Abstract

Patient-reported outcomes are important in nonalcoholic fatty liver disease (NAFLD). Pruritus is of special interest for evolving therapies with farnesoid X receptor (FXR) agonists. The aim of this study was to investigate the prevalence of pruritus in a real-life NAFLD cohort and analyze associations with anxiety and depression. Pruritus was assessed using a visual analogue- (VAS) and 5-D itch-scale (5-D). Anxiety and depression were evaluated by Beck’s-Depression-Inventory (BDI) and the Hospital Anxiety and Depression Scale (HADS-A, HADS-D). An optimal logistic regression model was found with a stepwise procedure to investigate variables associated with pruritus. In total, 123 NAFLD patients were recruited. VAS and 5-D were highly correlated (Spearman’s correlation coefficient 0.89). Moderate/severe pruritus was reported in 19% (VAS) and 21% (5-D) of patients. Anxiety and depression were present in 12% and 4% (HADS-A and HADS-D, respectively) and 12% (BDI) of cases. There was a significant association between VAS and BDI (p = 0.019). The final multivariate model for 5-D included diabetes mellitus (OR 4.51; p = 0.01), BDI (OR 5.98; p = 0.024), and HADS-A (OR 7.75; p = 0.011). One-fifth of NAFLD patients reported moderate or severe pruritus. 5-D was significantly associated with diabetes mellitus, depression, and anxiety. These findings should be tested in larger populations and considered in candidates for treatment with FXR agonists.

Highlights

  • Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the western world and has become a significant clinical and epidemic health problem

  • There were no significant differences in age, sex, or BMI, nor were there significant differences in controlled attenuation parameter (CAP), liver stiffness measurement (LSM), and the non-invasive fibrosis scores between the patients with no or mild pruritus compared to individuals with moderate or severe pruritus

  • Patient-reported outcomes are increasingly important in NAFLD, and pruritus is of special interest for evolving therapies with farnesoid X receptor (FXR) agonists

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Summary

Introduction

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the western world and has become a significant clinical and epidemic health problem. The term NAFLD encompasses a broad spectrum of diseases such as simple hepatic steatosis as well as non-alcoholic steatohepatitis (NASH), the more advanced form with a higher risk of disease progression to advanced fibrosis and liver cirrhosis [1–4]. Despite the tremendous clinical relevance, NAFLD and NASH are often considered to be clinically asymptomatic, at least if they have not progressed to cirrhosis. Controlled clinical trials for the development of drugs ameliorating NASH have assessed patient-reported outcomes (PROs) with validated and standardized questionnaires. They show significantly impaired quality of life in a Biomedicines 2022, 10, 451.

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