Edratide: demographic characteristics and disease activity scores at baseline by treatment group
| TV4710/201 (PRELUDE) | 0.5 mg Edratide (N=84) | 1.0 mg Edratide (N=87) | 2.5 mg Edratide (N=82) | Placebo (N=87) | All (N=340) |
|---|---|---|---|---|---|
| Sex | |||||
| Female N (%) | 81 (96.4%) | 82 (94.3%) | 77 (93.9%) | 80 (92.0%) | 320 (94.1%) |
| Male N (%) | 3 (3.6%) | 5 (5.7%) | 5 (6.1%) | 7 (8.0%) | 20 (5.9%) |
| Race | |||||
| Asian/Oriental N (%) | 1 (1.2%) | 2 (2.3%) | 1 (1.2%) | 2 (2.3%) | 6 (1.8%) |
| Black or African American N (%) | 7 (8.3%) | 5 (5.7%) | 5 (6.1%) | 8 (9.2%) | 25 (7.4%) |
| Caucasian N (%) | 64 (76.2%) | 73 (83.9%) | 66 (80.5%) | 67 (77.0%) | 270 (79.4%) |
| Hispanic N (%) | 3 (3.6%) | 2 (2.3%) | 4 (4.9%) | 3 (3.4%) | 12 (3.5%) |
| Other N (%) | 9 (10.7%) | 5 (5.7%) | 6 (7.3%) | 7 (8.0%) | 27 (7.9%) |
| Age (years) Mean±SD | 40.2±11.0 | 40.8±1.8 | 39.0±11.5 | 38.8±11.7 | 39.7±11.5 |
| BMI Mean±SD | 27.3±7.2 | 26.2±6.2 | 27.4±6.4 | 25.6±5.9 | 26.6±6.5 |
| SLEDAI score Mean | 8.5 | 8.8 | 9.0 | 8.7 | 8.8 |
| BILAG score Mean | 8.8 | 8.0 | 8.2 | 8.1 | 8.3 |
| Years from SLE diagnosis Mean±SD | 7±6.5 | 8.5±7.8 | 8.1±7.1 | 7±6.9 | 7.6±7.1 |
At baseline, 84 patients in the 0.5 mg dose, 87 in the 1 mg dose, 82 in the 1.5 mg dose and 87 on placebo had either BILAG A or B.
BILAG, British Isles Lupus Assessment Group; PRELUDE, A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus; SLE, systemic lupus erythematosus.