Table 1.
Baseline demographics and disease characteristics
| Non-achievers at week 16 of SOLO 1 and 2 | ||
|---|---|---|
| EASI-75 (n = 364) | IGA 0 or 1 (n = 383) | |
| Age, years, mean ± SD | 39.1 (13.9) | 39.3 (14.1) |
| Male gender, n (%) | 245 (67.3) | 256 (66.8) |
| Race, n (%) | ||
| White | 238 (65.4) | 252 (65.8) |
| Black/African American | 19 (5.2) | 21 (5.5) |
| Asian | 100 (27.5) | 103 (26.9) |
| Other/not reported | 7 (1.9) | 7 (1.8) |
| BMI, kg/m2, mean ± SD | 26.7 (5.7) | 26.7 (5.6) |
| Duration of AD, years, mean ± SD | 29.5 (14.8) | 29.5 (14.9) |
| EASI (range 0–72), mean ± SD | 20.3 (13.3) | 19.8 (13.3) |
| IGA (range 0–4), mean ± SD | 3.1 (0.6) | 3.0 (0.6) |
| Average treatment gap between parent study and OLE, n (%), weeks | ||
| < 6 | 39 (10.7) | 43 (11.2) |
| ≥ 6 and ≤ 13 | 283 (77.7) | 291 (76.0) |
| > 13 | 42 (11.5) | 49 (12.8) |
| Reasons for discontinuation, n (%) | ||
| Commercialization of study drug | 73 (20.1) | 79 (20.6) |
| Patients’ choice | 70 (19.2) | 72 (18.8) |
| Lack of efficacy | 12 (3.3) | 12 (3.1) |
| Adverse event | 18 (4.9) | 20 (5.2) |
| Lost to follow-up | 11 (3.0) | 11 (2.9) |
| Protocol deviation | 5 (1.4) | 5 (1.3) |
| Missing | 37 (10.2) | 39 (10.2) |
AD atopic dermatitis, BMI body mass, EASI Eczema Area and Severity Index, EASI-75 at least 75% improvement from baseline in EASI, IGA Investigator’s Global Assessment, OLE open-label extension, SD standard deviation