INTRODUCTION & OBJECTIVES: ASSURE-CSU study (ASSessment of The Economic and Humanistic Burden of Chronic Spontaneous/Idiopathic Urticaria Patients) is the first international study to quantify the humanistic and economic burden of illness of patients with chronic spontaneous urticaria (CSU) also known as chronic idiopathic urticaria (CIU). Herein, we report, for the first time, the pooled results describing the profile of CSU patients with inadequate control from treatment.
MATERIAL & METHODS: This observational, non-interventional, multinational, and multicentre study was conducted in 7 countries (Canada, France, Germany, Italy, Netherlands, Spain and United Kingdom). Patients with CSU, aged ≥ 18 years, with disease persisting for ≥ 12 months, symptomatic despite current treatment were recruited. The study involved a retrospective medical chart review, a cross-sectional patient survey, and a 7-day patient diary to evaluate outcomes. Demographics, treatments and clinical characteristics of CSU patients were extracted from the medical charts, including age, sex, ethnicity, disease duration, severity, diagnosis, angioedema and diagnostic tests. After recruitment, patients completed the Urticaria Activity Scores over 7 days (UAS7). All study measures were summarised using mean values and standard deviations (SD) for continuous variables and counts and proportions for categorical variables.
RESULTS: A total of 64 sites recruited 673 eligible patients for which chart data were extracted and among them 614 (91.2%) returned the UAS7. The mean (SD) age of patients at enrolment was 48.8 (15.47) years, at symptom onset was 42.3 (16.54) years and at the time of diagnosis 44.2 (15.92) years. Mean (SD) disease duration between symptom onset and diagnosis was 24.0 (63.36) months and 57.7 (77.79) months from diagnosis to enrolment. The majority of enrolled patients were female (72.7%) and White/Caucasian (90.4%). Diagnostic testing to exclude trigger factors was performed in 75.1% of patients. Autologous serum skin test was performed in 97 (14.4%) patients, of which 42 (43.3%) patients showed positive results. At diagnosis, 75 (11.2%), 211 (31.4%) and 245 (36.5%) of patients were assessed by their treating physician as having mild, moderate and severe disease, respectively (for 21% data were not available). The most used severity criteria were number of flares, medication requirements and impact on quality of life. More than half of the patients (58.5%) experienced angioedema with a mean (SD) of 19.0 (42.13) episodes/patient over 12 months. The mean (SD) UAS7 score was 17.3 (10.49) and 49.4% of patients had a score ≥ 16 reflecting moderate to severe disease.
CONCLUSIONS: Patients recruited in this first real-world international study had a diagnosed disease duration of almost 5 years on average but had experienced symptoms for 2 years before diagnosis. More than half of them were assessed at diagnosis as moderate to severe; angioedema was present in 58.5%. Moderate-severe symptoms were reported by half of the patients with UAS7 data despite current treatment. These first pooled results suggest that there is still unmet need for optimised disease diagnosis and management.
