Haematological and biochemical parameters
| Baseline result | Change to week 12/ET | Change to week 28/ET | Change to Week 52/ET | ||||||||
| Placebo (N=170) | Peficitinib 100 mg (N=174) | Peficitinib 150 mg (N=174) | Placebo (N=170) | Peficitinib 100 mg (N=174) | Peficitinib 150 mg (N=174) | Placebo (N=170) | Peficitinib 100 mg (N=174) | Peficitinib 150 mg (N=174) | Peficitinib 100 mg (N=170) | Peficitinib 150 mg (N=170) | |
| Absolute neutrophil count (106/L) | 5803.5 (2171.9) | 5746.0 (1901.3) | 5679.9 (2058.8) | −41.4 (1496.4) | −579.7 (1717.0) | −720.5 (1823.8) | −89.9 (1611.6) | −640.7 (1782.2) | −802.9 (1701.5) | −694.8 (1725.7) | −740.4 (1937.3) |
| Haemoglobin (g/L) | 119.0 (13.0) | 121.4 (14.6) | 122.4 (13.2) | 0.2 (7.4) | 4.5 (8.4) | 5.0 (7.7) | 0.2 (8.6) | 5.1 (9.8) | 5.3 (10.6) | 4.7 (10.5) | 4.4 (10.2) |
| Platelets (109/L) | 327.4 (73.7) | 320.9 (84.6) | 320.9 (82.2) | 1.6 (47.1) | −40.7 (49.4) | −48.8 (48.9) | −1.4 (59.0) | −47.9 (55.9) | −49.1 (56.6) | −50.2 (57.0) | −46.9 (61.4) |
| LDL cholesterol (mmol/L) | 2.799 (0.665) | 2.843 (0.706) | 2.842 (0.742) | 0.016 (0.387) | 0.281 (0.533) | 0.246 (0.468) | 0.033 (0.441) | 0.306 (0.569) | 0.310 (0.617) | 0.261 (0.618) | 0.353 (0.599) |
| HDL cholesterol (mmol/L) | 1.620 (0.424) | 1.628 (0.427) | 1.567 (0.424) | 0.011 (0.221) | 0.235 (0.322) | 0.330 (0.294) | 0.018 (0.247) | 0.320 (0.364) | 0.396 (0.373) | 0.340 (0.353) | 0.403 (0.353) |
| Serum creatinine (μmol/L) | 51.22 (11.12) | 51.21 (13.53) | 51.01 (12.38) | −0.13 (5.19) | 4.73 (4.61) | 5.24 (6.61) | 0.64 (5.99) | 6.50 (5.61) | 7.26 (6.70) | 7.31 (5.46) | 9.13 (7.93) |
| Creatine kinase (U/L) | 60.3 (35.3) | 63.3 (36.6) | 61.9 (49.4) | −1.7 (26.6) | 49.0 (46.1) | 61.9 (93.3) | 4.6 (45.1) | 62.8 (61.4) | 72.6 (75.8) | 74.0 (72.3) | 80.1 (79.2) |
| ALT (U/L) | 20.5 (16.0) | 20.1 (16.3) | 20.2 (13.6) | −0.2 (12.8) | 3.8 (16.7) | 6.9 (19.6) | −0.7 (15.0) | 4.2 (17.3) | 7.9 (19.8) | 3.2 (16.5) | 7.5 (19.9) |
| AST (U/L) | 23.4 (11.9) | 23.6 (12.5) | 23.6 (11.6) | −0.1 (10.8) | 3.6 (11.9) | 5.6 (14.4) | 0.2 (12.9) | 4.3 (12.0) | 6.5 (14.8) | 4.2 (12.4) | 7.0 (16.0) |
Results shown are mean (SD).
ALT, alanine aminotransferase; AST, aspartate aminotransferase; EOT, end of treatment; ET, early termination; HDL, high-density lipoprotein; LDL, low-density lipoprotein.