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      Differences in chronic spontaneous urticaria between Europe and Central/South America: results of the multi-center real world AWARE study

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          Abstract

          Background

          Global chronic urticaria (CU) disease experience and management is not well documented. This study descriptively compares these aspects among CU patients residing in Europe (EU) and Central and South America (C/SA).

          Methods

          AWARE (A World-wide Antihistamine-Refractory chronic urticaria patient Evaluation) is a global prospective, non-interventional study of CU in the real-world setting. Patients were ≥ 18 years with a diagnosis of H1-antihistamine-refractory CU for > 2 months. Differences between the EU and C/SA regions in demographic and clinical characteristics, quality of life (QoL), work and activity impairment, pharmacological treatment, and healthcare resource use were examined.

          Results

          In total, 4224 patients were included in the analysis (C/SA 492; EU 3732). Rates of untreated patients were greater in the C/SA region (45.1% vs. 31.9%; P < 0.005) and escalation to third-line therapy was rare in both regions. Differences in disease experience emerged, with C/SA patients more commonly experiencing angioedema (C/SA 50.8% vs. EU 46.1%; P = 0.03) or comorbid chronic inducible urticaria (C/SA 30% vs. EU 22%; P < 0.001). Correspondingly, rates of uncontrolled urticaria were higher among C/SA patients (82.8% vs. 77.5%; P = 0.017) and patients in the C/SA region showed significantly greater work and activity impairment (absenteeism: 10.4 ± 19.7 vs. 6.7 ± 19.0, P = 0.004; presenteeism: 30.3 ± 31.9 vs. 24.4 ± 25.8, P = 0.001; work productivity loss: 33.9 ± 33.9 vs. 26.5 ± 27.5, P < 0.001; activity impairment: 37.7 ± 34.7 vs. 32.7 ± 30.1, P = 0.001). However, QoL impairment was greater in the EU region (Dermatology Life Quality Index: C/SA 6.5 ± 5.9 vs. EU 8.3 ± 7.0; P < 0.001). There was a significant difference in use of healthcare resources, including emergency services (39.6% vs. 29.3%; P < 0.001), hospitalization (7.7% vs 21.9%; P < 0.001) general practitioners (31.7% vs 57.3%; P < 0.001), and additional allergists or dermatologists (50.6% vs. 47.3%, P < 0.001), among patients in the C/SA and EU region, respectively. In both regions, patients with a primary diagnosis of CU with angioedema had significantly greater impairment in work and non-work activities and healthcare resource utilization compared to those without angioedema.

          Conclusions

          This study revealed that CU is a heterogeneous condition with differences in healthcare utilization and outcomes between EU and C/SA. However, overall there is a high unmet need of H1-antihistamine-refractory CU patients, which is associated with high use of healthcare resources, and has a large negative effect on QoL and work productivity.

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          Most cited references35

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          The EAACI/GA²LEN/EDF/WAO Guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update

          This evidence- and consensus-based guideline was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. The conference was held on 1 December 2016. It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the EU-founded network of excellence, the Global Allergy and Asthma European Network (GA²LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) with the participation of 48 delegates of 42 national and international societies. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell-driven disease, presenting with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria are disabling, impair quality of life and affect performance at work and school. 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.
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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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                Author and article information

                Contributors
                +49 30 450 518 043 , marcus.maurer@charite.de
                khoughton@rti.org
                anaceliacosta@sapo.pt
                fabianfdabove@gmail.com
                100alergia@gmail.com
                anamariagimenezarnau@gmail.com
                gmguillet@wanadoo.fr
                gnkonstantinou@gmail.com
                mlabrador@vhebron.net
                hilde.lapeere@ugent.be
                meshkova.raisa@yandex.ru
                elide.pastorello@ospedaleniguarda.it
                margarita.velasquez@udea.edu.co
                limataqui@hotmail.com
                chr-vest@post9.tele.dk
                nadine.chapman-rothe@novartis.com
                Journal
                World Allergy Organ J
                World Allergy Organ J
                The World Allergy Organization Journal
                BioMed Central (London )
                1939-4551
                16 November 2018
                16 November 2018
                2018
                : 11
                : 1
                : 32
                Affiliations
                [1 ]ISNI 0000 0001 2218 4662, GRID grid.6363.0, Department of Dermatology and Allergy, , Charité - Universitätsmedizin Berlin, ; Charitéplatz 1, 10117 Berlin, Germany
                [2 ]RTI Health Solutions, Carolina, North, USA
                [3 ]ISNI 0000 0001 2295 9747, GRID grid.411265.5, Serviço de Imunoalergologia, Hospital de Santa Maria, ; Lisbon, Portugal
                [4 ]Center of Medical Specialties Lobos, Buenos Aires, Argentina
                [5 ]CPAlpha Clinical Research Center, São Paulo, Brazil
                [6 ]ISNI 0000 0000 9080 8521, GRID grid.413471.4, Hospital Sírio-Libanês, ; São Paulo, Brazil
                [7 ]GRID grid.7080.f, Hospital del Mar, Parc de Salut Mar, IMIM, , Universitat Autònoma de Barcelona, ; Barcelona, Spain
                [8 ]ISNI 0000 0000 9336 4276, GRID grid.411162.1, Service de Dermato-allergologie, CHU Poitiers, ; Poitiers, France
                [9 ]Department of Allergy and Clinical Immunology, 424 General Military Training Hospital, Thessaloniki, Greece
                [10 ]GRID grid.7080.f, Hospital Vall d’Hebron, VHIR, , Universitat Autònoma de Barcelona, ; Barcelona, Spain
                [11 ]ISNI 0000 0004 0626 3303, GRID grid.410566.0, Department of Dermatology, , Ghent University Hospital, ; Ghent, Belgium
                [12 ]ISNI 0000 0004 0620 2113, GRID grid.446122.7, Allergy and Clinical Immunology, , Smolensk State Medical University, ; Smolensk, Russia
                [13 ]S.C. di Allergologia e Immunologia ASST Grande Ospedale Metropolitano Niguarda Milan, Milan, Italy
                [14 ]ISNI 0000 0000 8882 5269, GRID grid.412881.6, Centro de Investigaciones Dermatológicas, CIDERM, , University of Antioquia, ; Medellín, Colombia
                [15 ]ISNI 0000 0004 0487 2295, GRID grid.412249.8, Pontificia Bolivariana University, ; Medellín, Colombia
                [16 ]ISNI 0000 0004 0512 597X, GRID grid.154185.c, Department of Dermatology and Venereology, , Aarhus University Hospital, ; Aarhus, Denmark
                [17 ]ISNI 0000 0001 1515 9979, GRID grid.419481.1, Novartis Pharma AG, ; Basel, Switzerland
                Article
                216
                10.1186/s40413-018-0216-1
                6238280
                30464782
                28fb04ad-fd10-4cec-8499-7923b5b03add
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( 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 ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 June 2018
                : 9 October 2018
                Funding
                Funded by: Novartis Pharma AG
                Categories
                Original Research
                Custom metadata
                © The Author(s) 2018

                Immunology
                angioedema,chronic spontaneous urticaria,quality of life,urticaria
                Immunology
                angioedema, chronic spontaneous urticaria, quality of life, urticaria

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