Bezafibrate Effective in Reducing Cholestasis-Related Pruritus: Presented at Liver Meeting

By Nancy Melville

BOSTON -- November 12, 2019 -- Bezafibrate, a peroxisome proliferator-activated receptor (PPAR) agonist, shows safety and efficacy over placebo in reducing cholestasis-associated pruritus, according to a study presented here at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

“Bezafibrate should be considered as first-line treatment of pruritus in patients with primary sclerosing cholangitis and primary biliary cholangitis,” said Elsemieke de Vries, MD, Amsterdam University Medical Center, Amsterdam, the Netherlands.

Pruritus affects up to 70% of patients with primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) during the course of disease, causing substantial quality of life issues to patients with liver diseases. However, current pharmacological strategies show limited efficacy in the treatment of pruritis, while potentially causing side effects.

“Efficacy and tolerability with existing therapies are limited and therefore alternative treatment options are urgently needed,” said Dr. de Vries.

The Fibrates for Cholestatic ITCH (FITCH) study evaluated bezafibrate in patients with pruritus due to PSC (n = 44), PBC (n = 24) or secondary sclerosing cholangitis (n = 2). Patients were eligible if they reported an itch intensity of at least 5 on a visual analogue scale (VAS) from 0 to 10, with 10 as the worst itch possible at least twice a week.

Patients were randomised to receive once-daily bezafibrate 400 mg (n = 37) or placebo (n = 33) for 21 days and were evaluated at baseline and at day 21 and day 35.

Of the patients in the bezafibrate group, 45% achieved the primary endpoint of a 50% or greater reduction of pruritus compared with 11% of patients in the placebo group (P = .03) in the intention-to-treat analysis, and similar findings were reported in the per protocol analysis.

The VAS score in the bezafibrate group went from 7.3 at baseline to 4.0 at day 21, although it returned to 7 at day 35. The placebo group did not have any change in VAS score.

The median intensity of pruritus on VAS was greater in the bezafibrate group in the morning
(P = .01) and evening (PP

In both PSC and PBC groups, the pruritus VAS score reduction correlated with serum alkaline phosphatase decrease (P = .01); however, there were no significant effects on serum autotaxin activity (P = .38) or total bile acids (P = .17).

“This supports our hypothesis that alleviation of hepatobiliary inflammation in fibrosing cholangiopathies may reduce the formation or secretion of the aforementioned biliary itch factor and thereby reduce pruritus,” said Dr. de Vries.

[Presentation title: Bezafibrate Is More Effective Than Placebo in Pruritus of Chronic Cholestasis: the Fitch Trial. Abstract 13]

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