Burden of fatigue or pruritus in patients with primary biliary cholangitis: a United States matched case–control study
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: Primary biliary cholangitis (PBC) is a rare liver disease associated with high morbidity. This study assessed the burden of fatigue and/or pruritus among patients with PBC in the US. Materials & methods: This retrospective study used IQVIA PharMetrics® Plus data (2016–2022). Patients with PBC and fatigue and/or pruritus were selected as cases. Controls were patients with PBC (no fatigue nor pruritus), matched 1:1 to cases by key characteristics. The index date for cases was a random symptom diagnosis date post-initial PBC diagnosis and for controls, a random medical visit date matching the time distribution from initial PBC diagnosis to index. Cumulative incidence of PBC comorbidities was described using Kaplan–Meier analysis and compared via Cox Proportional hazard models. Generalized estimating equations compared healthcare resource use (HRU) and costs per-patient-per-year. Results: A total of 1839 fatigue cases/controls (mean age [years]: 56.5; 88.7% female) and 760 pruritus cases/controls were included (mean age [years]: 55.8; 90.8% female). Comorbidities at 1, 3 and 5-years post-index were higher for cases than controls (fatigue: 1.7 vs 0.7, 2.2 vs 0.9 and 2.5 vs 1.0; pruritus: 1.9 vs 0.8, 2.3 vs 1.0 and 2.7 vs 1.0; all p < 0.001). Common comorbidities were anxiety, urinary tract infection, depression and sleep disorders (hazard ratios in cases vs controls: fatigue, 1.3–4.0; pruritus, 1.5–2.8; all p < 0.01). One-year post-index, cases had higher rates of healthcare visits (incidence rate ratios: fatigue, 1.8–5.8; pruritus 1.6–6.1) and total healthcare costs (mean cost difference: fatigue, $42,515; pruritus $40,536). Conclusion: Patients with PBC who experience fatigue and/or pruritus faced a greater clinical and economic burden compared with those without these symptoms, highlighting the need for effective treatments to alleviate PBC symptoms.
Plain language summary: How fatigue or itching affect people with primary biliary cholangitis in the US compared with people without the disease
What is this article about?
Primary biliary cholangitis (PBC) is a long-term rare liver disease that can increase the risk of developing other health problems. PBC symptoms can make it difficult for patients to have a good quality of life. The most common symptoms of PBC are tiredness (fatigue) and itchiness (pruritus).
What were the results?
This study found that patients with PBC who experienced tiredness or itchiness were more likely to have additional health problems over time than patients who were not itchy or tired. These health problems were: increased risk of anxiety, urinary tract infections, depression and trouble sleeping. In addition, patients with tiredness or itchiness had about two to six-times more visits to the hospital, doctor’s office or emergency room than patients without these symptoms. On average, the total healthcare costs were more than $40,000 higher among patients with tiredness or itchiness than those without, mostly because of more hospital stays, showing that tiredness and itchiness can increase the financial burden experienced by patients.
Why is this important?
These results show the importance of finding effective treatments to reduce the symptoms of tiredness or itchiness for people living with PBC.
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References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
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Received: 31 October 2025
Accepted: 8 July 2026
Published online: 12 August 2026
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Burden of fatigue or pruritus in patients with primary biliary cholangitis: a United States matched case–control study. (2026) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2025-0179
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