Chronic urticaria in the real‐life clinical practice setting in Sweden, Norway and Denmark: baseline results from the non‐interventional multicentre AWARE study

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 ‐Q 2 oL; 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/m 2 , 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. Conclusion 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.