Table 4.
Biomarker | Participants With ≥ 25% ALP Reduction (n = 5) | Participants With < 25% ALP Reduction (n = 15)* | |||
---|---|---|---|---|---|
Absolute Value | Change From Baseline (%) | Absolute Value | Change From Baseline (%) | ||
GGT (U/L) | Mean (SD) | −163.4 (61.7) | −28.1 (14.5) | −5.1 (186.6) | −0.6 (24.5) |
Median | −135.0 | −33.7 | −39.0 | −7.2 | |
Min, Max | −235, −109 | −45, −12 | −491, 362 | −32, 44 | |
ALT (U/L) | Mean (SD) | −73.6 (145.5) | −26.6 (34.3) | −11.9 (65.4) | 4.8 (35.1) |
Median | −19.0 | −20.8 | −2.0 | −4.3 | |
Min, Max | −332, 20 | −79, 17 | −233, 50 | −52, 83 | |
AST (U/L) | Mean (SD) | −72.6 (134.5) | −32.9 (35.5) | −4.6 (48.4) | 6.4 (44.7) |
Median | −17.0 | −27.4 | 1.0 | 3.0 | |
Min, Max | −312, 7 | −83, 16 | −152, 58 | −57, 119 | |
Total bilirubin (mg/dL) | Mean (SD) | −0.1 (0.2) | −11.1 (31.7) | 0.5 (1.6) | 62.3 (178.5) |
Median | −0.2 | −28.6 | 0.1 | 20.0 | |
Min, Max | −0.3, 0.2 | −33.3, 40.0 | −0.2, 6.2 | −40.0, 688.9 | |
Direct bilirubin (mg/dL) | Mean (SD) | −0.1 (0.1) | −28.7 (27.9) | 0.4 (1.3) | 110.0 (319.2) |
Median | −0.1 | −33.3 | 0.0 | 0.0 | |
Min, Max | −0.3, 0.0 | −60.0, 0.0 | −0.1, 5.0 | −50.0, 1250.0 | |
Albumin (g/dL) | Mean (SD) | −0.1 (0.1) | −3.13 (2.6) | 0.01 (0.3) | 0.3 (7.3) |
Median | −0.1 | −2.3 | 0.1 | 2.3 | |
Min, Max | −0.3, 0.0 | −6.8, 0.0 | −0.7, 0.3 | −17.5, 7.9 | |
TE | |||||
LSM (kPa) | Mean (SD) | 1.2 (0.7) | 16.3 (9.9) | 1.37 (5.9) | 15.6 (57.5) |
Median | 0.9 | 14.3 | −0.3 | −4.8 | |
Min, Max | 0.5, 2.0 | 7.8, 32.8 | −5.0, 18.6 | −41.0, 182.4 | |
Noninvasive biomarkers of liver fibrosis | |||||
APRI score | Mean (SD) | −1.1 (2.3) | −32.2 (38.5) | −0.1 (0.6) | 5.0 (48.0) |
Median | −0.1 | −26.2 | −0.01 | −4.8 | |
Min, Max | −5.2, 0.1 | −85.2, 15.6 | −2.1, 0.6 | −56.5, 116.4 | |
FIB‐4 Index score | Mean (SD) | −1.0 (1.7) | −24.3 (30.2) | 0.04 (0.4) | 6.3 (40.7) |
Median | −0.1 | −15.8 | 0.03 | 8.8 | |
Min, Max | −3.9, 0.04 | −65.3, 9.1 | −0.6, 1.0 | −39.2, 86.2 |
Baseline was selected as the last available predose value.
n = 13 for noninvasive biomarkers of liver fibrosis.
Abbreviations: LSM, liver stiffness measure; Max, maximum; Min, minimum.