Dupilumab treatment results in early and sustained improvements in itch in adolescents and adults with moderate to severe atopic dermatitis: Analysis of the randomized phase 3 studies SOLO 1 and SOLO 2, AD ADOL, and CHRONOS

医学 特应性皮炎 杜皮鲁玛 皮肤病科 随机对照试验 外科
作者
Jonathan I. Silverberg,Gil Yosipovitch,Eric L. Simpson,Brian Kim,Jashin J. Wu,Laurent Eckert,Isabelle Guillemin,Zhen Chen,Marius Ardeleanu,Ashish Bansal,Mandeep Kaur,Ana B. Rossi,Neil M.H. Graham,Naimish Patel,Abhijit Gadkari
出处
期刊:Journal of The American Academy of Dermatology [Elsevier BV]
卷期号:82 (6): 1328-1336 被引量:106
标识
DOI:10.1016/j.jaad.2020.02.060
摘要

BackgroundPruritus (itch) is a cardinal symptom in atopic dermatitis (AD).ObjectiveTo evaluate the timing and effect of dupilumab on itch.MethodsAnalysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428).ResultsDupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO −47.5% vs −20.5%; AD-ADOL −47.9% vs −19.0%; CHRONOS −57.3% vs −30.9% (P < .0001 for all).LimitationsShort duration of monotherapy trials (16 weeks).ConclusionAcross 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year. Pruritus (itch) is a cardinal symptom in atopic dermatitis (AD). To evaluate the timing and effect of dupilumab on itch. Analysis of data from 1505 patients with moderate to severe AD included in 4 randomized controlled studies, treated for up to 52 weeks. Adults received dupilumab 300 mg every 2 weeks or placebo monotherapy (SOLO 1: NCT02277743; SOLO 2: NCT02277769), with concomitant topical corticosteroids (CHRONOS: NCT02260986); adolescents (≥12 to <18 y) were treated with dupilumab monotherapy every 2 weeks (200 mg for baseline weight of <60 kg; 300 mg for baseline weight of ≥60 kg) or placebo (AD ADOL: NCT03054428). Dupilumab showed significant rapid improvements from baseline in daily Peak Pruritus Numerical Rating Scale scores versus placebo, by day 2 in adults and day 5 in adolescents. At treatment end, dupilumab vs placebo/control had greater least-squares mean percent change from baseline in the weekly average of Peak Pruritus Numerical Rating Scale scores: SOLO −47.5% vs −20.5%; AD-ADOL −47.9% vs −19.0%; CHRONOS −57.3% vs −30.9% (P < .0001 for all). Short duration of monotherapy trials (16 weeks). Across 4 randomized trials, dupilumab treatment showed rapid and sustained improvements in the magnitude of itch, starting with first dose; responses progressively increased and were sustained through to the end of treatment, up to 1 year.
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