298 Sleep improvement with dupilumab in adults with moderate-to-severe atopic dermatitis: Results of the DUPISTAD study

Background: Patients with atopic dermatitis (AD) often report sleep disturbance due to nighttime itching and scratching, leading daytime fatigue impaired quality of life. The DUPISTAD phase 4 randomized double-blinded placebo-controlled study (NCT04033367) evaluated the impact dupilumab treatment on in adults moderate-to-severe AD. Methods: Adult patients an Eczema Area Severity Index (EASI) ≥ 12, Peak Pruritus Numerical Rating Scale (NRS) 3 NRS ≤ 5 were 2:1 300 mg every 2 weeks (q2w) or placebo for 12 (W12); both groups permitted apply concomitant topical corticosteroids as needed. primary endpoint was percentage change from baseline W12 quality, assessed a 0–10 NRS, where 0 "worst possible sleep" 10 "best sleep," which reversed analysis measure disturbance. Results: 127 received q2w, 61 placebo. Mean SCORing Atopic Dermatitis (SCORAD) EASI scores well balanced between groups: SCORAD 64.7 vs 62.8, 26.2 26.0). Sleep significantly improved dupilumab-treated at (least squares mean difference [LSMD] –15.1%; P < 0.001). Further, Visual Analog also (LSMD –2.3, Treatment-emergent adverse events occurred 55.9% group 67.2% Serious 1.6% groups. Conclusion: In this study, adult AD, acceptable safety profile.