The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study

Background & Aims: Data on the economic and humanistic burden of non-alcoholic steatohepatitis (NASH) are scarce. This study assessed the comparative burden of NASH, relative to a representative sample from the general population and a type 2 diabetes mellitus (T2DM) cohort, in terms of health-r...

Full description

Bibliographic Details
Main Authors: Maria-Magdalena Balp, Nancy Krieger, Raymond Przybysz, Nate Way, Jennifer Cai, Dion Zappe, Sarah Jane McKenna, Garth Wall, Nico Janssens, Elliot Tapper
Format: Article
Language:English
Published: Elsevier 2019-09-01
Series:JHEP Reports
Online Access:http://www.sciencedirect.com/science/article/pii/S2589555919300576
_version_ 1811270098851201024
author Maria-Magdalena Balp
Nancy Krieger
Raymond Przybysz
Nate Way
Jennifer Cai
Dion Zappe
Sarah Jane McKenna
Garth Wall
Nico Janssens
Elliot Tapper
author_facet Maria-Magdalena Balp
Nancy Krieger
Raymond Przybysz
Nate Way
Jennifer Cai
Dion Zappe
Sarah Jane McKenna
Garth Wall
Nico Janssens
Elliot Tapper
author_sort Maria-Magdalena Balp
collection DOAJ
description Background & Aims: Data on the economic and humanistic burden of non-alcoholic steatohepatitis (NASH) are scarce. This study assessed the comparative burden of NASH, relative to a representative sample from the general population and a type 2 diabetes mellitus (T2DM) cohort, in terms of health-related quality of life, work productivity and activity impairment (WPAI), and healthcare resource use. Methods: Data across 5 European countries came from the 2016 National Health and Wellness Survey, a nationally representative patient-reported outcomes survey. Outcomes included mental (MCS) and physical (PCS) component scores from the Short-Form (SF)-36v2, WPAI scores, self-reported physician diagnosis of sleep difficulties, anxiety, and depression, and healthcare resource use: healthcare professional visits, hospital visits, and emergency room visits in the previous 6 months. Bivariate and multivariable analyses were conducted for each outcome and comparative group. Results: After adjusting for matching criteria and covariates, patients with NASH (n = 184) reported significantly worse health-related quality of life, worse WPAI scores, and more healthcare resource use than the general population (n = 736) (MCS 39.22 vs. 45.16, PCS 42.84 vs. 47.76; overall work impairment 49.15% vs. 30.77%, healthcare professional visits 10.73 vs. 6.01, emergency room visits 0.57 vs. 0.22, hospitalizations 0.47 vs. 0.17, p ≪0.05 for all). Patients with NASH did not differ from patients with T2DM (n = 368) on PCS and WPAI scores, suggesting a similar impairment on work and daily activities, but did report significantly worse mental status (MCS 39.64 vs. 43.64, p ≪0.05) and more healthcare resource use than those with T2DM (healthcare professional visits 10.85 vs. 7.86, emergency room visits 0.65 vs. 0.23, hospitalizations 0.39 vs. 0.19, p ≪0.05 for all). Conclusions: These findings suggest that the burden of NASH may be underestimated, highlighting the unmet needs of patients with NASH. Lay summary: These findings show that patients with non-alcoholic steatohepatitis (NASH) experience a significant burden of illness, in terms of health-related quality of life, work productivity and activity impairment, and healthcare resource use. As there is currently no approved treatment for NASH, these findings highlight the unmet medical need of patients with NASH. Keywords: non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, type 2 diabetes, burden of illness
first_indexed 2024-04-12T21:54:49Z
format Article
id doaj.art-2c470badbfe9413faa72f9b3bb0fe0ea
institution Directory Open Access Journal
issn 2589-5559
language English
last_indexed 2024-04-12T21:54:49Z
publishDate 2019-09-01
publisher Elsevier
record_format Article
series JHEP Reports
spelling doaj.art-2c470badbfe9413faa72f9b3bb0fe0ea2022-12-22T03:15:21ZengElsevierJHEP Reports2589-55592019-09-0113154161The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes studyMaria-Magdalena Balp0Nancy Krieger1Raymond Przybysz2Nate Way3Jennifer Cai4Dion Zappe5Sarah Jane McKenna6Garth Wall7Nico Janssens8Elliot Tapper9Novartis Pharma AG, Basel, SwitzerlandNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USHealth Outcomes Practice, Kantar Health, San Mateo, California, US; Corresponding author. Address: 1810 Gateway Drive, Suite 120, San Mateo, CA 94404; Tel.: +1 805 249 9036.Novartis Pharmaceuticals Corp., East Hanover, New Jersey, USNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USNovartis Business Services Centre, Dublin, IrelandNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USNovartis Pharma AG, Basel, SwitzerlandUniversity of Michigan, Ann Arbor, Michigan, USBackground & Aims: Data on the economic and humanistic burden of non-alcoholic steatohepatitis (NASH) are scarce. This study assessed the comparative burden of NASH, relative to a representative sample from the general population and a type 2 diabetes mellitus (T2DM) cohort, in terms of health-related quality of life, work productivity and activity impairment (WPAI), and healthcare resource use. Methods: Data across 5 European countries came from the 2016 National Health and Wellness Survey, a nationally representative patient-reported outcomes survey. Outcomes included mental (MCS) and physical (PCS) component scores from the Short-Form (SF)-36v2, WPAI scores, self-reported physician diagnosis of sleep difficulties, anxiety, and depression, and healthcare resource use: healthcare professional visits, hospital visits, and emergency room visits in the previous 6 months. Bivariate and multivariable analyses were conducted for each outcome and comparative group. Results: After adjusting for matching criteria and covariates, patients with NASH (n = 184) reported significantly worse health-related quality of life, worse WPAI scores, and more healthcare resource use than the general population (n = 736) (MCS 39.22 vs. 45.16, PCS 42.84 vs. 47.76; overall work impairment 49.15% vs. 30.77%, healthcare professional visits 10.73 vs. 6.01, emergency room visits 0.57 vs. 0.22, hospitalizations 0.47 vs. 0.17, p ≪0.05 for all). Patients with NASH did not differ from patients with T2DM (n = 368) on PCS and WPAI scores, suggesting a similar impairment on work and daily activities, but did report significantly worse mental status (MCS 39.64 vs. 43.64, p ≪0.05) and more healthcare resource use than those with T2DM (healthcare professional visits 10.85 vs. 7.86, emergency room visits 0.65 vs. 0.23, hospitalizations 0.39 vs. 0.19, p ≪0.05 for all). Conclusions: These findings suggest that the burden of NASH may be underestimated, highlighting the unmet needs of patients with NASH. Lay summary: These findings show that patients with non-alcoholic steatohepatitis (NASH) experience a significant burden of illness, in terms of health-related quality of life, work productivity and activity impairment, and healthcare resource use. As there is currently no approved treatment for NASH, these findings highlight the unmet medical need of patients with NASH. Keywords: non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, type 2 diabetes, burden of illnesshttp://www.sciencedirect.com/science/article/pii/S2589555919300576
spellingShingle Maria-Magdalena Balp
Nancy Krieger
Raymond Przybysz
Nate Way
Jennifer Cai
Dion Zappe
Sarah Jane McKenna
Garth Wall
Nico Janssens
Elliot Tapper
The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study
JHEP Reports
title The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study
title_full The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study
title_fullStr The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study
title_full_unstemmed The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study
title_short The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study
title_sort burden of non alcoholic steatohepatitis nash among patients from europe a real world patient reported outcomes study
url http://www.sciencedirect.com/science/article/pii/S2589555919300576
work_keys_str_mv AT mariamagdalenabalp theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT nancykrieger theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT raymondprzybysz theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT nateway theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT jennifercai theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT dionzappe theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT sarahjanemckenna theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT garthwall theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT nicojanssens theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT elliottapper theburdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT mariamagdalenabalp burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT nancykrieger burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT raymondprzybysz burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT nateway burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT jennifercai burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT dionzappe burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT sarahjanemckenna burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT garthwall burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT nicojanssens burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy
AT elliottapper burdenofnonalcoholicsteatohepatitisnashamongpatientsfromeuropearealworldpatientreportedoutcomesstudy