Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis.

Background & Aims Nonalcoholic steatohepatitis (NASH) affects patients’ health-related quality of life (HRQoL). Patient-reported outcomes (PROs) evaluating HRQoL were assessed in the REGENERATE study, which showed that obeticholic acid (OCA) significantly improved fibrosis in patients with NASH. Methods Noncirrhotic NASH patients in a phase 3, double-blind, randomized, placebo-controlled, multicenter, international study of OCA. The Chronic Liver Disease Questionnaire–NASH and EuroQol EQ-5D-5L were administered at baseline, 6, 12, and 18 months. Results There were 1218 patients (age, 54.1 ± 11.5 y; 57% women; 43% stage F3) in the expanded intent-to-treat population (stages, F1–F3) assigned randomly to 10 mg (N = 407) or 25 mg (N = 404) OCA or placebo (N = 407). Baseline measurements were balanced across treatment groups for EuroQol EQ-5D-5L and Chronic Liver Disease Questionnaire–NASH, including Itch score: 5.75 ± 1.53 (scale 1–7, with 7 representing no itching). Nineteen (1.6%) patients discontinued therapy (protocol mandated) because of grade 3 pruritus. Patients receiving 25 mg OCA experienced mild worsening of itch scores primarily in the first months of treatment: mean ± SE change from baseline –0.66 ± 0.12, –0.44 ± 0.12, and –0.42 ± 0.13 at 6, 12, and 18 months, respectively (all P Conclusions NASH patients evaluated in REGENERATE had impaired quality of life and underlying pruritus at baseline. Improvement of NASH corresponded with improvement in several HRQoL domains. Generally mild pruritus occurs early after OCA therapy initiation and does not worsen over time. ClinicalTrials.gov : NCT02548351 .