| Controlled, double-blind study population | All-exposed population | ||||
---|---|---|---|---|---|---|
 | Tocilizumab 8 mg/kg monotherapy, % (n) n= 288 | Methotrexate (control), % (n) n= 284 | Tocilizumab 4 mg/kg + DMARDs, % (n) n= 774 | Tocilizumab 8 mg/kg + DMARDs, % (n) n= 1,582 | DMARD monotherapy, % (n) n= 1,170 | Tocilizumab, % (n/n) n= 4,009c |
ALT,a n = normal at baseline | n = 269 | n = 269 | n = 706 | n = 1,465 | n = 1,080 | Â |
> 1-3× ULN > 3-5× ULN > 5× ULN | 33.8 (91) 1.1 (3) 0.7 (2) | 32.0 (86) 2.6 (7) 1.1 (3) | 42.8 (302) 4.0 (28) 1.0 (7) | 45.9 (672) 4.3 (63) 1.4 (20) | 19.1 (206) 0.8 (9) 0.3 (3) | 57.3 (2,112/3,696) 7.2 (267/3,696) 2.2 (83/3,696) |
AST,a n = normal at baseline | n = 283 | n = 269 | n = 743 | n = 1,502 | n = 1,123 | Â |
> 1-3× ULN > 3-5× ULN > 5× ULN | 20.8 (59) 0.4 (1) 0.7 (2) | 24.9 (67) 1.1 (3) 0.4 (1) | 32.4 (241) 0.9 (7) -- | 38.8 (583) 1.5 (23) 0.2 (3) | 14.5 (163) 0.3 (3) 0.1 (1) | 51.4 (1,961/3,818) 2.6 (98/3,818) 0.6 (22/3,818) |
Dose heldb | 8.0 (23) | 9.9 (28) | 2.5 (19) | 2.5 (39) | 0.7 (8) | 10.3 (413/4,009) |
Discontinued | 0.3 (1)b | 1.4 (4)b | 1.3 (10)b | 1.3 (21)b | 0.2 (2)b | 2.3 (91/4,002) |