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 dupilumab 300mg every 2 weeks (q2w) or placebo for 12 weeks (W12); both groups were permitted concomitant topical corticosteroids. The primary efficacy endpoint was sleep quality percentage change from baseline to W12, assessed by 11-point sleep NRS. Secondary endpoints included percent change in peak

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... us NRS, change in SCORing AD (SCORAD), SCORAD sleep visual analog scale (VAS), EASI and the Patient-Reported Outcomes Measurement Information System sleep-impairment SF8a score (PROMIS-T). 127 patients received dupilumab 300mg q2w and 61 placebo. Mean baseline SCORAD was 64.7 vs 62.9, and EASI 26.2 vs 26.0 (dupilumab vs placebo). Sleep NRS significantly improved in dupilumab-treated patients at W12 vs. placebo (LSMD -15.1%; p<0.001). Peak pruritus NRS (LSMD-28.6%, p<0.001), SCORAD (LSM -14.4, p<0.001), SCORAD sleep VAS (LSMD-2.3, p<0.001), and PROMIS-T Score (LSMD-3.6, p¼0.001) improved significantly with dupilumab vs placebo. Treatment-emergent adverse events (TEAE) occurred in 52.8% in the dupilumab group vs 62.3% with placebo. Four TEAEs (dupilumab: 3[2.4%]; placebo: 1[1.6]%) resulted in study discontinuation. Dupilumab significantly improved sleep, itch and total SCORAD in adults with moderate-to-severe AD.