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Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis.
Stine, Jonathan G; Munaganuru, Nagambika; Barnard, Abbey; Wang, Jennifer L; Kaulback, Kellee; Argo, Curtis K; Singh, Siddarth; Fowler, Kathryn J; Sirlin, Claude B; Loomba, Rohit.
Afiliación
  • Stine JG; Division of Gastroenterology and Hepatology, Department of Medicine, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Milton S. Hershey Medical Center, Pennsylvania State University College of Medicine,
  • Munaganuru N; Department of Medicine, University of California, San Diego, La Jolla, California.
  • Barnard A; Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla, California.
  • Wang JL; Division of Gastroenterology and Hepatology, Department of Medicine, University of Chicago, Chicago, Illinois.
  • Kaulback K; Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.
  • Argo CK; Division of Gastroenterology and Hepatology, Department of Medicine, University of Virginia, Charlottesville, Virginia.
  • Singh S; Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla, California.
  • Fowler KJ; Liver Imaging Group, Department of Radiology, University of California, San Diego, La Jolla, California.
  • Sirlin CB; Liver Imaging Group, Department of Radiology, University of California, San Diego, La Jolla, California.
  • Loomba R; Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla, California; Division of Epidemiology, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California; NAFLD Research Center, University of C
Clin Gastroenterol Hepatol ; 19(11): 2274-2283.e5, 2021 11.
Article en En | MEDLINE | ID: mdl-32882428
BACKGROUND & AIMS: Magnetic resonance imaging proton density fat fraction (MRI-PDFF) offers promise as a non-invasive biomarker of treatment response in early-phase nonalcoholic steatohepatitis (NASH) trials. We performed a systematic review to quantify the association between a ≥ 30% reduction in MRI-PDFF and histologic response in NASH. METHODS: We searched the Cochrane Library, Embase, Medline and trial registries through May 2020 for early-phase clinical trials that incorporated MRI-PDFF and examined histologic response following intervention in adults with NASH. Subjects were classified as MRI-PDFF responders (relative decline in liver fat ≥30%) or non-responders (relative decline in liver fat <30%). MRI-PDFF responders versus non-responders were compared. Primary outcome was histologic response defined as a 2-point improvement in NAFLD Activity Score with at least 1-point improvement in lobular inflammation or ballooning. Secondary outcome was NASH resolution. Proportions and random effects odds ratios (OR) with corresponding 95% confidence intervals (CI) were calculated. RESULTS: Seven studies met inclusion criteria, comprising 346 subjects (median age 51 years; 59% female; 46% with diabetes). MRI-PDFF responders were significantly more likely to have a histologic response (51% vs 14%, P < .001; OR 6.98, 95% CI 2.38-20.43, P < .001) and NASH resolution (41% vs 7%, P < .001; OR 5.45, 95% CI 1.53-19.46, P = .009) compared to non-responders. CONCLUSIONS: This meta-analysis demonstrates that a ≥30% relative decline in MRI-PDFF is associated with higher odds of histologic response and NASH resolution. These results support the use of MRI-PDFF in non-invasive monitoring of treatment response in early-phase NASH clinical trials and provide helpful data for sample-size estimation for histology-based assessment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad del Hígado Graso no Alcohólico Tipo de estudio: Systematic_reviews Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Gastroenterol Hepatol Asunto de la revista: GASTROENTEROLOGIA Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad del Hígado Graso no Alcohólico Tipo de estudio: Systematic_reviews Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Gastroenterol Hepatol Asunto de la revista: GASTROENTEROLOGIA Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos