Conference Coverage

Bezafibrate beats placebo in pruritus of chronic cholestasis: The FITCH trial



– Bezafibrate was superior to placebo for ameliorating pruritus in patients with chronic cholestatic liver diseases, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.

Improvements in itch were reported by four times as many patients treated with the peroxisome proliferator-activated receptor (PPAR) agonist, compared with those treated with placebo, according to results of the FITCH (Fibrates for cholestatic ITCH) trial.

That finding from FITCH is very encouraging for patients with this “vexing” clinical issue, which can be highly distressing and is a common feature of cholestatic liver diseases, said Michael R. Charlton, MBBS, FRCP, director of the Transplant Institute and hepatology chief at the University of Chicago.

“It’s generally a misery-making condition,” Dr. Charlton said in a podium discussion of the FITCH study results at the Liver Meeting 2019. “I had a patient tell me that they felt like the subject of Edvard Munch’s ‘Scream’ painting.”

As of this meeting, bezafibrate should be considered superior to placebo for treatment of pruritus in cholangiopathies and should be “considered as first-line treatment” for pruritus in primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), added Dr. Charlton, who was not involved in the study.

Investigators in FITCH recruited a total of 74 patients – all enrolled in the Netherlands or Spain – with cholestasis-induced pruritus who reported itch with an intensity of least 5 out of 10 on a visual analogue scale (VAS). Of the 70 patients who completed the trial, 44 had PSC, 24 had PBC, and 2 had secondary sclerosing cholangitis. Patients were randomly allocated to receive bezafibrate 400 mg once daily or placebo for 21 days.

The hypothesis was that PPAR agonist treatment would relieve itch by alleviating hepatobiliary inflammation and reducing formation of a biliary itch factor, according to the investigators, led by Elsemieke de Vries, MD, of the department of gastroenterology and hepatology, Amsterdam University Medical Centers.

“Guideline-approved pharmacological strategies show limited efficacy and can provoke serious side effects,” Dr. de Vries and coauthors said in the published abstract on the study.

The primary study endpoint, a 50% reduction in pruritus VAS score, was achieved in 45% of patients in the bezafibrate treatment arm (17 of 38 patients) versus just 11% in the placebo arm (4 of 36 patients; P = .003), according to updated results presented at the meeting.

The mean VAS score, comparable at baseline, was significantly lower in the bezafibrate group vs. the placebo group at day 21 (P < .001), the results showed.

Authors of the FITCH study reported disclosures related to Intercept Pharmaceuticals, Gilead, Takeda, Tillotts, Pliant, and Dr. Falk GmbH.

SOURCE: de Vries E et al. The Liver Meeting 2019. Abstract 13.

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