Z Gastroenterol 2019; 57(01): e39-e40
DOI: 10.1055/s-0038-1677147
2. Clinical Hepatology, Surgery, LTX
Georg Thieme Verlag KG Stuttgart · New York

The journey of a patient with biopsy-proven non-alcoholic steatohepatitis (NASH) – results from a real-world study

M Rinella
1   Northwestern University Feinberg School of Medicine, Chicago, IL, USA
,
V Ratziu
2   Hospital Pitié-Salpêtrière, Institute of Cardiometabolism and Nutrition (ICAN), Sorbonne Universités, Université Pierre et Marie Curie, Paris, France
,
MM Balp
3   Novartis Pharma AG, Basel, Switzerland
,
SJ McKenna
4   Novartis Business Services Center, Dublin, Ireland
,
R Przybysz
5   Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
,
J Cai
5   Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
,
C Brass
5   Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
,
T Howe
6   Ipsos, Waltham, MA, USA
,
M Gavaghan
6   Ipsos, Waltham, MA, USA
,
D Rosen
7   Ipsos, NY, USA
,
A Knight
7   Ipsos, NY, USA
,
A Geier
8   Universitätsklinikum Würzburg, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
04 January 2019 (online)

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Background:

In this study we report for the first time, the journey of patients with biopsy-confirmed NASH in real-world settings.

Methods:

Data for this non-interventional study come from Ipsos NASH-Atlas database and were collected between July and November 2017 among physicians managing NASH patients in the United States (US), France (FR) and Germany (DE). Data from medical charts including demographics, clinical characteristics, and diagnostic algorithms for the next 5 to 7 eligible patients were reported. A subset of patients accepted to complete a paper survey on their experience with NASH. Data were pooled and analyzed using descriptive statistics.

Results:

Medical chart data for 786 patients with NASH confirmed by biopsy (out of 1,216 total) are reported. Mean (SD) age was 55 (12) years, BMI 31.2 (6.9), disease duration since diagnosis 32 (45) months. 42% of patients were referred to their diagnosing physician by a diabetologist and 21% by a primary care physician; 48% and 26% of patients were diagnosed by a gastroenterologist and hepatologist respectively. The most common diagnostic tests and procedures were: Serum transaminases (62%), lipid profiles (47%), platelet count (43%) and gamma glutamyl transferase (41%), ultrasound (59%), Fibroscan® (18%) and CT scan (17%). At diagnosis, biopsy revealed that 22%, 35%, 27% and 6% of patients had stage 1, 2, 3 and 4 fibrosis, respectively. For 61% of patients, lifestyle modification was the initial approach recommended. Reasons for not performing a biopsy included patient refusal (43%), invasiveness of the procedure (28%), non-invasive tests considered conclusive (26%), lack of approved therapies (13%). Among 160 biopsy-proven NASH patients who completed the patient survey, 51% reported symptoms, with 57% reporting fatigue as most influential in their decision to seek medical attention.

Conclusion:

NASH can be perceived as a 'silent' disease, resulting in a high number of late fibrosis stage patients at time of diagnosis. Patient refusal and invasiveness of biopsy emphasize the need for non-invasive confirmatory diagnostic measures. Additionally, lifestyle modification as the primary treatment approach highlights the need for a NASH-specific pharmacotherapy to ultimately reduce the development of disease progression.