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Table 1 Demographics and disease characteristics of patients with systemic lupus erythematosus in the phase 1a study

From: Treatment of systemic lupus erythematosus patients with the BAFF antagonist “peptibody” blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials

  

Blisibimod

 

Placebo

mg/kg SC

mg/kg IV

All

Baseline characteristics

(n = 14)

0.1 (n = 6)

0.3 (n = 6)

1.0 (n = 9)

3.0 (n = 6)

1.0 (n = 6)

3.0 (n = 1)

6.0 (n = 6)

(N = 40)

Sex, n (%)

         

 Female

13 (93)

5 (83)

6 (100)

8 (89)

6 (100)

6 (100)

1 (100)

6 (100)

38 (95)

 Male

1 (7)

1 (17)

0 (0.0)

1 (11)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

2 (5)

Race, n (%)

         

 White

2 (14)

2 (33)

1 (17)

1 (11)

0 (0)

2 (33)

1 (100)

3 (50)

10 (25)

 Black

5 (36)

5 (50)

3 (50)

1 (11)

2 (33)

1 (17)

0 (0)

2 (33)

12 (30)

 Hispanic

7 (50)

0 (0)

2 (33)

7 (78)

4 (67)

3 (50)

0 (0)

0 (0)

16 (40)

 Asian

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (17)

1 (3)

 Pacific Islander

0 (0)

1 (17)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (3)

Age (years)

         

 Median

39.5

48.5

47.5

46.0

45.0

38.0

52.0

53.0

46.0

 Range

21–55

32–53

30–52

31–55

36–53

28–55

--

32–55

28–55

Medications, n (%)

         

 Prednisone (+ MePred)

7 (50)

3 (50)

1 (17)

7 (78)

4 (67)

3 (50)

1 (17)

0 (0)

18 (45)

 Hydroxychloroquine

6 (43)

2 (33)

2 (33)

6 (67)

4 (67)

1 (17)

0 (0)

0 (0)

15 (38)

 Azathioprine

4 (29)

3 (50)

1 (17)

3 (33)

1 (17)

1 (17)

0 (0)

0 (0)

9 (23)

 Mycophenolate

4 (29)

0 (0)

2 (33)

3 (33)

1 (17)

0 (0)

1 (17)

0 (0)

7 (18)

 Methotrexate

1 (7)

0 (0)

0 (0)

1 (11)

0 (0)

2 (33)

0 (0)

0 (0)

3 (8)

Anti-dsDNA, n

12

6

6

9

6

4

5

0

36

 Median (range), IU/mLa

30 (30–300)

179 (30–300)

30 (30–206)

30 (30–300)

30 (30–187)

30 (30–294)

30 (30–40)

--

30 (30–300)

C3 (IU,mL), median (range)

114 (58–168)

131 (76–189)

132 (104–188)

126 (95–187)

123 (63–154)

148 (95–173)

113 (111–120)

--

125 (63–189)

C4 (IU,mL), median (range)

13 (5–38)

17 (13–40)

34 (12–38)

22 (13–44)

14 (9–30)

33 (23–40)

23 (18–31)

--

23 (9–44)

  1. Abbreviations: C3 complement 3, C4, complement 4, dsDNA double-stranded DNA, IV intravenous, MePred methylprednisolone, SC subcutaneous
  2. aReference ranges are < 30 IU/mL for negative, 30–75 IU/mL for borderline, and > 75 UI/mL for positive for all age ranges