Table 6

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

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)


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.

Schiff et al. Arthritis Research & Therapy 2011 13:R141   doi:10.1186/ar3455

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