1. Improvements of Fibrosis and Disease Activity Are Associated With Improvement of Patient‐Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
- Author
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Younossi, Zobair M, Stepanova, Maria, Noureddin, Mazen, Kowdley, Kris V, Strasser, Simone I, Kohli, Anita, Ruane, Peter, Shiffman, Mitchell L, Sheikh, Aasim, Gunn, Nadege, Caldwell, Stephen H, Huss, Ryan S, Myers, Robert P, Wong, Vincent Wai‐Sun, Alkhouri, Naim, Goodman, Zachary, and Loomba, Rohit
- Subjects
Clinical Research ,Digestive Diseases ,Hepatitis ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Oral and gastrointestinal ,Good Health and Well Being - Abstract
Patient-reported outcomes (PROs) are important endpoints for clinical trials. The impact of investigational drugs on PROs of patients with advanced nonalcoholic steatohepatitis (NASH) was investigated. Patients with NASH with bridging fibrosis or compensated cirrhosis were enrolled in a phase 2, randomized, placebo-controlled study of selonsertib, firsocostat, or cilofexor, alone or in two-drug combinations (NCT03449446). PROs included Short Form 36 (SF-36), Chronic Liver Disease Questionnaire (CLDQ)-NASH, EuroQol Five Dimension (EQ-5D), Work Productivity and Impairment (WPAI), and 5-D Itch before and during treatment. A total of 392 patients with NASH (mean ± SD, 60 ± 9 years old; 35% men; 89% white; 72% diabetes; and 56% compensated cirrhosis) were included. Baseline Physical Functioning (PF) and Bodily Pain of SF-36 and Fatigue and Worry of CLDQ-NASH were significantly lower in patients with cirrhosis (total CLDQ-NASH score mean ± SD, 4.91 ± 1.06 with cirrhosis vs. 5.16 ± 1.14 without cirrhosis; P
- Published
- 2021