Assessment of adherence to guidelines for biochemical monitoring and ursodeoxycholic acid treatment response in a retrospective cohort of US patients with primary biliary cholangitis

Document Type

Article

Publication Date

10-22-2025

Publication Title

BMJ Open Gastroenterol

Keywords

Humans, Ursodeoxycholic Acid, Female, Male, Retrospective Studies, Guideline Adherence, Middle Aged, Liver Cirrhosis, Biliary, United States, Cholagogues and Choleretics, Alkaline Phosphatase, Aged, Practice Guidelines as Topic, Disease Progression, Treatment Outcome

Abstract

OBJECTIVE: American Association for the Study of Liver Disease guidelines recommend regular testing of alkaline phosphatase (ALP) among patients with primary biliary cholangitis (PBC) to monitor disease progression and response to treatment with ursodeoxycholic acid (UDCA), but previous studies have shown that adherence to recommended testing intervals is low. We used data from the Fibrotic Liver Disease (FOLD) Consortium to evaluate rates of adherence among US routine care patients.

METHODS: PBC cases were confirmed with chart abstraction. Patients from three FOLD sites (Henry Ford Health (Detroit, MI), Kaiser Permanente-Southern California (Los Angeles, California) and Kaiser Permanente-Northwest (Portland, Oregon)) were observed from 1 January 2018 through 31 December 2021. We divided our evaluation of adherence to monitoring guidelines into two segments: (1) the first 12 months post-UDCA initiation; and (2) >12 months post-UDCA initiation.

RESULTS: A total of 1756 patients were identified for the 2018-2021 period; 67 patients did not receive UDCA and were excluded from the sample. A total of 1689 patients were included in one or both segments (segment 1: 740, segment 2: 1689). Only 52% of patients received appropriate ALP testing to ascertain response to UDCA after roughly 1 year of treatment; rates were significantly higher among patients with specialist care compared with those without (54% vs 45%, p=0.001). For the period following the first year of UDCA treatment, the observed monitoring rate was 67%, where hepatology or gastroenterology specialist care was associated with significantly higher rates of monitoring (65%-78%) compared with those without care from a specialist (30%-57%, p< 0.0001) with the same level of comorbidity.

CONCLUSION: In a large US PBC cohort, there were concerning levels of non-adherence to recommended biochemical monitoring. Receipt of care from a specialist was associated with higher rates of monitoring. Strategies to increase rates of biochemical testing are needed.

Medical Subject Headings

Humans; Ursodeoxycholic Acid; Female; Male; Retrospective Studies; Guideline Adherence; Middle Aged; Liver Cirrhosis, Biliary; United States; Cholagogues and Choleretics; Alkaline Phosphatase; Aged; Practice Guidelines as Topic; Disease Progression; Treatment Outcome

PubMed ID

41125399

Volume

12

Issue

1

Find It @ Sladen

Share

COinS