In primary biliary cholangitis (PBC), the first-line therapy is ursodeoxycholic acid (UDCA). Which biochemical response criterion at 12 months is used to define inadequate UDCA response (Paris-II criteria), indicating need for add-on therapy?

• A Failure to normalize ALP to within normal range at 12 months
• B Persistent ALP >2× ULN and bilirubin >3.0 mg/dL at any time point
• C Any detectable anti-mitochondrial antibody at 12 months despite UDCA
• D ALP >1.5× ULN or AST >2× ULN or bilirubin >1.5 mg/dL at 12 months on UDCA ✓

Explanation

The Paris-II criteria for inadequate UDCA response in PBC define biochemical non-response as ALP and/or AST >1.5× ULN or total bilirubin >1.5 mg/dL at 12 months after initiating UDCA 13–15 mg/kg/day. These patients have increased risk of cirrhosis and death. Obeticholic acid (OCA), a farnesoid X receptor agonist, is approved as add-on therapy for inadequate UDCA responders or as monotherapy in UDCA-intolerant patients. AMA titers do not guide treatment.

Reference: Harrison's Principles of Internal Medicine, 21st ed.

High-yield for: NEET PGINI-CETNExTFMGEUSMLEPLABMRCP

Written and medically reviewed by the StethoPrep medical team.