Table 1. Baseline Demographics and Disease Characteristics in the mITT Population.
| Baseline demographics | No. (%) | |
|---|---|---|
| PBO + TCS (N = 66) | LEB + TCS (N = 145) | |
| Age, mean (SD), y | 36.7 (17.9) | 37.5 (19.9) |
| Adolescents (aged 12 to <18 y) | 14 (21.2) | 32 (22.1) |
| Adults (aged ≥18 y) | 52 (78.8) | 113 (77.9) |
| Female | 33 (50.0) | 70 (48.3) |
| Race | ||
| Asian | 13 (19.7) | 18 (12.4) |
| Black/African American | 9 (13.6) | 19 (13.1) |
| White | 40 (60.6) | 90 (62.1) |
| Weight, mean (SD), kg | 79.8 (24.4) | 74.6 (23.3) |
| BMI, mean (SD) | 27.9 (7.5) | 26.5 (7.2) |
| Geographic region | ||
| United States | 48 (72.7) | 103 (71.0) |
| Europe | 10 (15.2) | 28 (19.3) |
| Rest of the world | 8 (12.1) | 14 (9.7) |
| Prior systemic treatment | 34 (51.5) | 66 (45.5) |
| Systemic corticosteroids | 22 (33.3) | 41 (28.3) |
| Phototherapy | 14 (21.2) | 24 (16.6) |
| Dupilumab | 9 (13.6) | 20 (13.8) |
| Cyclosporine | 4 (6.1) | 18 (12.4) |
| Methotrexate | 6 (9.1) | 13 (9.0) |
| Janus kinase inhibitors | 4 (6.1) | 5 (3.4) |
| Photochemotherapy (PUVA) | 2 (3.0) | 3 (2.1) |
| Mycophenolate-mofetil | 0 | 4 (2.8) |
| Tralokinumab | 1 (1.5) | 1 (0.7) |
| Other biologics | 5 (7.6) | 16 (11.0) |
| Duration since AD diagnosis, mean (SD), year | 21.2 (13.9) | 21.0 (17.4) |
| Baseline disease characteristics | ||
| IGA (3) | 48 (72.7) | 98 (67.6) |
| IGA (4) | 18 (27.3) | 47 (32.4) |
| EASI, mean (SD) | 26.4 (10.6) | 27.7 (11.1) |
| Pruritus NRS, mean (SD) | 6.8 (2.0) | 7.3 (1.8) |
| Sleep-loss due to pruritus, mean (SD) | 1.9 (0.9) | 2.1 (0.9) |
| BSA affected, mean (SD) | 38.2 (20.8) | 40.4 (21.9) |
| DLQI, mean (SD) | 13.5 (7.5) | 14.9 (7.2) |
Abbreviations: AD, atopic dermatitis; BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; LEB, lebrikizumab; mITT: modified intent-to-treat; NRS, numeric rating scale; PBO, placebo; PUVA, psoralen + UV-A; TCS, topical corticosteroids.