Suboptimal PBC Response — RACP Adult Medicine MCQ

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HardGastroenterology & HepatologySuboptimal PBC ResponseRACP Adult Medicine

A 60-year-old woman with primary biliary cholangitis on UDCA 15 mg/kg/day has a suboptimal biochemical response (ALP remains 2.5× ULN after 12 months). What additional therapy should be considered?

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Correct answer: A — Liver transplant assessment

Obeticholic acid (OCA – a farnesoid X receptor agonist) is the second-line treatment for PBC with inadequate response to UDCA (defined as ALP >1.67× ULN and/or elevated bilirubin after ≥12 months of UDCA at 13–15 mg/kg/day – the 'Paris criteria'). The POISE trial showed ALP reduction and improved surrogates of liver disease. However, OCA carries a risk of pruritus (dose-limiting in ~10%) and must be used cautiously in advanced cirrhosis (risk of hepatic decompensation). Fibrates (bezafibrate – BEZURSO trial) are an emerging alternative or add-on.

Reference: eTG – 2025 – Gastrointestinal; AASLD – 2019 – PBC Practice Guidance