RESPONSE Pruritus Results

The only primary biliary cholangitis (PBC) treatment proven to reduce pruritus with statistical significance1,2

Key secondary endpoint: Change in pruritus Numerical Rating Scale (NRS) at month 61

Reduction in pruritus

A single-item patient-reported outcome (PRO), the pruritus NRS, evaluated patients’ daily worst itching intensity on an 11-point rating scale, with scores ranging from 0 (“no itching”) to 10 (“worst itching imaginable”) in RESPONSE. The pruritus NRS was administered daily in a 14-day run-in period prior to randomization through month 6 and then for 7 consecutive days during each month up to the end of the treatment period.1,2

Patients treated with LIVDELZI demonstrated greater improvement in pruritus compared to the placebo arm. Improvements were observed through month 12.1

The figure below presents the results of the comparison between LIVDELZI and placebo on the key secondary endpoint evaluating the change from baseline in pruritus score based on pruritus NRS at month 6 in patients with baseline average pruritus scores greater than or equal to 4. The baseline average pruritus score for each patient was calculated by averaging the pruritus NRS scores administered in the run-in period and on day 1 before treatment initiation. The pruritus scores at month 6 for each patient were calculated by averaging the pruritus NRS scores within the last week in the month.1

Line graph titled “Change From Baseline in Pruritus NRS Over Time” comparing the change in the Numerical Rating Scale for pruritus over a 12-­month period in the RESPONSE trial. The graph shows that patients in the LIVDELZI ± UDCA group experienced a greater reduction in itchiness over time compared to patients in the placebo ± UDCA treatment arm. The difference between groups was statistically significant at month 6; P=0.0051.Line graph titled “Change From Baseline in Pruritus NRS Over Time” comparing the change in the Numerical Rating Scale for pruritus over a 12-­month period in the RESPONSE trial. The graph shows that patients in the LIVDELZI ± UDCA group experienced a greater reduction in itchiness over time compared to patients in the placebo ± UDCA treatment arm. The difference between groups was statistically significant at month 6; P=0.0051.

LS=least squares; SE=standard error; UDCA=ursodeoxycholic acid.

Changes from baseline in mean pruritus NRS score at month 6 was analyzed using a mixed-effect model for repeated measures.1

Pruritus NRS scores at months 1 and 9 were exploratory endpoints and months 3 and 12 were secondary endpoints. For these endpoints, multiplicity was not controlled.

Rapid improvement in pruritus seen as early as month 1, with a statistically significant difference at month 6 (P=0.0051); improvements were observed through month 121,3
References: 1. LIVDELZI [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; 2024. 2. Hirschfield GM, Bowlus CL, Mayo MJ, et al. A phase 3 trial of seladelpar in primary biliary cholangitis. N Engl J Med. 2024;390(9):783-794. doi:10.1056/NEJMoa2312100 3. Data on file. Gilead Sciences, Inc.; 2024.