To assess the effectiveness and adverse effects of treatment of refractory primary biliary cholangitis (PBC), data from patients included in the ColHai Registry treated with OCA (obeticholic acid), fibrates, or both and were recorded during one year, as well as adverse effects and treatment discontinuation.
A total of 86 patients were treated with OCA, 250 with fibrates (81% bezafibrate; 19% fenofibrate), and 15 with OCA plus fibrates. The OCA group had baseline significantly higher alkaline phosphatase (ALP) and lower platelets than fibrates. Both treatments significantly decreased ALP, GGT, and transaminases and improved GLOBE score. Albumin and immunoglobulin type M improved in the fibrates group. ALP decrease was higher under fibrates, whereas ALT decline was higher under OCA.
Although baseline transaminases and GGT were higher in patients with OCA plus fibrates, significant ALP, GGT, ALT and GLOBE score improvement were observed during triple therapy. Adverse events were reported in 14.7% of patients (21.3% OCA, 17.6% fenofibrate, 10.7% bezafibrate). This was mainly pruritus (10.1% with OCA). Discontinuation was more frequent in fenofibrate treatment, mainly because of intolerance or adverse events. It was concluded that second-line therapy with OCA or fibrates improved hepatic biochemistry and the GLOBE score in PBC patients with suboptimal response to USDA. Simultaneous treatment with OCA and fibrates improved ALP as well.
Reig, A., Alvarez-Nevascues, C., Vergara, M., et al. “Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric, Observational Study.” American Journal of Gastroenterology, Vol. 116, November 2021, pp. 2250-2257.