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Table 1 Patient demographics and clinical characteristics a

From: A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis

Demographics and characteristics

 

Brodalumab

 

Placebo

SC

IV

  

SC

IV

All

50 mg

140 mg

210 mg

420 mg

700 mg

All

Total

(N = 6)

(N = 4)

(N=10)

(N = 6)

(N = 6)

(N = 6)

(N = 6)

(N = 6)

(N = 30)

(N = 40)

Females, n (%)

5 (83)

4 (100)

9 (90)

6 (100)

6 (100)

5 (83)

5 (83)

3 (50)

25 (83)

34 (85)

Race, n (%)

          

 White

4 (67)

2 (50)

6 (60)

3 (50)

2 (33)

1 (17)

5 (83)

1 (17)

12 (40)

18 (45)

 Black

1 (17)

1 (25)

2 (20)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

2 (5)

 Latino

1 (17)

1 (25)

2 (20)

3 (50)

4 (67)

4 (67)

1 (17)

5 (83)

17 (57)

19 (48)

 Asian

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (17)

0 (0)

0 (0)

1 (3)

1 (3)

Age (yr)

52 (10)

56 (12)

53 (10)

46 (12)

57 (9)

46 (10)

56 (7)

50 (6)

51 (10)

51 (10)

Height (cm)

162 (8)

163 (5)

163 (7)

159 (13)

158 (8)

158 (13)

168 (6)

161 (10)

161 (11)

161 (10)

Weight (kg)

75 (10)

101 (28)

85 (22)

80 (17)

77 (12)

64 (11)

81 (12)

79 (14)

76 (14)

79 (17)

BMI (kg/m2)

29 (4)

37 (9)

32 (7)

33 (14)

31 (3)

26 (3)

29 (4)

31 (4)

30 (7)

30 (7)

Tender/painful joint counts

24 (12)

30 (21)

26 (15)

23 (12)

40 (26)

32 (27)

42 (21)

32 (12)

34 (21)

32 (20)

Swollen joint counts

15 (15)

19 (8)

17 (12)

10 (6)

22 (13)

20 (7)

19 (11)

21 (16)

18 (11)

18 (11)

Patient global assessment of disease activity

72 (23)

57 (22)

67 (23)

57 (16)

68 (23)

51 (25)

44 (18)

54 (23)

55 (21)

57 (22)

Physician global assessment of disease activity

7.7 (1.8)

6.0 (1.8)

7.0 (1.9)

6.7 (2.1)

6.3 (2.2)

7.3 (2.0)

6.8 (1.9)

7.0 (0.9)

6.8 (1.8)

6.9 (1.8)

Patient global assessment of pain

72 (23)

63 (18)

68 (20)

60 (18)

71 (17)

49 (28)

49 (14)

60 (24)

58 (21)

60 (21)

HAQ-DI

1.4 (0.9)

1.4 (0.5)

1.4 (0.7)

1.3 (0.7)

1.7 (0.6)

1.7 (1.0)

1.5 (0.7)

1.7 (0.5)

1.6 (0.7)

1.5 (0.7)

CRP (mg/L)

15 (17)

26 (39)

19 (26)

7 (9)

7 (4)

28 (39)

24 (50)

33 (53)

20 (36)

20 (34)

ESR (mm/h)

27 (23)

39 (29)

32 (26)

19 (11)

16 (11)

23 (15)

23 (28)

41 (45)

24 (26)

26 (25)

RF-positive, n (%)

4 (67)

4 (100)

8 (80)

5 (83)

4 (67)

5 (83)

5 (83)

5 (83)

24 (80)

32 (80)

  1. aBMI, body mass index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; IV, intravenous; RF, rheumatoid factor; SC, subcutaneous. All data are means (SD) unless otherwise indicated.