Table 2.
Primary and key secondary outcomes ITT population
Endpoint | n | Responders, % (95% CI) | Adjusted % difference (95% CI) | Nominal P value |
---|---|---|---|---|
EASI 75 at week 16 | ||||
Placebo | 34 | 11.8% (0.9–22.6%) | ||
Risankizumab 150 mg | 69 | 24.6% (14.5–34.8%) | 13.0% (–1.7 to 27.7%) | 0.084 |
Risankizumab 300 mg | 69 | 21.7% (12.0–31.5%) | 10.0% (–4.6 to 24.6%) | 0.179 |
vIGA-AD 0/1 with ≥ 2-point reduction from baseline at week 16 | ||||
Placebo | 34 | 5.9% (0.0–13.8%) | ||
Risankizumab 150 mg | 69 | 14.5% (6.2–22.8%) | 8.7% (–2.5 to 20.0%) | 0.129 |
Risankizumab 300 mg | 69 | 5.8% (0.3–11.3%) | 0.0% (–9.4 to 9.4%) | 0.994 |
WP-NRS with ≥ 4-point reduction from baseline at week 16 | ||||
Placebo | 33 | 0.0 | ||
Risankizumab 150 mg | 66 | 13.6% (5.4–21.9%) | 13.7% (5.4–22.1%) | 0.001 |
Risankizumab 300 mg | 66 | 15.2% (6.5–23.8%) | 15.3% (6.6–24.0%) | < 0.001 |
EASI 75 ≥ 75% reduction from baseline in Eczema Area and Severity Index, ITT intent to treat, vIGA-AD Validated Investigator Global Assessment for Atopic Dermatitis, WP-NRS Worst Pruritus Numeric Rating Scale