Abstract
BackgroundA Worldwide Antihistamine-Refractory Chronic Urticaria (CU) patient Evaluation (AWARE) is a non-interventional, multicenter study including patients from Europe, Central and Latin America, Asia-Pacific, and the Middle East. AWARE describes real-world evidence for CU, including clinical characteristics, treatment patterns and the impact on quality of life. MethodsOver the 2-year study, therapy changes, angioedema occurrence, and patient-reported outcomes (PROs) were recorded over 9 visits, including dermatology life quality index (DLQI) and 7-day urticaria activity score (UAS7). Data were stratified into subgroups: chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), or CSU + CIndU. ResultsOut of 4838 patients analyzed, 9.9% were receiving no treatment for their CU symptoms at baseline, and 20.4% were receiving first-line non-sedating H1-antihistamine at approved doses. The predominant baseline therapy was up-dosed non-sedating H1-antihistamines (25.5%). By Visit 2, omalizumab was the overall most commonly used therapy (29.6%), increasing to 30.1% by the end of the study. Baseline DLQI scores for patients with CSU, CIndU and CSU + CIndU were 8.3, 7.6 and 9.1, respectively; scores decreased over the study for CSU and CSU + CIndU patients, but fluctuated for CIndU patients. Baseline angioedema occurrence was higher in CSU and CSU + CIndU patients, reported in 45.4% and 45.5% of patients, respectively, compared to 17.0% in CIndU patients. By the final visit, angioedema had decreased to 11.9% and 11.2% for CSU and CSU + CIndU, respectively, and 9.6% for CIndU. ConclusionCU patients are undertreated at baseline; after entering the AWARE study, more patients received appropriate treatment. However, over two thirds are not escalated to third-line treatments.
Highlights
Chronic urticaria (CU) is a heterogeneous group of skin diseases characterized by the rapid and recurrent appearance of itchy wheals, angioedema, or both, for longer than 6 weeks.[1]
Out of 4838 total patients, 480 (9.9%) patients were receiving no treatment for their Chronic Urticaria (CU) symptoms at baseline, and only 986 (20.4%) were receiving the recommended first-line non-sedating H1-antihistamine at approved doses
The proportion of patients either on no treatment, first, second or third-line treatments did not differ between baseline (77%) and the end of the study (77.8%; Table 2)
Summary
Chronic urticaria (CU) is a heterogeneous group of skin diseases characterized by the rapid and recurrent appearance of itchy wheals, angioedema, or both, for longer than 6 weeks.[1]. CSU is characterized by the spontaneous occurrence of wheals and/or angioedema, is more common than CIndU, and accounts for approximately two-thirds of CU cases.[2] In CIndU, specific triggers such as cold temperatures induce wheals and angioedema (cold urticaria).[3] Around 20% of patients with CU have a combination of CSU and CIndU (CSU þ CIndU).[4] With a point prevalence of 0.5–1% and a peak incidence in individuals between 20 and 40 years of age,[2] CU is a common disorder that has a profound impact on patients’ quality of life (QoL).[5,6,7]. AWARE describes real-world evidence for CU, including clinical characteristics, treatment patterns and the impact on quality of life
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