Table 1

Patient demographics and disease characteristics by treatment groups

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)


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

Furie et al. Arthritis Research & Therapy 2008 10:R109   doi:10.1186/ar2506

Open Data