Sleep Disorders and PBC Disease Severity, with Ana Marenco Flores, MD

New research is shedding light on the prevalence of sleep disorders in patients with primary biliary cholangitis (PBC), additionally highlighting their association with worse biochemical markers, greater symptom burden, and reduced treatment response rates.

The data were presented at Digestive Disease Week (DDW) 2025 by Ana Marenco Flores, MD, a research fellow in medicine in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, and highlight the potential benefit of assessing sleep disorders as part of routine clinical care and implementing timely interventions for improving outcomes and quality of life in this patient population.

“In clinical practice, almost 80 to 85% of patients are going to tell you they are having fatigue, having trouble sleeping, having a lot of itching, or having difficulties at their job because they’re feeling tired a lot,” Marenco Flores explained to HCPLive. “There’s a really strong association between quality of life or patient reported outcomes with PBC.”

To assess this association in the context of sleep disorders, she and colleagues conducted a prospective study of patients with PBC enrolled in a single-center Autoimmune Liver Registry between 2018-2024. Diagnoses were based on EASL criteria and all patients received standard ursodeoxycholic acid therapy with ≥ 1 year of follow-up. Exclusion criteria included autoimmune overlap, drug-induced liver injury, viral hepatitis, alcohol-associated liver disease, and incomplete questionnaires.

Sleep disorders and fatigue were assessed using the CLDQ and PBC-40 questionnaires, while pruritus was evaluated using the Visual Analogue Scale (VAS) and the 5-D Itch Scale at the 1-year follow-up. Treatment response was defined according to Paris-II criteria.

Among 104 patients with PBC, 33% reported sleep disorders. Investigators noted this group had significantly increased alkaline phosphatase (ALP) levels (median 203 IU/L vs 122 IU/L; P = .003) and total bilirubin (TBIL) levels (median 0.6 mg/dL vs 0.4 mg/dL; P = .031) compared to those without sleep disorders. They also reported more severe fatigue (P = .016), poorer overall health ratings (P <.001), and a significantly lower likelihood of achieving treatment response (44% vs 94%; P <.001). Of note, pruritus severity did not differ significantly between the groups (P = .523).

“Before, there were studies that said that most patients have difficulty sleeping because they have itch. In our cohort, we saw that even though some patients have itching and sleep issues, a lot of them didn't report itching but still had sleep difficulties,” Marenco Flores said.

Multivariable analysis identified greater ALP (odds ratio [OR], 1.01; P <.001) and poorer self-rated health (OR, 3.4; P <.001) as independent predictors of sleep disorders.

“I think for us as a lab, especially in autoimmune liver diseases, we aim to also assess patient reported outcomes,” Marenco Flores said. “The objective parameters are obviously really important, but sometimes patients will do great with the labs and the treatment and still have some complaints. For them, feeling good in every aspect of their life is as good as having a great ALP or another imaging test, so that's what we aim for.”

Editors’ note: Marenco Flores has no relevant disclosures.

Reference

1. Marenco-Flores A, Amaris NR, Barba R, et al. SLEEP DISORDERS IN PRIMARY BILIARY CHOLANGITIS: INDEPENDENT OF PRURITUS BUT PREDICTIVE OF DISEASE SEVERITY IN A U.S. SINGLE-CENTER COHORT. Abstract presented at Digestive Disease Week 2025 in San Diego, CA, from May 3 - May 6, 2025.