ASSURE-CSU: a real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria.
- Weller K Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany.
- Maurer M Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany.
- Grattan C Dermatology Centre, Norfolk and Norwich University Hospital, Norwich, UK.
- Nakonechna A Allergy and Immunology Clinic, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK.
- Abuzakouk M Allergy and Immunology Clinic, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK.
- Bérard F Clinical Immunology and Allergology, CH Lyon-Sud, Claude Bernard University Lyon I - Faculty of Medicine, Lyon Sud, Lyon, France.
- Sussman G Gordon Sussman Clinical Research Inc. 202 St Clair Avenue West, Toronto, Canada.
- Giménez-Arnau AM Dermatology Department, Hospital del Mar, Institut Mar d'Investigacions Mèdiques, Universitat Autònoma, Barcelona, Spain.
- Ortiz de Frutos J Hospital Universitario 12 de Octoubre, Dermatology Department, Madrid, Spain.
- Knulst A Department of Dermatology and Allergy, UMC, Utrecht, The Netherlands.
- Canonica GW University of Genoa, San Martino-IST, Genoa, Italy.
- Hollis K RTI Health Solutions, Raleigh, NC USA.
- McBride D RTI Health Solutions, Manchester, UK.
- Balp MM Novartis Pharma AG, Basel, Switzerland.
- 2015-08-19
Published in:
- Clinical and translational allergy. - 2015
Absenteeism
Angioedema
Chronic idiopathic urticaria
Chronic spontaneous urticaria
Disease burden
Economic cost
Humanistic burden
Observational
Presenteeism
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s13601-015-0072-9
- PMID 26284152
- Persistent URL
- https://sonar.ch/global/documents/145849
Statistics
Document views: 41
File downloads:
- Full-text: 0