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Table 2 Demographics and disease characteristics of patients with systemic lupus erythematosus in the phase 1b 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

6.0 mg/kg IV

All

Baseline characteristics

(n = 13)

0.3 (n = 12)

1.0 (n = 13)

3.0 (n = 12)

(n = 12)

(N = 49)

Sex, n (%)

      

 Female

12 (92)

12 (100)

12 (92)

12 (100)

9 (75)

45 (92)

 Male

1 (8)

0 (0)

1 (8)

0 (0)

3 (25)

4 (8)

Race, n (%)

      

 White

6 (46)

7 (58)

9 (69)

4 (33)

5 (42)

25 (51)

 Black

2 (15)

3 (25)

3 (23)

1 (8)

2 (17)

9 (18)

 Hispanic

5 (38)

1 (8)

1 (8)

6 (50)

5 (42)

13 (27)

 Asian

0 (0)

1 (8)

0 (0)

1 (8)

0 (0)

2 (4)

 Pacific Islander

      

Age (years), median (range)

45.0 (22–64)

41.5 (21–62)

47.0 (34–63)

44.0 (24–66)

44.5 (26–62)

43.0 (21–66)

SLEDAI, median (range)

3 (0–11)

4 (0–6)

2 (0–14)

4 (0–12)

2 (0–10)

2 (0–14)

Medications, n (%)

      

 Prednisone (+ MePred)

7 (54)

4 (33)

5 (38)

6 (50)

4 (33)

19 (39)

 Hydroxychloroquine

13 (100)

4 (33)

9 (69)

9 (75)

9 (75)

31 (63)

 Azathioprine

4 (31)

1 (8)

4 (31)

1 (8)

1 (8)

7 (14)

 Mycophenolate

2 (15)

2 (17)

1 (8)

1 (8)

0 (0)

4 (8)

 Methotrexate

0 (0)

1 (8)

0 (0)

1 (8)

1 (8)

3 (6)

Anti-dsDNA, n

13

12

13

11

12

48

 Median (range), IU/mLa

36 (30–300)

30 (30–300)

36 (11–300)

30 (30–300)

30 (30–300)

30 (11–300)

C3 (IU/mL), median (range)

96 (47–167)

131 (78–179)

100 (65–266)

107 (74–160)

119 (82–168)

119 (65–266)

C4 (UI/mL), median (range)

20 (9–43)

19 (5–58)

23 (7–55)

21 (8–46)

23 (5–50)

21 (5–58)

  1. Abbreviations: C3 complement 3, C4 compliment 4, dsDNA double-stranded DNA, IV intravenous, MePred methylprednisolone, SC subcutaneous, SLEDAI Systemic Lupus Erythematosus Disease Activity Index
  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