Table 6.
Grade 3 or 4 laboratory abnormalities in the upadacitinib Japanese and global RA populations
| Laboratory parameters | Japanese RA population | Global RA population | ||||
|---|---|---|---|---|---|---|
| Upadacitinib 7.5 mg once daily [n = 121] |
Upadacitinib 15 mg once daily [n = 126] |
Upadacitinib 30 mg once daily [n = 124] |
Upadacitinib 6 mg twice daily/ 15 mg once daily [n = 2883] |
Upadacitinib 12 mg twice daily/ 30 mg once daily [n = 1375] |
||
| Hemoglobin (g/L) | ||||||
| Grade 3 (70 to < 80 or decreased 21 to < 30) | 2 (1.7) | 2 (1.6) | 16 (12.9) | 169 (5.9)a | 160 (11.7)b | |
| Grade 4 (< 70 or decreased ≥ 30) | 1 (0.8) | 0 | 9 (7.3) | 51 (1.8)a | 59 (4.3)b | |
| Neutrophils (× 109/L) | ||||||
| Grade 3 (0.5 to < 1.0) | 2 (1.7) | 1 (0.8) | 4 (3.2) | 29 (1.0)c | 34 (2.5)d | |
| Grade 4 (< 0.5) | 1 (0.8) | 0 | 0 | 7 (0.2)c | 3 (0.2)d | |
| Lymphocytes (× 109/L) | ||||||
| Grade 3 (0.5 to < 1.0) | 48 (39.7) | 40 (31.7) | 56 (45.2) | 572 (20.0)c | 333 (24.4)d | |
| Grade 4 (< 0.5) | 6 (5.0) | 2 (1.6) | 6 (4.8) | 45 (1.6)c | 39 (2.9)d | |
| CPK (U/L) | ||||||
| Grade 3 (> 5.0 to 10.0 × ULN) | 3 (2.5) | 3 (2.4) | 5 (4.0) | 48 (1.7)e | 29 (2.1)f | |
| Grade 4 (> 10.0 × ULN) | 1 (0.8) | 1 (0.8) | 4 (3.2) | 15 (0.5)e | 16 (1.2)f | |
| Creatinine (µmol/L) | ||||||
| Grade 3 (> 3.0 to 6.0 × ULN) | 0 | 0 | 0 | 1 (< 0.1)c | 1 (< 0.1)g | |
| Grade 4 (> 6.0 × ULN) | 0 | 1 (0.8) | 0 | 2 (< 0.1)c | 0g | |
| Alanine aminotransferase (U/L) | ||||||
| Grade 3 (> 3.0 to 8.0 × ULN) | 1 (0.8) | 3 (2.4) | 5 (4.0) | 89 (3.1)h | 48 (3.5)i | |
| Grade 4 (> 8.0 × ULN) | 0 | 1 (0.8) | 1 (0.8) | 12 (0.4)h | 7 (0.5)i | |
| Aspartate aminotransferase (U/L) | ||||||
| Grade 3 (> 3.0 to 8.0 × ULN) | 1 (0.8) | 2 (1.6) | 2 (1.6) | 55 (1.9)e | 22 (1.6)i | |
| Grade 4 (> 8.0 × ULN) | 0 | 1 (0.8) | 0 | 8 (0.3)e | 5 (0.4)i | |
Data are expressed as n (%)
CPK creatine phosphokinase, RA rheumatoid arthritis, ULN upper limit of normal
an = 2858
bn = 1364
cn = 2857
dn = 1363
en = 2855
fn = 1367
gn = 1368
hn = 2856
in = 1366