Blisibimod | |||||||||
---|---|---|---|---|---|---|---|---|---|
Placebo | mg/kg SC | mg/kg IV | All | ||||||
Baseline characteristics | (n = 14) | 0.1 (n = 6) | 0.3 (n = 6) | 1.0 (n = 9) | 3.0 (n = 6) | 1.0 (n = 6) | 3.0 (n = 1) | 6.0 (n = 6) | (N = 40) |
Sex, n (%) | |||||||||
Female | 13 (93) | 5 (83) | 6 (100) | 8 (89) | 6 (100) | 6 (100) | 1 (100) | 6 (100) | 38 (95) |
Male | 1 (7) | 1 (17) | 0 (0.0) | 1 (11) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5) |
Race, n (%) | |||||||||
White | 2 (14) | 2 (33) | 1 (17) | 1 (11) | 0 (0) | 2 (33) | 1 (100) | 3 (50) | 10 (25) |
Black | 5 (36) | 5 (50) | 3 (50) | 1 (11) | 2 (33) | 1 (17) | 0 (0) | 2 (33) | 12 (30) |
Hispanic | 7 (50) | 0 (0) | 2 (33) | 7 (78) | 4 (67) | 3 (50) | 0 (0) | 0 (0) | 16 (40) |
Asian | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (17) | 1 (3) |
Pacific Islander | 0 (0) | 1 (17) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (3) |
Age (years) | |||||||||
Median | 39.5 | 48.5 | 47.5 | 46.0 | 45.0 | 38.0 | 52.0 | 53.0 | 46.0 |
Range | 21–55 | 32–53 | 30–52 | 31–55 | 36–53 | 28–55 | -- | 32–55 | 28–55 |
Medications, n (%) | |||||||||
Prednisone (+ MePred) | 7 (50) | 3 (50) | 1 (17) | 7 (78) | 4 (67) | 3 (50) | 1 (17) | 0 (0) | 18 (45) |
Hydroxychloroquine | 6 (43) | 2 (33) | 2 (33) | 6 (67) | 4 (67) | 1 (17) | 0 (0) | 0 (0) | 15 (38) |
Azathioprine | 4 (29) | 3 (50) | 1 (17) | 3 (33) | 1 (17) | 1 (17) | 0 (0) | 0 (0) | 9 (23) |
Mycophenolate | 4 (29) | 0 (0) | 2 (33) | 3 (33) | 1 (17) | 0 (0) | 1 (17) | 0 (0) | 7 (18) |
Methotrexate | 1 (7) | 0 (0) | 0 (0) | 1 (11) | 0 (0) | 2 (33) | 0 (0) | 0 (0) | 3 (8) |
Anti-dsDNA, n | 12 | 6 | 6 | 9 | 6 | 4 | 5 | 0 | 36 |
Median (range), IU/mLa | 30 (30–300) | 179 (30–300) | 30 (30–206) | 30 (30–300) | 30 (30–187) | 30 (30–294) | 30 (30–40) | -- | 30 (30–300) |
C3 (IU,mL), median (range) | 114 (58–168) | 131 (76–189) | 132 (104–188) | 126 (95–187) | 123 (63–154) | 148 (95–173) | 113 (111–120) | -- | 125 (63–189) |
C4 (IU,mL), median (range) | 13 (5–38) | 17 (13–40) | 34 (12–38) | 22 (13–44) | 14 (9–30) | 33 (23–40) | 23 (18–31) | -- | 23 (9–44) |