title: Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Dermatology, Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu.
authors.forename: Eric L
authors.initials: EL
authors.lastname: Simpson
authors.affiliation: Department of Dermatology and Allergy, University of Bonn, Bonn, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bieber
authors.affiliation: Sanofi, Bridgewater, New Jersey.
authors.forename: Laurent
authors.initials: L
authors.lastname: Eckert
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Richard
authors.initials: R
authors.lastname: Wu
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Marius
authors.initials: M
authors.lastname: Ardeleanu
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Neil M H
authors.initials: NM
authors.lastname: Graham
authors.affiliation: Sanofi, Bridgewater, New Jersey.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Pirozzi
authors.affiliation: Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
authors.forename: Vera
authors.initials: V
authors.lastname: Mastey
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D002648:Child; D002675:Child, Preschool; D017281:Cost of Illness; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D003875:Drug Eruptions / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C582203:dupilumab
keywords: adults; atopic dermatitis; burden of illness; patient-reported outcomes; pruritus; quality of life