Silverberg Jonathan I, Yosipovitch Gil, Simpson Eric L, Kim Brian S, Wu Jashin J, Eckert Laurent, Guillemin Isabelle, Chen Zhen, Ardeleanu Marius, Bansal Ashish, Kaur Mandeep, Rossi Ana B, Graham Neil M H, Patel Naimish, Gadkari Abhijit
Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.
Department of Dermatology and Itch Center, University of Miami Miller School of Medicine, Miami, Florida.
J Am Acad Dermatol. 2020 Jun;82(6):1328-1336. doi: 10.1016/j.jaad.2020.02.060. Epub 2020 Mar 3.
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.
瘙痒是特应性皮炎（AD）的主要症状。
评估度普利尤单抗治疗瘙痒的时机和效果。
对纳入4项随机对照研究的1505例中度至重度AD患者的数据进行分析，治疗时间长达52周。成人每2周接受300mg度普利尤单抗或安慰剂单药治疗（SOLO 1：NCT02277743；SOLO 2：NCT02277769），同时使用外用糖皮质激素（CHRONOS：NCT02260986）；青少年（≥12至<18岁）每2周接受度普利尤单抗单药治疗（基线体重<60kg者200mg；基线体重≥60kg者300mg）或安慰剂治疗（AD ADOL：NCT03054428）。
与安慰剂相比，度普利尤单抗在每日峰值瘙痒数字评定量表评分上自基线起有显著快速改善，成人在第2天，青少年在第5天。在治疗结束时，度普利尤单抗与安慰剂/对照相比，峰值瘙痒数字评定量表评分每周平均值自基线起的最小二乘均值变化百分比更高：SOLO为-47.5%对-20.5%；AD-ADOL为-47.9%对-19.0%；CHRONOS为-57.3%对-30.9%（所有P<0.0001）。
单药治疗试验持续时间短（16周）。
在4项随机试验中，度普利尤单抗治疗从首剂开始即显示出瘙痒程度的快速且持续改善；反应逐渐增强并持续至治疗结束，长达1年。
