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Abstract Details
Fatigue and Pruritus in Patients with Advanced Fibrosis Due to Nonalcoholic Steatohepatitis: The Impact on Patient-Reported Outcomes
Hepatol Commun. 2020 Aug 28;4(11):1637-1650. doi: 10.1002/hep4.1581. eCollection 2020 Nov.
Zobair M Younossi12, Vincent Wai-Sun Wong3, Quentin M Anstee45, Manuel Romero-Gomez6, Michael H Trauner7, Stephen A Harrison8, Eric J Lawitz9, Takeshi Okanoue10, Marianne Camargo11, Kathryn Kersey11, Robert P Myers11, Zachary Goodman12, Maria Stepanova12
Author information
1Betty and Guy Beatty Center for Integrated Research Inova Health System Falls Church VA USA.
2Department of Medicine Center for Liver Diseases Inova Fairfax Hospital Falls Church VA USA.
3The Chinese University of Hong Kong Hong Kong China.
4Clinical & Translational Research Institute Faculty of Medical Sciences Newcastle University Newcastle upon Tyne United Kingdom.
5Newcastle NIHR Biomedical Research Centre Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle-upon-Tyne United Kingdom.
6Digestive Diseases UCM Virgen del Rocio University Hospital Institute of Biomedicine of Seville University of Seville Seville Spain.
7Division of Gastroenterology and Hepatology Medical University of Vienna Vienna Austria.
8Radcliffe Department of Medicine Oxford University Oxford United Kingdom.
9Texas Liver Institute University of Texas Health San Antonio San Antonio TX USA.
10Saiseikai Suita Hospital Suita City, Osaka Japan.
11Gilead Sciences, Inc. Foster City CA USA.
12Center for Outcomes Research in Liver Disease Washington DC USA.
Abstract
Fatigue and pruritus are common in patients with chronic liver diseases of all etiologies, but clinical awareness is mostly restricted to those with cholestatic liver diseases. We assessed the impact of fatigue and pruritus on patient-reported outcomes (PROs) of patients with advanced nonalcoholic steatohepatitis (NASH). Specifically, PROs (Short Form-36, Chronic Liver Disease Questionnaire-NASH, Euro-Qol 5 Dimension, and Work Productivity and Activity Impairment instruments) were assessed at baseline in patients with histologically confirmed bridging fibrosis (F3) or compensated cirrhosis (F4) due to NASH enrolled in STELLAR 3 and 4. Presence of fatigue and pruritus were indicated by a score of 4 or less on the respective items of the Chronic Liver Disease Questionnaire-NASH (scale range, 1-7). Among the included 1,669 patients with advanced NASH (mean age = 58 ± 9 years, 48% F3, 42% with psychiatric comorbidities), 33% and 27% had fatigue and pruritus, respectively. Patients with NASH with fatigue were younger, more likely to be female, cirrhotic, and diabetic, and had higher body mass index and more comorbidities (all P < 0.05). All PRO scores of patients with fatigue were significantly impaired (mean up to -31% of a PRO range size in comparison to patients without fatigue). In multivariate analysis, predictors of fatigue included diabetes, history of depression or nervous system comorbidities, and lower serum albumin (P < 0.05). Patients with pruritus had demographic characteristics similar to those with fatigue, but a higher prevalence of dermatologic comorbidities. All PROs were impaired (by up to -19% of a range size, all P < 0.01) in patients with NASH with pruritus. Female gender, lower serum albumin, and a history of depression, nervous system, and dermatologic comorbidities were associated with increased risk of pruritus (P < 0.05). Conclusion: Clinically significant fatigue and pruritus are common in patients with advanced NASH, and these symptoms negatively affect PROs.