Table 1.
Baseline demographics and disease characteristics
| Placebo-controlled (to week 16) | All-bari-2-mg-AD | ||
|---|---|---|---|
| Placebo (N = 889) | Baricitinib 2 mg (N = 721) | All-bari-2-mg-AD (N = 1598) | |
| Age (years) | 36.3 (13.7) | 36.7 (13.9) | 36.7 (14.2) |
| Female, n (%) | 365 (41.1) | 282 (39.1) | 662 (41.4) |
| Duration since AD diagnosis (years) | 24.6 (15.0) | 24.8 (14.6) | 24.7 (15.1) |
| BMI (kg/m2) | 25.7 (5.4) | 26.3 (6.0) | 26.1 (5.6) |
| Geographic region, n (%) | |||
| Central/South America and Mexico | 76 (8.5) | 56 (7.8) | 177 (11.1) |
| USA/Canada (including Puerto Rico) | 187 (21.0) | 176 (24.4) | 405 (25.3) |
| Asia (excluding Japan) | 99 (11.1) | 62 (8.6) | 135 (8.4) |
| Japan | 134 (15.1) | 101 (14.0) | 163 (10.2) |
| Europe | 365 (41.1) | 297 (41.2) | 637 (39.9) |
| Rest of world | 28 (3.1) | 29 (4.0) | 81 (5.1) |
| Prior topical therapy, n (%) | |||
| Topical corticosteroids | 783 (88.1) | 632 (87.7) | 1437 (89.9) |
| Topical calcineurin inhibitor | 461/809 (57.0) | 358/625 (57.3) | 749/1495 (50.1) |
| Prior systemic therapy, n (%) | |||
| Cyclosporine | 265/800 (33.1) | 271/628 (43.2) | 450/1551 (29.0) |
| vIGA-AD score of 4a, n (%) | 384/840 (45.7) | 318/684 (46.5) | 615/1314 (46.8) |
| EASIb | 30.7 (12.5) | 30.3 (12.9) | 30.4 (12.8) |
| Percentage body surface area affected | 49.5 (23.0) | 48.7 (23.3) | 48.6 (23.2) |
| Itch NRSc | 6.9 (2.1) | 6.8 (2.2) | 6.9 (2.1) |
Data are mean (SD) unless otherwise indicated
AD atopic dermatitis, BMI body mass index, EASI Eczema Area and Severity Index, N number of patients in the analysis set, n number of patients in the specified category, NRS Numeric Rating Scale, SD standard deviation, vIGA-AD validated Investigator Global Assessment for Atopic Dermatitis
avIGA-AD measures the investigator global assessment of disease severity based on a static 5-point scale from 0 (clear skin) to 4 (severe disease)
bEASI scores range from 0 to 72, with higher scores indicating greater severity
cItch NRS ranges from 0 (no itch) to 10 (worst itch imaginable)