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Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults - 16/02/16

Doi : 10.1016/j.jaad.2015.10.043 
Eric L. Simpson, MD, MCR a, , Thomas Bieber, MD b, Laurent Eckert, PhD c, Richard Wu, PhD d, Marius Ardeleanu, MD d, Neil M.H. Graham, MD d, Gianluca Pirozzi, MD, PhD c, Vera Mastey, MSc d
a Department of Dermatology, Oregon Health and Science University, Portland, Oregon 
b Department of Dermatology and Allergy, University of Bonn, Bonn, Germany 
c Sanofi, Bridgewater, New Jersey 
d Regeneron Pharmaceuticals, Inc, Tarrytown, New York 

Reprint requests: Eric L. Simpson, MD, MCR, Department of Dermatology (CH16D), Oregon Health and Science University, 3303 SW Bond Ave, Portland, OR 97239-4501.Department of Dermatology (CH16D)Oregon Health and Science University3303 SW Bond AvePortlandOR97239-4501

Abstract

Background

The adult burden of atopic dermatitis (AD) is poorly characterized.

Objective

We sought to characterize AD burden in adults with moderate to severe disease from the patient's perspective.

Methods

Patient-reported outcomes collected at screening in a phase 2b clinical trial of dupilumab included pruritus numeric rating scale, 5-Dimension Pruritus Scale, subjective components of SCORing AD, Patient-Oriented Eczema Measure, Hospital Anxiety and Depression Scale, Dermatology Life Quality Index, and 5-Dimension EuroQol.

Results

Most of the 380 patients had been living with AD for nearly all their lives, whereas approximately 40% were given a diagnosis as adults; 40.3% had asthma and 60.5% had other allergic conditions. Despite 48.2% of patients using systemic therapies in the past year, patients reported problems with itch frequency (85% of patients), duration (41.5% reported itching ≥18 h/d), and severity (6.5 of 10 on numeric rating scale); 55% reported AD-related sleep disturbances 5 d/wk or more. Hospital Anxiety and Depression Scale scores suggesting clinically relevant anxiety or depression were reported by 21.8% of patients. Quality of life was impaired on Dermatology Life Quality Index and 5-dimension EuroQol.

Limitations

This study had limited generalizability; conclusions may not reflect those with mild AD or not participating in a clinical trial.

Conclusions

Adults with moderate to severe AD report multidimensional burden including disease activity, patient-reported symptoms, comorbidities, and quality-of-life impact.

Le texte complet de cet article est disponible en PDF.

Key words : adults, atopic dermatitis, burden of illness, patient-reported outcomes, pruritus, quality of life

Abbreviations used : AD, DLQI, EQ-5D, HADS, HRQoL, IL, POEM, SCORAD, VAS


Plan


 Supported by Sanofi and Regeneron Pharmaceuticals, Inc. Editorial support for the preparation of this manuscript was provided by E. Jay Bienen, PhD, funded by Regeneron Pharmaceuticals, Inc.
 Disclosure: Dr Simpson or his institution received grants/research support from Amgen, Asubio Pharmaceuticals, Celgene, Chugai, Galderma, Genentech, MedImmune, Regeneron Pharmaceuticals, Inc, and Tioga; is a consultant for Galderma, Genentech, MedImmune, and Regeneron Pharmaceuticals, Inc; served on advisory boards for Celgene, Pfizer, and Valeant; and served as a speaker for Anacor and Regeneron Pharmaceuticals, Inc. Dr Bieber is an investigator and consultant for Regeneron Pharmaceuticals, Inc; received honoraria, advisory board, or consulting fees provided by Novartis, Astellas, and Atopix; and received grant support from Astellas, Atopix, and MSD. Drs Eckert and Pirozzi are employees of Sanofi and may hold stock and/or stock options in the company. Drs Wu, Ardeleanu, and Graham and Ms Mastey are employees and shareholders of Regeneron Pharmaceuticals, Inc.


© 2015  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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P. 491-498 - mars 2016 Retour au numéro
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