Table 1 |
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|
Patient demographics and disease characteristics by treatment groups |
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|
Patient demographic or disease characteristic |
Placebo (n = 13) |
Belimumab |
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|
|
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|
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) |
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|
|
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|
Sex (n [%]) |
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|
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 [%]) |
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|
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 [%]) |
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|
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. |
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|
Furie et al. Arthritis Research & Therapy 2008 10:R109 doi:10.1186/ar2506 |
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