Table I.
Baseline demographic and clinical characteristics of safety population
| Characteristic | Variable | Part 1 |
Part 2 |
||||
|---|---|---|---|---|---|---|---|
| Telazorlimab |
Placebo (n = 80) | Telazorlimab 600 mg q2w (n = 75) | Placebo (n = 74) | ||||
| 300 mg q2w (n = 76) | 300 mg q4w (n = 78) | 75 mg q4w (n = 77) | |||||
| Baseline demographics | Age (years), mean [SD] | 40.2 [13.1] | 36.6 [14.8] | 38.4 [16.9] | 36.3 [13.1] | 37.9 [13.3] | 36.0 [13.8] |
| Female sex, no. (%) | 32 (42.1) | 44 (56.4) | 41 (53.2) | 44 (55.0) | 37 (49.3) | 47 (63.5) | |
| Body mass index (kg/m2), mean [SD] | 28.7 [7.5] | 27.5 [6.2] | 26.3 [6.2] | 27.2 [6.6] | 26.0 [5.2] | 26.5 [5.4] | |
| Race, no. (%) | |||||||
| White | 58 (76.3) | 59 (75.6) | 65 (84.4) | 58 (72.5) | 66 (88.0) | 69 (93.2) | |
| Black or African American | 13 (17.1) | 14 (17.9) | 6 (7.8) | 15 (18.8) | 6 (8.0) | 4 (5.4) | |
| Asian | 5 (6.6) | 4 (5.1) | 4 (5.2) | 7 (8.8) | 2 (2.7) | 1 (1.4) | |
| Mixed | 0 | 1 (1.3) | 2 (2.6) | 0 | 0 | 0 | |
| Other | 0 | 0 | 0 | 0 | 1 (1.3) | 0 | |
| Ethnicity, no. (%) | |||||||
| Hispanic or Latino | 5 (6.6) | 3 (3.8) | 2 (2.6) | 2 (2.5) | 3 (4.0) | 0 | |
| Not Hispanic or Latino | 71 (93.4) | 75 (96.2) | 75 (97.4) | 78 (97.5) | 72 (96.0) | 73 (98.6) | |
| Region, no. (%) | |||||||
| North America | 34 (44.7) | 37 (47.4) | 35 (45.5) | 36 (45.0) | 17 (22.7) | 15 (20.3) | |
| European Union | 42 (55.3) | 41 (52.6) | 42 (54.5) | 44 (55.0) | 58 (77.3) | 59 (79.7) | |
| Baseline clinical characteristics | Time since AD diagnosis (years), mean [SD] | 27.7 [15.8] | 29.7 [15.6] | 25.3 [14.1] | 28.4 [14.4] | 27.6 [16.5] | 27.9 [15.4] |
| EASI, mean [SD] | 30.4 [14.1] | 33.8 [14.9] | 28.4 [11.6] | 30.7 [13.2] | 29.9 [13.2] | 31.8 [14.3] | |
| IGA, no. (%) | |||||||
| 3. Moderate | 49 (64.5) | 48 (61.5) | 49 (63.6) | 52 (65.0) | 48 (64.0) | 47 (63.5) | |
| 4. Severe | 27 (35.5) | 30 (38.5) | 28 (36.4) | 28 (35.0) | 27 (36.0) | 27 (36.5) | |
| Pruritus NRS score, mean [SD] | 7.4 [1.6] | 7.5 [1.7] | 7.5 [1.6] | 7.3 [1.8] | 7.4 [1.5] | 7.4 [1.7] | |
| Body surface area involvement [%], mean [SD] | 46.7 [21.4] | 50.8 [24.2] | 46.7 [21.2] | 48.4 [22.4] | 48.4 [21.0] | 52.9 [24.8] | |
| SCORAD, mean [SD] | 67.5 [14.3] | 69.1 [14.3] | 66.2 [12.4] | 66.1 [12.7] | 66.4 [12.3] | 67.7 [13.6] | |
| GISS, mean [SD] | 9.1 [1.8] | 9.4 [1.7] | 9.1 [1.7] | 8.9 [1.8] | 9.0 [1.7] | 8.9 [1.6] | |
| DLQI, mean [SD] | 15.2 [6.8] | 15.4 [7.1] | 14.3 [7.2] | 14.3 [6.8] | 14.1 [6.0] | 14.7 [6.8] | |
| POEM total score, mean [SD] | 20.2 [5.8] | 20.9 [5.6] | 19.8 [5.3] | 21.2 [5.4] | 20.7 [4.6] | 21.1 [4.8] | |
| HADS, mean [SD] | |||||||
| Anxiety | 6.1 [4.5] | 6.1 [4.8] | 6.1 [4.2] | 6.2 [3.7] | 6.0 [4.4] | 6.7 [4.1] | |
| Depression | 4.3 [3.9] | 4.8 [4.4] | 4.9 [4.2] | 4.2 [3.2] | 4.7 [3.8] | 5.0 [4.3] | |
q2w, Every 2 weeks; q4w, every 4 weeks.