Dupilumab monotherapy improves signs, symptoms and quality of life in adult and adolescent patients with erythrodermic atopic dermatitis

Journal of Investigative Dermatology(2020)

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摘要
Erythrodermic atopic dermatitis (E-AD; ≥90% body surface area [BSA] affected and baseline [BL] erythema score ≥1 from Global Individual Signs Score) is often difficult to treat and highly disturbs patient (pt) physical/mental health. We report pooled efficacy data from dupilumab (DPL) monotherapy trials in adult and adolescent pts with E-AD. In 16-week DPL trials, 136 adults and adolescents with E-AD received DPL 300mg weekly (qw; n=38); DPL 200mg (adolescents: BL weight <60kg) or 300mg (adolescents: BL weight ≥60kg; and adults) every 2 weeks (q2w; n=48); or placebo (PBO; n=50). DPL monotherapy significantly improved Eczema Area and Severity Index (EASI) at Week (Wk) 16; LS mean percent changes from BL at Wk16 were −58.5%/−58.3%/−22.3% for qw/q2w/PBO (P=0.004/P=0.003 vs PBO); mean EASI (qw/q2w/PBO) decreased from 58.7/55.0/59.3 at BL to 24.4/24.3/46.4 at Wk16 (P=0.003/P=0.003 vs PBO). DPL also improved mean BSA affected (BL [qw/q2w/PBO]: 94.8%/94.6%/95.5%; Wk16: 51.7%/55.6%/81.9%; P=0.028/P=0.026); global erythema score (BL: 2.7/2.7/2.8; Wk16: 1.8/1.7/2.8; P=0.008/P=0.002) and weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) score (BL: 7.4/7.8/8.0; Wk16: 4.2/4.8/7.4; P=0.0002/P=0.0003). More DPL- vs PBO-treated patients at Wk16 achieved ≥50% improvement in EASI (EASI-50; 44.7%/41.7%/6.0%; P<0.0001); EASI-75 (26.3%/25.0%/4.0%; P=0.002/P=0.011); PP-NRS ≥3-point improvement (43.2%/36.2%/0; P<0.0001) and ≥4-point improvement for adults/≥6-point improvement for adolescents in Dermatology Life Quality Index (48.6%/60.9%/12.0%; P=0.0003/P<0.0001). DPL had an acceptable safety profile in E-AD pts overall. DPL monotherapy significantly improves signs, symptoms and quality of life in E-AD pts.
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关键词
atopic dermatitis,dupilumab monotherapy
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