The burden of chronic spontaneous urticaria is substantial: Real‐world evidence from ASSURE ‐ CSU
Open accessAbstract
BACKGROUND: Chronic spontaneous urticaria (CSU) can be debilitating, difficult to treat, and frustrating for patients and physicians. Real-world evidence for the burden of CSU is limited. The objective of this study was to document disease duration, treatment history, and disease activity, as well as impact on health-related quality of life (HRQoL) and work among patients with inadequately controlled CSU, and to describe its humanistic, societal, and economic burden. METHODS: This international observational study assessed a cohort of 673 adult patients with CSU whose symptoms persisted for ≥12 months despite treatment. Demographics, disease characteristics, and healthcare resource use in the previous 12 months were collected from medical records. Patient-reported data on urticaria and angioedema symptoms, HRQoL, and work productivity and activity impairment were collected from a survey and a diary. RESULTS: Almost 50% of patients had moderate-to-severe disease activity as reported by Urticaria Activity Score. Mean (SD) Dermatology Life Quality Index and Chronic Urticaria Quality of Life Questionnaire scores were 9.1 (6.62) and 33.6 (20.99), respectively. Chronic spontaneous urticaria markedly interfered with sleep and daily activities. Angioedema in the previous 12 months was reported by 66% of enrolled patients and significantly affected HRQoL. More than 20% of patients reported ≥1 hour per week of missed work; productivity impairment was 27%. These effects increased with increasing disease activity. Significant healthcare resources and costs were incurred to treat CSU. CONCLUSIONS: Chronic spontaneous urticaria has considerable humanistic and economic impacts. Patients with greater disease activity and with angioedema experience greater HRQoL impairments.
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Achieving timely diagnosis and optimal symptom control remains challenging due to the unpredictable nature of chronic urticaria.
“Despite the existence of specialized UCARE centers and various participation opportunities in the diagnostic and therapeutic process, achieving a timely diagnosis and optimal symptom control remains challenging due to the unpredictable nature of CU, which significantly burdens the affected individuals [7].”
From Acceptance and perceived usefulness of digital health services in the management of chronic urticaria: a survey of patients and physicians (2025) · cites this paper as [7]
The Discussion reports substantial delays from symptom onset to diagnosis and persistent moderate-to-severe symptoms; the Conclusions also describe CSU as challenging to treat adequately. The Introduction says CSU has no identifiable specific triggers, but the paper does not establish that its unpredictable nature causes the diagnostic delays or difficulty controlling symptoms. The findings concern chronic spontaneous urticaria specifically, rather than all chronic urticaria. (LLM, conf=0.86)
Experimental — accuracy not yet measuredUrticaria can lead to sleep problems, difficulties in everyday activities, and a strong increase in anxiety and stress.
“Urticaria can lead to sleep problems, difficulties in everyday activities, and a strong increase in anxiety and stress [6–8].”
From Acceptance and perceived usefulness of digital health services in the management of chronic urticaria: a survey of patients and physicians (2025) · cites this paper as [7]
The Results section ('CSU has a major impact on HRQoL, sleep, and daily life'; page not provided) reports interference with sleep and daily activities, and says 47.4% of patients reported moderate or extreme anxiety/depression problems. It does not establish a strong increase in anxiety or measure stress, so that part of the claim is not supported. (LLM, conf=0.87)
Experimental — accuracy not yet measuredOther studies have reported a pattern of undertreatment and that guidelines are not properly followed.
“Other studies have reported that there is a pattern of undertreatment and that guidelines are not properly followed [3, 7, 14, 15].”
From Acceptance and perceived usefulness of digital health services in the management of chronic urticaria: a survey of patients and physicians (2025) · cites this paper as [7]
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“…the existence of specialized UCARE centers and various participation opportunities in the diagnostic and therapeutic process, achieving a timely diagnosis and optimal symptom control remains challenging due to the unpredictable nature of CU, which significantly burdens the affected individuals [7].”
- Authors
- Maurer, M., Abuzakouk, M., Bérard, F., Canonica, W., Oude Elberink, H., Giménez‐Arnau, A., Grattan, C., Hollis, K., Knulst, A., Lacour, J. ‐., Lynde, C., Marsland, A., McBride, D., Nakonechna, A., Ortiz de Frutos, J., Proctor, C., Sussman, G., Sweeney, C., Tian, H., Weller, K., Wolin, D., & Balp, M. ‐.
- Affiliations
- Charité – Universitätsmedizin Berlin (DE)
- Cleveland Clinic Abu Dhabi (AE)
- Lyon 1 Université (FR)
- IRCCS‐Humanitas Research Hospital Humanitas University Rozzano‐Milano Italy
- University of Groningen Groningen The Netherlands
- Universitat Autònoma de Barcelona (ES)
- Guy's Hospital (GB)
- RTI Health Solutions (US)
- University Medical Center Utrecht (NL)
- Université Nice Sophia Antipolis (FR)
- Lynde Centre for Dermatology (CA)
- University of Manchester (GB)
- Royal Liverpool and Broadgreen University Hospital NHS Trust (GB)
- Hospital 12 Octubre Madrid Spain
- University of Toronto (CA)
- Novartis (United States) (US)
- Novartis (Switzerland) (CH)
- Corresponding author
- Maurer, M.
- ORCID
- Venue
- Allergy
- Publisher
- Wiley
- Published
- 2017-07-10
- Volume
- 72
- Issue
- 12
- Pages
- 2005-2016
- ISSN
- 0105-4538 (ISSN-L)
- 1398-9995
- PMC
- PMC5724512
- OpenAlex
- W2619731065
- Cited by
- 383
- References
- 0
- Citations by year
- 2026: 63 · 2025: 63 · 2024: 47 · 2023: 38 · 2022: 46 · 2021: 50 · 2020: 27 · 2019: 27 · 2018: 19 · 2017: 3
- FWCI
- 18.17
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Allergy (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by-nc)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Research Explorer (The University of Manchester) (submittedVersion, cc-by-nc)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc)
- Repositori digital de la UPF (Universitat Pompeu Fabra) (submittedVersion, cc-by-nc)
- Funders
- Novartis Pharma AG
- Topics
- Health Sciences › Medicine › Rheumatology › Urticaria and Related Conditions
- Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
- Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
- Keywords
- chronic spontaneous urticaria, disease burden, health-related quality of life, labor productivity, angioedema, disease activity, health care utilization, health care costs, missed work, sleep disorders, treatment history
- MeSH terms
- Activities of Daily Living, Adult, Aged, Aged, 80 and over, Chronic Disease, Cross-Sectional Studies, Female, Health Surveys, Humans, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Sleep, Urticaria, Health Care Costs, Cost of Illness, Guideline Adherence, Young Adult
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