TABLE 1.
Patient baseline demographics and clinical characteristics
| Placebo (N=87) | Seladelpar 5 mg (N=89) | Seladelpar 10 mg (N=89) | Total (N=265) | |
|---|---|---|---|---|
| Age (y) | 55.9 (8.2) | 54.7 (9.7) | 55.6 (9.1) | 55.4 (9.0) |
| Female, n (%) | 85 (98) | 82 (92) | 83 (93) | 250 (94) |
| Race, n (%) | ||||
| White | 80 (92) | 83 (93) | 77 (87) | 240 (91) |
| Othera | 7 (8) | 6 (7) | 12 (13) | 25 (9) |
| Body mass index (kg/m2) | 28.2 (5.5) | 27.7 (6.1) | 27.6 (5.9) | 27.8 (5.8) |
| Duration of PBC (y) | 8.4 (6.2) | 8.3 (6.4) | 8.4 (6.4) | 8.4 (6.3) |
| UDCA | ||||
| Use at baseline, n (%) | 85 (98) | 83 (93) | 81 (91) | 249 (94) |
| Total daily dose (mg/kg) | 15.0 (2.6) | 15.6 (4.4) | 15.3 (3.7) | 15.3 (3.6) |
| Minimum, maximum (mg/kg) | 10.0, 23.4 | 7.3, 36.1 | 7.5, 26.7 | 7.3, 36.1 |
| ALP (U/L) | 293.4 (106.2) | 290.5 (104.2) | 290.8 (109.1) | 291.5 (106.1) |
| ≥350 U/L (3×ULN), n (%) | 19 (22) | 22 (25) | 23 (26) | 64 (24) |
| Total bilirubin (mg/dL) | 0.71 (0.32) | 0.76 (0.35) | 0.72 (0.32) | 0.73 (0.33) |
| >1×ULN, n (%) | 9 (10) | 13 (15) | 9 (10) | 31 (12) |
| ALT (U/L) | 44.4 (20.7) | 47.7 (21.0) | 46.9 (20.8) | 46.4 (20.8) |
| AST (U/L) | 37.5 (16.8) | 40.1 (14.5) | 40.3 (14.9) | 39.3 (15.4) |
| GGT (U/L) | 228.9 (193.0) | 231.3 (212.0) | 243.1 (227.7) | 234.5 (210.8) |
| Pruritus history, n (%) | 57 (66) | 66 (74) | 65 (73) | 188 (71) |
| Pruritus NRS | 2.9 (2.5) | 2.8 (2.5) | 2.7 (2.6) | 2.8 (2.6) |
| ≥4, n (%) | 27 (31) | 27 (30) | 27 (30) | 81 (31) |
| ≥4 | 6.1 (1.2) | 6.1 (1.4) | 6.2 (1.4) | 6.1 (1.3) |
| Antimitochondrial antibodies, n (%) | ||||
| Positive | 75 (86) | 79 (89) | 81 (91) | 235 (89) |
| Negative | 9 (10) | 8 (9) | 8 (9) | 25 (9) |
| Equivocal | 3 (3) | 2 (2) | 0 | 5 (2) |
| Cirrhosis, n (%) | 7 (8) | 9 (10) | 13 (15) | 29 (11) |
| Prior PBC medicationsb | ||||
| UDCA | 87 (100) | 89 (100) | 89 (100) | 265 (100) |
| Obeticholic acid | 11 (13) | 13 (15) | 16 (18) | 40 (15) |
| Fibrates | 8 (9) | 9 (10) | 6 (7) | 23 (9) |
| Otherc | 17 (20) | 8 (9) | 10 (11) | 35 (13) |
Note: modified intent-to-treat (mITT) population. All values are mean (SD) unless specified otherwise.
a
Includes American Indian or Alaska Native, Asian, and Black or African American.
b
All listed medications except UDCA were discontinued before study entry.
c
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.