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It was with great interest that we read the recent guidelines from the British Society of Gastroenterology on the treatment and management of primary biliary cholangitis (PBC).1 The authors propose a pragmatic drug approach to treat cholestatic pruritus with cholestyramine as first-line and rifampicin as second-line use, followed by naltrexone, sertraline or gabapentin as third-line options, although with concerns regarding tolerability and adverse events.
Pruritus is a characteristic, potentially agonising symptom of PBC that remains poorly cared.2 New drug options are definitively needed to relieve patients of this symptom. Bezafibrate, a pan-agonist of peroxisome proliferator-activated receptors, has been suggested to reduce itch intensity in patients with PBC.3 This beneficial effect has recently been confirmed in a placebo-controlled phase III trial Bezafibrate in Combination with Ursodeoxycholic Acid in PBC (BEZURSO).4 The mechanisms by which bezafibrate improves pruritus in PBC remain unknown. As the lysophospholipase autotaxin (ATX) and its product, lysophosphatidic acid, have been identified as potential key players in the pathogenesis of cholestatic pruritus,5 the present post-hoc analysis of the BEZURSO trial aims to investigate the role of ATX in the antipruritic effect of bezafibrate in patients with PBC.
All patients met the following criteria at inclusion: (1) PBC diagnosis and (2) …
Contributors CC: coordinating investigator, codesigner of the trial, data acquisition, analysis and interpretation, drafting of the article. AEK: data acquisition, analysis and interpretation, drafting of the article. OC: data acquisition, analysis and interpretation, drafting of the article. ALC: data interpretation, critical revision. SL: data interpretation, critical revision. KW: data acquisition. LDC: data acquisition, analysis and interpretation, critical revision. SC-M: data acquisition, analysis and interpretation, critical revision. LH: data acquisition. DR: data acquisition, analysis and interpretation, critical revision. RP: codesigner of the trial, critical revision.
Funding This study is funded by the French Ministry of Health (grant number: PHRC 2010 (BEZURSO_P100109)) and Arrow Génériques, Lyon, France (grant number: RAF 13.022_BEZURSO_P100109_N°VAL 2013/2011-078-02).
Competing interests CC reports receiving consulting fees from Intercept and Inventiva, grant support from Arrow and Intercept, and fees for teaching from GlaxoSmithKline. AEK reports receiving consulting fees from GlaxoSmithKline and Intercept, and fees for teaching from Falk and Intercept. OC reports receiving grant support from Aptalis, fees for teaching from Mayoly Spindler, consulting fees from Genfit, and fees for teaching and consulting fees from Intercept. RP reports receiving consulting fees from Intercept.
Patient consent Obtained.
Ethics approval Committee for the Protection of Persons and the French National Agency for Medicines and Health Products Safety.
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement The data presently reported on the association between the antipruritic effect of bezafibrate and serum autotaxin measures in patients with primary biliary cholangitis were generated from a post-hoc analysis of the BEZURSO trial and are still unpublished. Data sets used and/or analysed are available from the corresponding author on request.
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