Laboratory parameters at week 12 ((A) changes from baseline and (B) shifts from baseline)
| Placebo (N=56) | Peficitinib 25 mg (N=55) | Peficitinib 50 mg (N=57) | Peficitinib 100 mg (N=55) | Peficitinib 150 mg (N=58) | |
|---|---|---|---|---|---|
| (A) Changes from baseline | |||||
| Absolute neutrophil count (106/L) | 146.4±1105.0 | 20.0±1308.3 | 66.7±1297.2 | −532.7±1449.3 | −444.8±1729.6 |
| Lymphocytes (106/L) | 57.1±375.6 | −150.9±403.6 | −77.2±420.0 | 56.4±435.4 | 48.3±481.3 |
| Haemoglobin (g/L) | −5.2±8.5 | −0.8±7.3 | −1.6±6.4 | 1.5±8.2 | 2.0±7.9 |
| Platelets (109/L) | 26.9±54.0 | 0.4±48.8 | −6.7±56.5 | −21.1±55.4 | −26.1±47.6 |
| Creatinine (μmol/L) | −0.1±5.5 | 1.8±4.7 | 2.6±4.9 | 3.6±5.8 | 5.4±4.3 |
| CPK (U/L) | −5.6±26.1 | 13.8±25.0 | 7.6±101.9 | 33.7±30.1 | 63.7±117.7 |
| Total cholesterol (mmol/L) | −0.259±0.641 | 0.051±0.567 | 0.133±0.585 | 0.315±0.647 | 0.559±0.704 |
| LDL cholesterol (mmol/L) | −0.162±0.479 | −0.028±0.423 | 0.035±0.479 | 0.080±0.507 | 0.208±0.605 |
| HDL cholesterol (mmol/L) | −0.091±0.234 | 0.080±0.205 | 0.128±0.222 | 0.269±0.265 | 0.338±0.284 |
| Triglycerides (mmol/L) | 0.003±0.230 | 0.035±0.332 | 0.073±0.373 | 0.133±0.484 | 0.187±0.472 |
| (B) Shifts from baseline | |||||
| Decreased neutrophils | |||||
| Mild | 1 (1.8%) | 0 | 0 | 2 (3.6%) | 0 |
| Moderate to severe | 0 | 0 | 0 | 2 (3.6%) | 1 (1.7%) |
| Life threatening | 0 | 0 | 0 | 0 | 0 |
| Decreased lymphocytes | |||||
| Mild | 19 (33.9%) | 13 (23.6%) | 15 (26.3%) | 13 (23.6%) | 16 (27.6%) |
| Moderate to severe | 32 (57.1%) | 36 (65.5%) | 34 (59.6%) | 32 (58.2%) | 36 (62.1%) |
| Life threatening | 0 | 0 | 0 | 0 | 1 (1.7%) |
| Decreased haemoglobin | |||||
| Mild to moderate | 23 (41.1%) | 4 (7.3%) | 10 (17.5%) | 9 (16.4%) | 9 (15.5%) |
| Severe | 3 (5.4%) | 1 (1.8%) | 0 | 1 (1.8%) | 0 |
| Potentially life threatening | 0 | 0 | 0 | 0 | 0 |
| Elevated ALT | |||||
| ≥1× ULN | 0 | 1 (1.8%) | 1 (1.8%) | 3 (5.5%) | 0 |
| ≥2× ULN | 0 | 0 | 0 | 1 (1.8%) | 1 (1.7%) |
| ≥3× ULN | 1 (1.8%) | 0 | 0 | 0 | 0 |
| Maximum LDL (mg/dL) | |||||
| <100 | 17 (30.4%) | 12 (21.8%) | 11 (19.3%) | 14 (25.5%) | 11 (19.0%) |
| 100 to <130 | 23 (41.1%) | 22 (40.0%) | 21 (36.8%) | 21 (38.2%) | 21 (36.2%) |
| 130 to <160 | 11 (19.6%) | 16 (29.1%) | 13 (22.8%) | 9 (16.4%) | 15 (25.9%) |
| 160 to <190 | 4 (7.1%) | 5 (9.1%) | 8 (14.0%) | 7 (12.7%) | 6 (10.3%) |
| ≥190 | 1 (1.8%) | 0 | 4 (7.0%) | 4 (7.3%) | 5 (8.6%) |
Data are expressed as mean±SD, and baseline is the last non-missing measurement prior to initial dosing of study drug.
Data are expressed as patient number and the percentage.
The following categorisations defined using Outcome Measures in Rheumatology (OMERACT) criteria: Decreased neutrophils were categorised as mild (≥1500 to <2000 cells/mm3), moderate to severe (<1500 to ≥500 cells/mm3) and life threatening (<500 cells/mm3). Decreased lymphocytes were categorised as mild (≥1500 to <2000 cells/mm3), moderate to severe (<1500 to ≥500 cells/mm3) and life threatening (<500 cells/mm3). Decreased haemoglobin were categorised as mild to moderate (decrease from baseline: ≥1 to ≤2 g/dL), severe (decrease from baseline: >2 to <3 g/dL or absolute value: >7 and <8 g/dL) and potentially life threatening (decrease from baseline: ≥3 or absolute value: ≤7 g/dL).
ALT, alanine aminotransferase; CPK, creatine phosphokinase; HDL, high-density lipoprotein; LDL, low-density lipoprotein; ULN, upper limit of normal.