TABLE 1.
Baseline PBC-40 scores in the ITT population and across the three treatment groups
| Baseline PBC-40 score, mean (SEM) | ||||
|---|---|---|---|---|
| PBC-40 domain | ITT population (n=111) | Placebo (n=37) | Setanaxib 400 mg OD (n=38) | Setanaxib 400 mg BID (n=36) |
| Fatigue | 28.2 (1.1) | 28.4 (2.0) | 26.7 (1.7) | 29.5 (1.9) |
| Emotional | 7.6 (0.3) | 7.6 (0.5) | 7.1 (0.5) | 8.2 (0.6) |
| Social | 21.1 (0.9) | 22.2 (1.6) | 19.8 (1.3) | 21.3 (1.6) |
| Symptom | 14.4 (0.5) | 15.3 (0.8) | 14.1 (0.7) | 13.9 (0.9) |
| Itch | 4.4 (0.4) | 5.2 (0.8) | 4.4 (0.7) | 3.7 (0.6) |
| Cognitive | 12.5 (0.6) | 13.0 (1.0) | 11.7 (0.9) | 12.9 (1.1) |
| Marker of liver disease | Baseline measurement, median (min–max) unless otherwise stated | |||
| Liver stiffness, kPa, n,a median (min–max) | 91 8.1 (2.0–75.0) | 32 8.9 (3.0–35.0) | 33 8.0 (4.0–75.0) | 26 7.5 (2.0–16.0) |
| ALP, U/L | 269.0 (175.0–1091.0) | 251.0 (175.0–788.0) | 267.0 (179.0–809.0) | 319.5 (175.0–1091.0) |
| hsCRP, mg/L, n,b median (min–max) | 108 3.9 (0.0–29.0) | 37 3.9 (0.0–26.0) | 38 4.3 (1.0–29.0) | 33 3.1 (1.0–21.0) |
| IL-6, pg/mL, n,b mean (SEM) | 103 5.6 (0.5) | 36 5.9 (1.0) | 36 5.2 (0.6) | 31 5.7 (0.9) |
a
Only patients with liver stiffness values at both baseline and Week 24 visits are shown here.
b
Some patients had missing values at baseline.
Abbreviations: ALP, alkaline phosphatase; BID, twice daily; hsCRP, high-sensitivity C-reactive protein; ITT, intention-to-treat; max, maximum; min, minimum; OD, once daily; PBC, primary biliary cholangitis; PBC-40, primary biliary cholangitis-40 item questionnaire.