Publications

Background: Most data on chronic spontaneous urticaria (CSU) originate from highly selected patient populations treated at specialized centres. Little is known about CSUpatient characteristics and the burden of CSU in routine clinical practice. AWARE (AWorld-wide Antihistamine-Refractory chronic urticaria patient Evaluation) is an ongoingglobal study designed to assess chronic urticaria in the real-life setting.

Objective: To describe the baseline characteristics of the first 1539 German AWARE patients with H1-antihistamine-refractory CSU.

Methods: This prospective non-interventional study included patients (18–75 years) with a diagnosis of H1-antihistamine-refractory CSU for>2 months. Baseline demographic and disease characteristics, comorbidities, and pharmacological treatments were recorded. Quality of life (QoL) was assessed using the dermatology life quality index (DLQI), chronicurticaria QoL questionnaire (CU-Q2oL), and angioedema QoL questionnaire (AE-QoL, incases of angioedema). Previous healthcare resource utilization and sick leave data werecollected retrospectively.

Results: Between March and December 2014, 1539 patients were assessed in 256 sites across Germany. The percentage of females, mean age, and mean body mass index were70%, 46.3 years, and 27 kg/m2, respectively. The mean urticaria control test score was7.9, one in two patients had angioedema, and the most frequent comorbidities werechronic inducible urticaria (CIndU; 24%), allergic rhinitis (18.2%), hypertension (18.1%),asthma (12%), and depression (9.5%). Overall, 57.6% of patients were receiving at leastone pharmacological treatment including second-generation H1-antihistamines (46.3%),first-generation H1-antihistamines (9.1%), and corticosteroids (15.8%). The mean DLQI,total CU-Q2oL, and total AE-QoL scores were 8.3, 36.2, and 46.8, respectively. CSUpatients reported frequent use of healthcare resources, including emergency services(29.7%), general practitioners (71.9%), and additional allergists or dermatologists (50.7%).

Conclusions and Clinical Relevance: This study reveals that German H1-antihistamine-refractory CSU patients have high rates of uncontrolled disease, angioedema, and comorbid CIndU, are under treated, have impaired QoL, and rely heavily on healthcare resources.