34297 Dupilumab provides long-term improvement in sleep loss in children, adolescents, and adults with atopic dermatitis

Background: Sleep disturbance impacts quality-of-life and overall health of patients with atopic dermatitis (AD). In adults, adolescents, and children with AD, we evaluated the efficacy of dupilumab treatment up to 1 year (1Y; adults = 52 weeks; adolescents/children = 48 weeks) on sleep, using SCORing AD (SCORAD) sleep loss score (0 [no sleeplessness]–10 [worst imaginable sleeplessness], recall period: 3 days/nights). Methods: Data of patients who continuously received dupilumab in the 16-week parent studies and subsequent extension trials are reported. We included 80 adults with moderate-to-severe AD who optimally responded (achieved Investigator’s Global Assessment score 0/1 or 75% improvement from baseline in EASI) to dupilumab 300 mg every 2 weeks (q2w) in LIBERTY AD SOLO 1/2 (NCT02277743/NCT02277769) and continued dupilumab monotherapy in SOLO-CONTINUE (NCT02395133); 73 adolescents (aged 12-17) with moderate-to-severe AD who received dupilumab 200/300 mg-q2w monotherapy (weight-dependent) in LIBERTY AD ADOL (NCT03054428) and continued with dupilumab 300 mg-q4w in LIBERTY AD PED-OLE (NCT02612454); and 162 children (aged 6-11) with severe AD who received dupilumab+TCS (<30 kg:300 mg-q4w/≥30 kg:300 mg-q4w/≥30 kg:200 mg-q2w) in LIBERTY AD PEDS (NCT03345914) and continued with dupilumab 300 mg-q4w in PED-OLE. Results: Patients in all age groups reported sustained improvement in sleep up to 1Y. Baseline/Wk16/1Y mean SCORAD sleep loss scores for adults and adolescents were 5.2/0.9/1.1 and 5.3/2.0/1.3, respectively. In children (<30 kg-q4w/≥30 kg-q4w/≥30 kg-q2w; q4w in PED-OLE), corresponding scores were 6.7/6.8/5.4 (baseline); 2.1/2.3/1.3 (Wk16); and 1.5/1.8/1.4 (1Y). Dupilumab was generally well tolerated with a favorable safety profile. Conclusion: Dupilumab treatment up to 1Y provided sustained improvement in sleep loss in children with severe AD, and adolescents and adults with moderate-to-severe AD.