Table 1.
Patient baseline demographics and disease characteristics
| All randomized (N = 380) | Placebo q2w + TCS (N = 127) | Tralokinumab q2w + TCS (N = 253) | |
|---|---|---|---|
| Mean age, years | 39.1 | 37.7 | 39.8 |
| Male, n (%) | 209 (55.0) | 84 (66.1) | 125 (49.4) |
| Race, n (%) | |||
| White | 288 (75.8) | 85 (66.9) | 203 (80.2) |
| Black or African American | 35 (9.2) | 12 (9.4) | 23 (9.1) |
| Asian | 41 (10.8) | 24 (18.9) | 17 (6.7) |
| Native Hawaiian or other Pacific Islander | 2 (0.5) | 1 (0.8) | 1 (0.4) |
| Other | 14 (3.7) | 5 (3.9) | 9 (3.6) |
| Mean duration of atopic dermatitis, years (SD) | n = 379; 28.2 (16.0) | n = 126; 28.7 (15.0) | n = 253; 28.0 (16.5) |
| Mean BSA involvement, % (SD) | 48.1 (24.2) | 49.0 (25.9) | 47.6 (23.3) |
| IGA, n (%) | |||
| Moderate (IGA 3) | 202 (53.2) | 66 (52.0) | 136 (53.8) |
| Severe (IGA 4) | 176 (46.3) | 60 (47.2) | 116 (45.8) |
| Missinga | 2 (0.5) | 1 (0.8) | 1 (0.4) |
| Mean EASI score (SD) | n = 378; 29.4 (12.3) | n = 126; 30.4 (12.8) | n = 252; 28.8 (12.0) |
| Mean DLQI score (SD) | n = 375; 17.5 (7.1) | n = 125; 17.2 (7.2) | n = 250; 17.6 (7.1) |
| Mean weekly average of worst daily pruritus NRS score (SD) | n = 377; 7.7 (1.5) | n = 126; 7.9 (1.5) | n = 251; 7.7 (1.5) |
| Mean weekly average of eczema-related sleep NRS (SD) | n = 377; 7.0 (2.1) | n = 126; 7.1 (2.2) | n = 251; 6.9 (2.1) |
BSA body surface area involvement, DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, IGA Investigator’s Global Assessment, NRS numeric rating scale, q2w every 2 weeks, SD standard deviation, TCS topical corticosteroids
aTwo patients (one in each arm) did not receive a treatment dose and were not included in the full analysis