cirrhosismentioning

confidence: 99%

Intercellular crosstalk of liver sinusoidal endothelial cells in liver fibrosis, cirrhosis and hepatocellular carcinoma

Li¹

2022

Digestive and Liver Disease

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Section: Supervised Pep Anti-fibrosis Anti-cirrhosismentioning

confidence: 99%

Intercellular crosstalk of liver sinusoidal endothelial cells in liver fibrosis, cirrhosis and hepatocellular carcinoma

Li¹

2022

Digestive and Liver Disease

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“…The "normalisation" of aminotransferases, especially using more stringent criteria to define the healthy ranges, might be a debatable end-point, and more so since response to treatment is assessed on decrease and normalization of ALP levels [10]. However, aminotransferases are part of validated prognostic scores to predict patients' outcome, and more recently a secondary analysis of OCA registration study data showed that treatment with OCA is also associated in an improvement in the aspartate aminotransferase-toplatelet ratio index (APRI), besides improvement in GLOBE score, thus emphasizing how (successful) response to treatment may also include the evaluation of hepatic necroinflammatory activity [25].…”

Section: Discussionmentioning

confidence: 99%

Obeticholic Acid Improves Aminotransferases Early during Treatment in Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid: A Study in Clinical Practice

Labanca

Cacciato

Borro

et al. 2021

Immuno

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Obeticholic acid (OCA) improves cholestasis and is generally well tolerated in patients with primary biliary cholangitis (PBC) not responding, or intolerant, to ursodeoxycholic acid (UDCA). As PBC is mainly a cholestatic disorder, less attention is paid to aminotransferase behavior in the course of treatment. In this study we evaluated, in clinical practice, the efficacy of OCA treatment on both alkaline phosphatase (ALP) and alanine aminotransferase (ALT) using updated healthy ranges for aminotransferases. Fifteen PBC patients, non-responders to UDCA, were evaluated at baseline and during OCA treatment with serial measurement of cholestasis indexes and ALT, that were also assessed using updated normal ranges (<30 IU/L in males, <19 IU/L in females). Median ALP and ALT decreased from 2.16 to 1.27 × upper limit of normal (p = 0.003) and from 0.93 to 0.78 × upper limit of normal (p = 0.008), respectively, in the course of OCA treatment. At treatment day-15, median ALT decreased by 29.7% and ALP by 8.8%. Bilirubin and albumin were unmodified throughout treatment. Using updated normal ranges, ALT levels were normal in 6.7% of patients at baseline and in 33.3% of patients at 18 months of treatment. OCA treatment improves cholestasis and, also, indexes of hepatocyte necrosis, with a decline in necro-inflammatory activity even predating the improvement in cholestasis. Use of recalibrated healthy ranges for aminotransferases might be a useful tool to assess hepatic histological activity and its improvement with OCA treatment.

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“… 62 A post hoc analysis by Harms et al in the POISE study reported that 12 months of OCA treatment resulted in the reduction of APRI and GLOBE scores. 63 They reported that in patients who had GLOBE score >0.3 at baseline, the use of OCA 5-1 mg was associated with a greater percentage of patients achieving a GLOBE score <0.3, compared to placebo (27% vs 6%). Furthermore, a lower proportion of patients in the OCA treated group with GLOBE score≤0.3 at baseline were noted to progress to GLOBE score >0.3, compared to placebo (3–13% vs 33%).…”

Section: Approved Treatments and The Risk Stratification Scoresmentioning

confidence: 99%

Primary Biliary Cholangitis: Promising Emerging Innovative Therapies and Their Impact on GLOBE Scores

Sohal¹,

Kowdley²

2023

HMER

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Primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, is an autoimmune disorder leading to the destruction of intra-hepatic bile ducts. If untreated, progressive bile duct damage and cholestasis can lead to ductopenia and result in cirrhosis. Ursodiol, the first drug approved for PBC, has changed the natural history of this disease and improved patient outcomes. Subsequently, several new prediction models incorporating a response to ursodiol were developed. These include the GLOBE score, which was shown to predict long-term outcomes in patients with PBC. In 2016, obeticholic acid (OCA) became the second drug to be approved by the FDA, predominantly based on improvement in alkaline phosphatase (ALP) levels. This trial has subsequently influenced the design of clinical trials. Several drugs are currently being evaluated as therapeutic options for PBC, with improvement in ALP being a main endpoint. In this review, we will discuss the impact of new therapies on GLOBE scores in patients with PBC.

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Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis

Cited by 11 publications

References 17 publications

Intercellular crosstalk of liver sinusoidal endothelial cells in liver fibrosis, cirrhosis and hepatocellular carcinoma

Intercellular crosstalk of liver sinusoidal endothelial cells in liver fibrosis, cirrhosis and hepatocellular carcinoma

Obeticholic Acid Improves Aminotransferases Early during Treatment in Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid: A Study in Clinical Practice

Primary Biliary Cholangitis: Promising Emerging Innovative Therapies and Their Impact on GLOBE Scores

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