NAFLD and NASH biomarker qualification in the LITMUS consortium – Lessons learned

Clinical Utility of Magnetic Resonance Imaging Biomarkers for Identifying Nonalcoholic Steatohepatitis Patients at High Risk of Progression: A Multicenter Pooled Data and Meta-Analysis

(2021) Anneli Andersson et al.   Clinical Gastroenterology and Hepatology

Liquid biomarkers for fibrotic NASH – progress in a complex field

(2021) Detlef Schuppan et al.   JOURNAL OF HEPATOLOGY

Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease

(2021) Arun J. Sanyal et al.   NEW ENGLAND JOURNAL OF MEDICINE

R&D Costs of New Medicines: A Landscape Analysis

(2021) Steven Simoens et al.   Frontiers in Medicine

Goals of Treatment for Improved Survival in Primary Biliary Cholangitis

(2020) Carla F. Murillo Perez et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study

(2020) Philip N Newsome et al.   Lancet Gastroenterology & Hepatology

Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis

(2020) Stephen A. Harrison et al.   GASTROENTEROLOGY

Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials

(2020) Beth A. Davison et al.   JOURNAL OF HEPATOLOGY

Prognostic value of multiparametric magnetic resonance imaging, transient elastography and blood‐based fibrosis markers in patients with chronic liver disease

(2020) Arjun N.A. Jayaswal et al.   LIVER INTERNATIONAL

Mortality in biopsy-confirmed nonalcoholic fatty liver disease: results from a nationwide cohort

(2020) Tracey G Simon et al.   GUT

From NASH to HCC: current concepts and future challenges

(2019) Quentin M. Anstee et al.   Nature Reviews Gastroenterology & Hepatology

Determinants of fibrosis progression and regression in NASH

(2018) Detlef Schuppan et al.   JOURNAL OF HEPATOLOGY

Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016–2030

(2018) Chris Estes et al.   JOURNAL OF HEPATOLOGY

Biomarkers of drug-induced acute kidney injury: a regulatory perspective

(2018) Melanie Blank et al.   Expert Opinion on Drug Metabolism & Toxicology

The enhanced liver fibrosis (ELF) test in diagnosis and management of liver fibrosis

(2018) James W Day et al.   BRITISH JOURNAL OF HOSPITAL MEDICINE

Effect of NGM282, an FGF19 analogue, in primary sclerosing cholangitis: A multicenter, randomized, double-blind, placebo-controlled phase II trial

(2018) Gideon M. Hirschfield et al.   JOURNAL OF HEPATOLOGY

Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial

(2018) Arun Sanyal et al.   LANCET

Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention

(2017) Zobair Younossi et al.   Nature Reviews Gastroenterology & Hepatology

Use of CTX-I and PINP as bone turnover markers: National Bone Health Alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability

(2017) P. Szulc et al.   OSTEOPOROSIS INTERNATIONAL

Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes

(2016) Zobair M. Younossi et al.   HEPATOLOGY

EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease

(2016)   JOURNAL OF HEPATOLOGY

Industry perspectives on biomarker qualification

(2015) G Lavezzari et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

(2015) S Amur et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

ELF score ≥9.8 indicates advanced hepatic fibrosis and is influenced by age, steatosis and histological activity

(2015) Kevin J. Fagan et al.   LIVER INTERNATIONAL

Levels of Alkaline Phosphatase and Bilirubin Are Surrogate End Points of Outcomes of Patients With Primary Biliary Cirrhosis: An International Follow-up Study

(2014) Willem J. Lammers et al.   GASTROENTEROLOGY

Plasma Pro-C3 (N-terminal type III collagen propeptide) predicts fibrosis progression in patients with chronic hepatitis C

(2014) Mette J. Nielsen et al.   LIVER INTERNATIONAL

Efficacy and Safety of Ivacaftor in Patients Aged 6 to 11 Years with Cystic Fibrosis with aG551DMutation

(2013) Jane C. Davies et al.   AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis

(2013) Quentin M. Anstee et al.   Nature Reviews Gastroenterology & Hepatology

The discovery and development of belimumab: the anti-BLyS–lupus connection

(2012) William Stohl et al.   NATURE BIOTECHNOLOGY

Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults

(2011) G. Vernon et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Changes in the Prevalence of the Most Common Causes of Chronic Liver Diseases in the United States From 1988 to 2008

(2011) Zobair M. Younossi et al.   Clinical Gastroenterology and Hepatology

Prevalence of non-alcoholic fatty liver disease and advanced fibrosis in Hong Kong Chinese: a population study using proton-magnetic resonance spectroscopy and transient elastography

(2011) Vincent Wai-Sun Wong et al.   GUT

The cost of drug development: A systematic review

(2011) Steve Morgan et al.   HEALTH POLICY

Endpoints and clinical trial design for nonalcoholic steatohepatitis

(2011) Arun J. Sanyal et al.   HEPATOLOGY

Factor V Leiden thrombophilia

(2010) Jody Lynn Kujovich   GENETICS IN MEDICINE