Pruritus
SE, pruritus, itch, NRS
Among patients in the prespecified subgroup with moderate-to-severe pruritus (pruritus NRS ≥4) at baseline who were evaluable at month 3 (placebo, n=18; seladelpar 5 mg, n=17; and seladelpar 10 mg, n=18), the mean decrease from baseline in pruritus NRS was significantly greater in the seladelpar 10-mg (−3.14, Absolute LS mean (SE) change from baseline in pruritus numerical rating scale (NRS) at month 3 (A) and proportion of patients who achieved point reductions from baseline in pruritus NRS at month 3 (B). For (A) and (B), populations included only patients with pruritus NRS ≥4 at baseline. For (A), change from baseline was estimated by an analysis of covariance model with treatment group and randomization alkaline phosphatase stratification as factors and baseline pruritus score as a covariate. For (B), patients who discontinued treatment before month 3 due to reasons other than study termination and who did not have evaluable data at month 3 were considered nonresponders. Greater changes from baseline with seladelpar versus placebo at months 1 and 3 in the 5-domain itch scale total and individual domain scores (Supplemental Figure S3A–L, 