RT Journal Article
T1 Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis.
A1 Younossi, Zobair M
A1 Stepanova, Maria
A1 Anstee, Quentin M
A1 Lawitz, Eric J
A1 Wai-Sun Wong, Vincent
A1 Romero-Gomez, Manuel
A1 Kersey, Kathryn
A1 Li, Georgia
A1 Subramanian, G Mani
A1 Myers, Robert P
A1 Djedjos, C Stephen
A1 Okanoue, Takeshi
A1 Trauner, Michael
A1 Goodman, Zachary
A1 Harrison, Stephen A
K1 BMI
K1 Emotional
K1 NAFLD
K1 Physical Function
K1 Utilities
AB Patient-reported outcomes (PROs) are used to measure patients' experience with their disease. However, there are few PRO data from patients with NASH. We collected data from the STELLAR clinical trials to assess PROs for NASH and advanced fibrosis. We analyzed data from 1667 patients (58 ± 9 years, 40% male, 52% with cirrhosis, 74% with diabetes) with NASH and bridging fibrosis or compensated cirrhosis (metavir scores, F3 or F4) enrolled in the phase 3 STELLAR trials of selonsertib (NCT03053050 and NCT03053063) who completed PRO questionnaires (SF-36, CLDQ-NASH, EQ-5D, or WPAI:SHP) before treatment initiation. Compared with patients with F3 fibrosis, higher proportions of patients with F4 fibrosis were female, were white, had more hematologic and gastrointestinal comorbidities, and had type 2 diabetes (P ≤ .01). Mean physical health-related PRO scores were significantly lower than those of the general population: patients with F4 fibrosis had score reductions of 4.4% to 12.9% in 6/8 SF-36 domains and patients with F3 fibrosis had score reductions of 3.9% to 11.7% in 4/8 domains (P  PROs are significantly lower in patients with NASH with advanced fibrosis who participated in the STELLAR clinical trials. Treatment of patients with NASH should focus on improving not only clinical outcomes but also quantifiable symptom burden and health-related quality of life.
YR 2019
FD 2019-02-16
LK http://hdl.handle.net/10668/13588
UL http://hdl.handle.net/10668/13588
LA en
DS RISalud
RD Apr 6, 2025