title: Chronic urticaria in the real-life clinical practice setting in Sweden, Norway and Denmark: baseline results from the non-interventional multicentre AWARE study.
abstract: BACKGROUND
  Chronic urticaria (CU) is characterized by the recurrence of itchy hives and/or angioedema for more than 6 weeks. AWARE (A World-wide Antihistamine-Refractory Chronic Urticaria Patient Evaluation) is a multinational study designed to document the real-life treatment situation, burden of disease and clinical resource usage of H1-antihistamine-refractory CU patients.
  
  
  OBJECTIVE
  To examine baseline data from Scandinavian AWARE patients.
  
  
  METHODS
  AWARE is a prospective, non-interventional, multinational, umbrella design study, which includes adults (≥18 years) with a confirmed CU diagnosis (>2 months) that is refractory to H1-antihistamines. Baseline patient characteristics, disease activity (urticaria control test [UCT]), pharmacological treatment, comorbidities and healthcare usage were documented by the treating physician. Quality of life (QoL; dermatology life quality index [DLQI]; chronic urticaria quality of life questionnaire [CU-Q2oL; Danish patients only]) and work productivity and activity impairment (WPAI) scores were also assessed.
  
  
  RESULTS
  Overall, 158 CU patients from seven centres in Denmark (n = 80), Norway (n = 50) and Sweden (n = 28) were included in this baseline analysis. Mean age and BMI were 40.3 years and 26.5 kg/m2, respectively. The majority of patients were female (69.6%), had uncontrolled CU (75.6%; UCT score <12) and had a 'spontaneous' component to their CU (61.4% CSU; 20.3% both CSU and chronic inducible urticaria). Common comorbidities included asthma (19.6%), allergic rhinitis (16.5%) and food allergies (8.2%). Overall, 60.1% of patients reported using treatments for CU including non-sedative H1-antihistamines (40.5%), corticosteroids (19%), montelukast (14.6%) and omalizumab (8.2%). Pharmacological treatment rates increased to 96.2% during the baseline visit. On average, patient QoL was moderately affected (mean DLQI score 7.7) and healthcare resource usage was high.
  
  
  CONCLUSIONS
  Adult Scandinavian H1-antihistamine-refractory CU patients reported high rates of healthcare usage and QoL impairment. Rates of pharmacological treatment use were low before study enrolment but increased to almost 100% during the baseline visit.
authors.affiliation: Department of Dermatology, Bispebjerg Hospital & Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: S F
authors.initials: SF
authors.lastname: Thomsen
authors.affiliation: Departement of Dermatology, Stavanger University Hospital, Stavanger, Norway.
authors.forename: E C
authors.initials: EC
authors.lastname: Pritzier
authors.affiliation: Divison of dermatology, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
authors.forename: C D
authors.initials: CD
authors.lastname: Anderson
authors.affiliation: Novartis Norge AS, Oslo, Norway.
authors.forename: N
authors.initials: N
authors.lastname: Vaugelade-Baust
authors.affiliation: Novartis Pharmaceutical A/S, Copenhagen, Denmark.
authors.forename: R
authors.initials: R
authors.lastname: Dodge
authors.affiliation: Novartis Sweden AB, Stockholm, Sweden.
authors.forename: A-K
authors.initials: AK
authors.lastname: Dahlborn
authors.affiliation: Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Vestergaard
mesh_terms: D000293:Adolescent; D000328:Adult; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012537:Scandinavian and Nordic Countries / Q000453:epidemiology; D014581:Urticaria / Q000453:epidemiology / Q000503:physiopathology*