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, Karstenca
  • dc.contributor.author Maurer, Marcusca
  • dc.contributor.author Grattan, Cliveca
  • dc.contributor.author Nakonechna, Allaca
  • dc.contributor.author Abuzakouk, Mohamedca
  • dc.contributor.author Bérard, Frédéricca
  • dc.contributor.author Sussman, Gordonca
  • dc.contributor.author Giménez Arnau, Anna Mariaca
  • dc.contributor.author Ortiz de Frutos, Javierca
  • dc.contributor.author Knulst, Andréca
  • dc.contributor.author Canonica, G. Walterca
  • dc.contributor.author Hollis, Kellyca
  • dc.contributor.author McBride, Doreenca
  • dc.contributor.author Balp, Maria Magdalenaca
  • dc.date.accessioned 2015-10-23T09:03:04Z
  • dc.date.available 2015-10-23T09:03:04Z
  • dc.date.issued 2015
  • 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.ca
  • dc.description.sponsorship This study is sponsored by Novartis Pharma AG, Basel, Switzerland
  • dc.format.mimetype application/pdfca
  • 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.ca
  • dc.identifier.doi http://dx.doi.org/10.1186/s13601-015-0072-9
  • dc.identifier.issn 2045-7022
  • dc.identifier.uri http://hdl.handle.net/10230/24891
  • dc.language.iso engca
  • dc.publisher BioMed Centralca
  • 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.ca
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/ca
  • dc.subject.other Urticàriaca
  • dc.title ASSURE-CSU: a real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria.ca
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersion