Table 1.
Baseline demographics and disease characteristics in the safety population
| Attribute | LEB 250 mg Q2W (N = 206) |
|---|---|
| Baseline demographics | |
| Age (years), mean (SD) | 14.6 (1.8) |
| Female, n (%) | 108 (52.4) |
| Male, n (%) | 98 (47.6) |
| Race, n (%) | |
| White | 138 (67.0) |
| Black or African American | 26 (12.6) |
| Asian | 24 (11.7) |
| Multiple | 11 (5.3) |
| Not reported | 3 (1.5) |
| American Indian or Alaska Native | 2 (1.0) |
| Othera | 2 (1.0) |
| Weight (kg), mean (SD) | 66.3 (20.4) |
| ≥ 40 and < 60 kg, n (%) | 92 (44.7) |
| ≥ 60 to < 100 kg, n (%) | 95 (46.1) |
| ≥ 100 kg, n (%) | 19 (9.2) |
| Body mass index (kg/m2), mean (SD) | 24.3 (6.3) |
| Country, n (%) | |
| US | 111 (53.9) |
| Poland | 63 (30.6) |
| Canada | 20 (9.7) |
| Australia | 12 (5.8) |
| Disease characteristics | |
| Duration since AD onset (years), mean (SD) | 12.4 (3.9) |
| IGA score, n (%) | |
| 3, moderate | 133 (64.6) |
| 4, severe | 73 (35.4) |
| EASI, mean (SD) | 28.5 (11.8) |
| %BSA affected, mean (SD) | 45.4 (22.3) |
| Baseline DLQI, mean (SD) | 12.3 (5.5) |
| Baseline CDLQI, mean (SD) | 10.1 (5.7) |
| Baseline PROMIS Anxiety Score, mean (SD) | 51.5 (11.2) |
| Baseline PROMIS Depression Score, mean (SD) | 49.3 (11.4) |
| AD treatment history at Baseline | |
| None | 5 (2.4) |
| Topical corticosteroids | 200 (97.1) |
| Topical calcineurin inhibitors | 97 (47.1) |
| Systemic treatment | 90 (43.7) |
| Systemic corticosteroids | 64 (31.1) |
| Phototherapy | 27 (13.1) |
| Cyclosporine | 17 (8.3) |
| Janus kinase inhibitors | 12 (5.8) |
| Dupilumab | 9 (4.4) |
| Methotrexate | 4 (1.9) |
| Photochemotherapy (PUVA) | 2 (1.0) |
| Azathioprine | 1 (0.5) |
| Other biologics (eg, cell depleting biologics) | 1 (0.5) |
| Tralokinumab | 1 (0.5) |
| Other non-biologic medication/treatmentb | 40 (19.4) |
Data are presented as n (%) unless otherwise specified
Abbreviations: AD atopic dermatitis, BSA Body Surface Area, CDLQI Children’s Dermatology Life Quality Index, DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, IGA Investigator’s Global Assessment, LEB lebrikizumab, N number of patients in the analysis population, n number of patients in the specified category, PROMIS Patient-Reported Outcomes Measurement Information System, SD standard deviation, Q2W every 2 weeks, US United States
a1 patient reported Native American and 1 reported Mexican
bMajority (50%) of other treatments included anti-histamine drugs