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J Dermatolog Treat. 2019 Jun 9:1-9. doi: 10.1080/09546634.2019.1612836. [Epub ahead of print]

Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2.

Author information

1
a Sheffield Dermatology Research, Department of Infection and Immunity , University of Sheffield Medical School , Beech Hill, Sheffield , UK.
2
b Sanofi , Chilly-Mazarin , France.
3
c Department of Dermatology , Oregon Health & Science University , Portland , OR , USA.
4
d Department of Dermatology, Keck School of Medicine at USC , University of Southern California , Los Angeles , CA , USA.
5
e Department of Dermatology , CHU Hôtel-Dieu , Nantes , France.
6
f Department of Dermatology, Hospital de la Santa Creu i Sant Pau , Universitat Autònoma de Barcelona , Barcelona , Spain.
7
g Department of Medicine, Section of Dermatology and Venereology , University of Verona , Verona , Italy.
8
h University Medical Center Utrecht , Utrecht , The Netherlands.
9
i Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie , Munich , Germany.
10
j Department of Dermatology , Osaka Habikino Medical Center , Habikino City, Osaka , Japan.
11
k Helsinki University Central Hospital , Helsinki , Finland.
12
l Department of Dermatology , Technische Universität Dresden , Dresden , Germany.
13
m Regeneron Pharmaceuticals Inc. , Tarrytown , NY , USA.

Abstract

Background: Atopic dermatitis (AD) profoundly affects quality of life (QoL). Dupilumab significantly improves clinical outcomes, is well tolerated, and approved to treat inadequately controlled moderate-to-severe AD in adults; however, its effect on patient-reported outcomes (PROs) is not fully characterized. Objective: To evaluate the impact of dupilumab on patient-reported AD symptoms and QoL. Methods: Pooled data were analyzed from two identically designed phase 3 studies, LIBERTY AD SOLO 1 (NCT02277743) and SOLO 2 (NCT02277769), assessing the following PROs: Peak Pruritus Numerical Rating Scale (NRS), Pruritus Categorical Scale, SCORing AD (SCORAD), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), five-dimension EuroQoL questionnaire (EQ-5D), and patient-assessed disease status and treatment effectiveness. Results: Dupilumab rapidly improved (vs. placebo) Peak Pruritus NRS scores by day 2 (p < .05), anxiety and depression (HADS), and QoL (DLQI) by week 2, and maintained through week 16 (p < .0001). At week 16, more dupilumab-treated than placebo-treated patients reported improvement in SCORAD itch and sleep, and no pain/discomfort (EQ-5D) (p < .0001). Limitations: Cultural differences of translated PROs. Conclusion: Dupilumab had a significant, positive impact on AD symptoms, including itch, sleep, pain, anxiety and depression, and QoL in adults with moderate-to-severe AD.

KEYWORDS:

Atopic dermatitis; dupilumab; patient-reported outcomes; quality of life

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