Sirukumab dose | CTCAE grade | Global study – with MTX | Global study – no MTX | ||
---|---|---|---|---|---|
50mg q4w | 100mg q2w | 50mg q4w | 100mg q2w | ||
(n=562) | (n=564) | (n=86) | (n=85) | ||
ALT increased | 1 | 330 (58.7) | 312 (55.3) | 27 (31.4) | 33 (38.8) |
2 | 32 (5.7) | 46 (8.2) | 2 (2.3) | 5 (5.9) | |
3 | 9 (1.6) | 20 (3.5) | 1 (1.2) | 0 | |
4 | 0 | 0 | 0 | 0 | |
AST increased | 1 | 266 (47.3) | 283 (50.2) | 22 (25.6) | 28 (32.9) |
2 | 15 (2.7) | 20 (3.5) | 2 (2.3) | 1 (1.2) | |
3 | 1 (0.2) | 5 (0.9) | 0 | 0 | |
4 | 0 | 0 | 0 | 0 | |
Neutrophils decreased | 1 | 104 (18.5)a | 113 (20.1)b | 17 (19.8)c | 15 (17.6) |
2 | 66 (11.8)a | 63 (11.2)b | 9 (10.5)c | 11 (12.9) | |
3 | 20 (3.6)a | 13 (2.3)b | 2 (2.3)c | 3 (3.5) | |
4 | 0 | 1 (0.2)b | 0 | 0 |
an=561. bn=563. cn=85.