417 Dupilumab Significantly Improves Sleep Disturbance in Adults with Moderate-to-Severe Atopic Dermatitis: Results of the DUPISTAD study

DUPISTAD (NCT04033367) evaluated the impact of dupilumab on sleep. Adults with moderate-to-severe AD (EASI ≥12, Pruritus numerical rating scale (NRS) ≥ 3 and sleep NRS ≥5) were randomized 2:1 to 300mg every 2 weeks (q2w) or placebo for 12 (W12); both groups permitted concomitant topical corticosteroids. The primary efficacy endpoint was quality percentage change from baseline W12, assessed by 11-point NRS. Secondary endpoints included percent in peak pruritus NRS, SCORing (SCORAD), SCORAD visual analog (VAS), EASI Patient-Reported Outcomes Measurement Information System sleep-impairment SF8a score (PROMIS-T). 127 patients received q2w 61 placebo. Mean 64.7 vs 62.9, 26.2 26.0 (dupilumab placebo). Sleep significantly improved dupilumab-treated at W12 vs. (LSMD -15.1%; p<0.001). Peak (LSMD-28.6%, p<0.001), (LSM -14.4, VAS (LSMD-2.3, PROMIS-T Score (LSMD-3.6, p=0.001) Treatment-emergent adverse events (TEAE) occurred 52.8% group 62.3% Four TEAEs (dupilumab: 3[2.4%]; placebo: 1[1.6]%) resulted study discontinuation. Dupilumab sleep, itch total adults AD.