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

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dc.contributor.author Weller, Karsten
dc.contributor.author Maurer, Marcus
dc.contributor.author Grattan, Clive
dc.contributor.author Nakonechna, Alla
dc.contributor.author Abuzakouk, Mohamed
dc.contributor.author Bérard, Frédéric
dc.contributor.author Sussman, Gordon
dc.contributor.author Giménez Arnau, Anna Maria
dc.contributor.author Ortiz de Frutos, Javier
dc.contributor.author Knulst, André
dc.contributor.author Canonica, G. Walter
dc.contributor.author Hollis, Kelly
dc.contributor.author McBride, Doreen
dc.contributor.author Balp, Maria Magdalena
dc.date.accessioned 2015-10-23T09:03:04Z
dc.date.available 2015-10-23T09:03:04Z
dc.date.issued 2015
dc.identifier.citation Weller K, Maurer M, Grattan C, Nakonechna A, Abuzakouk M, Bérard F. et al. ASSURE-CSU: a real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria. Clin Transl Allergy. 2015 Aug 17;5:29. doi: 10.1186/s13601-015-0072-9.
dc.identifier.issn 2045-7022
dc.identifier.uri http://hdl.handle.net/10230/24891
dc.description.abstract 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.
dc.description.sponsorship This study is sponsored by Novartis Pharma AG, Basel, Switzerland
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartof Clinical and Translational Allergy. 2015 Aug 17;5:29
dc.rights © 2015 Weller et al. Open Access This article is distributed under the terms of the http://creativecommons.org/licenses/by/4.0/, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver/n(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.other Urticària
dc.title ASSURE-CSU: a real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria.
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1186/s13601-015-0072-9
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion


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