Table IV.
Exploratory endpoints at week 16, interim analysis (intent-to-treat population)∗
| Endpoint | Overall |
Adolescents |
||||
|---|---|---|---|---|---|---|
| Placebo (n = 90) | Upadacitinib 15 mg (n = 91) | Upadacitinib 30 mg (n = 91) | Placebo (n = 9) | Upadacitinib 15 mg (n = 10) | Upadacitinib 30 mg (n = 10) | |
| vIGA-AD 0/1 with at least 2 grades of reduction from baseline (NRI), n (%) | 6 (6.7) | 37 (40.7) | 43 (47.3) | 1 (11.1) | 7 (70.0) | 5 (50.0) |
| EASI 90 (NRI), n (%) | 6 (6.7) | 38 (41.8) | 44 (48.4) | 1 (11.1) | 4 (40.0) | 6 (60.0) |
| EASI 75 (NRI), n (%) | 17 (18.9) | 59 (64.8) | 68 (74.7) | 2 (22.2) | 7 (70.0) | 9 (90.0) |
| EASI 50 (NRI), n (%) | 26 (28.9) | 77 (84.6) | 79 (86.8) | 3 (33.3) | 9 (90.0) | 10 (100) |
| Percent reduction in EASI from baseline (MMRM), LSM | −36.9 | −75.4 | −82.3 | −23.9 | −77.3 | −90.9 |
| Worst Pruritus NRS improvement ≥4 from baseline (NRI), n (%)† | 11 (12.2) | 37 (41.1)‡ | 43 (47.3) | 0 | 1 (10.0) | 3 (30.0) |
| Percent reduction in Worst Pruritus NRS from baseline (MMRM), LSM | −28.3 | −47.1 | −53.7 | −34.8 | −46.4 | −47.1 |
EASI 90/75/50, ≥90%/75%/50% reduction in Eczema Area and Severity Index; LSM, least squares mean; MMRM, mixed-effect model repeated measures; NRI, nonresponder imputation; NRS, numeric rating scale; vIGA-AD, validated Investigator Global Assessment for Atopic Dermatitis.
∗
Adults were aged ≥18 years, and adolescents were aged <18 years.
†
Among patients with a baseline Worst Pruritus NRS score of ≥4.
‡
N = 90.