TY - JOUR
T1 - 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
T2 - analysis of pooled data from the randomized trials SOLO 1 and SOLO 2
AU - Cork, Michael J.
AU - Eckert, Laurent
AU - Simpson, Eric L.
AU - Armstrong, April
AU - Barbarot, Sébastien
AU - Puig, Luis
AU - Girolomoni, Giampiero
AU - de Bruin-Weller, Marjolein
AU - Wollenberg, Andreas
AU - Kataoka, Yoko
AU - Remitz, Anita
AU - Beissert, Stefan
AU - Mastey, Vera
AU - Ardeleanu, Marius
AU - Chen, Zhen
AU - Gadkari, Abhijit
AU - Chao, Jingdong
N1 - Funding Information:
Dr. Cork is an investigator and consultant for AbbVie, Astellas Pharma, Boots Pharmaceuticals, Dermavant, Galapagos NV, Galderma, Hyphens Pharma, Johnson & Johnson, Leo Pharma, L’Oréal, Menlo Therapeutics, Inc., Novartis, Oxagen Limited, Pfizer, Procter & Gamble, Regeneron Pharmaceuticals, Inc., Reckitt Benckiser, and Sanofi Genzyme. Dr. Eckert is an employee of and may hold stock and/or stock options in Sanofi. Dr. Simpson has received research funding from AbbVie, Amgen, Celgene, Chugai, Dermira, Galderma, Genentech, Lilly, Menlo Therapeutics, Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme, and has received consultancy honoraria from Anacor, Asubio, Celgene, Galderma, Genentech, Medicis, and Merck. Dr. Armstrong is an employee of The University of Southern California and has received consultancy honoraria from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, and Pfizer; research funding from AbbVie, Eli Lilly and Janssen; and speaker honoraria from AbbVie. Dr. Barbarot is an investigator and consultant with honorarium for Pierre Fabre Laboratories and has received honoraria as a speaker for Bioderma and for participation on advisory boards for Sanofi Genzyme. Dr. Puig has received research funding and consultancy honoraria from Regeneron Pharmaceuticals, Inc. and Sanofi. Dr. Girolomoni has received consultancy honoraria from and/or is an advisory board member for AbbVie, Abiogen, Allmirall, Biogen, Celgene, Eli Lilly, Galderma, Hospira, Leo Pharma, Menlo Therapeutics, Merck, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Inc, Samsung, Sandoz, Sanofi, and Sun Pharma. Dr. de Bruin-Weller is principal investigator, advisory board member, and consultant for Regeneron Pharmaceuticals, Inc., and Sanofi Genzyme; and principal investigator and advisory board member for AbbVie. Dr. Wollenberg has received lecturer and/or consultancy honoraria from Almirall, Anacor, Astellas, Beiersdorf, Bioderma, Celgene, Chugai, Galderma, GSK, Hans Karrer, Leo Pharma, L’Oreal, MEDA, MedImmune, Merck Sharp & Dohme, Novartis, Pierre Fabre, Pfizer, Regeneron Pharmaceuticals, Inc., and Sanofi. Dr. Kataoka has received research funding from Sanofi and lecturer honoraria from Sysmex. Dr. Remitz has served as primary investigator, consultant, and lecturer for AbbVie, Eli Lily, Leo Pharma, Novartis, Roche, and Regeneron-Sanofi. Dr. Beissert has received speaker honoraria from Abbvie, Actelion, Bristol Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Novartis, Pfizer, and La Roche-Posay, and is an advisory board member for Actelion, Amgen, Celgene, Galderma, Janssen-Cilag, Leo Pharma, Lilly, Menlo Therapeutics, Merck Sharp & Dohme, Novartis, and Pfizer. Drs. Mastey, Ardeleanu, Chen, Gadkari, and
Funding Information:
Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Medical writing and editorial assistance was provided by Lola MacRae, PhD, and Vicki Schwartz, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.
Publisher Copyright:
© 2019 The Author(s). Published with license by Taylor & Francis Group, LLC.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/8/17
Y1 - 2020/8/17
N2 - 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.
AB - 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.
KW - Atopic dermatitis
KW - dupilumab
KW - patient-reported outcomes
KW - quality of life
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U2 - 10.1080/09546634.2019.1612836
DO - 10.1080/09546634.2019.1612836
M3 - Article
C2 - 31179791
AN - SCOPUS:85067564682
VL - 31
SP - 606
EP - 614
JO - Journal of Dermatological Treatment
JF - Journal of Dermatological Treatment
SN - 0954-6634
IS - 6
ER -