Global, regional, and national levels and trends in burden of urticaria: A systematic analysis for the Global Burden of Disease study 2019.

Background: Urticaria places a significant burden on individuals and society due to its widespread nature. The aim of this study was to evaluate the burden of urticaria in different regions and nations by analysing data from the Global Burden of Disease study 2019 (GBD 2019), with the goal of providing information to health care policymakers. Methods: By utilising data from the GBD 2019 database, this study analysed metrics such as incidence, prevalence, disability-adjusted life years (DALYs), age-standardised rate (ASR), and estimated annual percentage changes (EAPC) globally and across 204 countries and regions. The data was further stratified by age, sex, and sociodemographic index (SDI). Results: In 2019, global incidence cases, prevalence cases, and overall disease burden as measured by DALYs all increased. The distribution of the burden exhibited marked geographical heterogeneity. At the regional level, the burden is highest in Central and Eastern Europe and Central Asia, with the strongest growth in South Asia, compared with a decline in the high-income Asia Pacific. At the country level, Nepal reports the highest burden of urticaria, while Portugal has the lowest. Gender and age analyses showed that the burden of urticaria is higher in females than in males, with urticaria cases declining with age, especially in children, and picking up among the elderly. The study also finds a correlation between the burden of urticaria and the SDI, with the central part of the SDI showing a consistent increasing trend. Conclusion: This study found that the global burden of urticaria has risen from 1990 to 2019. Factors like geographic location, gender, and SDI influenced the urticaria burden. Overall, these results offer a resource to guide public health strategies seeking to reduce the burden of urticaria.

A Specialized Therapeutic Approach to Chronic Urticaria Refractory to H1-Antihistamines Improves Disease Burden: The Spanish AWARE Experience.

OBJECTIVE: During its first year, the AWARE study assessed disease activity, patient quality of life (QOL), and treatment patterns in chronic urticaria (CU) refractory to H1-antihistamines (H1-AH) in clinical practice. METHODS: We performed an observational, prospective (24 months), international, multicenter study. The inclusion criteria were age ≥18 years and H1-AH-refractory CU (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), and QOL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], and Angioedema Quality of Life Questionnaire [AE-QoL]). We present data for Spain. RESULTS: The study population comprised 270 evaluable patients (73.3% female, mean [SD] age, 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1 year, first- and second-line treatments became less frequent and third-line treatments became more frequent. At baseline, 47.0% of patients experienced angioedema; at 1 year, this percentage had fallen to 11.8%. The mean (SD) AE-QoL score decreased from 45.2 (28.7) to 24.0 (25.8). The mean (SD) UCT score decreased from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% of patients reported absence of wheals and itch in the previous 7 days at 1 year compared with 8.3% at baseline. The mean (SD) DLQI score decreased from 8.0 (7.4) to 2.8 (4.6). At the 1-year visit, the percentage of patients reporting a high or very high impact on QOL fell from 29.9% to 9.6%. CONCLUSION: H1-AH-refractory CU in Spain is characterized by absence of control of symptoms and a considerable impact on QOL. Continuous follow-up of CU patients and third-line therapies reduce disease burden and improve patients' QOL.

Prevalence, Management, and Anaphylaxis Risk of Cold Urticaria: A Systematic Review and Meta-Analysis.

BACKGROUND: Cold urticaria is a subtype of chronic inducible urticaria (CIndU) associated with significant morbidity and a risk for anaphylaxis. Few studies have assessed the prevalence, management, and prevalence of associated anaphylaxis of cold urticaria. OBJECTIVES: To evaluate the prevalence of cold urticaria among CIndU and chronic urticaria (CU) cases, to assess the management of cold urticaria, and to determine the prevalence of associated anaphylaxis. METHODS: We searched PubMed and EMBASE for studies pertaining to cold urticaria and/or CIndU published in the past 10 years. We conducted meta-analyses to evaluate the prevalence of cold urticaria among CIndU and CU cases, the management of cold urticaria with H1-antihistamines and omalizumab, and the prevalence of associated anaphylaxis. RESULTS: Twenty-two studies were included in the systematic review and 14 in the meta-analysis. The pooled prevalence of cold urticaria among patients with CU and CIndU was 7.62% (95% confidence interval [CI], 3.45% to 15.99%; I2 = 98%) and 26.10% (95% CI, 14.17% to 43.05%; I2 = 97%), respectively. Cold urticaria was managed by H1-antihistamines in 95.67% (95% CI, 92.47% to 97.54%; I2 = 38%) of patients and omalizumab in 5.95% (95% CI , 2.55% to 13.27%; I2 = 83%) of patients. The pooled prevalence of anaphylaxis among patients with cold urticaria was 21.49% (95% CI, 15.79% to 28.54%; I2 = 69%). CONCLUSIONS: Cold urticaria constitutes an appreciable proportion of CIndU and CU cases and is predominantly managed with H1-antihistamines; few patients receive omalizumab. Anaphylaxis is common, and an epinephrine autoinjector prescription may be considered.

[Clinical profile of patients with chronic urticaria in a tertiary care hospital of the social security system in Costa Ricas]. / Perfil clínico de los pacientes con urticaria crónica en un hospital de tercer nivel de atención del sistema de seguridad social de Costa Rica.

OBJECTIVE: To describe the medical and laboratory profile of the patients who have been diagnosed with chronic urticaria in the outpatient clinic of a tertiary care hospital of the social security system in Costa Rica. METHODS: All patients over 13 years of age who had been diagnosed with chronic urticaria between January 1st, 2014, and December 31st, 2018 were included. Variables of medical and laboratory data were statistically analyzed, and the treatment of the patients between their first and last medical consultation was compared. RESULTS: This was about 160 patients who had been diagnosed with chronic urticaria; 129 of them were women, 45.7 % between the ages of 30-49 years; in 17.5 % of them (28 patients), inducible urticaria was associated; 54.8 % (46/84) had positive antithyroperoxidase antibodies; 16.9 % (27 patients) maintained a single dose of second-generation anti-H1 antihistamines in the last consultation; 16.3 % (26 patients) no longer required antihistamine treatment in the last consultation. Cyclosporine was used in 8.8 % (14 patients), and omalizumab was used in 2.5 % (four patients). CONCLUSION: Since this is a real-life study in a geographic region with limited publications on this pathology, we trust that the provided information will contribute to the scientific community in order to improve the quality of life of patients with chronic urticaria through a timely diagnosis and an effective and efficient treatment.

Objetivo: Describir el perfil clínico y de laboratorio de los pacientes diagnosticados con urticaria crónica en la consulta externa de alergología en un hospital de tercer nivel de atención del sistema de seguridad social de Costa Rica. Métodos: Se incluyeron todos los pacientes mayores de 13 años diagnosticados con urticaria crónica entre el 1 de enero de 2014 y el 31 de diciembre de 2018. Se analizaron estadísticamente variables de datos clínicos y de laboratorio y se comparó el tratamiento de los pacientes entre la primera y última consulta. Resultados: Se trató de 160 pacientes con diagnóstico de urticaria crónica: 129 del sexo femenino, 45.7 % con edad entre 30 y 49 años, en 17.5 % (28 pacientes) se asoció urticaria inducible, 54.8 % (46/84) presentó anticuerpo antitiroperoxidasa positivo, 16.9 % (27 pacientes) se mantuvo en la última consulta con una dosis de antihistamínicos anti-H1 de segunda generación; 16.3 % (26 pacientes) ya no requería tratamiento antihistamínico en la última consulta. En 8.8 % de los casos (14 pacientes) se utilizó ciclosporina y en 2.5 % (cuatro pacientes), omalizumab. Conclusión: Al tratase de un estudio de vida real en una región geográfica con limitadas publicaciones sobre esta patología, confiamos que la información provista contribuya a la comunidad científica a mejorar la calidad de vida de los pacientes con urticaria crónica mediante un diagnóstico oportuno y un tratamiento eficaz y efectivo.

Global Epidemiology of Urticaria: Increasing Burden among Children, Females and Low-income Regions.

Urticaria has a high socioeconomic burden worldwide. However, the global epidemiology of urticaria and its geographical and temporal trends are not well studied. Using the Global Burden of Disease dataset, the aim of this study was to analyse the age-standardized prevalence, incidence, years lived with disability, and mean duration of urticaria in 195 countries from 1990 to 2017. In addition, the relationship between socioeconomic development and urticaria was evaluat-ed. The global prevalence of urticaria in 2017 was 86 million people. Females and children aged 1-4 years were more commonly affected than males and adults, respectively: these differences were outside the 95% uncertainty intervals. Regression analyses show-ed that a lower gross domestic product per capita was associated with a higher prevalence and incidence of urticaria (p < 0.001). The global prevalence of urticaria, incidence, and years lived with disability have remained stable from 1990 to 2017.

Prevalence estimates for chronic urticaria in the United States: A sex- and age-adjusted population analysis.

BACKGROUND: Disease burden in chronic urticaria (CU) is poorly understood. OBJECTIVE: To estimate standardized overall and sex-, age-, and race-specific prevalence estimates for CU among adults in the United States. METHODS: A cross-sectional analysis with electronic health records data for a demographically heterogeneous population-based sample of >55 million patients across all 4 census regions. RESULTS: The overall CU prevalence was 0.23%, or 230 CU cases/100,000 adults. The adjusted prevalence in women was 310 (95% confidence interval [CI] 307-312) cases/100,000 adults, more than twice that of men (146 [95% CI 143-148] cases/100,000 adults, P < .001). CU prevalence was highest among patients aged 40-49 years (256 [95% CI 252-261] cases/100,000 adults) and 50-59 years (246 [95% CI 242-251] cases/100,000 adults) compared with all other age groups (P < .0001). Adjusted prevalences for black (292 [95% CI 285-298] cases/100,000 adults) and other (331 [95% CI 323-338] cases/100,000 adults) patients were higher than that for white patients (262 [95% CI 260-264] cases/100,000 adults; P < .001). LIMITATIONS: Use of administrative data has the potential to underestimate burden. CONCLUSION: There are >500,000 people estimated to have CU in the United States, most of whom are women or adults ≥40 years of age.

The Prevalence of Atopic Dermatitis and Chronic Spontaneous Urticaria are Associated with Parental Socioeconomic Status in Adolescents in China.

The association of atopic dermatitis and chronic spontaneous urticaria with socioeconomic status has been little studied. The aim of this study was to investigate the prevalence of skin diseases and their association with socioeconomic status in adolescents in China. A cross-sectional study was conducted at Central South University, Changsha, China. All newly enrolled students underwent dermatological examination and completed a survey. Socioeconomic status was measured in terms of parental education level and income. Two-level logistic regression models were used. A total of 8,226 students consented to participate. On dermatological examination, moderate to severe acne (10.2%) had the highest prevalence, followed by chronic spontaneous urticaria (2.7%), atopic dermatitis (2.5%), and tinea (1.7%). Socioeconomic status was positively associated with the prevalence of chronic spontaneous urticaria (ptrend = 0.001) and atopic dermatitis (ptrend = 0.0094). Tinea was inversely associated with socioeconomic status (ptrend = 0.025). Higher parental socioeconomic status was associated with higher risk of atopic dermatitis and chronic spontaneous urticaria, but lower risk of tinea.

Assessment of atopic dermatitis as a risk factor for chronic spontaneous urticaria in a pediatric population.

Background: Atopic dermatitis (AD) and chronic spontaneous urticaria (CSU) represent two of the most common chronic inflammatory pruritic skin diseases. Any relationship between atopic skin disorders and CSU is controversial, mostly due to the paucity of relevant epidemiologic and pathogenetic data. Objective: To evaluate whether a history of AD in early childhood represents a risk factor for the subsequent occurrence of CSU in a pediatric population. Methods: Retrospective data of new cases of patients who visited the outpatient allergy unit of a tertiary pediatric hospital in Athens, Greece, between June 2014 and August 2016, were analyzed. Diagnoses of CSU and AD were based on diagnostic criteria proposed by the European Academy of Allergy and Clinical Immunology and the Hanifin and Rajka criteria, respectively. The data analyzed included CSU and AD diagnoses and the association with gender and season of birth as well as a personal and family history of allergy-related diseases (e.g., asthma, allergic rhinitis, AD, and food and drug allergies). Results: Records from 2261 children were included in the analysis (1365 boys; mean ± standard deviation [SD] age, 8.7 ± 5.8 years). Fifty-one children (31 boys; mean ± SD age, 9.1 ± 4.6 years) were diagnosed with CSU, whereas AD was reported in 761 children (466 boys; mean ± SD age, 5.2 ± 3.8 years). Multivariate data analysis showed that the children with a history of an early diagnosis of AD were at increased risk for later CSU occurrence (odds ratio 2.923 [95% confidence interval, 1.647-5.189], p < 0.001). No significant associations were observed with respect to other demographic and atopy-associated characteristics of the patients. Conclusion: Results of our study indicated that AD may constitute an important risk factor to the subsequent occurrence of CSU. This notion warrants further study with well-designed prospective cohorts.

Impact of chronic urticaria on quality of life and work in Japan: Results of a real-world study.

Little attention has been given to the burden of chronic urticaria (CU) in Japan compared with other skin diseases, such as atopic dermatitis (AD) and psoriasis. The primary objective of the RELEASE study was to evaluate the real-life quality-of-life impairment in CU patients in Japan. Data were collected from 1443 urticaria, 1668 AD and 435 psoriatic patients; 552 urticaria patients who presented urticaria symptoms for over 6 weeks were defined as CU. The mean Dermatology Life Quality Index (DLQI) total score was 4.8, 6.1 and 4.8 in CU, AD and psoriatic patients, respectively. Disease control of urticaria evaluated by the Urticaria Control Test (UCT) and DLQI exhibited a strong correlation with a Spearman's rank correlation coefficient of -0.7158. CU and AD patients had relatively higher scores in all Work Productivity and Activity Impairment - General Health subscales except for absenteeism. At the time of the survey, approximately 64% of CU patients reported UCT scores of <12 and demonstrated higher work productivity loss and activity impairment versus patients with UCT scores of ≥12. Patients with lower UCT scores also displayed a higher percentage of dissatisfaction with their health state and the treatment they received. Approximately 85% of patients with CU had visited dermatology clinics, and less than 20% had visited hospital, indicating existence of a highly burdened population outside specialized centers. These results highlight the unmet medical needs of CU patients, suggesting the need to increase awareness of CU burden among both physicians and patients and to pursue improved real-life patient care.

Chronic urticaria in a health maintenance organization of Buenos Aires, Argentina - new data that increase global knowledge of this disease.

BACKGROUND: In spite of the frequency of chronic urticaria, there are no epidemiological studies on its prevalence in Argentina. OBJECTIVE: The objective of this study was to define the prevalence and epidemiological characteristics of chronic urticaria patients in Buenos Aires. METHODS: The population studied were the members of the Italian Hospital Medical Care Program, a prepaid health maintenance organization located in the urban areas around the Autonomous City of Buenos Aires, Argentina. All patients with diagnosis of chronic urticaria members of the Italian Hospital Medical Care Program, and with at least 12 months of follow up were included in the study. All medical records obtained between January 1st, 2012 and December 31, 2014 were analyzed. The prevalence ratio for chronic urticaria per 100,000 population with 95% CI for December 31, 2014 was calculated. The prevalence rate for the entire population and then discriminated for adults and pediatric patients (less than 18 years old at diagnosis) was assessed. RESULTS: 158,926 members were analyzed. A total of 463 cases of chronic urticaria were identified on prevalence date (68 in pediatrics, 395 in adults), yielding a crude point prevalence ratio of 0.29% (CI 95% 0.26-0.31%). The observed prevalence of chronic urticaria in the adult population was 0.34 % (95% CI 0.31-0.38%), while in pediatrics it was 0.15 % (95% CI 0.11-0.20%). STUDY LIMITATIONS: the main weakness is that the results were obtained from an HMO and therefore the possibility of selection bias. CONCLUSIONS: chronic urticaria is a global condition. Its prevalence in Buenos Aires is comparable with other countries.

Health care burden and treatment patterns in commercially insured children with chronic idiopathic/spontaneous urticaria: A real-world study in the United States.

BACKGROUND: Chronic idiopathic urticaria (CIU)/spontaneous urticaria (CSU) is defined by the presence of wheals, angioedema, or both for ≥6 weeks, with or without an identifiable trigger. Real-world health care data among children with CIU/CSU remain scarce. OBJECTIVES: To describe treatment patterns, health care resource utilization (HRU), and costs in pediatric patients with CIU/CSU (<12 years old) and to compare these with pediatric patients without CIU/CSU. METHODS: A commercial administrative claims data base (September 2013 to June 2016) was used. The CIU/CSU cohort included pediatric patients with either two or more claims for a diagnosis of urticaria ≥6 weeks apart or one or more claims for a diagnosis of urticaria and one or more claims for a diagnosis of angioedema ≥6 weeks apart (index was defined as the first claim). The control cohort comprised pediatric patients without urticaria or angioedema (index randomly assigned). Patients with <6 months of eligibility before and after the index date were excluded. HRU and costs were compared between the cohorts during the observation period after propensity score matching. RESULTS: A total of 6109 pediatric patients with CIU/CSU were selected, and 6107 were 1:1 matched with controls. The patients with CIU/CSU who had a mean ± standard deviation age of 4.58 ± 3.36 years, and 47.9% were girls. CIU/CSU-related medication use increased after diagnosis (e.g., baseline versus 6-month follow-up, 2.2 versus 8.0% for nonsedating prescription H1 antihistamines; 7.4 versus 17.4% for oral corticosteroids). Relative to the controls, the patients with CIU/CSU had higher rates of HRU (incidence rate ratios of 1.71, 2.39, and 2.07 for inpatient, emergency department, and outpatient visits, respectively; all p < 0.01), and higher all-cause per patient per year costs (mean cost differences of $2090, $1606, and $483 for total, medical, and pharmacy costs, respectively; all p < 0.01). CONCLUSION: This study highlighted unmet needs in pediatric patients with CIU/CSU who had increased medication (e.g., oral corticosteroids) and HRU burden after a diagnosis for CIU/CSU, and higher rates of HRU and costs relative to those without CIU/CSU.

Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria.

BACKGROUND: Bilastine is an H1-antihistamine approved for symptomatic treatment of patients with allergic rhinoconjunctivitis or urticaria. The safety profile of bilastine in clinical trials of allergic rhinoconjunctivitis or urticaria, assessed by type and frequency of adverse events (AE), was similar to that of placebo. OBJECTIVE: As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed. METHODS: A prospective, multicenter, observational, open-label, 3-month follow-up study was performed to assess the safety profile of bilastine 20 mg in patients aged ≥65 years with allergic rhinoconjunctivitis and/or urticaria. RESULTS: A total of 74 of 146 patients (50.7%) reported 129 treatment-emergent AEs (TEAE) during the study period. The incidence of TEAEs was low, with monthly and quarterly rates of 0.29 (95% confidence intervals [CI], 0.229-0.367) and 0.88 (95% CI, 0.688-1.100), respectively. Monthly and quarterly incidence rates were 0.04 (95% CI, 0.016-0.082) and 0.12 (95% CI, 0.048-0.246), respectively, for related TEAEs (eight TEAEs in seven patients) and were 0.02 (95% CI, 0.003-0.048) and 0.05 (95% CI, 0.010-0.143), respectively, for serious TEAEs (five TEAES in three patients). All serious TEAEs were considered to be unrelated to bilastine. CONCLUSION: Bilastine 20 mg showed a favorable safety profile with a low incidence of TEAEs in patients aged ≥65 years. The results were in accordance with the known safety profile of bilastine 20 mg and incidence of AEs reported in previous studies and described in the approved summary of product characteristics.

Chronic urticaria in a health maintenance organization of Buenos Aires, Argentina - new data that increase global knowledge of this disease

Abstract: Background: In spite of the frequency of chronic urticaria, there are no epidemiological studies on its prevalence in Argentina. Objective: The objective of this study was to define the prevalence and epidemiological characteristics of chronic urticaria patients in Buenos Aires. Methods: The population studied were the members of the Italian Hospital Medical Care Program, a prepaid health maintenance organization located in the urban areas around the Autonomous City of Buenos Aires, Argentina. All patients with diagnosis of chronic urticaria members of the Italian Hospital Medical Care Program, and with at least 12 months of follow up were included in the study. All medical records obtained between January 1st, 2012 and December 31, 2014 were analyzed. The prevalence ratio for chronic urticaria per 100,000 population with 95% CI for December 31, 2014 was calculated. The prevalence rate for the entire population and then discriminated for adults and pediatric patients (less than 18 years old at diagnosis) was assessed. Results: 158,926 members were analyzed. A total of 463 cases of chronic urticaria were identified on prevalence date (68 in pediatrics, 395 in adults), yielding a crude point prevalence ratio of 0.29% (CI 95% 0.26-0.31%). The observed prevalence of chronic urticaria in the adult population was 0.34 % (95% CI 0.31-0.38%), while in pediatrics it was 0.15 % (95% CI 0.11-0.20%). Study limitations: the main weakness is that the results were obtained from an HMO and therefore the possibility of selection bias. Conclusions: chronic urticaria is a global condition. Its prevalence in Buenos Aires is comparable with other countries.

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

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.

Corticosteroid-related toxicity in patients with chronic idiopathic urticariachronic spontaneous urticaria.

BACKGROUND: Treatments for patients with chronic idiopathic urticaria (CIU)chronic spontaneous urticaria (CSU) who were unresponsive to antihistamines include oral corticosteroids (OCS). Risks of OCS-related side effects in these patients have not been described quantitatively. OBJECTIVE: To investigate the relationship between OCS use and the risk of developing side effects possibly attributable to OCS and associated health care costs in privately insured patients with CIU/CSU. METHODS: This retrospective cohort study analyzed a commercial claims data base from January 1, 2008, to December 31, 2012. Patients with CIU/CSU were identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes via a validated algorithm. Possible OCS-related side effects included the following: diabetes mellitus, hypertension, lipid disorders, cataracts, depression or mania, osteoporosis or fractures, and infectious diseases. A time-dependent Cox regression (adjusted for age, sex, Charlson Comorbidity Index, and immunomodulator use) was used to separately model cumulative oral prednisone-equivalent exposure and the risk of side effects. Incremental total adjusted health care costs were compared in patients with versus patients without possible OCS-related side effects. RESULTS: Among 12,647 patients with CIU/CSU, 55.4% used OCS. An additional 1 g of prednisone-equivalent exposure was associated with a 7% increase in the likelihood of developing a possible side effect (hazard ratio, 1.07 [95% confidence interval, 1.051.08]). From the period before to the period after OCS initiation, the total mean adjusted annual health care costs increased by 1833 in users of OCS with new possible side effects and decreased by 2183 in patients without new possible side effects (p 0.001). CONCLUSION: Patients with CIU/CSU who were treated with OCS had an increased risk of possible OCS-related side effects and higher total health care costs than their counterparts not treated with OCS.

The Angioedema Quality of Life Questionnaire (AE-QoL) - assessment of sensitivity to change and minimal clinically important difference.

BACKGROUND: The Angioedema Quality of Life Questionnaire (AE-QoL) has recently been developed and validated as the first specific patient-reported outcome tool to assess quality of life (QoL) impairment in recurrent angioedema patients. As of yet, its sensitivity to change and minimal clinically important difference (MCID) have not been established. METHODS: Recurrent angioedema patients with chronic spontaneous urticaria or hereditary angioedema were repeatedly asked to complete the AE-QoL along with the SF-12 and other anchors for QoL impairment and disease activity during routine care visits. The sensitivity to change of AE-QoL was determined by correlating changes in its scores over time with changes in the applied anchors. In addition, the MCID was determined using anchor-based and distributional criterion-based approaches. RESULTS: Two hundred and seventy-eight patients contributed data sets for analysis. Baseline AE-QoL values were found to correlate well with SF-12 results as well as all other applied anchors for angioedema-related QoL impairment and disease activity. In addition, AE-QoL score changes over time correlated significantly with changes in the above anchors, thus demonstrating its sensitivity to change. The MCID of the AE-QoL total score was found to be six points. CONCLUSION: The AE-QoL is a valuable tool to assess changes of QoL impairment in recurrent angioedema patients over time, including changes due to treatment.