التفاصيل البيبلوغرافية
| العنوان: |
Longitudinal correlations between MRE, MRI-PDFF, and liver histology in patients with non-alcoholic steatohepatitis: Analysis of data from a phase II trial of selonsertib |
| المؤلفون: |
Jayakumar, Saumya, Middleton, Michael S, Lawitz, Eric J, Mantry, Parvez S, Caldwell, Stephen H, Arnold, Hays, Diehl, Anna Mae, Ghalib, Reem, Elkhashab, Magdy, Abdelmalek, Manal F, Kowdley, Kris V, Djedjos, C Stephen, Xu, Ren, Han, Ling, Subramanian, G Mani, Myers, Robert P, Goodman, Zachary D, Afdhal, Nezam H, Charlton, Michael R, Sirlin, Claude B, Loomba, Rohit |
| المصدر: |
Journal of Hepatology, vol 70, iss 1 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2019 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Digestive Diseases, Hepatitis, Substance Misuse, Clinical Research, Chronic Liver Disease and Cirrhosis, Liver Disease, Biomedical Imaging, 4.2 Evaluation of markers and technologies, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Oral and gastrointestinal, Good Health and Well Being, Adolescent, Adult, Aged, Benzamides, Biopsy, Disease Progression, Dose-Response Relationship, Drug, Elasticity Imaging Techniques, Female, Humans, Imidazoles, Injections, Subcutaneous, Liver, Magnetic Resonance Imaging, Male |
| جغرافية الموضوع: |
133 - 141 |
| الوصف: |
Background & aimsNon-invasive tools for monitoring treatment response and disease progression in non-alcoholic steatohepatitis (NASH) are needed. Our objective was to evaluate the utility of magnetic resonance (MR)-based hepatic imaging measures for the assessment of liver histology in patients with NASH.MethodsWe analyzed data from patients with NASH and stage 2 or 3 fibrosis enrolled in a phase II study of selonsertib. Pre- and post-treatment assessments included centrally read MR elastography (MRE)-estimated liver stiffness, MR imaging-estimated proton density fat fraction (MRI-PDFF), and liver biopsies evaluated according to the NASH Clinical Research Network classification and the non-alcoholic fatty liver disease activity score (NAS).ResultsAmong 54 patients with MRE and biopsies at baseline and week 24, 18 (33%) had fibrosis improvement (≥1-stage reduction) after undergoing 24 weeks of treatment with the study drug. The area under the receiver operating characteristic curve (AUROC) of MRE-stiffness to predict fibrosis improvement was 0.62 (95% CI 0.46-0.78) and the optimal threshold was a ≥0% relative reduction. At this threshold, MRE had 67% sensitivity, 64% specificity, 48% positive predictive value, 79% negative predictive value. Among 65 patients with MRI-PDFF and biopsies at baseline and week 24, a ≥1-grade reduction in steatosis was observed in 18 (28%). The AUROC of MRI-PDFF to predict steatosis response was 0.70 (95% CI 0.57-0.83) and the optimal threshold was a ≥0% relative reduction. At this threshold, MRI-PDFF had 89% sensitivity and 47% specificity, 39% positive predictive value, and 92% negative predictive value.ConclusionsThese preliminary data support the further evaluation of MRE-stiffness and MRI-PDFF for the longitudinal assessment of histologic response in patients with NASH.Lay summaryLiver biopsy is a potentially painful and risky method to assess damage to the liver due to non-alcoholic steatohepatitis (NASH). We analyzed data from a clinical trial to determine if 2 methods of ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
unknown |
| العلاقة: |
qt96b1p0vj; https://escholarship.org/uc/item/96b1p0vjTest |
| الإتاحة: |
https://escholarship.org/uc/item/96b1p0vjTest |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.31EC9280 |
| قاعدة البيانات: |
BASE |
