Table 1.
Patient characteristics at baseline
| Steroids only (N = 139) |
AM only (N = 77) |
Steroids + AM (N = 346) |
Steroids + AM + IS (N = 272) |
|||||
|---|---|---|---|---|---|---|---|---|
| Characteristic | Placebo (n = 61, 44%) | Belimumab 10 mg/kg (n = 78, 56%) | Placebo (n = 32, 42%) | Belimumab 10 mg/kg (n = 45, 58%) | Placebo (n = 186, 54%) | Belimumab 10 mg/kg (n = 160, 46%) | Placebo (n = 139, 51%) | Belimumab 10 mg/kg (n = 133, 49%) |
| Female, n (%) | 60 (98) | 73 (94) | 27 (84) | 43 (96) | 174 (94) | 150 (94) | 124 (89) | 132 (>99) |
| Mean age (SD), years | 40.6 (12.11) | 38.4 (11.07) | 42.6 (9.71) | 43.5 (12.37) | 36.1 (11.96) | 36.9 (11.87) | 35.4 (11.47) | 34.4 (9.64) |
| Ethnicity, n (%) | ||||||||
| White/Caucasian | 31 (51) | 32 (41) | 27 (84) | 29 (64) | 75 (40) | 66 (41) | 52 (37) | 52 (39) |
| Asian | 17 (28) | 27 (35) | 1 (3) | 3 (7) | 41 (22) | 41 (26) | 40 (29) | 39 (29) |
| Black/African American | 6 (10) | 7 (9) | 2 (6) | 8 (18) | 17 (9) | 8 (5) | 14 (10) | 14 (11) |
| Other | 7 (11) | 12 (15) | 2 (6) | 5 (11) | 53 (28) | 45 (28) | 33 (24) | 28 (21) |
| Disease duration (SD), years | 7.2 (6.54) | 7.0 (6.51) | 8.4 (7.70) | 6.1 (7.24) | 5.7 (6.16) | 5.7 (6.26) | 6.9 (6.39) | 5.8 (5.77) |
| Mean (SD) SELENA-SLEDAI | 10.3 (4.71) | 10.6 (4.08) | 9.3 (3.65) | 9.6 (3.94) | 9.5 (3.17) | 9.6 (3.85) | 10.2 (4.02) | 9.5 (3.53) |
| SELENA-SLEDAI 6–9, n (%) | 30 (49) | 30 (38) | 19 (59) | 23 (51) | 89 (48) | 80 (50) | 57 (41) | 64 (48) |
| SELENA-SLEDAI ≥10, n (%) | 31 (51) | 48 (62) | 13 (41) | 22 (49) | 97 (52) | 80 (50) | 82 (59) | 69 (52) |
| Mean (SD) PGA | 1.5 (0.48) | 1.5 (0.48) | 1.3 (0.53) | 1.4 (0.43) | 1.4 (0.47) | 1.4 (0.49) | 1.4 (0.48) | 1.3 (0.49) |
| BILAG 1A or 2B, n (%) | 43 (70) | 53 (68) | 22 (69) | 28 (62) | 109 (59) | 90 (56) | 81 (58) | 74 (56) |
| ≥1 severe flare, n (%) | 1 (2) | 2 (3) | 0 | 0 | 0 | 2 (1) | 2 (1) | 1 (<1) |
| Mean (SD) steroid dose, mg/day | 15.4 (8.38) | 15.3 (8.49) | 0 | 0 | 11.4 (7.08) | 11.6 (8.14) | 12.5 (8.88) | 12.8 (9.05) |
| Steroid use >7.5 mg, n (%) | 53 (87) | 66 (85) | 0 | 0 | 117 (63) | 98 (61) | 87 (63) | 87 (65) |
| Anti-dsDNA positive and low C3/C4 | 28 (46) | 49 (63) | 11 (34) | 15 (33) | 114 (61) | 99 (62) | 93 (67) | 91 (68) |
AM: antimalarial; anti-dsDNA: anti-double-stranded DNA; BILAG: British Isles Lupus Assessment Group; C3/C4: complement 3/4; IS: immunosuppressant; PGA: Physician’s Global Assessment; SD: standard deviation; SELENA-SLEDAI” Safety of Estrogen in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index.