Table 2

Baseline patient demographic and disease characteristicsa

SAD

MAD


Demographics and disease characteristics

Placebo

(n = 6)

All pateclizumab

(n = 24)

Placebo

(n = 7)

1.0 mg/kg SC

(n = 8)

3.0 mg/kg SC

(n = 16)

5.0 mg/kg IV

(n = 4)

All pateclizumab

(n = 28)


Demographics

Sex, female:male

6:0

20:4

7:0

6:2

14:2

3:1

23:5

Median age, years (range)

57

(25 to 69)

57.5

(35 to 75)

57

(29 to 69)

56

(41 to 73)

56

(23 to 70)

54

(48 to 61)

57

(23 to 73)

Race, white:black

5:1

23:1

7:0

7:1

16:0

3:1

26:2

Region, USA:Hungary

All USA

All USA

3:4

6:2

5:11

2:2

13:15

Disease characteristics

Median disease duration, years

3

5

5.4

9

7.5

7

8

RF- and anti-CCP-positive (%)

17

67

71.4

87.5

87.5

50.0

82.1

Concomitant medications (%)

Prior anti-TNF-α

33

33

0

25

19

0

18

MTX

67

63

29

13

44

50

36

Leflunomide

0

4

43

38

6

25

18

Steroids

33

25

57

50

69

75

54

Median CRP, mg/dl (IQR)

0.2

(0.1 to 1.1)

0.7

(0.0 to 6.2)

1.6

(1.2 to 3.3)

2.1

(1.1 to 4.6)

1.6

(0.9 to 4.5)

3.7

(0.9 to 4.4)

2

(0.9 to 4.6)

Median ESR, mm/hour (IQR)

25.5

(12 to 48)

27

(2 to 59)

34

(24 to 65)

42.6

(14 to 86)

31

(11 to 97)

39.5

(22 to 66)

30.5

(11 to 97)

Median SJC (range)

12

(6 to 26)

14.5

(0 to 34)

6

(5 to 12)

13

(6 to 23)

7

(5 to 35)

12

(5 to 45)

10.5

(5 to 45)

Median TJC (range)

19

(12 to 38)

27.5

(0 to 66)

11

(5 to 33)

22

(5 to 60)

20

(7 to 65)

30

(12 to 56)

19.5

(5 to 65)

Median baseline DAS28-CRP (IQR)

4.8

(4.6 to 5.5)

5.4

(2.19 to 7.2)

5.7

(3.9 to 6.0)

6.0

(4.8 to 7.9)

5.4

(4.0 to 7.5)

5.7

(4.2 to 7.0)

5.6

(3.9 to 7.9)


aCCP = cyclic citrullinated peptide; CRP = C-reactive protein; DAS28-CRP = Disease Activity Score in 28 joints, C-reactive protein; ESR = erythrocyte sedimentation rate; IV = intravenously; MAD = multiple ascending dose; MTX = methotrexate; RA = rheumatoid arthritis; RF = rheumatoid factor; SAD = single ascending dose; SC = subcutaneously; SJC = swollen joint count; TJC = tender joint count.

Emu et al. Arthritis Research & Therapy 2012 14:R6   doi:10.1186/ar3554

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