Background: PROs of NASH patients have not been fully assessed. We assessed the impact of fatigue and pruritus on PROs of patients with advanced NASH.
Methods: Baseline PROs including fatigue and pruritis (SF-36, CLDQ-NASH, EQ-5D, and WPAI instruments) were collected from patients with biopsy-proven NASH and advanced fibrosis (stage≥F3).
Results: Fatigue (33%) and pruritus (27%) were reported among NASH patients (n=1,669; mean age 58±9 years, 48% F3, 42% psychiatric comorbidities). Fatigued patients were younger, female, cirrhotic, diabetic with higher BMI and more comorbidities (all p<0.05) than those without fatigue. Fatigued patients also had lower albumin, higher alkaline phosphatase (ALP), bile acids, glucose, HbA1c, C-reactive protein (CRP), GGT, ELF, Fibrotest, NFS, and liver stiffness (p<0.05). PROs of fatigued patients were significantly impaired (mean up to -31.4% of a PRO range). In multivariate analysis, predictors of fatigue were female gender [OR=1.47 (1.15-1.89)], history of depression [2.18 (1.67-2.83)], lower serum albumin, younger age, non-Asian race, diabetes, other nervous system or psychiatric comorbidities and some laboratory tests (p<0.05). NASH patients with pruritus had similar demographic profile to fatigued patients but had more skin-related comorbidities than patients without pruritus and a lower hemoglobin and serum albumin, higher ALP, fasting glucose, HOMA, HbA1c, CRP, GGT, higher liver stiffness, ELF, and NFS (all p<0.05). Pruritus patients had impairment in all PROs (all p<0.01). Female gender [odds ratio (OR)=1.33 [1.05-1.68)], history of depression (1.53 (1.19-1.96), nervous [1.40 (1.11-1.77)] and skin-related [1.59 (1.25-2.01)] comorbidities and lower serum albumin were associated with a greater risk of pruritus (p<0.05).
Conclusion: One-third of patients with advanced NASH have fatigue and pruritus which negatively impact their PROs.
Z. Younossi: Consultant; Self; AbbVie Inc., Bristol-Myers Squibb, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Novo Nordisk Inc., Terns and Viking. Q. Anstee: Consultant; Self; 89Bio, Abbott Laboratories, Acuitas Medical, Allergan/Tobira, AstraZeneca, Axcella, Blade, BNN Cardio, Celgene, Cirius, CymaBay, EcoR1, E3Bio, Eli Lilly & Company Ltd., Galmed, Genentech, Genfit S, Intercept Pharma Europe Ltd., Inventiva, IQVIA, Janssen, Madrigal, MedImmune, Metacrine, NewGene, NGMBio, North Sea Therapeutics, Novartis, Novo Nordisk A/S, Pfizer Ltd., Poxel, ProSciento, Raptor Pha. Research Support; Self; Abbvie, Allergan/Tobira, AstraZeneca, GlaxoSmithKline, Glympse Bio, Novartis Pharma AG, Pfizer Ltd., Vertex. Speaker’s Bureau; Self; Abbott Laboratories, Allergan/Tobira, BMS, Clinical Care Options, Falk, Fishawack, Genfit SA, Gilead, Integritas Communications, Kenes, MedScape. V.W.S. Wong: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Gilead Sciences, Inc. Consultant; Self; AbbVie Inc., Allergan plc., Echosens, Intercept Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc. M. Trauner: Advisory Panel; Self; Gilead Sciences, Inc. Research Support; Self; Gilead Sciences, Inc. Speaker’s Bureau; Self; Gilead Sciences, Inc. Other Relationship; Self; Gilead Sciences, Inc. M. Camargo: Employee; Self; Gilead Sciences, Inc. Z. Goodman: None. L. Henry: None. M. Stepanova: None. M. Romero-Gomez: Consultant; Self; Kaleido Biosciences, Merck & Co., Inc., Novo Nordisk Inc., Siemens Corporation, Zydus Pharmaceuticals, Inc. R. Myers: None. E. Lawitz: None.
Gilead Sciences Foundation