Table 3.
Demographics and clinical characteristics of patients across different country groups.
| Asia Pacific N = 143 | Canada/USA N = 151 | Europe#N = 176 | Latin America N = 290 | P-value | |
|---|---|---|---|---|---|
| Patient characteristics | |||||
| Age at baseline (years) | 32.9 ± 9.9 | 41.7 ± 11.6 | 38.1 ± 12.0 | 36.7 ± 10.7 | <0.001 |
| Female sex | 135 (94.4%) | 139 (92.1%) | 167 (94.9%) | 276 (95.2%) | 0.582 |
| Ancestries | |||||
| Asian | 138 (96.5%) | 5 (3.3%) | 1 (0.6%) | 0 | <0.001 |
| Black/African American | 0 | 39 (25.8%) | 1 (0.6%) | 15 (5.2%) | <0.001 |
| Indigenous American* | 1 (0.7%) | 8 (5.3%) | 1 (0.6%) | 200 (69.0%) | <0.001 |
| White/Caucasian | 4 (2.8%) | 99 (65.6%) | 173 (98.3%) | 75 (25.9%) | <0.001 |
| Hispanic ethnicity | 0 | 34 (22.5%) | 0 | 285 (98.3%) | <0.001 |
| Clinical data | |||||
| SLE duration at baseline (years) | 3.6 (0.8–7.4) | 4.9 (1.4–9.6) | 5.0 (1.7–10.3) | 3.2 (1.0–7.3) | 0.004 |
| SLEDAI-2K score | |||||
| Baseline | 11.4 ± 3.6 | 10.3 ± 3.4 | 10.5 ± 3.8 | 10.6 ± 3.5 | 0.016 |
| Week 52 | 3.8 ± 2.3 | 3.5 ± 2.5 | 3.8 ± 3.2 | 3.3 ± 2.4 | 0.074 |
| SDI score | |||||
| Baseline | 0.5 ± 0.9 0.0 (0.0–1.0) | 1.1 ± 1.5 0.0 (1.0–1.0) | 0.7 ± 1.1 0.0 (0.0–1.0) | 0.5 ± 1.0 0.0 (0.0–1.0) | <0.001 |
| Week 52 | 0.6 ± 1.0 0.0 (0.0–1.0) | 1.2 ± 1.6 0.0 (0.0–2.0) | 0.8 ± 1.1 0.0 (0.0–1.0) | 0.5 ± 1.0 0.0 (0.0–1.0) | <0.001 |
| SDI score > 0 | |||||
| Baseline | 47 (32.9%) | 87 (57.6%) | 75 (42.6%) | 84 (29.0%) | <0.001 |
| Week 52 | 49 (34.3%) | 89 (58.9%) | 79 (44.9%) | 90 (31.0%) | <0.001 |
| Serological profile at baseline | |||||
| Anti-dsDNA (+) | 119 (83.2%) | 80 (53.0%) | 122 (69.3%) | 196 (67.6%) | <0.001 |
| Anti-Sm (+) | 53 (37.1%) | 36 (23.8%) | 36 (20.7%); N=174 | 99 (34.1%) | 0.001 |
| Low C3 | 86 (60.1%) | 45 (29.8%) | 71 (40.3%) | 109 (37.6%) | <0.001 |
| Low C4 | 85 (59.4%) | 55 (36.4%) | 104 (59.1%) | 151 (52.1%) | <0.001 |
| Prednisone eq. dose (mg/day) | |||||
| Baseline | 13.1 ± 9.2 | 7.1 ± 8.4 | 12.1 ± 8.0 | 13.1 ± 9.1 | <0.001 |
| Week 52 | 8.4 ± 5.2; N=142 | 5.3 ± 6.2; N=149 | 10.0 ± 7.0; N=174 | 9.9 ± 7.2; N=289 | <0.001 |
| Antimalarial agents at week 52† | 85 (59.4%) | 107 (70.9%) | 84 (47.7%) | 202 (69.7%) | <0.001 |
| Immunosuppressants at week 52 | |||||
| Azathioprine | 22 (15.4%) | 22 (14.6%) | 33 (18.8%) | 72 (24.8%) | 0.027 |
| Methotrexate | 6 (4.2%) | 24 (15.9%) | 13 (7.4%) | 35 (12.1%) | 0.004 |
| Mycophenolic acid | 8 (5.6%) | 23 (15.2%) | 24 (13.6%) | 17 (5.9%) | 0.001 |
| Other immunosuppressants‡ | 3 (2.1%) | 3 (2.0%) | 3 (1.7%) | 6 (2.1%) | 0.993 |
| Trial intervention | |||||
| Placebo | 42 (29.4%) | 45 (29.8%) | 42 (23.9%) | 88 (30.3%) | 0.472 |
| Belimumab 1 mg/kg | 42 (29.4%) | 59 (39.1%) | 57 (32.4%) | 100 (34.5%) | 0.343 |
| Belimumab 10 mg/kg | 59 (41.3%) | 47 (31.1%) | 77 (43.8%) | 102 (35.2%) | 0.069 |
Data are presented as numbers (percentage) or means ± standard deviation. In case of non-normal distributions, medians (interquartile range) are indicated. In case of missing values, the total number of patients with available data is indicated. Statistically significant P-values are in bold.
Alaska Native or American Indian from North, South or Central America.
Hydroxychloroquine, chloroquine, mepacrine, mepacrine hydrochloride or quinine sulphate.
Cyclosporine, oral cyclophosphamide, leflunomide, mizoribine or thalidomide.
Including Israel.
C3, complement component protein 3; C4, complement component protein 4; dsDNA, double stranded DNA; SDI, Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index; SLE, systemic lupus erythematosus; SLEDAI-2K, SLE Disease Activity Index 2000; Sm, Smith.