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      The burden of chronic spontaneous urticaria is substantial: Real‐world evidence from ASSURE‐CSU

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          Abstract

          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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          Most cited references40

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          The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update.

          This guideline is the result of a systematic literature review using the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE) methodology and a structured consensus conference held on 28 and 29 November 2012, in Berlin. It is a joint initiative of the Dermatology Section of the European Academy of Allergy and Clinical Immunology (EAACI), the EU-funded network of excellence, the Global Allergy and Asthma European Network (GA(2) LEN), the European Dermatology Forum (EDF), and the World Allergy Organization (WAO) with the participation of delegates of 21 national and international societies. Urticaria is a frequent, mast cell-driven disease, presenting with wheals, angioedema, or both. The life-time prevalence for acute urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria do not only cause a decrease in quality of life, but also affect performance at work and school and, as such, are members of the group of severe allergic diseases. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors and pathomechanisms. In addition, it outlines evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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            Translating the science of quality of life into practice: What do dermatology life quality index scores mean?

            This study's aim was to determine the relationship between Dermatology Life Quality Index (DLQI) scores and a Global Question (GQ) concerning patients' views of the overall impairment of their skin-related quality of life (QoL), and to express this relationship by identifying bands of DLQI scores equivalent to each GQ descriptor. A DLQI questionnaire and the GQ were mailed to 3834 adult general dermatology outpatients. There were 1993 (52%) responses: male 841; female 1152. Mean DLQI score = 4.86 (range 0-30, standard deviation (SD) = 5.83). Mean GQ score = 1.22 (range 0-4, SD = 1.20). The mean, mode, and median of the GQ scores for each DLQI score were used to devise several sets of bands of DLQI scores, and kappa coefficients of agreement calculated. The set proposed for adoption is: DLQI scores 0-1 = no effect on patient's life (GQ = 0, n = 754); DLQI scores 2-5 = small effect on patient's life (GQ = 1, n = 611); DLQI scores 6-10 = moderate effect on patient's life (GQ = 2, n = 327); DLQI scores 11-20 = very large effect on patient's life (GQ = 3, n = 242); DLQI scores 21-30 = extremely large effect on patient's life (GQ = 4, n = 59); kappa coefficient 0.489. Banding of the DLQI will aid the clinical interpretation of an individual's DLQI score and allow DLQI scores to inform clinical decisions.
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              EAACI/GA(2)LEN/EDF/WAO guideline: definition, classification and diagnosis of urticaria.

              This guideline, together with its sister guideline on the management of urticaria [Zuberbier T, Asero R, Bindslev-Jensen C, Canonica GW, Church MK, Giménez-Arnau AM et al. EAACI/GA(2)LEN/EDF/WAO Guideline: Management of urticaria. Allergy, 2009; 64:1427-1443] is the result of a consensus reached during a panel discussion at the 3rd International Consensus Meeting on Urticaria, Urticaria 2008, a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the EU-funded network of excellence, the Global Allergy and Asthma European Network (GA(2)LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO). Urticaria is a frequent disease. The life-time prevalence for any subtype of urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria do not only cause a decrease in quality of life, but also affect performance at work and school and, as such, are members of the group of severe allergic diseases. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors, and pathomechanisms. In addition, it outlines evidence-based diagnostic approaches for different subtypes of urticaria. The correct management of urticaria, which is of paramount importance for patients, is very complex and is consequently covered in a separate guideline developed during the same consensus meeting. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS).
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                Author and article information

                Contributors
                marcus.maurer@charite.de
                Journal
                Allergy
                Allergy
                10.1111/(ISSN)1398-9995
                ALL
                Allergy
                John Wiley and Sons Inc. (Hoboken )
                0105-4538
                1398-9995
                10 July 2017
                December 2017
                : 72
                : 12 ( doiID: 10.1111/all.2017.72.issue-12 )
                : 2005-2016
                Affiliations
                [ 1 ] Charité — Universitätsmedizin Berlin Berlin Germany
                [ 2 ] Cleveland Clinic Abu Dhabi Abu Dhabi UAE
                [ 3 ] Claude Bernard University Lyon Lyon France
                [ 4 ] IRCCS‐Humanitas Research Hospital Humanitas University Rozzano‐Milano Italy
                [ 5 ] University of Groningen Groningen The Netherlands
                [ 6 ] Hospital del Mar Universitat Autònoma Barcelona Spain
                [ 7 ] Guy's Hospital London UK
                [ 8 ] RTI Health Solutions Research Triangle Park NC USA
                [ 9 ] University Medical Center Utrecht Utrecht The Netherlands
                [ 10 ] Université Nice Sophia Antipolis Nice France
                [ 11 ] Lynderm Research Toronto ON Canada
                [ 12 ] Salford Royal Hospital University of Manchester Salford UK
                [ 13 ] RTI Health Solutions Manchester UK
                [ 14 ] Royal Liverpool and Broadgreen University Hospitals Liverpool UK
                [ 15 ] Hospital 12 Octubre Madrid Spain
                [ 16 ] University of Toronto Toronto ON Canada
                [ 17 ] Novartis Pharmaceuticals Corporation East Hanover NJ USA
                [ 18 ] Novartis Pharma AG Basel Switzerland
                Author notes
                [*] [* ] Correspondence

                Marcus Maurer, Charité — Universitätsmedizin Berlin, Berlin, Germany.

                Email: marcus.maurer@ 123456charite.de

                Author information
                http://orcid.org/0000-0002-4121-481X
                http://orcid.org/0000-0003-4437-0313
                Article
                ALL13209
                10.1111/all.13209
                5724512
                28543019
                80c4b4a5-a50b-4131-b27f-29496b4189cc
                © 2017 The Authors. Allergy Published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 16 May 2017
                Page count
                Figures: 5, Tables: 1, Pages: 11, Words: 6755
                Funding
                Funded by: Novartis Pharma AG
                Categories
                Original Article
                ORIGINAL ARTICLES
                Skin and Eye Diseases
                Custom metadata
                2.0
                all13209
                December 2017
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.2.8 mode:remove_FC converted:11.12.2017

                Immunology
                angioedema,economic burden,observational study,quality of life,urticaria
                Immunology
                angioedema, economic burden, observational study, quality of life, urticaria

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