Table 6 |
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|
Changes in ALT/AST values from normal at baseline to highest value in the all-control and in the all-exposed population |
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|
Controlled, double-blind study population |
All-exposed population |
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|
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 |
|
|
|
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|
ALT,a n = normal at baseline |
n = 269 |
n = 269 |
n = 706 |
n = 1,465 |
n = 1,080 |
|
|
> 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 |
|
|
> 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) |
|
|
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|
ALT, alanine aminotransferase; AST, aspartate aminotransferase; DMARD, disease-modifying antirheumatic drug; ULN, upper limit of normal. aPercentages are based on number of patients with normal ALT (or AST) at baseline. bPercentages are based on total treatment-group sample size. cExcluding patients with missing values. |
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|
Schiff et al. Arthritis Research & Therapy 2011 13:R141 doi:10.1186/ar3455 |
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