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. 2023 Apr 5;23(1):109.
doi: 10.1186/s12876-023-02726-2.

The burden of nonalcoholic steatohepatitis (NASH) in the United States

Elliot B Tapper  1 , Nancy Krieger  2 , Raymond Przybysz  2 , Nate Way  3 , Jennifer Cai  2 , Dion Zappe  2 , Sarah Jane McKenna  4 , Garth Wall  2 , Nico Janssens  5 , Maria-Magdalena Balp  5
Affiliations

The burden of nonalcoholic steatohepatitis (NASH) in the United States

Elliot B Tapper et al. BMC Gastroenterol. .

Abstract

Background: There is limited data on the comparative economic and humanistic burden of non-alcoholic steatohepatitis (NASH) in the United States. The objective was to examine the burden of disease comparing NASH to a representative sample of the general population and separately to a type 2 diabetes mellitus (T2DM) cohort by assessing health-related quality of life (HRQoL) measures, healthcare resource use (HRU) and work productivity and activity impairment (WPAI).

Methods: Data came from the 2016 National Health and Wellness Survey, a nationally representative patient-reported outcomes survey conducted in the United States. Respondents with physician-diagnosed NASH, physician-diagnosed T2DM, and respondents from the general population were compared. Humanistic burden was examined with mental (MCS) and physical (PCS) component summary scores from the Short-Form (SF)-36v2, concomitant diagnosis of anxiety, depression, and sleep difficulties. Economic burden was analysed based on healthcare professional (HCP) and emergency room (ER) visits, hospitalizations in the past six months; absenteeism, presenteeism, overall work impairment, and activity impairment scores on WPAI questionnaire. Bivariate and multivariable analysis were conducted for each outcome and matched comparative group.

Results: After adjusting for baseline demographics and characteristics, NASH (N = 136) compared to the matched general population cohort (N = 544), reported significantly lower (worse) mental (MCS 43.19 vs. 46.22, p = 0.010) and physical (PCS 42.04 vs. 47.10, p < 0.001) status, higher % with anxiety (37.5% vs 25.5%, p = 0.006) and depression (43.4% vs 30.1%, p = 0.004), more HCP visits (8.43 vs. 5.17), ER visits (0.73 vs. 0.38), and hospitalizations (0.43 vs. 0.2) all p's < 0.05, and higher WPAI scores (e.g. overall work impairment 39.64% vs. 26.19%, p = 0.011). NASH cohort did not differ from matched T2DM cohort (N = 272) on mental or work-related WPAI scores, but had significantly worse physical status (PCS 40.52 vs. 44.58, p = 0.001), higher % with anxiety (39.9% vs 27.8%, p = 0.043), more HCP visits (8.63 vs. 5.68, p = 0.003) and greater activity impairment (47.14% vs. 36.07%, p = 0.010).

Conclusion: This real-world study suggests that burden of disease is higher for all outcomes assessed among NASH compared to matched general controls. When comparing to T2DM, NASH cohort has comparable mental and work-related impairment but worse physical status, daily activities impairment and more HRU.

Keywords: Burden of illness; NAFLD; Nonalcoholic fatty liver disease; Type 2 diabetes; US.

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Conflict of interest statement

Elliot B. Tapper received a consultancy fee for his medical expertise on this project from Novartis Pharmaceuticals Corp., US. Maria-Magdalena Balp and Nico Janssens are employees of Novartis Pharma AG, Basel, Switzerland. Nate Way is an employee of Cerner Enviza (formally Kantar Health), Raymond Przybysz and Jennifer Cai are employees of Novartis Pharmaceuticals Corp., US, and Sarah Jane McKenna is an employee of Novartis Business Services Centre, Ireland.

Nancy Krieger, Dion Zappe and Garth Wall were employees of Novartis Pharmaceuticals Corp., US at the time of the study and the initial development of the manuscript.

Figures

Fig. 1
Fig. 1
MCS and PCS scores: NASH vs. matched general population and NASH vs. matched T2DM. Note: The above scores are multivariable results and displayed as adjusted means. Standard error and upper and lower 95% confidence intervals are presented in Supplementary Table 2; p-values represent significance of the regression coefficient in the regression model for each comparison (NASH vs matched general population and NASH vs matched T2DM). Lower scores mean lower status. Abbreviations: NASH, non-alcoholic steatohepatitis; MCS, mental component summary; PCS, physical component summary; T2DM, type 2 diabetes mellitus
Fig. 2
Fig. 2
Patients with psychological comorbidities: NASH vs. matched general population and NASH vs. matched T2DM. Note: The above scores are multivariable results reported as percentage of patients with diagnosed anxiety, depression, or sleep difficulties; p-values represent significance of the regression coefficient in the regression model for each matched comparison. Standard error and upper and lower 95% confidence intervals are presented in Supplementary Table 3. Abbreviations: NASH, nonalcoholic steatohepatitis; T2DM, type 2 diabetes mellitus
Fig. 3
Fig. 3
HRU: NASH vs. matched general population and NASH vs. matched T2DM. Note: Multivariable results displayed as adjusted mean over the past 6 months; p-values represent significance of the regression coefficient in the regression model for each matched comparison. Standard error and upper and lower 95% confidence intervals are presented in Supplementary Table 6. Abbreviations: ER, emergency room; HCP, healthcare professional; HRU, healthcare resource use; NASH, nonalcoholic steatohepatitis; T2DM, type 2 diabetes mellitus
Fig. 4
Fig. 4
WPAI scores: NASH vs. matched general population and NASH vs. matched T2DM. Note: Multivariable results presented as adjusted % means; p-values represent significance of the regression coefficient in the regression model for each matched comparison. Absenteeism, presenteeism, and overall work impairment reported only by employed respondents. Standard error and upper and lower 95% confidence intervals are presented in Supplementary Table 4. Higher scores mean higher impairment. Abbreviations: NASH, nonalcoholic steatohepatitis; T2DM, type 2 diabetes mellitus; WPAI, Work Productivity and Activity Impairment
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