Table 1.
Baseline demographic and disease characteristics
| All randomised patients | mFAS* | |||
| Ustekinumab | Placebo | Ustekinumab | Placebo | |
| Patients, n† | 308 | 208 | 173 | 116 |
| Female | 291 (94.5) | 191 (91.8) | 165 (95.4) | 108 (93.1) |
| Age | 42.9±11.4 | 44.5±12.3 | 43.4±11.4 | 45.8±11.3 |
| Race | ||||
| White | 208 (67.5) | 136 (65.4) | 130 (75.1) | 86 (74.1) |
| Black | 24 (7.8) | 18 (8.7) | 14 (8.1) | 10 (8.6) |
| Asian | 57 (18.5) | 46 (22.1) | 22 (12.7) | 20 (17.2) |
| Disease duration (years) | 8.8±8.0 | 9.1±7.6 | 8.8±8.6 | 9.4±7.7 |
| SLEDAI-2K (0–105) | 10.4±3.4 | 10.5±3.7 | 10.5±3.8 | 10.5±3.7 |
| Physician’s global assessment (VAS, 0–3) | 1.8±0.4 | 1.8±0.4 | 1.8±0.5 | 1.8±0.4 |
| BILAG | ||||
| ≥1 BILAG A | 144 (46.8) | 79 (38.0) | 71 (41.0) | 43 (37.1) |
| ≥2 BILAG B | 170 (55.2) | 124 (59.6) | 103 (59.5) | 69 (59.5) |
| Tender joint count | 15.0±11.4 | 13.9±10.4 | 16.6±12.1 | 14.8±11.0 |
| Swollen joint count | 9.1±6.8 | 8.4±6.4 | 9.8±6.9 | 8.7±6.3 |
| Joints with both tenderness and inflammation | 8.7±6.5 | 7.8±6.0 | 9.5±6.8 | 8.2±6.0 |
| CLASI activity score (0–70) | ||||
| Patients, n | 307 | 208 | 172 | 116 |
| Mean±SD | 8.4±6.8 | 7.9±6.4 | 7.6±6.0 | 8.0±5.4 |
| ANA‡ | 282/302 (93.4) | 189/204 (92.6) | 155/167 (92.8) | 105/113 (92.9) |
| Anti-dsDNA (>75 kIU/L)‡ | 113 (36.7) | 77 (37.0) | 59 (34.1) | 36 (31.0) |
| Low complement‡ | ||||
| C3 | 129 (41.9) | 90 (43.3) | 66 (38.2) | 49 (42.2) |
| C4 | 79 (25.6) | 57 (27.4) | 35 (20.2) | 26 (22.4) |
| Patients with lupus nephritis | 52 (16.9) | 48 (23.1) | 31 (17.9) | 23 (19.8) |
| Concomitant medications | ||||
| Oral glucocorticoids | 249 (80.8) | 163 (78.4) | 140 (80.9) | 92 (79.3) |
| Dose (mg/day) | 9.7±4.8 | 9.6±5.5 | 9.3±4.5 | 8.8±4.6 |
| Antimalarials | 223 (72.4) | 155 (74.5) | 122 (70.5) | 86 (74.1) |
Data reported as n (%), n/N (%), or mean ± standard deviation unless otherwise noted.
*The mFAS included patients who either completed their week 52 visit or would have had a week 52 visit at the time of study discontinuation by the sponsor.
†Patients were enrolled at sites located in Argentina (7 sites), Bulgaria (3 sites), Canada (1 site), China (3 sites), Colombia (6 sites), Germany (4 sites), Hungary (3 sites), Japan (18 sites), Lithuania (4 sites), Poland (8 sites), Portugal (1 site), Republic of Korea (3 sites), Russian Federation (7 sites), Serbia (7 sites), Spain (5 sites), South Africa (4 sites), Taiwan (5 sites), Thailand (5 sites), Ukraine (6 sites), USA (40 sites).
‡Analyses of ANA, anti-ds-DNA, C3, and C4 were performed by a central laboratory. The presence of ANA (determined as either positive or negative) was assessed using the Kallestad HEp-2 indirect fluorescent antibody method (Bio-Rad Laboratories). Anti-dsDNA was measured using the QUANTA Lite dsDNA SC ELISA (INOVA diagnostics) with the following reference values: negative defined as <30 IU/mL, borderline defined as 30–75 IU/mL, positive defined as >75 IU/mL. C3 levels were measured using Tina-quant complement C3c V.2 kit (Roche Diagnostics) with a reference range of 0.90–1.80 g/L. C4 levels were measured using the Tina-quant complement C4 V.2 kit (Roche Diagnostic) with a reference range of 0.1–0.4 g/L.
ANA, anti-nuclear antibodies; BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; dsDNA, double-strand DNA; mFAS, modified full analysis set; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; VAS, Visual Analogue Scale.