Table 1.
Patient demographics and baseline characteristics (SAF)
| Parameter | Placebo (n = 11) | Bleselumab dose (mg/kg) | ||||
|---|---|---|---|---|---|---|
| 0.1 (n = 20) | 0.3 (n = 10) | 1.0 (n = 10) | 3.0 (n = 9) | Total (n = 49) | ||
| Male, n (%) | 6 (54.5) | 11 (55.0) | 8 (80.0) | 6 (60.0) | 7 (77.8) | 32 (65.3) |
| Race, n (%) | ||||||
| Caucasian | 10 (90.9) | 18 (90.0) | 10 (100.0) | 8 (80.0) | 8 (88.9) | 44 (89.8) |
| Asian | 0 | 1 (5.0) | 0 | 2 (20.0) | 0 | 3 (6.1) |
| Other | 1 (9.1) | 1 (5.0) | 0 | 0 | 1 (11.1) | 2 (4.1) |
| Age, years | ||||||
| Mean ± SD | 40.7 ± 10.9 | 44.4 ± 13.4 | 49.2 ± 16.0 | 49.2 ± 11.8 | 47.8 ± 8.8 | 47.0 ± 12.8 |
| Median | 41.0 | 45.5 | 49.0 | 51.0 | 47.0 | 47.0 |
| Minimum; maximum | 27; 57 | 21; 68 | 25; 70 | 28; 72 | 31; 63 | 21; 72 |
| Weight, kg | ||||||
| Mean ± SD | 95.3 ± 15.3 | 93.9 ± 19.0 | 89.4 ± 22.2 | 93.2 ± 18.3 | 98.8 ± 31.2 | 93.7 ± 21.7 |
| Median | 100 | 94.5 | 82.5 | 86.7 | 95.4 | 87.8 |
| Minimum; maximum | 68.9; 114 | 69.5; 134 | 69.5; 142 | 68.3; 118 | 62.0; 157 | 62.0; 157 |
| Height, cm | ||||||
| Mean ± SD | 172 ± 7.5 | 172 ± 9.6 | 176 ± 8.9 | 165 ± 7.0 | 173 ± 9.1 | 172 ± 9.3 |
| Median | 171 | 174 | 176 | 166 | 175 | 172 |
| Minimum; maximum | 162; 186 | 152; 186 | 165; 190 | 153; 173 | 160; 188 | 152; 190 |
| BMI, kg/m2 | ||||||
| Mean ± SD | 32.3 ± 5.7 | 31.5 ± 4.9 | 28.7 ± 4.7 | 34.4 ± 8.0 | 32.6 ± 7.6 | 31.7 ± 6.2 |
| Median | 33.0 | 32.2 | 27.6 | 33.5 | 29.1 | 29.9 |
| Minimum; maximum | 24.7; 40.5 | 22.2; 39.5 | 23.4; 39.3 | 23.2; 44.8 | 22.9; 44.5 | 22.2; 44.8 |
| PASI score | ||||||
| Classic | ||||||
| Mean ± SD | 15.6 ± 7.0 | 17.5 ± 7.4 | 12.0 ± 3.6 | 11.2 ± 3.3 | 14.0 ± 13.9 | 14.4 ± 8.1 |
| Median | 15.5 | 16.2 | 12.5 | 11.4 | 7.8 | 12.2 |
| Minimum; maximum | 7; 34 | 8; 43 | 7; 18 | 6; 17 | 5; 47 | 5; 47 |
| Linear | ||||||
| Mean ± SD | 10.4 ± 7.8 | 10.5 ± 7.7 | 6.4 ± 2.9 | 4.1 ± 1.6 | 9.1 ± 13.0 | 8.1 ± 7.7 |
| Median | 7.7 | 9.2 | 5.8 | 4.2 | 4.3 | 5.5 |
| Minimum; maximum | 3; 31 | 4; 37 | 3; 12 | 2; 6 | 2; 42 | 2; 42 |
| PSGA score | ||||||
| Mean ± SD | 2.5 ± 0.5 | 3.1 ± 0.7 | 2.6 ± 0.7 | 2.6 ± 0.7 | 2.8 ± 0.7 | 2.8 ± 0.7 |
| Median | 3.0 | 3.0 | 2.5 | 2.5 | 3.0 | 3.0 |
| Minimum; maximum | 2; 3 | 2; 4 | 2; 4 | 2; 4 | 2; 4 | 2; 4 |
| BSA, % | ||||||
| Mean ± SD | 26.2 ± 21.9 | 21.4 ± 12.0 | 15.5 ± 6.3 | 9.9 ± 3.8 | 17.4 ± 19.3 | 17.1 ± 12.2 |
| Median | 20.0 | 18.3 | 12.5 | 9.3 | 10.7 | 12.5 |
| Minimum; maximum | 9; 86 | 10; 58 | 10; 26 | 5; 17 | 6; 67 | 5; 67 |
BMI, body mass index; BSA, body surface area; PASI, Psoriasis Area and Severity Index; PSGA, Physician Static Global Assessment; SAF, safety‐analysis set; SD, standard deviation.