IgM response is a prognostic biomarker of primary biliary cholangitis treated with ursodeoxycholic acid and bezafibrate

Background and Aim Primary biliary cholangitis (PBC) patients who are refractory to ursodeoxycholic acid (UDCA) are at risk for progression to cirrhosis and liver failure. Bezafibrate could be an alternative second‐line therapeutic option in these patients. This study aimed to evaluate the long‐term outcome(s) of combined UDCA and bezafibrate therapy in UDCA‐refractory PBC patients and identify prognostic factors. Methods Among 445 patients treated with UDCA, 150 patients inadequately responded to UDCA monotherapy and received long‐term UDCA plus bezafibrate (median, 15 years). Data from these patients were used for this retrospective analysis. Results Combination therapy resulted in significant improvements in serum biochemistry and liver transplantation risk estimated using the UK‐PBC‐risk and the GLOBE scores. The cumulative normalization rates of alkaline phosphatase, gamma‐glutamyltransferase, and immunoglobulin M (IgM) were significantly higher in patients without cirrhosis‐related symptoms or liver‐related events than in those with them. Overall, IgM constantly emerged as a significant factor associated with cirrhosis‐related symptoms and liver‐related events at all time points. Cumulative survival rates were significantly lower in patients with IgM ≥ 240 mg/dL than in patients with IgM