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 characterised by the recurrence of itchy hives and/or angioedema for more than six 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.

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.

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