Sussman G, Maurer M, Weller K, Nakonechna A, Abouzakouk M, Hollis K, McBride D, Balp MM, Berard F, Gimenez-Arnau AM, Frutos JO, Canonica GW, Knulst AC, Grattan C. Assessment of economic and humanistic burden of refractory chronic spontaneous/idiopathic urticaria: study design of the first observational study, ASSURE-CSU. Poster presented at the American Academy of Dermatology Annual Meeting; March 20, 2015.

Background: Chronic spontaneous/idiopathic urticaria (CSU/CIU) is defined as the spontaneous appearance of itchy hives and/or angioedema that recur for >6 weeks. Chronic urticaria affects many aspects of patient’s health-related quality-of-life (HRQoL) and healthcare resource utilization. Little information is published on the clinical aspects of refractory CIU/CSU including description of angioedema, the disease burden and the impact on healthcare systems.

Objective: To assess the burden of refractory CIU/CSU on patients, healthcare payers and society.

Methods: ASSURE-CSU (ASsessment of the Economic and Humanistic Burden of Chronic Spontaneous/Idiopathic URticaria PatiEnts) assesses the impact of disease on HRQoL, healthcare resource utilization and societal aspects among patients with refractory CSU/CIU. It is a non-interventional, international, multi-center study conducted in UK, Germany, Canada, France, Italy, Spain and the Netherlands. CSU patients aged >=18 years, with disease persisting >=12 months, and symptomatic despite current treatment are assessed. The study includes a retrospective medical chart review that collects data on demographics, disease history, co-morbidities, medical resource utilization, a cross-sectional assessment of patient-reported outcomes (PRO), and an 8-day diary to collect data on disease activity and impact on work productivity. HRQOL data will be analysed and reported per country and pooled across the 7 participating countries and the economic data will be analysed and reported per country.

Results: The results will provide data on patient demographics and clinical aspects of refractory CIU/CSU, treatment patterns, as well as medical resources. The PRO results will come from EuroQoL-5D 3 level version, Dermatology Life Quality Index, Chronic Urticaria QoL Questionnaire, Angioedema QoL Questionnaire, Angioedema Questionnaire and Urticaria Activity Score over 7 days. Results on activity and work productivity impairment will be reported from the Work Productivity & Activity Impairment Questionnaire. The study has been completed in UK, Germany, and Canada; a total of 294 patients were enrolled.

Conclusion: This is the first international study assessing the burden of refractory CIU/CSU on patients, healthcare payers and society. The study will contribute to a better understanding of this condition, its economic and humanistic impact and allow in the future a holistic approach of disease management.

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