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


CONCLUSIONS
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.
Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany.
Karsten
K
Weller
Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany.
Marcus
M
Maurer
Dermatology Centre, Norfolk and Norwich University Hospital, Norwich, UK.
Clive
C
Grattan
Allergy and Immunology Clinic, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK.
Alla
A
Nakonechna
Allergy and Immunology Clinic, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK.
Mohamed
M
Abuzakouk
Clinical Immunology and Allergology, CH Lyon-Sud, Claude Bernard University Lyon I - Faculty of Medicine, Lyon Sud, Lyon, France.
Frédéric
F
Bérard
Gordon Sussman Clinical Research Inc. 202 St Clair Avenue West, Toronto, Canada.
Gordon
G
Sussman
Dermatology Department, Hospital del Mar, Institut Mar d'Investigacions Mèdiques, Universitat Autònoma, Barcelona, Spain.
Ana M
AM
Giménez-Arnau
Hospital Universitario 12 de Octoubre, Dermatology Department, Madrid, Spain.
Javier
J
Ortiz de Frutos
Department of Dermatology and Allergy, UMC, Utrecht, The Netherlands.
André
A
Knulst
University of Genoa, San Martino-IST, Genoa, Italy.
G Walter
GW
Canonica
RTI Health Solutions, Raleigh, NC USA.
Kelly
K
Hollis
RTI Health Solutions, Manchester, UK.
Doreen
D
McBride
Novartis Pharma AG, Basel, Switzerland.
Maria-Magdalena
MM
Balp
Absenteeism; Angioedema; Chronic idiopathic urticaria; Chronic spontaneous urticaria; Disease burden; Economic cost; Humanistic burden; Observational; Presenteeism