Table 1.
Patient baseline demographics and disease characteristics
| Pooled placebo (n=5) | Mezagitamab 45 mg (n=6) |
Mezagitamab 90 mg (n=6) |
Mezagitamab 135 mg (n=5) |
|
| Age, years (SD) | 36.4 (6.6) | 51.0 (22.0) | 46.7 (6.5) | 49.6 (13.5) |
| Sex, female, n (%) | 5 (100) | 6 (100) | 5 (83.3) | 4 (80) |
| Baseline weight, kg, mean (SD) | 87.3 (17.7) | 75.0 (18.4) | 85.6 (28.4) | 64.6 (8.16) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 1 (20) | 2 (33.3) | 0 | 1 (20) |
| Non-Hispanic and Latino | 4 (80) | 4 (66.7) | 6 (100) | 4 (80) |
| Race, n (%)* | ||||
| American Indian | 0 | 0 | 0 | 1 (20) |
| Asian | 0 | 0 | 0 | 1 (20) |
| Black or African American | 2 (40) | 4 (66.7) | 1 (16.7) | 2 (40) |
| White | 3 (60) | 2 (33.3) | 4 (66.7) | 1 (20) |
| Multiracial | 0 | 0 | 1 (16.7) | 0 |
| SLEDAI-2K at baseline, mean (SD) | 8.4 (1.67) | 9.7 (4.27) | 9.7 (3.67) | 8.8 (1.79) |
| CLASI at baseline, mean (SD) | 4.8 (4.76) | 7.2 (5.81) | 5.2 (4.62) | 11.8 (11.37) |
| SLE background treatment | ||||
| Antimalarials, n (%) | 4 (80.0) | 5 (83.3) | 6 (100) | 4 (80.0) |
| Hydroxychloroquine | 3 (60.0) | 3 (50.0) | 4 (66.7) | 3 (60.0) |
| Hydroxychloroquine sulphate | 1 (20.0) | 2 (33.3) | 2 (33.3) | 1 (20.0) |
| Corticosteroids, n (%)(mean dose (mg)) | 3 (60.0) (8.3) |
2 (33.3) (10) |
2 (33.3) (7) |
3 (60.0) (4.7) |
| Prednisone | 3 (60.0) | 2 (33.3) | 1 (16.7) | 3 (60.0) |
| Methylprednisolone | 0 | 0 | 1 (16.7) | 0 |
| Mycophenolate, n (%) | 1 (20.0) | 2 (33) | 1 (16.7) | 3 (60.0) |
| Mycophenolate mofetil | 1 (20.0) | 1 (16.7) | 0 | 2 (40.0) |
| Mycophenolate sodium | 0 | 0 | 1 (16.7) | 0 |
| Mycophenolic acid | 0 | 1 (16.7) | 0 | 1 (20.0) |
| Methotrexate, n (%) | 1 (20.0) | 2 (33.3) | 0 | 0 |
*Subject may have more than one race. Those subjects selecting multiple races are counted only under ‘multiracial’.
CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; SLE, systemic lupus erythematosus; SLEDAI-2K, SLE Disease Activity Index 2000.