Difficult‐to‐treat primary biliary cholangitis responds well to triple therapy

Triple therapy with ursodeoxycholic acid (UDCA), obeticholic acid (OCA), and fibrates leads to normalization of biochemical liver tests and pruritus improvement in patients with difficult‐to‐treat primary biliary cholangitis (PBC), as shown in a study.

The study included 58 PBC patients who had shown inadequate response to UDCA. All patients were treated for ≥3 months with UDCA, OCA, and fibrates (bezafibrate or fenofibrate).

Of the patients, 29 received OCA in the second‐line and fibrates in the third‐line setting, while the other half had the inverse therapeutic sequence. The mean duration of triple treatment was 11 months.

Triple therapy produced a greater decrease in alkaline phosphatase (ALP; 22 percent, 95 percent confidence interval [CI], 12–31), an effect that was stronger in the OCA‐fibrate than in the fibrate‐OCA group.

The treatment regimen was also associated with a more than threefold higher likelihood of achieving normal ALP (odds ratio [OR], 3.4, 95 percent CI, 1.4–8.2), as well as meaningful reductions in gamma‐glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin.

Of note, triple therapy significantly improved the chances of achieving the Paris‐2 and Toronto criteria of adequate biochemical response (OR, 6.8, 95 percent CI, 2.8–16.7 and OR, 9.2, 95 percent CI, 3.4–25.1, respectively).

Finally, a significant improvement was seen in pruritus in the OCA‐fibrate but not in the fibrate‐OCA group.