Table 1 Demographics and baseline characteristics
BLyS mRNA low | BLyS mRNA medium | BLyS mRNA high | IFN-1 mRNA low | IFN-1 mRNA high | Revised BLyS mRNA low | Revised BLyS mRNA high | BLyS protein* low | BLyS protein* high | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PBO | BEL | PBO | BEL | PBO | BEL | PBO | BEL | PBO | BEL | PBO | BEL | PBO | BEL | PBO | BEL | PBO | BEL | |
n = 85 | n = 99 | n = 104 | n = 81 | n = 84 | n = 101 | n = 43 | n = 49 | n = 230 | n = 232 | n = 93 | n = 111 | n = 180 | n = 170 | n = 208 | n = 220 | n = 64 | n = 61 | |
Age, years, mean (SD) | 39.2 (13.17) | 38.8 (11.06) | 36.5 (12.12) | 36.8 (11.34) | 37.6 (10.70) | 37.0 (11.29) | 43.3 (13.66) | 42.5 (11.27) | 36.6 (11.47) | 36.5 (10.95) | 38.9 (13.35) | 38.5 (10.69) | 37.0 (11.32) | 36.9 (11.54) | 38.0 (12.27) | 38.4 (11.41) | 36.3 (11.26) | 34.4 (9.99) |
Female, n (%) | 79 (92.9) | 96 (97.0) | 95 (91.3) | 81 (100.0) | 78 (92.9) | 97 (96.0) | 39 (90.7) | 47 (95.9) | 213 (92.6) | 227 (97.8) | 86 (92.5) | 108 (97.3) | 166 (92.2) | 166 (97.6) | 197 (94.7) | 213 (96.8) | 54 (84.4) | 61 (100.0) |
SLE disease duration, years, mean (SD) | 6.0 (6.23) | 5.8 (7.30) | 6.4 (6.41) | 6.9 (6.54) | 7.7 (6.35) | 6.3 (5.99) | 6.0 (6.52) | 4.8 (5.99) | 6.8 (6.32) | 6.6 (6.72) | 6.1 (6.07) | 5.8 (7.12) | 7.0 (6.48) | 6.7 (6.28) | 6.3 (6.09) | 6.0 (6.38) | 8.1 (7.03) | 7.3 (7.41) |
BILAG organ domain involvement, n (%) | ||||||||||||||||||
≥ 1A or 2B | 54 (63.5) | 47 (47.5) | 63 (60.6) | 48 (59.3) | 56 (66.7) | 57 (56.4) | 28 (65.1) | 24 (49.0) | 145 (63.0) | 128 (55.2) | 60 (64.5) | 56 (50.5) | 113 (62.8) | 96 (56.5) | 126 (60.6) | 112 (50.9) | 47 (73.4) | 40 (65.6) |
≥ 1A | 8 (9.4) | 3 (3.0) | 10 (9.6) | 12 (14.8) | 13 (15.5) | 9 (8.9) | 6 (14.0) | 1 (2.0) | 25 (10.9) | 23 (9.9) | 8 (8.6) | 3 (2.7) | 23 (12.8) | 21 (12.4) | 25 (12.0) | 18 (8.2) | 6 (9.4) | 6 (9.8) |
≥ 1A or 1B | 80 (94.1) | 84 (84.8) | 94 (90.4) | 72 (88.9) | 76 (90.5) | 89 (88.1) | 41 (95.3) | 43 (87.8) | 209 (90.9) | 202 (87.1) | 86 (92.5) | 96 (86.5) | 164 (91.1) | 149 (87.6) | 191 (91.8) | 187 (85.0) | 58 (90.6) | 58 (95.1) |
No A or B | 5 (5.9) | 15 (15.2) | 10 (9.6) | 9 (11.1) | 8 (9.5) | 12 (11.9) | 2 (4.7) | 6 (12.2) | 21 (9.1) | 30 (12.9) | 7 (7.5) | 15 (13.5) | 16 (8.9) | 21 (12.4) | 17 (8.2) | 33 (15.0) | 6 (9.4) | 3 (4.9) |
SELENA-SLEDAI category, n (%) | ||||||||||||||||||
≤ 9 | 55 (64.7) | 56 (56.6) | 51 (49.0) | 35 (43.2) | 35 (41.7) | 48 (47.5) | 27 (62.8) | 33 (67.3) | 114 (49.6) | 106 (45.7) | 57 (61.3) | 59 (53.2) | 84 (46.7) | 80 (47.1) | 117 (56.3) | 118 (53.6) | 24 (37.5) | 21 (34.4) |
10–11 | 19 (22.4) | 20 (20.2) | 27 (26.0) | 20 (24.7) | 19 (22.6) | 22 (21.8) | 9 (20.9) | 9 (18.4) | 56 (24.3) | 53 (22.8) | 22 (23.7) | 23 (20.7) | 43 (23.9) | 39 (22.9) | 47 (22.6) | 46 (20.9) | 17 (26.6) | 16 (26.2) |
≥ 12 | 11 (12.9) | 23 (23.2) | 26 (25.0) | 26 (32.1) | 30 (35.7) | 31 (30.7) | 7 (16.3) | 7 (14.3) | 60 (26.1) | 73 (31.5) | 14 (15.1) | 29 (26.1) | 53 (29.4) | 51 (30.0) | 44 (21.2) | 56 (25.5) | 23 (35.9) | 24 (39.3) |
SELENA-SLEDAI score, mean (SD) | 8.6 (2.43) | 9.2 (3.74) | 9.4 (3.87) | 9.6 (3.50) | 10.4 (4.57) | 9.7 (3.56) | 8.6 (2.91) | 8.5 (3.65) | 9.6 (3.92) | 9.7 (3.56) | 8.8 (2.73) | 9.3 (3.64) | 9.8 (4.21) | 9.6 (3.59) | 8.9 (3.21) | 9.2 (3.59) | 11.0 (4.98) | 10.5 (3.48) |
Anti-dsDNA (≥ 30 IU/mL), n (%) | 42 (49.4) | 57 (57.6) | 75 (72.1) | 58 (71.6) | 61 (72.6) | 82 (81.2) | 17 (39.5) | 18 (36.7) | 161 (70.0) | 179 (77.2) | 49 (52.7) | 65 (58.6) | 129 (71.7) | 132 (77.6) | 126 (60.6) | 145 (65.9) | 51 (79.7) | 52 (85.2) |
Low C3 and/or low C4, n (%) | 39 (45.9) | 62 (62.6) | 71 (68.3) | 52 (64.2) | 61 (72.6) | 75 (74.3) | 12 (27.9) | 21 (42.9) | 159 (69.1) | 168 (72.4) | 44 (47.3) | 69 (62.2) | 127 (70.6) | 120 (70.6) | 121 (58.2) | 137 (62.3) | 49 (76.6) | 52 (85.2) |
Anti-dsDNA (≥ 30 IU/mL) and low C3 and/or low C4), n (%) | 26 (30.6) | 44 (44.4) | 60 (57.7) | 43 (53.1) | 52 (61.9) | 70 (69.3) | 8 (18.6) | 10 (20.4) | 130 (56.5) | 147 (63.4) | 31 (33.3) | 48 (43.2) | 107 (59.4) | 109 (64.1) | 97 (46.6) | 110 (50.0) | 40 (62.5) | 47 (77.0) |