TOPLINE:

An uptake of ursodeoxycholic acid (UDCA) among patients with primary biliary cholangitis (PBC) exceeded 95%; however, nearly 40% were prescribed a suboptimal dosage. Higher body weight, older age, and complete biochemical response predicted suboptimal prescribing.

METHODOLOGY:

• Researchers conducted a retrospective cohort study across 71 Dutch hospitals to assess whether patients with PBC receive optimal UDCA dosing and appropriate second‑line therapy and to identify factors linked to suboptimal prescribing.
• They included 2638 patients with PBC (median age, 64 years; 89.5% women) who were under clinical follow-up on January 1, 2019; recorded the use and dosage of UDCA (optimal dose ≥ 13 mg/kg/d) for all patients; and evaluated the use of any second-line therapy only in those without PBC and autoimmune hepatitis variant syndrome.
• Second-line therapy included the off-label use of peroxisome proliferator-activated receptor agonists such as bezafibrate, ciprofibrate, or gemfibrozil; budesonide; and/or obeticholic acid.
• Biochemical response to UDCA was defined as alkaline phosphatase (ALP) and aspartate aminotransferase (AST) levels less than or equal to 1.5-fold the upper limit of normal (ULN) and total bilirubin levels less than or equal to the ULN.

TAKEAWAY:

• Among 2205 patients with available body weight data, only 61.8% had received a median UDCA dosage of 13.8 mg/kg/d.
• Older age (odds ratio [OR], 1.01; P = .02), higher body weight (OR, 1.04; P < .01), and achieving biochemical response to UDCA (OR, 1.35; P = .01) were independently associated with a UDCA dosage < 13 mg/kg/d.
• Among 638 patients with incomplete biochemical response after at least 12 months of UDCA therapy, only 15.8% were prescribed second-line therapy.
• Among incomplete biochemical responders, younger age, female sex, treatment in an academic centre, and higher ALP and AST levels were associated with a greater use of second-line therapy (P < .05 for all).

IN PRACTICE:

"It is important to keep track of the body weight of an individual patient and adjust the dosage when indicated," the authors of the study wrote.

SOURCE:

This study was led by Ellen Werner, Erasmus University Medical Center, Rotterdam, Netherlands. It was published online on April 14, 2026, in Alimentary Pharmacology and Therapeutics.

LIMITATIONS:

The analysis was retrospective in nature, and the timing of data collection varied between centres. Additionally, the restricted availability and reimbursement of some second‑line agents and off‑label status of fibrates may have affected the uptake of second‑line therapies.

DISCLOSURES:

This study was supported by Zambon Nederland B.V. One author reported receiving grants and speaker fees and being a consultant for various biotech and pharmaceutical companies, including the funding company.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.