ASSURE-CSU: A real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria

Karsten Weller, Marcus Maurer, Clive Grattan, Alla Nakonechna, Mohamed Abuzakouk, Frédéric Bérard, Gordon Sussman, Ana M. Giménez-Arnau, Javier Ortiz De Frutos, André Knulst, G. Walter Canonica, Kelly Hollis, Doreen McBride, Maria Magdalena Balp

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    34 Citations (Scopus)

    Abstract

    © 2015 Weller et al. Background: Chronic spontaneous urticaria (CSU) formerly known as chronic idiopathic urticaria (CIU) is a severe and distressing skin condition that remains uncontrolled in approximately one half of patients, despite the use of licensed, recommended doses of modern, second-generation H1-antihistamines. So far, the humanistic, societal and economic burden of CSU/CIU has not been well quantified. Therefore it is important to broaden our understanding of how CSU/CIU impacts patients, society, and healthcare systems, by determining the disease burden of CSU/CIU and the associated unmet need; as well as to further guide the use of new treatments in an efficient and cost-effective manner. Methods: ASSURE-CSU is an observational, multicenter study being conducted in the UK, Germany, Canada, France, Italy, Spain, and The Netherlands. The study comprises a retrospective medical chart review in conjunction with patient surveys (including validated tools for assessment of disease impact) and an 8-day patient diary. The primary objectives of the study are to describe patient demographics, medical history, treatments, and healthcare resource utilization based on medical-record data and to assess the impact of disease, healthcare resource utilization, work days missed, and productivity loss based on patient-reported data. Approximately 700 patients (aged ≥18 years) will be enrolled who have CSU/CIU despite currently receiving treatment, and have had persistent symptoms for at least 12 months. Data will be collected retrospectively for the 12 months (±1 month) prior to enrolment wherever possible, and prospectively for the week following enrolment. Discussion: ASSURE-CSU will be the first study to examine the economic and humanistic burden of disease in patients diagnosed with CSU/CIU who are symptomatic despite treatment. By combining retrospective evaluation of medical records with prospective patient surveys and 8-day diaries, across seven different countries, the ASSURE-CSU study will contribute to a better understanding and acknowledgement of the burden of disease in patients with symptomatic chronic spontaneous urticaria.
    Original languageEnglish
    Article number5
    JournalClinical and Translational Allergy
    Volume5
    Issue number1
    DOIs
    Publication statusPublished - 17 Aug 2015

    Keywords

    • Absenteeism
    • Angioedema
    • Chronic idiopathic urticaria
    • Chronic spontaneous urticaria
    • Disease burden
    • Economic cost
    • Humanistic burden
    • Observational
    • Presenteeism

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