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Table 6 Changes in ALT/AST values from normal at baseline to highest value in the all-control and in the all-exposed population

From: Integrated safety in tocilizumab clinical trials

  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  
> 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)
  1. 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.