Improvement of hepatic fibrosis and patient-reported outcomes in non-alcoholic steatohepatitis treated with selonsertib

Liver International

Volumn 38, Issue 10, 2018, Pages 1849-1859

  Younossi, Zobair M ^a   Stepanova, Maria ^b   Lawitz, Eric ^c   Charlton, Michael ^d   Loomba, Rohit ^e   Myers, Robert P ^f   Subramanian, Mani ^f   McHutchison, John G ^f   Goodman, Zachary ^g  

^a INOVA FAIRFAX HOSPITAL   (United States)

^b Center for Outcomes Research in Liver Diseases   (United States)

^c Texas Liver Institute   (United States)

^d INTERMOUNTAIN MEDICAL CENTER   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f GILEAD SCIENCES   (United States)

^g BETTY AND GUY BEATTY CENTER FOR INTEGRATED RESEARCH   (United States)

Author keywords

ASK 1; health utility; health related quality of life; work productivity

Indexed keywords

ADIPONECTIN; ALKALINE PHOSPHATASE; ALPHA SMOOTH MUSCLE ACTIN; BILIRUBIN; C REACTIVE PROTEIN; CHOLESTEROL; COLLAGEN; CYTOKERATIN 18; GLUCOSE; HIGH DENSITY LIPOPROTEIN; INTERLEUKIN 6; MONOCYTE CHEMOTACTIC PROTEIN 2; PLASMINOGEN ACTIVATOR INHIBITOR 1; SELONSERTIB; SIMTUZUMAB; TRIACYLGLYCEROL; TUMOR NECROSIS FACTOR;

ADULT; ARTICLE; ASSESSMENT OF HUMANS; CHRONIC LIVER DISEASE QUESTIONNAIRE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DIABETES MELLITUS; DIGESTIVE SYSTEM DISEASE ASSESSMENT; FEMALE; HEALTH; HUMAN; HUMAN TISSUE; LIVER BIOPSY; LIVER FIBROSIS; LIVER HISTOLOGY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NONALCOHOLIC FATTY LIVER; PATIENT REPORTED OUTCOME; PERSONAL EXPERIENCE; PHASE 2 CLINICAL TRIAL; POPULATION; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; TREATMENT DURATION; TREATMENT INDICATION; WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT; WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT SPECIFIC HEALTH PROBLEM;

EID: 85042357143     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/liv.13706     Document Type: Article

References (34)

1. Chalasani N, Younossi Z, Lavine JE, et al. The Diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American association for the study of liver diseases. Hepatology. 2018;67:328-357.
2. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64:73-84.
3. Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011;34:274-285.
4. Younossi ZM, Stepanova M, Rafiq N, et al. Nonalcoholic steatofibrosis independently predicts mortality in nonalcoholic fatty liver disease. Hepatol Commun. 2017;1:421-428.
5. Dulai PS, Singh S, Patel J, et al. Increased risk of mortality by fibrosis stage in non-alcoholic fatty liver disease: systematic review and meta-analysis. Hepatology. 2017;65:1557-1565.
6. Angulo P, Kleiner DE, Dam-Larsen S, et al. Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2015;149:389-397. e10.
7. Ekstedt M, Hagstro¨m H, Nasr P, et al. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology. 2015;61:1547-1554.
8. Hannah WN Jr, Torres DM, Harrison SA. Nonalcoholic Steatohepatitis and Endpoints in Clinical Trials. Gastroenterol Hepatol (N Y). 2016;12:756-763.
9. Friedman S, Sanyal A, Goodman Z, et al. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016;47:356-365.
10. Younossi ZM, Henry L. Economic and quality-of-life implications of non-alcoholic fatty liver disease [review]. Pharmacoeconomics. 2015;33:1245-1253.
11. Younossi ZM, Zheng L, Stepanova M, Venkatesan C, Mishra A. Clinical outcomes and resource utilization in Medicare patients with chronic liver disease: a historical cohort study. BMJ Open. 2014;4:e004318.
12. Younossi ZM, Blissett D, Blissett R, et al. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016;64:1577-1586.
13. Golabi P, Otgonsuren M, Cable R, et al. Non-alcoholic fatty liver disease (NAFLD) is associated with impairment of health related quality of life (HRQOL). Health Qual Life Outcomes. 2016;14:18.
14. Sayiner M, Stepanova M, Pham H, Noor B, Walters M, Younossi ZM. Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease. BMJ Open Gastroenterol. 2016;3:e000106.
15. Dan AA, Kallman JB, Wheeler A, et al. Health-related quality of life in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2007;26:815-820.
16. Loomba R, Lawitz E, Mantry PS, et al. The ASK1 inhibitor selonsertib in patients with nonalcoholic steatohepatitis: a randomized, phase 2 trial. Hepatology. 2017;67:549-559.
17. Gilead Sciences. Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3. https://clinicaltrials.gov/ct2/show/NCT02466516. Last accessed on July 11, 2017.
18. Grundy SM, Cleeman JI, Daniels SR, et al. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005;112:2735-2752.
19. Kleiner DE, Brunt EM, Van Natta M, et al. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005;41:1313-1321.
20. Ngo Y, Munteanu M, Messous D, et al. A prospective analysis of the prognostic value of biomarkers (FibroTest) in patients with chronic hepatitis C. Clin Chem. 2006;52:1887-1896.
21. Guha IN, Parkes J, Roderick P, et al. Noninvasive markers of fibrosis in nonalcoholic fatty liver disease: validating the European Liver Fibrosis Panel and exploring simple markers. Hepatology. 2008;47:455-460.
22. Kamath PS. Kim WR; Advanced Liver Disease Study Group. The model for end-stage liver disease (MELD). Hepatology. 2007;45:797-805.
23. Ware JE, Kosinski M. Interpreting SF-36 summary health measures: a response. Qual Life Res. 2001;10:405-413; discussion 415-20.
24. Younossi ZM, Guyatt G, Kiwi M, Boparai N, King D. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut. 1999;45:295-300.
25. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353-365.
26. Kharroubi SA, Brazier JE, Roberts J, O'Hagan A. Modelling SF-6D health state preference data using a nonparametric Bayesian method. J Health Econ. 2007;26:597-612.
27. Younossi ZM, Stepanova M, Nader F, Lam B, Hunt S. The patient's journey with chronic hepatitis C from interferon plus ribavirin to interferon- and ribavirin-free regimens: a study of health-related quality of life. Aliment Pharmacol Ther. 2015;42:286-295.
28. Younossi ZM, Stepanova M, Henry L, Nader F, Hunt S. An in-depth analysis of patient-reported outcomes in patients with chronic hepatitis c treated with different anti-viral regimens. Am J Gastroenterol. 2016;111:808-816.
29. Dowlati Y, Herrmann N, Swardfager W, et al. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010;67:446-457.
30. Sprangers MA, Thong MS, Bartels M, et al. Biological pathways, candidate genes, and molecular markers associated with quality-of-life domains: an update. Qual Life Res. 2014;23:1997-2013.
31. Ji YB, Bo CL, Xue XJ, et al. Association of inflammatory cytokines with the symptom cluster of pain, fatigue, depression, and sleep disturbance in chinese patients with cancer. J Pain Symptom Manage. 2017;54:843-852.
32. Vogelaar L, de Haar C, Aerts BR, et al. Fatigue in patients with inflammatory bowel disease is associated with distinct differences in immune parameters. Clin Exp Gastroenterol. 2017;2:83-90.
33. Chawla KS, Talwalkar JA, Keach JC, Malinchoc M, Lindor KD, Jorgensen R. Reliability and validity of the Chronic Liver Disease Questionnaire (CLDQ) in adults with non-alcoholic steatohepatitis (NASH). BMJ Open Gastroenterol. 2016;3:e000069.
34. Younossi ZM, Stepanova M, Henry L, et al. A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD. Liver Int. 2017;37:1209-1218.