Table 3.
Change from baseline in haematological and biochemical parameters to week 12/ET and week 52/ET (SAF)
| Baseline result | Change to week 12/ET | Change to Week 52/ET | |||||||||
| Placebo (N=100) | Peficitinib 100 mg (N=102) | Peficitinib 150 mg (N=101) | Etanercept (open-label arm) (N=200) | Placebo (N=100) | Peficitinib 100 mg (N=102) | Peficitinib 150 mg (N=101) | Etanercept (open-label arm) (N=200) | Peficitinib 100 mg (N=102) | Peficitinib 150 mg (N=101) | Etanercept (open-label arm) (N=200) | |
| Absolute neutrophil count (106/L) | 5610.9 (2282.7) | 5326.0 (2024.4) | 5955.9 (2410.4) | 5477.5 (1828.7) | −465.0 (1812.9) | −102.9 (1741.9) | −937.6 (1836.0) | −1359.5 (1690.6) | −289.2 (2142.6) | −1160.4 (1832.9) | −1459.5 (1704.1) |
| Haemoglobin (g/L) | 121.3 (14.6) | 121.5 (13.3) | 122.3 (14.0) | 123.7 (14.6) | −0.4 (8.5) | 1.4 (7.5) | 4.1 (8.4) | 4.5 (8.0) | 2.3 (10.8) | 5.5 (11.6) | 5.2 (10.1) |
| Platelets (109/L) | 303.1 (78.4) | 318.9 (89.2) | 316.3 (83.6) | 304.1 (97.1) | 1.8 (46.8) | −19.3 (49.0) | −47.2 (54.3) | −55.4 (53.5) | −24.3 (65.1) | −45.9 (62.8) | −56.3 (67.4) |
| LDL cholesterol (mmol/L) | 2.770 (0.870) | 2.737 (0.790) | 2.851 (0.782) | 2.704 (0.767) | 0.020 (0.487) | 0.130 (0.422) | 0.281 (0.713) | 0.124 (0.503) | 0.209 (0.547) | 0.385 (0.723) | 0.105 (0.561) |
| HDL cholesterol (mmol/L) | 1.510 (0.395) | 1.595 (0.417) | 1.562 (0.424) | 1.572 (0.470) | 0.023 (0.240) | 0.261 (0.297) | 0.363 (0.313) | 0.110 (0.246) | 0.251 (0.265) | 0.439 (0.405) | 0.061 (0.303) |
| Serum creatinine (μmol/L) | 55.22 (14.80) | 54.62 (14.96) | 52.83 (15.84) | 53.52 (12.52) | −0.25 (5.32) | 3.90 (6.26) | 5.40 (6.60) | 3.54 (7.18) | 4.47 (7.57) | 8.39 (6.54) | 4.24 (7.46) |
| Creatine kinase (U/L)* | 63.1 (54.6) | 67.8 (45.8) | 70.1 (45.8) | 80.0 (155.8) | 0.6 (22.3) | 55.5 (118.6) | 67.7 (61.1) | 79.5 (1117.7) | 91.9 (213.9) | 102.2 (105.4) | 86.4 (1117.8) |
| ALT (U/L) | 18.3 (13.4) | 17.9 (10.0) | 21.1 (17.5) | 19.0 (13.9) | 2.0 (12.4) | 2.3 (8.9) | 6.9 (17.4) | 4.6 (15.9) | 3.8 (12.2) | 5.9 (22.9) | 3.2 (15.0) |
| AST (U/L) | 23.1 (12.8) | 22.2 (9.5) | 25.0 (16.9) | 23.2 (10.4) | 0.8 (7.9) | 2.7 (7.1) | 4.9 (14.6) | 4.3 (18.6) | 4.3 (10.3) | 5.1 (16.4) | 3.8 (19.0) |
Data are presented as mean (SD).
*Median changes in creatine kinase from baseline to Wweek 12/ET were −1.0, 36.5, 52.0 and 8.5 U/L in the placebo, peficitinib 100 mg, peficitinib 150 mg and etanercept groups, respectively; changes to week 52 ET were 38.5, 75.0 and 10.0 U/L in the peficitinib 100 mg, peficitinib 150 mg and etanercept groups, respectively.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ET, early termination; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SAF, safety analysis set.