Table 1.
Baseline demographics and disease characteristics (ITT population).
| Placebo (n = 25) | OCA 1.5–3.0 mg (n = 25) | OCA 5–10 mg (n = 26) | |
|---|---|---|---|
| Age, year; mean (SD) | 43.7 (13.1) | 41.6 (12.6) | 44.9 (14.3) |
| >65 y, n (%) | 1 (4) | 1 (4) | 3 (12) |
| Sex, n (%) | |||
| Male | 14 (56) | 15 (60) | 12 (46) |
| Female | 11 (44) | 10 (40) | 14 (54) |
| Race, n (%) | |||
| White | 22 (88) | 21 (84) | 22 (85) |
| Black | 3 (12) | 3 (12) | 4 (15) |
| Asian | 0 | 1 (4) | 0 |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 1 (4) | 2 (8) | 2 (8) |
| Age at diagnosis, y; mean (SD) | 36.2 (14.5) | 35.3 (11.8) | 36.0 (14.5) |
| UDCA | |||
| Current use, n (%) | 12 (48) | 12 (48) | 12 (46) |
| Highest previous daily dose, mg/kg; mean (SD) | 17 (4) | 13 (3) | 13 (4) |
| ALP, U/L; mean (SD) | 562.8 (300.2) | 422.5 (123.1) | 428.5 (178.2) |
| Total bilirubin, mg/dl; mean (SD) | 1.2 (0.7) | 1.0 (0.5) | 1.1 (0.6) |
| IBD, n (%) | 13 (52) | 15 (60) | 15 (58) |
| UC | 10 (40) | 12 (48) | 10 (38) |
| Crohn’s disease | 3 (12) | 3 (12) | 5 (19) |
| Partial Mayo score; mean (SD) | 1.1 (1.2) | 0.3 (0.5) | 0.9 (1.0) |
| Intrahepatic disease, n(%) | 16 (64) | 14 (56) | 14 (54) |
| Intra- and extrahepatic disease, n (%) | 9 (36) | 11 (44) | 10 (38) |
| Pruritus, n (%) | |||
| Baseline | 16 (64) | 10 (40) | 9 (35) |
| Previous | 2 (8) | 5 (20) | 7 (27) |
| Moderate severity of most recent pruritus event | 4 (16) | 4 (16) | 8 (31) |
| Pruritus VAS, mean (SD) | 18.2 (21.9) | 15.7 (19.0) | 11.6 (21.3) |
ALP, alkaline phosphatase; IBD, inflammatory bowel disease; ITT, intent-to-treat; OCA, obeticholic acid; UC, ulcerative colitis; UDCA, ursodeoxycholic acid; VAS, visual analog scale.