Patient disposition
primary biliary cholangitis, cholestasis
PRIMARY BILIARY CHOLANGITIS, CHOLESTASIS, DISEASE CHARACTERISTIC, PBC
Among 501 patients screened, 265 were randomized to receive placebo (n=87) or seladelpar 5 mg (n=89) or 10 mg (n=89). Two patients completed study treatment through month 12; 255 of 265 (96.2%) patients discontinued treatment due to study closure, 6 (2.3%) discontinued due to TEAEs, 1 (0.4%) withdrew consent, and 1 (0.4%) was lost to follow-up (Figure Patient flowchart. Screen failures (a patient may be counted in >1 reason for failure): alkaline phosphatase < 1.67× upper limit of normal (ULN) n=149, estimated glomerular filtration rate <60 mL/min/1.73 mBaseline demographics and disease characteristics, including biochemical markers of cholestasis, were well balanced among treatment groups (Table Patient baseline demographics and clinical characteristics
Includes American Indian or Alaska Native, Asian, and Black or African American.All listed medications except UDCA were discontinued before study entry.Steroids, immunosuppressants, methotrexate, systemic steroids, and colchicine.Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; n, number of patients in the category; N, number of patients in the treatment group; NRS, numerical rating scale; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.