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. 2023 Jun;68(6):2710-2730.
doi: 10.1007/s10620-023-07862-z. Epub 2023 Mar 18.

Cholestatic Pruritus Treatments in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Systematic Literature Review

Helen T Smith  1 , Andrea Ribeiro de Souza  2 , April H Thompson  3 , Megan M McLaughlin  4 , John J Dever  5 , Julie A Myers  5 , Jing Voon Chen  6
Affiliations

Cholestatic Pruritus Treatments in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Systematic Literature Review

Helen T Smith et al. Dig Dis Sci. 2023 Jun.

Abstract

Background and aims: We conducted a systematic literature review to understand the evidence supporting treatment decisions for cholestatic pruritus associated with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).

Methods: Studies that enrolled ≥ 75% participants with PBC or PSC and reported ≥ 1 endpoint(s) related to efficacy, safety, health-related quality of life (HRQoL) or other patient-reported outcomes were included. Bias was assessed using the Cochrane risk of bias tool for randomised controlled trials (RCTs) and the Quality of Cohort studies tool for non-RCTs.

Results: Thirty-nine publications were identified, covering 42 studies and six treatment classes (including investigational and approved products): anion-exchange resins, antibiotics (rifampicin/derivatives), opiates, selective serotonin reuptake inhibitors, fibrates, ileal bile acid transporter inhibitors and other agents not categorised in these six classes. Across studies, median sample size was small (n = 18), 20 studies were over 20 years old, 25 followed patients for ≤ 6 weeks, only 25 were RCTs. Pruritus was assessed using several different tools, with inconsistencies in their application. Cholestyramine, considered first-line therapy for moderate-severe cholestatic pruritus, was assessed in six studies (two RCTs) including 56 patients with PBC and 2 with PSC, with evidence of efficacy demonstrated in only three studies, among which, two RCTs were assessed as having a high risk of bias. Findings were similar for other drug classes.

Conclusions: There is a lack of consistent and reproducible evidence available on efficacy, impact on HRQoL, and safety of cholestatic pruritus treatments, leaving physicians to rely on clinical experience rather than evidence-based medicine for treatment selection.

Keywords: Cholestatic pruritus; Evidence-based medicine; Primary biliary cholangitis; Primary sclerosing cholangitis; Quality of life; Treatment decisions.

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Conflict of interest statement

HTS, ARdS and MMM are employees of GSK and hold stocks/shares in the company. AHT was an employee of GSK at the time of the study and holds GSK stocks/shares. JAM is an employee of Medical Decision Modelling Inc., which is a health economic firm commissioned by GSK to conduct this research. JJD and JVC were employees of Medical Decision Modelling Inc. at the time of the study.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram
See this image and copyright information in PMC

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