Bezafibrate: Potential Treatment for PBC and Itching From Biliary Disease

MedicalResearch.com Interview with:

Dr Christophe Corpechot Centre de Référence Maladie Rares: Maladies Inflammatoires des Voies Biliaires et Hépatites Auto-immunes (MIVB-H) Filière Maladies Rares: Maladies Rares du Foie de l’Adulte et de l’Enfant Hôpital Saint-Antoine (APHP) et Sorbonne Universités Paris

Dr. Corpechot

Dr Christophe Corpechot
Centre de Référence Maladie Rares: Maladies Inflammatoires des Voies Biliaires et Hépatites Auto-immunes (MIVB-H)
Filière Maladies Rares: Maladies Rares du Foie de l’Adulte et de l’Enfant
Hôpital Saint-Antoine (APHP) et Sorbonne Universités
Paris

MedicalResearch.com: What is the background for this study?

Response: Primary biliary cholangitis (PBC, previously known as “primary biliary cirrhosis”) is a rare, chronic, slowly progressive liver disease of unknown cause, mainly affecting women of middle age. It is characterized by serum marks of autoimmunity (specific auto-antibodies), chronic inflammation and destruction of small intra-hepatic bile ducts, and consequent bile secretion impairment (chronic cholestasis) leading to the progressive development of cirrhosis and liver failure. Ursodeoxycholic acid (UDCA) is the only first-line approved treatment for PBC. It improves the biochemical measures of cholestasis and prolongs survival without liver transplantation. However, 30% to 40% of UDCA-treated patients continue to have clinically significant abnormalities of their biochemical liver tests and those patients remain at high risk of developing end-stage liver disease complications.

Recently (2016), obeticholic acid (OCA) in association with UDCA has been conditionally approved in patients with an inadequate response to UDCA. This approval (FDA, EMA) was based one the results of a 1-year randomized, double-blind, placebo-controlled trial of OCA in patients with an incomplete response or intolerance to UDCA (POISE trial). In this trial, OCA was shown to improve the biochemical features of cholestasis (alkaline phosphatase (ALP) level < 1.67 times the upper limit of the normal range and a reduction of at least 15% from baseline) but was associated with a significant increase of pruritus, a characteristic, potentially debilitating symptom of PBC. BEZURSO is the first ever placebo-controlled phase 3 trial of a fibrate (a class of drugs known to be agonists of the peroxisome proliferator-activated receptors alpha) in PBC. In this 2-year randomized double-blind trial, 100 patients with an incomplete response to UDCA were assigned to bezafibrate 400 mg/day (n=50) or placebo (n=50), all in association with continued UDCA therapy.

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Serum IL-31 Linked to Itching in Hemodialysis Patients

MedicalResearch.com Interview wth:
Mei-Ju Ko, MD, PhD
Department of Dermatology, Taipei City Hospital
Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.

Medical Research: What are the main findings of the study?

Dr. Ko: In this study, not only did we find that serum levels of interleukin (IL)-31 were significantly higher in hemodialysis patients with pruritus symptoms, but we also demonstrated a positive exposure-response relationship between IL-31 levels and visual analog scale (VAS) scores of pruritus intensity. We also noted an inverse correlation between the severity of pruritus and the dialysis dose assessed by Kt/V.
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