Z. Younossi, M. Stepanova, R. Taub
Jul 27, 2021
Citations
1
Influential Citations
25
Citations
Quality indicators
Journal
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Abstract
BACKGROUND & AIMS Nonalcoholic steatohepatitis (NASH) is a chronic liver disease associated with adverse clinical outcomes and impaired health-related quality of life (HRQL). METHODS Patients with biopsy-proven non-cirrhotic NASH with hepatic fat fraction of ≥10% by MRI-proton density fat fraction (MRI-PDFF) were enrolled in a Phase 2, multicenter, double-blind, randomized, placebo-controlled study of resmetirom. HRQL was assessed using Short Form-36 (SF-36) throughout 36 weeks of treatment. RESULTS 125 NASH patients were enrolled (50±11 years old, 50% male, 94% white, BMI 35±6, 39% with diabetes mellitus). Of these, 84 patients received 80 mg of resmetirom daily and 41 received placebo. At baseline, HRQL scores were not different from general population norms (Physical Component Summary (PCS) 47.9 ± 9.3 vs. 50, Mental Component Summary 50.4 ± 10.0 vs. 50; all p>0.05). By treatment week 12, patients who received resmetirom experienced improvement of Bodily Pain and SF-6D utility scores (p<0.05); no HRQL improvement was noted in placebo (all p>0.05). Improvement in PCS continued upto week 36 of treatment with resmetirom; again with no improvement in placebo group (all p>0.05). Adjusted for the baseline score and clinico-demographic confounders, meeting the endpoint of a decrease in PDFF of ≥30% by week 12 (met by 54/116 treatment completers; 47/54 on resmetirom) was independently associated with greater improvements in Physical Functioning and PCS scores at week 36 (p<0.05). Patients with improvement in NASH and fibrosis on liver biopsy also showed improvement in components of HRQL. CONCLUSIONS Patients with NASH treated who improved their hepatic fat fraction and/or NAS on serial liver biopsy experienced improvement of HRQL. Further studies are needed to confirm long-term sustainability of that improvement (ClinicalTrials.gov #NCT02912260).