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Table 1 Patient demographics and disease characteristics by treatment groups

From: Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus

Patient demographic or disease characteristic

Placebo (n = 13)

Belimumab

  

1.0 mg/kg (n = 15)

4.0 mg/kg (n = 14)

10 mg/kg (n = 14)

20 mg/kg (n = 14)

All active (n = 57)

Sex (n [%])

      

   Female

11 (85)

15 (100)

13 (93)

12 (86)

13 (93)

53 (93)

   Male

2 (15)

0

1 (7)

2 (14)

1 (7)

4 (7)

Race (n [%])

      

   White

10 (77)

7 (47)

3 (21)

8 (57)

7 (50)

25 (44)

   African American

3 (23)

8 (53)

11 (79)

5 (36)

6 (43)

30 (53)

   Asian

0

0

0

1 (7)

1 (7)

2 (4)

Hispanic origin (n [%])

4 (31)

2 (13)

1 (7)

5 (36)

1 (7)

9 (16)

Age (years; median [range])

38 (30 to 58)

36 (22 to 56)

48.5 (23 to 62

37 (22 to 61)

38.5 (23 to 80)

39 (22 to 80)

Duration of SLE (years; median [range])

5.3 (0.4 to 15.3)

3.4 (0.4 to 13)

8.7 (0.4 to 37.7)

6.3 (1.8 to 20.8)

8.0 (0.3 to 29.4)

6.9 (0.3 to 37.7)

SELENA SLEDAI score (median [range])

4 (0 to 4)

2 (0 to 6)

0 (0 to 5)

2 (0 to 8)

2 (0 to 4)

2 (0 to 8)

ANA ≥1:40 at baseline (n [%])

12 (92)

13 (87)

14 (86)

13 (93)

13 (93)

53 (93)

Anti-dsDNA antibody (IU/ml; median [range])

9.5 (4.0 to 162.5)

6.0 (4.0 to 65.5)

4.5 (4.0 to 24.0)

27.0 (4.0 to 257.0)

5.0 (4.0 to 729.0)

6.5 (4.0 to 729.0)

Manifestations at the time of SLE diagnosis (n [%])

      

   Antinuclear antibody

13 (100)

14 (93)

14 (100)

14 (100)

13 (93)

55 (97)

   Immunologic disorder

12 (92)

12 (80)

12 (86)

14 (100)

12 (86)

50 (88)

   Arthritis

12 (92)

14 (93)

11 (79)

12 (86)

12 (86)

49 (86)

   Hematologic disorder

7 (54)

14 (93)

9 (64)

7 (50)

8 (57)

38 (67)

   Malar rash

6 (46)

8 (53)

5 (36)

12 (86)

8 (57)

33 (58)

   Photosensitivity

7 (54)

7 (47)

6 (43)

9 (64)

8 (57)

30 (53)

   Serositis

6 (46)

4 (27)

8 (57)

7 (50)

8 (57)

27 (47)

   Oral ulcers

8 (62)

10 (67)

6 (43)

6 (43)

5 (36)

27 (47)

   Renal disorder

4 (31)

2 (13)

4 (29)

6 (43)

4 (29)

16 (28)

   Discoid rash

3 (23)

1 (7)

5 (36)

4 (29)

2 (14)

12 (21)

   Neurologic disorder

0

3 (20)

1 (7)

1 (7)

1 (7)

6 (11)

  1. ANA, antinuclear antibody; SLE, systemic lupus erythematosus; SELENA, Safety of Estrogens in Lupus Erythematosus National Assessment; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.
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Arthritis Research & Therapy

ISSN: 1478-6362

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