Abstract
Background
Although chronic spontaneous urticaria (CSU) is a common form of chronic urticaria (CU), its impact on overall disease burden and treatment patterns in real‐world settings requires further understanding.
Objectives
To assess prevalence, treatment patterns, disease profile and burden in patients with CSU in five European countries (EU5: France, Germany, Italy, Spain and the United Kingdom [UK]).
Methods
Data were from the 2020 EU5 National Health and Wellness Survey (NHWS). Age‐ and sex‐adjusted prevalence of diagnosed CSU was estimated for the overall EU5 and by country. Sociodemographic, health characteristics, treatment history and dermatology‐specific quality of life were described for the CSU cohort. Patient‐reported outcomes, including the Short Form 12‐item Survey (SF‐12v2) mental (MCS), physical component (PCS) summary scores; SF‐6D; EQ‐5D; General Anxiety Disorder‐7 (GAD‐7); Patient Health Questionnaire‐9 (PHQ‐9); Work Productivity and Activity Impairment (WPAI) and healthcare resource use (HRU), were summarized for the CSU cohort, overall and by country and descriptively compared to the full NHWS sample.
Results
Of 62,319 respondents, 794 patients were diagnosed with CU. Among these, 519 had CSU. Weighted prevalence of CSU in EU5 was 0.92%. Roughly half of the CSU cohort was treated with prescription and/or over‐the‐counter medication. Among the CSU cohort, 36.7% of patients experienced a very large to extremely large disease impact (Dermatology Life Quality Index [DLQI] > 10); most had poorly controlled disease (71.6%). Mean MCS, PCS, SF‐6D and EQ‐5D scores were worse for CSU versus the full NHWS sample. A higher proportion of the CSU cohort, versus the full NHWS sample, had GAD‐7 and PHQ‐9 scores of ≥5. Mild–severe anxiety, depression and WPAI scores were highest in the UK. HRU was higher in the CSU cohort than in the full NHWS sample.
Conclusions
CSU negatively impacts patients' lives. Yet, many patients remain inadequately treated and uncontrolled. These results highlight a need for comprehensive care approaches to improve patient outcomes.
This study evaluates prevalence, treatment patterns, disease profile and burden in patients with chronic spontaneous urticaria (CSU) in five European countries (EU5: France, Germany, Italy, Spain and the United Kingdom [UK]). CU, chronic urticaria; ER, emergency room; GAD, General Anxiety Disorder‐7; HRU, healthcare resource use; HRQoL, health‐related quality of life; NHWS, National Health and Wellness Survey; OTC, over‐the‐counter medication; PHQ‐9, Patient Health Questionnaire‐9; UK, United Kingdom; WPAI, Work Productivity and Activity Impairment.
Why was the study undertaken?
CSU negatively affects health‐related quality of life (HRQoL), daily‐life function and work productivity. However, disease burden and treatment patterns in real‐world settings need to be better characterized.
What does this study add?
This study describes the prevalence, treatment patterns and burden in adult patients with CSU in five European countries using recent data from a nationally representative survey.
CSU has a substantial burden, with impaired HRQoL, mental health, work productivity and elevated HRU.
Majority of patients with CSU had poorly controlled urticaria and were untreated, with few receiving biologics.
What are the implications of this study for disease understanding and/or clinical care?
This real‐world study highlights the multifaceted impact of CSU on patients' lives, indicating that many patients with symptomatic CSU are inadequately treated; emphasizing the need for comprehensive care to obtain disease control.
INTRODUCTION
Chronic spontaneous urticaria (CSU) is an inflammatory skin condition characterized by the spontaneous occurrence of itch, hives and/or angioedema for more than 6 weeks. 1 CSU is the most common form of chronic urticaria (CU), which has a peak incidence in the population aged 30–50 2 and a higher prevalence among women than men. 3
Variation exists in prevalence estimates for CU. The estimated point prevalence of CU was higher in Asian countries (1.4%) compared to those from Europe (0.5%) and Northern America (0.1%). 4 This variation may be attributed to environmental differences, 5 , 6 inconsistencies in the definition of CU 4 and its subtypes, 7 shifts in disease awareness across studies and sampling/analytic procedures employed in studies. 8
Guidelines for treating CSU describe a sequential approach based on disease severity and control. 1 Standard dose second‐generation antihistamines (sgAHs), with progressive dosing increase within 2–4 weeks if no effect is observed, are recommended as first‐line. For second‐line, omalizumab can be added to sgAHs, and for third‐line, treatment guidelines indicate the use of sgAHs plus ciclosporin. 1 Despite these guidelines, many patients with CSU who respond inadequately to sgAHs do not receive further escalated treatment options, 9 and evidence suggests that many patients with inadequate control after up‐dosing do not receive the optimal treatment. 10
Although CSU is not life‐threatening, studies show CSU negatively affects health‐related quality of life (HRQoL), 5 , 6 daily‐life function, 5 , 11 reduces work productivity 6 , 11 and contributes to excess economic burden. 11 Still, the impact of the disease burden and treatment patterns in real‐world settings is unclear. 12 Thus, population‐based studies describing the clinical profile and burden of CSU and real‐world patient experience are necessary.
We aimed to estimate the prevalence, treatment patterns, disease profile and burden in adult patients with diagnosed CSU in five EU countries (EU5: France, Germany, Italy, Spain and the United Kingdom [UK]).
MATERIALS AND METHODS
Data were from the 2020 EU5 National Health and Wellness Survey (NHWS). The NHWS is an annual cross‐sectional, self‐administered, internet‐based survey designed to evaluate the health and well‐being of the general adult (aged ≥18 years) population. It evaluates the prevalence of >165 self‐reported health conditions 13 , 14 , 15 and uses quota sampling to ensure the demographic composition of NHWS reflects the general adult population within each country, relative to age and sex. The NHWS data representation has been validated and weighted against reliable sources, including health statistics from government agencies and unaffiliated third parties. 13 , 14 , 16 , 17 For EU5 countries, age and sex distributions (to support sampling) were based on 2019 and 2018 population estimates from the International Database, maintained by the US Census Bureau. 18
Chronic urticaria and subtypes
Respondents to the NHWS self‐reported whether they experienced symptoms of CU in the past 12 months. If symptoms were present, respondents were asked to self‐report whether they received a physician diagnosis for CU and the subtype (CSU/chronic inducible urticaria [CIndU]/both). This manuscript focuses on the diagnosed CSU cohort.
Patient characteristics
Sociodemographic and general health characteristics were summarized for the full NHWS sample and patients with CSU. Clinical characteristics (e.g. age at diagnosis, disease duration, angioedema in past 3 months) were evaluated for the CSU cohort only. All variables were presented in the pooled CSU cohort and by country.
Patient‐reported outcomes
Dermatology‐specific outcomes
For patients with CSU, dermatology‐related quality of life (QoL) was assessed using the Dermatology Life Quality Index (DLQI). The DLQI is a widely used validated measure for quantifying dermatology‐specific QoL, including chronic urticaria. The instrument is brief, patient‐friendly and appropriate for clinical settings. Moreover, given that the DLQI can be used for various dermatological conditions, QoL comparisons can be made across dermatological diseases. 19 The 10‐item scale covers 6 domains: symptoms/feelings, daily activities, leisure, work/school, personal relationships and treatment over the past week. 19 Scores (range: 0–30) are categorized as: ‘no effect at all’ (0–1); ‘small effect’ (2–5); ‘moderate effect’ (6–10); ‘very large effect’ (11–20); ‘extremely large effect’ (21–30) on patients' life. 20 , 21
Patients with diagnosed CSU completed the Urticaria Control Test (UCT), a validated measure of disease control that is comprised of four items: physical symptoms, QoL, treatment and overall urticaria control within the past 4 weeks. Scores (range: 0–16; higher = better control) <12 suggest poorly controlled urticaria. 22
Health‐related quality of life
General HRQoL was assessed among the full NHWS sample and patients with CSU using the Medical Outcomes Study Short Form 12‐item Survey (SF‐12v2). The SF‐12v2 assesses physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health over 4 weeks. Scores were summarized as Physical Component Summary (PCS) and Mental Component Summary (MCS) scores using a norm‐based algorithm, where a mean is set to 50 and the standard deviation (SD) to 10. Higher scores indicate better HRQoL. 23 , 24 , 25 Using the SF‐12v2, the SF‐6D utility index score was derived (range 0–1; higher = better QoL). 26
General HRQoL and health status were also assessed using EQ‐5D‐5L, which utilizes a descriptive system of mobility, self‐care, usual activities, pain/discomfort and anxiety/depression from which the EQ‐5D utility index score is derived (range: 0–1; higher = better). Respondents completed the EQ‐Visual Analogue scale (VAS) to assess their overall health at present, with scores ranging from 0 (worst imaginable health) to 100 (best imaginable health). 27
Mental health
For the full NHWS sample and CSU cohort, General Anxiety Disorder‐7 (GAD‐7) 28 and Patient Health Questionnaire‐9 (PHQ‐9) 29 described anxiety and depression symptoms, respectively. Both scales measured the frequency of symptoms experienced over past 2‐weeks using four response options ranging from 0 = ‘not at all’ to 3 = ‘nearly every day’. In this study, GAD‐7 (range: 0–21) and PHQ‐9 (range: 0–27) scores were dichotomized, such that scores ≥5 suggested mild to severe anxiety and depression symptoms, respectively. 28 , 29 , 30
Work productivity and activity impairment
For the full NHWS sample and the CSU cohort, the General Health version of the Work Productivity and Activity Impairment (WPAI) questionnaire was used to assess work‐related and non‐work‐related impairments in the past 7 days (higher scores = greater impairment). 31 Absenteeism, presenteeism and overall work impairment were calculated for respondents who were employed. Activity impairment was calculated for all respondents.
All‐cause healthcare resource use
Frequency of visits to any traditional healthcare providers (HCPs) in the last 6 months was reported and further delineated as visits to general practitioners (GP), dermatologists, allergists, psychologists and psychiatrists. We also reported emergency room (ER) visits and hospitalizations. Healthcare resource use (HRU) was summarized as the percentage of respondents utilizing each resource and the average number of visits among those who reported a healthcare encounter for the full NHWS sample and CSU cohort.
Statistical analysis
Raw counts were presented for the number of adults who experienced symptoms of CU in the past 12 months, self‐reported a physician diagnosis for CU and CU subtypes. Overall and country‐specific weighted prevalence of CSU was estimated using survey weights accounting for sex and age distribution within each country, as reported in the 2019 International Database. 18 Prevalence estimates were presented with 95% confidence intervals (CI).
Descriptive statistics (unweighted) summarized all other study variables for the pooled CSU cohort and by country. Continuous variables were represented using means and SDs and categorical variables as frequencies and percentages. Where applicable, a descriptive comparison was done between the full NHWS sample and the CSU cohort. Analyses were conducted using SPSS version 23.0 and SAS 9.4.
RESULTS
Of the 62,319 respondents surveyed in the 2020 EU5 NHWS, 1,040 (1.7%) patients reported experiencing CU symptoms in the past 12 months (CSU, n = 667; CIndU, n = 343; both CSU and CIndU, n = 30). Among these, 794 (76.3%) received a physician diagnosis for their CU, comprising 519 (65.4%) patients with CSU, 255 (32.1%) with CIndU and 20 (2.5%) with both CSU and CIndU (Figure 1). The prevalence of diagnosed CSU in the EU5 was 0.92% (95% CI: 0.92%–0.92%). Within each EU5 country, the prevalence was 0.76% (0.76%–0.76%) in France, 0.79% (0.78%–0.79%) in Germany, 0.79% (0.79%–0.79%) in the UK, 1.3% (1.3%–1.3%) in Italy and 1.0% (1.0%–1.0%) in Spain (Table 1).
FIGURE 1.
Frequency of chronic urticaria forms. CIndU, chronic inducible urticaria; CSU, chronic spontaneous urticaria; CU, chronic urticaria. *Presence of itch, hives and/or angioedema for ≥6 weeks. Respondents reported experiencing CSU (n = 667), CIndU (n = 343) and both CSU and CIndU (n = 30) in the past 12 months.
TABLE 1.
Prevalence of diagnosed chronic spontaneous urticaria in five European countries.
| Unweighted full NHWS sample | Unweighted count of patients with diagnosed CSU a | Weighted prevalence of diagnosed CSU (95% CI) b | |
|---|---|---|---|
| EU5 | 62,319 | 539 | 0.92 (0.92%–0.92%) |
| Country‐specific prevalence | |||
| France | 15,152 | 109 | 0.76 (0.76%–0.76%) |
| Germany | 15,020 | 112 | 0.79 (0.78%–0.79%) |
| United Kingdom | 15,047 | 109 | 0.79 (0.79%–0.79%) |
| Italy | 10,026 | 134 | 1.3 (1.3%–1.3%) |
| Spain | 7074 | 75 | 1.0 (1.0%–1.0%) |
Note: EU5 – France, Germany, United Kingdom, Italy, Spain.
Abbreviations: CI, confidence interval; CSU, chronic spontaneous urticaria.
Includes patients who said they were diagnosed by a physician for CSU or both CSU and CIndU (n = 20; 2.5%).
Weights were constructed to account for the distribution of sex and age in the EU using 2019 population estimates from the International Database.
Patient profile
Relative to the full NHWS sample, the CSU cohort (n = 539) was younger (mean [SD] age: 42.4 [14.8]; 59.6% were <45 years) and comprised more women (58.1%); more patients had a university degree or higher (49.2%) and more had ‘high’ income (26.0%). The proportion of patients with Charlson Comorbidity Index (CCI) 32 ≥2 and current smokers was higher among the CSU cohort than the full NHWS sample. Nearly one‐fifth of patients with CSU were obese, which was comparable to the full NHWS sample. Sociodemographic characteristics varied by country (Table 2).
TABLE 2.
Sociodemographic and general health characteristics for the full NHWS sample and for patients with diagnosed chronic spontaneous urticaria (pooled and by country).
| Full NHWS sample | Patients with diagnosed CSU | ||||||
|---|---|---|---|---|---|---|---|
| EU5 | France | Germany | UK | Italy | Spain | ||
| (N = 62,319) | (N = 539) | (N = 109) | (N = 112) | (N = 109) | (N = 134) | (N = 75) | |
| Age at survey (in years), n (%) | |||||||
| 18–24 | 5406 (8.7) | 52 (9.7) | 15 (13.8) | 14 (12.5) | 6 (5.5) | 8 (6.0) | 9 (12.0) |
| 25–34 | 9877 (15.9) | 153 (28.4) | 30 (27.5) | 38 (33.9) | 41 (37.6) | 25 (18.7) | 19 (25.3) |
| 35–44 | 10,556 (16.9) | 116 (21.5) | 20 (18.4) | 16 (14.3) | 27 (24.8) | 30 (22.4) | 23 (30.7) |
| 45–54 | 11,002 (17.7) | 101 (18.7) | 19 (17.4) | 18 (16.1) | 21 (19.3) | 29 (21.6) | 14 (18.7) |
| 55–64 | 10,456 (16.8) | 54 (10.0) | 9 (8.3) | 15 (13.4) | 7 (6.4) | 19 (14.2) | 4 (5.3) |
| 65+ | 15,022 (24.1) | 63 (11.7) | 16 (14.7) | 11 (9.8) | 7 (6.4) | 23 (17.2) | 6 (8.0) |
| Female n (%) | 33,241 (53.3) | 313 (58.1) | 64 (58.7) | 60 (53.6) | 59 (54.1) | 87 (64.9) | 43 (57.3) |
| University education n (%) | |||||||
| Less than university education | 34,515 (55.4) | 272 (50.5) | 45 (41.3) | 82 (73.2) | 38 (34.9) | 87 (64.9) | 20 (26.7) |
| University education or higher | 27,096 (43.5) | 265 (49.2) | 64 (58.7) | 28 (25.0) | 71 (65.1) | 47 (35.1) | 55 (73.3) |
| Decline to answer | 708 (1.1) | 2 (0.4) | 0 (0.0) | 2 (1.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Annual household income n (%) | |||||||
| Low: <20,000 €/20,000 £ | 15,066 (24.2) | 129 (23.9) | 26 (23.9) | 25 (22.3) | 31 (28.4) | 30 (22.4) | 17 (22.7) |
| Medium: 20,000 to <50,000 €/20,000 to <50,000 £ | 29,908 (48.0) | 250 (46.4) | 59 (54.1) | 47 (42.0) | 39 (35.8) | 63 (47.0) | 42 (56.0) |
| High: 50,000+ €/50,000 + £ | 11,941 (19.2) | 140 (26.0) | 23 (21.1) | 40 (35.7) | 37 (33.9) | 30 (22.4) | 10 (13.3) |
| Decline to answer | 5404 (8.7) | 20 (3.7) | 1 (0.9) | 0 (0.0) | 2 (1.8) | 11 (8.2) | 6 (8.0) |
| Employment, n (%) | |||||||
| Employed full time | 23,838 (38.3) | 255 (47.3) | 53 (48.6) | 49 (43.8) | 70 (64.2) | 39 (29.1) | 44 (58.7) |
| Employed part‐time | 6639 (10.7) | 63 (11.7) | 11 (10.1) | 19 (17.0) | 6 (5.5) | 18 (13.4) | 9 (12.0) |
| Self‐employed | 4161 (6.7) | 43 (8.0) | 7 (6.4) | 8 (7.1) | 6 (5.5) | 15 (11.2) | 7 (9.3) |
| Homemaker | 3462 (5.6) | 33 (6.1) | 7 (6.4) | 5 (4.5) | 4 (3.7) | 15 (11.2) | 2 (2.7) |
| Retired | 16,003 (25.7) | 78 (14.5) | 19 (17.4) | 18 (16.1) | 7 (6.4) | 30 (22.4) | 4 (5.3) |
| Student | 2875 (4.6) | 16 (3.0) | 4 (3.7) | 5 (4.5) | 2 (1.8) | 2 (1.5) | 3 (4.0) |
| Disability (short‐ and long‐term) | 1404 (2.3) | 24 (4.4) | 3 (2.7) | 5 (4.5) | 12 (11.0) | 2 (1.5) | 2 (2.7) |
| Unemployed (looking or not looking for work) | 3937 (6.3) | 27 (5.1) | 5 (4.6) | 3 (2.7) | 2 (1.8) | 13 (9.7) | 4 (5.3) |
| CCI Score ≥ 2, n (%) | 3626 (5.8) | 108 (20.0) | 17 (15.6) | 27 (24.1) | 34 (31.2) | 15 (11.2) | 15 (20.0) |
| Obese (≥30.0 kg/m2), n (%) | 10,693 (17.2) | 96 (17.8) | 15 (13.8) | 29 (25.9) | 24 (22.0) | 18 (13.4) | 10 (13.3) |
| Smoking status, n (%) | |||||||
| Never smoked | 28,618 (45.9) | 177 (32.8) | 38 (34.9) | 37 (33.0) | 33 (30.3) | 44 (32.8) | 25 (33.3) |
| Former smoker | 18,017 (28.9) | 132 (24.5) | 22 (20.2) | 18 (16.1) | 29 (26.6) | 40 (29.9) | 23 (30.7) |
| Current smoker | 15,684 (25.2) | 230 (42.7) | 49 (45.0) | 57 (50.9) | 47 (43.1) | 50 (37.3) | 27 (36.0) |
Note: EU5 – France, Germany, United Kingdom, Italy, Spain.
Abbreviations: CCI, Charlson Comorbidity Index; NHWS, National Health and Wellness Survey.
The mean (SD) age at diagnosis was 37.8 (16.8) years. The primary diagnosis of CSU was most frequently established by a primary care physician (35.1%), followed by dermatologist (34.7%) and allergist (26.7%). In the pooled CSU cohort, the most prevalent comorbidities were allergies (38.4%), migraine/headache (31.5%), anxiety (24.1%), depression (23.0%), autoimmune conditions (19.7%), hypertension (16.9%) and sleep difficulties (16.1%). The prevalence of these conditions varied slightly between countries (Table 3).
TABLE 3.
Clinical characteristics and treatment patterns of patients with diagnosed chronic spontaneous urticaria.
| Clinical characteristics | EU5 | France | Germany | UK | Italy | Spain |
|---|---|---|---|---|---|---|
| (N = 539) | (N = 109) | (N = 112) | (N = 109) | (N = 134) | (N = 75) | |
| Age at diagnosis in years, mean (SD) | 37.8 (16.8) | 39.5 (20.7) | 33.7 (15.6) | 34.7 (12.6) | 44.2 (16.2) | 33.9 (15.8) |
| Disease duration in years, mean (SD) | 9.2 (10.4) | 10.9 (13.3) | 11.1 (12.2) | 9.3 (7.9) | 6.0 (6.3) | 9.8 (11.2) |
| Diagnostician, n (%) | ||||||
| Primary care physician/GP/internist | 79 (35.1) | 20 (46.5) | 16 (29.6) | 22 (53.7) | 13 (21.7) | 8 (29.6) |
| Nurse practitioner/physician's assistant | 5 (2.2) | 1 (2.3) | 0 (0.0) | 3 (7.3) | 0 (0.0) | 1 (3.7) |
| Allergist | 60 (26.7) | 6 (14.0) | 14 (25.9) | 6 (14.6) | 24 (40.0) | 10 (37.0) |
| Dermatologist | 78 (34.7) | 15 (34.9) | 23 (42.6) | 10 (24.4) | 22 (36.7) | 8 (29.6) |
| Other | 3 (1.3) | 1 (2.3) | 1 (1.9) | 0 (0.0) | 1 (1.7) | 0 (0.0) |
| Missing | 314 (−) | 66 (−) | 58 (−) | 68 (−) | 74 (−) | 48 (−) |
| Most frequently diagnosed comorbidities, n (%) | ||||||
| Allergies | 207 (38.4) | 34 (31.2) | 45 (40.2) | 30 (27.5) | 65 (48.5) | 33 (44.0) |
| Migraine/headache a | 170 (31.5) | 37 (33.9) | 30 (26.8) | 28 (25.7) | 50 (37.3) | 25 (33.3) |
| Anxiety | 130 (24.1) | 24 (22.0) | 6 (5.4) | 32 (29.4) | 43 (32.1) | 25 (33.3) |
| Depression | 124 (23.0) | 19 (17.4) | 32 (28.6) | 33 (30.3) | 25 (18.7) | 15 (20.0) |
| Autoimmune conditions b | 106 (19.7) | 20 (18.4) | 24 (21.4) | 24 (22.0) | 23 (17.2) | 15 (20.0) |
| Hypertension | 91 (16.9) | 8 (7.3) | 25 (22.3) | 19 (17.4) | 28 (20.9) | 11 (14.7) |
| Sleep difficulties c | 87 (16.1) | 17 (15.6) | 19 (17.0) | 13 (11.9) | 26 (19.4) | 12 (16.0) |
| Thyroid | 82 (15.2) | 9 (8.3) | 25 (22.3) | 12 (11.0) | 24 (17.9) | 12 (16.0) |
| Asthma | 72 (13.4) | 12 (11.0) | 11 (9.8) | 19 (17.4) | 18 (13.4) | 12 (16.0) |
| Experienced angioedema in past 3 months, n (%) | 146 (27.1) | 37 (33.9) | 33 (29.5) | 47 (43.1) | 13 (9.7) | 16 (21.3) |
| Number of angioedema events in past 3 months, mean (SD) | 3.1 (2.4) | 2.9 (2.2) | 2.6 (2.0) | 3.4 (3.0) | 3.5 (2.4) | 3.2 (1.7) |
| Urticaria control test, n (%) | ||||||
| Poorly controlled (≤11) | 386 (71.6) | 85 (78.0) | 75 (67.0) | 80 (73.4) | 94 (70.1) | 52 (69.3) |
| Well‐controlled (≥12) | 153 (28.4) | 24 (22.0) | 37 (33.0) | 29 (26.6) | 40 (29.9) | 23 (30.7) |
| Currently taking treatment for CSU (prescription medication or OTC), n (%) | 261 (48.4) | 44 (40.4) | 56 (50.0) | 68 (62.4) | 61 (45.5) | 32 (42.7) |
| Currently using a prescription medication for CSU, n (%) d | 86 (16.0) | 15 (13.8) | 14 (12.5) | 24 (22.0) | 19 (14.2) | 14 (18.7) |
| Biologics | 4 (0.7) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 0 (0.0) | 3 (4.0) |
| H1‐Antihistamines | 73 (13.5) | 14 (12.8) | 14 (12.5) | 23 (21.1) | 11 (8.2) | 11 (14.7) |
| Other medications | 13 (2.4) | 1 (0.9) | 0 (0.0) | 2 (1.8) | 8 (6.0) | 2 (2.7) |
| Currently using an over‐the‐counter medication for CSU, n (%) e | 207 (38.4) | 35 (32.1) | 47 (42.0) | 52 (47.7) | 50 (37.3) | 23 (30.7) |
Note: EU5 – France, Germany, United Kingdom, Italy, Spain.
Abbreviations: CSU, chronic spontaneous urticaria; GP, general physician; OTC, over the counter; SD, standard deviation.
Patients self‐reported a physician diagnosis of migraine and/or headache.
Patients self‐reported a physician diagnosis for one or more of the following conditions: ulcerative colitis, Crohn's disease, rheumatoid arthritis, Sjogren's syndrome, lupus and ankylosing spondylitis.
Patients self‐reported a physician diagnosis for one or more of the following conditions: sleep difficulties, sleep apnea and narcolepsy.
Does not exclude patients who also took an over‐the‐counter medication.
Does not exclude patients who also took a prescription medication.
Treatment patterns and disease control
More than half of patients in the pooled CSU cohort did not report receiving any treatment and 48.4% were treated with either a prescription (n = 86 representing 16% of treated patients) and/or with an OTC medication at the time of the survey (38.4%). Among patients taking prescription medication for CSU, 13.5% reported taking H1‐antihistamines, 0.7% biologics and 2.4% other medications. Most patients with CSU had poorly controlled urticaria (71.6% had a UCT score ≤ 11) (Table 3), even when treated with a prescription/OTC medication (77.4% of treated patients [n = 261] had a UCT score <12.
The proportion of patients treated with either a prescription and/or with an OTC medication was highest in United Kingdom (62.4%) and lowest in France (40.4%) (Table 3). Antihistamine use was most common among patients from the United Kingdom (21.1%) and least common among those from Italy (8.2%).
Health‐related quality of life
The mean (SD) DLQI score of the pooled cohort was 8.8 (9.3) and 36.7% of patients experienced a very large to extremely large disease impact (DLQI > 10) (Figure 2). The proportion of patients experiencing very large to extremely large disease impact was highest in the United Kingdom (54.1%) followed by Germany (42%), France (41.3%), Spain (30.6%) and Italy (17.9%).
FIGURE 2.
Dermatology‐specific quality of life according to the Dermatology Life Quality Index. CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; SD, standard deviation. Mean (SD) DLQI scores of patients with diagnosed CSU – EU5: 8.8 (9.3), France: 8.7 (8.5), Germany: 9.4 (9.4), United Kingdom: 13.3 (10.6), Italy: 5.4 (7.3), Spain: 7.4 (8.5). EU5 – France, Germany, United Kingdom, Italy, Spain.
Mean (SD) MCS and PCS scores for CSU patients were 40.6 (9.1) and 45.6 (9.8), respectively, which were worse than the average scores observed in the full NHWS sample. The difference in MCS and PCS scores between CSU patients and the full NHWS sample (5.3 and 4.5, respectively) exceeded the minimum important difference of 3 points, 33 , 34 and showed clinically relevant differences in mental and physical status between the two samples (Figure 3a). Spain had the highest MCS (41.9 [8.2]) and PCS (47.8 [8.4]) scores, and the United Kingdom had the lowest (MCS: 39.0 [9.7]; PCS: 42.4 [11.3]).
FIGURE 3.
Health‐related quality of life among patients with diagnosed chronic spontaneous urticaria – (a) MCS and PCS and (b) SF‐6D and EQ‐5D utility index scores. EQ‐5D, EuroQol 5‐Dimension; MCS, mental component summary; NHWS, National Health and Wellness Survey; PCS, physical component summary; SD, standard deviation; SF‐6D, six‐dimension health state short form. EU5 – France, Germany, United Kingdom, Italy, Spain.
Mean (SD) scores of SF‐6D and EQ‐5D in CSU patients were worse (SF‐6D: 0.61 [0.11]; EQ‐5D: 0.67 [0.30]) than the full NHWS sample (SF‐6D: 0.71 [0.13]; EQ‐5D: 0.81 [0.21]). Patients from the United Kingdom exhibited the lowest SF‐6D (0.56 [0.12]) and EQ‐5D (0.46 [0.42]) scores while patients from the remaining countries had SF‐6D scores similar to those observed in the overall CSU cohort (Figure 3b).
Mental health
A higher proportion of CSU patients had GAD‐7 scores ≥5 (72.4% vs. 39.6%) and PHQ‐9 depression scores ≥5 (75.7% vs. 45.1%) than adults from the full NHWS sample; this trend was consistent at the country level (GAD‐7 ≥ 5: 64.2%–84.4% and PHQ‐9 depression scores ≥5: 72.4%–86.2%). The greatest proportion of patients with mild–severe anxiety (84.4%) and depression (86.2%) was observed in the United Kingdom (Figure 4).
FIGURE 4.
Depression and anxiety among the full NHWS sample and patients with diagnosed chronic spontaneous urticaria. CSU, chronic spontaneous urticaria; GAD‐7, Generalized Anxiety Disorder‐7; NHWS, National Health and Wellness Survey; PHQ‐9, Patient Health Questionnaire‐9. EU5 – France, Germany, United Kingdom, Italy, Spain.
Work productivity and activity impairment
On average, absenteeism (24.1 [26.7] vs. 9.4 [22.5]), presenteeism (47.5 [31.8] vs. 22.3 [27.0]), overall work productivity impairment (54.4 [34.3] vs. 25.1 [29.8]) and overall activity impairment (48.13 [30.9] vs. 27.1 [28.4]) were worse among patients with diagnosed CSU than the full NHWS sample. All WPAI scores were highest for CSU patients from the United Kingdom (absenteeism: 31.4 [26.2]; presenteeism: 59.0 [34.7]; overall work productivity impairment: 64.9 [35.1]; overall activity impairment: 58.4 [33.6]) (Figure 5).
FIGURE 5.
Work productivity and activity impairment among patients with diagnosed chronic spontaneous urticaria. CSU, chronic spontaneous urticaria; NHWS, National Health and Wellness Survey; SD, standard deviation. EU5 – France, Germany, United Kingdom, Italy, Spain.
All‐cause healthcare resource use
Patients with CSU used more healthcare resources than the full NHWS sample, particularly with acute healthcare services (ER visits: 40.3% vs. 14.7%; hospitalizations: 32.1% vs. 9.6%). A greater proportion of patients with CSU reported any HCP visit in the past 6 months than the full NHWS sample (96.8% vs. 82.9%) including visits to dermatologists (22.6% vs. 8.4%) and allergists (17.8% vs. 2.9%) (Table S1).
DISCUSSION
This study estimated the prevalence of diagnosed CSU in adults, characterized patient profiles diagnosed with CSU, and assessed the population‐level burden using data from the 2020 EU5 NHWS. Our findings reinforce previously published studies on CSU's detrimental impact, demonstrating impaired HRQoL, poor mental health, work impairment and activity and increased HRU. Notably, more than half of patients reported no medication use despite having symptoms, and among those receiving treatment, only a small proportion were prescribed medication. A large proportion of patients had poorly controlled urticaria, as shown by UCT scores, even among patients receiving treatment.
Data on the prevalence of CSU in Europe is limited, with reported estimates varying based on study design. Previous reports from population‐based cross‐sectional studies suggest the prevalence of CU in Europe may range from 0.2% to 0.8%. 4 In our study, the sex‐ and age‐adjusted prevalence of diagnosed CSU in the EU5 was 0.92%, with higher rates in Italy (1.3%) and Spain (1.0%) compared to France, Germany and the United Kingdom (0.76%–0.79%). This country‐specific variation in prevalence may be due to differences in healthcare‐seeking behaviours and healthcare structures within each country, 10 though more research is needed. The higher prevalence observed in our study is likely attributed to methodological differences between the present study and those previously published. Specifically, rather than using data from clinical databases, 4 , 35 which tend to rely on restricted samples of patients with CSU (i.e. patients who have been diagnosed and are connected to care with a specific institution), our data came from a population‐based, patient‐reported survey. Therefore, our study likely captures a broader cross‐sectional sample of patients with diagnosed CSU covering patients managed in primary and specialty care but also those not actively seeking treatment for their condition. The true prevalence of CSU likely falls in the middle of what previous studies from healthcare/claims databases have reported, and what was reported in the present study.
We showed that patients with CSU experienced higher levels of work impairment than those observed in the full NHWS. Most patients with CSU in this study were female and <45 years of age, aligning with the patient profile observed in previous studies. 12 , 15 This tendency toward younger, working‐age adults suggests a significant societal burden associated with CSU 36 which may be further influenced by a high comorbidity burden, as reflected in higher CCI scores compared to the overall NHWS sample and a low treatment rate. In our study, almost three‐quarters of patients with CSU had poorly controlled disease and fewer than half were currently receiving treatment. Moreover, among the subset of patients using prescription medication, H1‐antihistamines were most used, whereas <1% were treated with approved biologics. While our study was not designed to evaluate treatment uptake or effectiveness, these findings may suggest that many patients were not seeking treatment or were receiving less effective treatment options, as reported in other studies. 9 , 11 Treatment patterns (specifically for antihistamines/biologics) can be influenced by various factors, including physician prescribing habits, cost and/or availability of treatment, reimbursement policies and patient preferences across countries. 10 As such, future studies designed to evaluate treatment patterns, as well as the dissemination of treatment guidelines for CSU, may identify unmet needs and opportunities for more effective treatment options. Combined, these efforts may contribute to reductions in patient and societal burden, though more research is needed.
The present study assessed dermatology‐specific and general HRQoL using validated patient‐reported outcome measures. Over one‐third of the patients experienced very large or extremely large disease impact on their QoL. We also noted that general HRQoL measures, relative to the full NHWS sample, were consistently worse among patients with CSU, corroborating previous reports of high humanistic burden. 12 , 15 , 37 Patients with CSU experienced more anxiety and depression symptoms than the full NHWS sample. These findings align with the current literature, 15 , 38 and extend existing literature by validating these results at the population level. Physical symptoms of CSU, such as itching, discomfort, appearance, impairment of concentration, sleep deprivation, unpredictability of hives and social stigma, may contribute to increased anxiety and depression levels. Additionally, angioedema with CSU is described as emotionally agitating. 39 , 40 , 41 In our study, over a quarter of CSU patients reported experiencing angioedema (≤3 months), though this rate could be underestimated due to its potential under‐recognition as a symptom of CSU or reluctance to report. 42 Finally, the chronic and unpredictable nature of CSU requires frequent ER visits and specialized care settings to manage symptoms effectively. This can be time‐consuming and inconvenient for patients. Patients with CSU in our study reported a greater average number of all‐cause HCP visits over the past 6 months, more ER visits and hospitalizations than the full NHWS sample. These findings are consistent with studies reporting economic burden in CSU. 37 , 43 For example, a previous analysis comparing the burden of CSU to psoriasis and atopic dermatitis in EU5 reported higher HRU among CSU. 15
At the country level, patients with CSU from the United Kingdom showed a worse profile on many aspects relative to other European countries in this study. A greater proportion of patients from the United Kingdom had worse dermatology‐specific and HRQoL scores, with higher depression or anxiety symptoms. Also, the highest levels of work productivity impairment were observed in the United Kingdom. Empirical evidence evaluating CSU‐related outcomes across individual countries is lacking. However, differences in disease management and healthcare access may be driving elevated burden among patients from the United Kingdom. Our study showed the proportion of CSU patients with CCI scores ≥2 was highest in the United Kingdom, suggesting that these patients have worse overall health.
Results from this study may be limited due to the self‐reported nature of the data and reliance on patient recall of their health status, diagnosis and history with no additional validation of condition diagnoses or outcomes. However, these are common limitations of direct‐to‐patient surveys that are well documented in literature. 44 Given the cross‐sectional nature of the data, temporality between CSU‐related variables and outcomes could not be established; therefore, causality cannot be inferred. Selection bias may limit the generalizability of results, particularly because this study utilized an internet‐based convenience sample, which may have resulted in overrepresentation of specific patient segments and underrepresentation of others. However, sociodemographic characteristics of the study population reflect those likely to be observed in a patient population with CSU (i.e. younger, higher % of females), which may speak to the external validity of our findings. Finally, the all‐cause measure of HRU and NHWS study design does not allow for disentangling visits specific to CSU versus other potential conditions.
CONCLUSIONS
Using real‐world data, our findings underscore the multifaceted impact of CSU on patients' lives, emphasizing the need for comprehensive care approaches that address both physical and mental health aspects of CSU. HCPs should prioritize timely diagnosis, personalized treatment strategies and communicate with patients to improve outcomes and mitigate the overall burden of CSU. Additionally, efforts to enhance physician awareness and education through specialized programs, increased access to specialized care and patient education regarding CSU, clinical manifestations and all consequences including physical and psychological impact may be warranted.
AUTHOR CONTRIBUTIONS
Maria‐Magdalena Balp: Conceptualization, writing—review and editing, supervision and funding acquisition; Kathryn Krupsky: Formal analyses, writing—original draft, writing—review and editing, visualization and project administration; Shaloo Gupta: Conceptualization formal analyses, writing—review and editing, visualization and project administration; Clementine Lienhard: Conceptualization and writing—review and editing; Ravneet K. Kohli: Writing—review and editing and project administration; Dhaval Patil: Writing—review and editing; Florence Tétart: Conceptualization and writing—review and editing; John Reed: Conceptualization and writing—review and editing; Tariq El‐Shanawany: Conceptualization and writing—review and editing.
FUNDING INFORMATION
Novartis Pharma AG, Basel, Switzerland.
CONFLICT OF INTEREST STATEMENT
Maria‐Magdalena Balp is an employee of Novartis Pharma AG, Basel, Switzerland. Ravneet Kaur Kohli is an employee of Novartis Healthcare Pvt. Ltd., Hyderabad, India. Clementine Lienhard is an employee of Novartis Pharma SAS France. Dhaval Patil is an employee of Novartis Pharmaceuticals Inc. New York, US. Dr. Florence Tétart received consultancy fees from Novartis Pharma SAS France for the clinical contribution to the study. Dr. Tariq El‐Shanawany has received educational support, research support, speaker fees and/or consultant fees from Alive DX, ALK Abello, Allergy Therapeutics, CSL, Grifols, Kalvista, Octapharma, Novartis, Takeda and Viatris. Dr. John Reed received speaker and consultancy fees from Novartis Pharmaceuticals UK. Kathryn Krupsky and Shaloo Gupta are employees of Oracle Life Sciences, who own the NHWS and conducted the data analysis.
ETHICAL APPROVAL
The study protocol and questionnaire were reviewed by the Pearl Institutional Review Board and granted exemption status. All research reported here was conducted in accordance with the Good Pharmacoepidemiology Practices (GPP) guidelines issued by the International Society for Pharmacoepidemiology (ISPE) and Declaration of Helsinki.
ETHICS STATEMENT
All respondents provided informed consent before participating.
Supporting information
Table S1
ACKNOWLEDGEMENTS
The medical writing support was provided by Praful Kamble, PhD, Sulekha Shafeeq, PharmD and Shalini Vasantha of Indegene Pvt. Ltd., Bangalore, India and funded by Novartis Pharma AG, Basel, Switzerland.
Balp M‐M, Krupsky K, Gupta S, Lienhard C, Kohli RK, Patil D, et al. Prevalence, treatment and burden of chronic spontaneous urticaria in five European countries. J Eur Acad Dermatol Venereol. 2025;39:1806–1817. 10.1111/jdv.20772
Linked Article: E. Kocatürk et al. J Eur Acad Dermatol Venereol 2025;39:1711–1712. https://doi.org/10.1111/jdv.70893.
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from Oracle Life Sciences, but restrictions apply to the availability of these data, which were used under licence for the current study and so are not publicly available. Data can be made available for non‐commercial use from the authors upon reasonable request and with permission of Oracle Life Sciences.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1
Data Availability Statement
The data that support the findings of this study are available from Oracle Life Sciences, but restrictions apply to the availability of these data, which were used under licence for the current study and so are not publicly available. Data can be made available for non‐commercial use from the authors upon reasonable request and with permission of Oracle Life Sciences.