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Italian Journal of Dermatology and Venereology 2021 Apr 21

DOI: 10.23736/S2784-8671.21.06952-2


lingua: Inglese

Dupilumab treatment induced similar improvements in signs, symptoms, and quality of life in adults with moderate-to-severe atopic dermatitis with baseline Eczema Area and Severity Index score < 24 or ≥ 24

Annamaria OFFIDANI 1, Luca STINGENI 2, Iria NERI 3, Filippo CIPRIANI 4, Zhen CHEN 5, Ana B. ROSSI 6, Yufang LU 5, Devis MORETTI 4

1 Dermatology Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, Italy; 2 Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy; 3 Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy; 4 Sanofi S.r.l., Milan, Italy; 5 Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 6 Sanofi Genzyme, Cambridge, MA, USA


BACKGROUND: In multiple phase 3 trials, dupilumab improved signs, symptoms (including pruritus), and quality-of-life (QoL) in adults with moderate-to-severe atopic dermatitis (AD). In Italy, dupilumab received innovation status but is currently only reimbursed by the National Health Service for adults with Eczema Area Severity Index (EASI) scores ≥24. This analysis assesses disease burden and dupilumab efficacy in adults with EASI scores above and below this threshold.
METHODS: This post-hoc analysis included 299 adults pooled from two, randomized, placebocontrolled, phase 3 trials, LIBERTY AD CAFÉ (NCT02755649) and LIBERTY AD CHRONOS (NCT02260986), who received the approved dupilumab regimen (300mg every 2 weeks) or placebo, with concomitant topical corticosteroids. EASI, Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) were assessed in patients with EASI scores ≥20 to <24 and ≥24 at week 16.
RESULTS: At baseline, EASI was weakly correlated with PP-NRS and DLQI (Spearman’s correlation coefficient = 0.22 and 0.29, respectively). At week 16, in both the EASI<24 and EASI≥24 populations, respectively, significantly more patients vs control achieved: ≥50% improvement in EASI (95.5% vs 55.6%; 80.6% vs 33.1%); ≥3-point improvement in PP-NRS (68.4% vs 35.3%; 55.3% vs 17.7%); and ≥4-point improvement in DLQI (83.3% vs 43.8%; 84.2% vs 41.9%); from baseline. Dupilumab was generally well tolerated with an acceptable safety profile.
CONCLUSIONS: Dupilumab treatment improves signs, symptoms, and QoL in moderate-to-severe AD adults with EASI<24, who can present with high disease burden. Opportunity may exist to use additional parameters to define disease severity and access to new therapies.

KEY WORDS: Atopic dermatitis; Dupilumab; Efficacy; EASI; Adults

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