Adding Fibrates to Ursodeoxycholic Acid Improves Healthcare Utilization in PBC

New research is shedding light on the real-world benefits of adding fibrates to ursodeoxycholic acid (UDCA) in patients with primary biliary cholangitis (PBC).1

Study findings were presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting by Mohammad Alabbas, MD, Cleveland Clinic Foundation, and highlight substantial reductions in spontaneous bacterial peritonitis and hospitalizations without additional hepatic or extrahepatic adverse events among patients treated with UDCA plus a fibrate.1

UDCA remains the only FDA-approved first-line therapy for the treatment of PBC. However, many patients do not respond to or cannot tolerate UDCA, necessitating additional treatment options. A pair of new second-line therapies, seladelpar (Livdelzi) and elafibranor (Iqirvo) received accelerated approval from the Agency in 2024, but fibrates are also commonly used off-label for UDCA non-responders.2,3

“Fibrates are considered a second line agent for PBC and improve biochemical responses in PBC patients not responding to UDCA. It is unclear whether these biochemical responses from fibrates result in improvement in clinical outcomes in the real world,” Alabbas and colleagues wrote.1

To address this gap in research, investigators compared liver-related complications, extrahepatic sequelae, and healthcare utilization in propensity-matched cohorts of PBC patients treated with UDCA alone or with UDCA plus a fibrate. Specifically, they queried the TriNetX Research Network for adults carrying a diagnosis of PBC who were prescribed UDCA and compared these individuals to a separate cohort of patients prescribed an additional fibrate on top of UDCA, including fenofibrate, gemfibrozil, bezafibrate, or ciprofibrate. Cohort B was on UDCA monotherapy.1

Investigators used 1:1 nearest-neighbor propensity-score matching to balance demographics, comorbidities, and baseline laboratories, yielding 1580 patients per group.1

Over the course of 5 years, patients on fibrates were less likely to develop spontaneous bacterial peritonitis (2.0% vs 1.1%; hazard ratio [HR], 0.52; 95% CI, 0.29-0.92), and had fewer incidences of all-cause hospitalizations (26.7% vs 21.8%; HR, 0.75; 95% CI, 0.65-0.86). However, investigators did not observe any significant difference in cirrhosis, ascites, hepatic encephalopathy, variceal bleeding, and hepatocellular carcinoma.1

Further analysis revealed fewer new diagnoses of fatigue with fibrates (9.0% vs 10.6%; HR, 0.77; 95% CI, 0.60-0.99), but the 2 groups did not differ significantly in the incidence of osteoporosis without fracture (8.3% vs 10.2%; HR, 0.737; 95% CI, 0.575-0.945). Additionally, 5-year all-cause mortality was identical in both cohorts (9.3% vs 9.3 %; HR, 0.919; 95% CI, 0.731-1.155).1

“These data suggest that fibrates are an effective adjunct therapy for PBC patients on UDCA,” investigators concluded.1 “Prospective trials are warranted to validate these findings and define optimal candidate selection.”

References

1. Alabbas M, Kawas H, Abu-Hammour MN, et al. Fibrates as an Adjunct Therapy in Primary Biliary Cholangitis Is Associated With Lower Hospitalization and Healthcare Utilization: A Propensity-Matched Analysis. Presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting. Phoenix, Arizona. October 27-29, 2025.

2. Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed October 27, 2025. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis

3. Brooks A. FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC. HCPLive. June 10, 2024. Accessed October 27, 2025. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-elafibranor-iqirvo-for-pbc