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) |