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. 2025 Apr 16;42(6):2808–2820. doi: 10.1007/s12325-025-03172-0

Incidence and Prevalence of Chronic Spontaneous Urticaria Among Adult and Pediatric Populations in the United States

Yvonne Geissbühler 1,✉, Maria M Balp 1, Aine McConnon 2, Justin Gomme 2, Sarah J McKenna 2, Ravneet K Kohli 3, Weily Soong 4
PMCID: PMC12085360  PMID: 40238059

Abstract

Introduction

Published evidence on the epidemiology of chronic spontaneous urticaria (CSU) in the USA is limited. This study aimed to estimate the age- and/or sex-standardized incidence and prevalence of diagnosed CSU in the US population.

Methods

The target population was identified using three anonymized databases: Optum Electronic Health Record (EHR), Optum Clinformatics Data Mart (CDM), and Truven Health MarketScan. The study population consisted of adult (aged ≥ 18 years) and pediatric (aged < 18 years) patients with diagnosed CSU based on ≥ 2 relevant International Classification of Diseases version 9 and/or 10 (ICD-9 and/or ICD-10) codes recorded ≥ 6 weeks apart. The data identification period for Optum EHR and Optum CDM was from January 1, 2012 to December 31, 2018, and for MarketScan it was January 1, 2012 to December 31, 2017. In Optum EHR the incidence rate and prevalence were standardized by age and sex as compound strata and by age (adult and pediatric populations separately), and in both Optum CDM and MarketScan, data was standardized by sex as a single stratum of adult and pediatric populations. The age- and sex-standardized incidence rate and prevalence were calculated and reported per 100 person-years and per 100 persons (%), respectively.

Results

A total of 108,384 patients (adults, 72.1%; pediatric patients, 27.9%) from Optum EHR, 107,682 (adults, 78.5%; pediatric patients, 21.5%) from Optum CDM, and 278,311 (adults, 63.5%; pediatric patients, 36.5%) from MarketScan were identified with CSU diagnosis during the identification period. The age- and sex-standardized incidence rate of diagnosed CSU among adult and pediatric populations in Optum EHR during the identification period (2012–2018) was 0.039 and 0.066 per 100 person-years, respectively, while the prevalence was 0.120% and 0.193%, respectively. The age-standardized incidence rate of diagnosed CSU among adult and pediatric populations in Optum CDM (2012–2018) was 0.094 and 0.109 per 100 person-years, respectively, while the prevalence was 0.277% and 0.304%, respectively. The sex-standardized combined (adult and pediatric) incidence rate and prevalence were 0.096 per 100 person-years and 0.283%, respectively. The age-standardized incidence rate of diagnosed CSU among adult and pediatric populations in MarketScan (2012–2017) was 0.102 and 0.097 per 100 person-years, respectively, while the prevalence was 0.256% and 0.264%, respectively. The sex-standardized combined (adult and pediatric) incidence rate and prevalence were 0.088 per 100 person-years and 0.244%, respectively.

Conclusion

The findings of this study highlight a general increasing trend in the incidence and prevalence of diagnosed CSU over time among the US population. Comparatively, the incidence and prevalence were higher among pediatric patients than adults.

Keywords: Chronic spontaneous urticaria, Epidemiology, Incidence, Prevalence

Key Summary Points

Published evidence on the actual incidence and prevalence of diagnosed chronic spontaneous urticaria (CSU) is limited in the USA. This study aimed to estimate the standardized incidence rate and prevalence of CSU in a large patient cohort representative of the US national population.
Adult and pediatric patients with diagnosed CSU were identified using three anonymized US databases: Optum Electronic Health Record (EHR), Optum Clinformatics Data Mart (CDM), and Truven Health MarketScan. The three databases were analyzed separately to estimate the age- and sex-standardized incidence rate and prevalence of diagnosed CSU.
The age- and sex-standardized incidence rate and prevalence of diagnosed CSU in both adult and pediatric populations varied from 0.039 to 0.109 per 100 person-years and 0.120% to 0.304%, respectively. These findings suggest a general increasing trend in the incidence and prevalence of CSU over time within the US population, with higher rates observed among pediatric patients than among adults.
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Introduction

Chronic urticaria (CU) is a skin disease characterized by the appearance of wheals (hives) and/or angioedema lasting for more than 6 weeks. CU can be classified as chronic spontaneous urticaria (CSU; previously known as chronic idiopathic urticaria and marked by the spontaneous appearance of hives and angioedema due to unknown causes) and chronic inducible urticaria [1].

According to a recent systematic review, the worldwide overall point prevalence of CU among the general population is estimated to be 0.70% [2]. CU appears to be more prevalent among children (0–19 years) than adults (point prevalence 1.43% versus 0.86%), and the prevalence also varies across different regions, ranging from 0.10% in Northern America to 1.40% in Asia [2]. In the USA, the age- and sex-adjusted point prevalence of CU was calculated as 0.23% using electronic medical records [3]. The prevalence of CSU varies from 0.08% to 0.11% according to US insurance claims-based studies [4, 5]. A study based on the US National Health and Wellness Survey (NHWS) reported the prevalence of diagnosed CSU (defined on the basis of proxy chronic hives) as 0.40% [6].

Epidemiological studies with primary data collection reporting the prevalence of diagnosed CSU are limited [4, 5]. Moreover, in most published epidemiological research, the disease was defined as CU, with no differentiation of type, and in other cases, CU or chronic hives was used as a proxy for CSU, limiting generalizability [4, 6]. In addition, epidemiological estimates vary depending on study design, data sources, methodology, and defined population or geography [2].

To gain a more comprehensive understanding of the actual incidence and prevalence of diagnosed CSU, large, nationally representative cohorts need to be considered. This study aimed to estimate the age- and/or sex-standardized incidence rate and prevalence of CSU among adult and pediatric populations using three large US healthcare databases.

Methodology

Study Design and Data Sources

A descriptive, noninterventional, retrospective cohort study of adult and pediatric patients with CSU in the USA was conducted using data from three anonymized databases: Optum Electronic Health Record (EHR), Optum Clinformatics Data Mart (CDM), and Truven Health MarketScan (Commercial Claims and Encounters, Medicare, and Medicaid MarketScan).

Optum EHR is a comprehensive database with anonymized patient data from approximately 104 million patients, reported by various healthcare providers across the USA [7, 8]. Optum CDM is a large administrative claims database with anonymized, verified, and adjudicated claims data from over 15 million individuals covered annually in the USA [9, 10]. The study period for both Optum EHR and Optum CDM was from January 1, 2011 to December 31, 2019, with a data identification period from January 1, 2012 to December 31, 2018 (Fig. 1).

Fig. 1.

Fig. 1

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Schematic diagram of study period and data identification period in Optum EHR, Optum CDM, and MarketScan. CDM Clinformatics Data Mart, EHR Electronic Health Record. aIncident cases are the newly identified patients with the first code recorded within the year of interest and no codes recorded in the 1 year prior to the index date. Incidence is reported annually over the data identification period. Annual incidence was calculated using incident cases only. bPrevalent cases are those with the first code recorded prior to or during the year of interest and the last code recorded during or after the year of interest. Annual diagnosed prevalence was calculated using both incident and prevalent cases

MarketScan includes anonymized records of over 250 million individuals in the USA, contributed by large employers, managed care organizations, hospitals, electronic medical record providers, Medicare, and Medicaid [9, 11]. The study period for MarketScan was from January 1, 2011 to December 31, 2018, with a data identification period from January 1, 2012 to December 31, 2017 (Fig. 1).

Patient Population

The study population consisted of prevalent and newly diagnosed adult (≥ 18 years) and pediatric (< 18 years) patients with CSU identified using a modified version of a two-code algorithm based on ≥ 2 relevant International Classification of Diseases version 9 and/or 10 (ICD-9 and/or ICD-10) codes for CSU recorded at least 6 weeks apart in each database [12]. The ICD-9 and/or ICD-10 codes used for identification of patients with CSU were 708.1, L50.1 (idiopathic urticaria); 708.8, L50.8 (other urticaria); 708.9, L50.9 (unspecified urticaria); 708.0, L50.0 (allergic urticaria), and 995.1, T78.3 (angioneurosis edema). Patients with hereditary angioedema (D84.1), vasculitis (L95.9), or acute urticaria were excluded from the study. Following inclusion criteria were used to identify patients with CSU:

  1. Two or more independent diagnoses for idiopathic (as a proxy for spontaneous), other, or unspecified urticaria ≥ 6 weeks apart) or

  2. One or more diagnoses for idiopathic, other, or unspecified urticaria and one or more diagnoses for angioedema ≥ 6 weeks apart, with any order between angioedema and urticaria diagnoses or

  3. One or more diagnoses for allergic urticaria followed by one or more diagnoses for idiopathic, other, or unspecified urticaria ≥ 6 weeks apart, and no further allergic urticaria diagnoses after the first diagnosis of idiopathic, other, or unspecified urticaria. It was, however, acceptable if the last diagnosis of allergic urticaria was on the same day as the first diagnosis of idiopathic, other, or unspecified urticaria.

Patients with continuous data available in the respective databases during the specified year were defined as active patients. For the entire study period, patients with one or more medical encounters or diagnoses during that period in Optum EHR and those with one or more claims in Optum CDM and MarketScan were considered to be active patients.

Incident cohorts included newly identified patients with the first urticaria or angioedema code within the year of interest and no codes 12 months prior to that year. Prevalent cohorts included patients with the first code prior to or during the year of interest and the last code during or after the year of interest. The first urticaria or angioedema diagnosis within the data identification period was considered as the index date. For the incident patients, this was also the first diagnosis recorded during the entire study period, while for the prevalent patients this was the most recent diagnosis during the data identification period.

Study Outcomes

The standardized incidence rate and prevalence estimates of CSU among adult and pediatric populations were calculated separately for all three databases. Estimates were calculated for each individual year as well as for the entire identification period.

The incidence rate and prevalence in Optum EHR were standardized by age and sex as compound strata, based on population values from the US census. In Optum CDM and MarketScan, the incidence rate and prevalence were standardized by age and sex as separate strata. The age-standardized estimates were calculated separately for adult and pediatric populations, while the sex-standardized estimates were calculated for the combined adult and pediatric populations. These estimates were based on the national estimates of the number of people with employer-sponsored private health insurance (ESI), derived from the Medical Expenditure Panel Survey (MEPS).

Statistical Analysis

The standardized incidence rate was calculated and reported per 100 person-years, while the standardized prevalence was reported per 100 persons (%) along with the 95% confidence intervals (CIs). The 95% CI was calculated using the Clopper-Pearson method. All statistical analyses were performed using SAS Software version 9.4 and R statistical software.

The databases are compliant with the Health Insurance Portability and Accountability Act. As data are commercially available and anonymized, institutional review board approval was not required. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki of 1964 and its later amendments or comparable ethical standards.

Results

A total of 79,963,106 patients from Optum EHR, 37,533,865 patients from Optum CDM, and 101,912,928 patients from MarketScan were identified as active patients during the identification period. Of these patients, 108,384 from Optum EHR, 107,682 from Optum CDM, and 278,311 from MarketScan had a CSU diagnosis. More than 60% of patients across the three databases were adults, and most of the patients (≥ 80%) were diagnosed with unspecified urticaria, followed by idiopathic urticaria and other urticaria (Table 1).

Table 1.

Frequency of patients with CSU identified from Optum EHR, Optum CDM, and MarketScan databases

Optum EHR
(2012–2018)
N (%)		 Optum CDM
(2012–2018)
N (%)		 MarketScan
(2012–2017)
N (%)
Patients with diagnosed CSU 108,384 (100.0) 107,682 (100.0) 278,311 (100.0)
Frequency of patients by age
 Adults (≥ 18 years) 78,160 (72.1) 84,512 (78.5) 176,780 (63.5)
 Pediatric patients (< 18 years) 30,224 (27.9) 23,170 (21.5) 101,531 (36.5)
Frequency of patients with CSU diagnosis by codea
 Idiopathic urticaria 21,890 (20.2) 40,550 (37.7) 92,820 (33.4)
 Other urticaria 32,910 (30.4) 35,903 (33.3) 88,061 (31.6)
 Unspecified urticaria 94,726 (87.4) 86,181 (80.0) 230,234 (82.7)
 Allergic urticaria 6271 (5.8) 11,213 (10.4) 31,981 (11.5)
 Angioedema 19,924 (18.4) 25,227 (23.4) 61,842 (22.2)
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CDM Clinformatics Data Mart, CSU chronic spontaneous urticaria, EHR Electronic Health Record

aCounts are for the combined cohort across the entire data identification period; some patients may have one or more medical encounters or diagnoses during the identification period

Standardized Incidence Rate and Prevalence of Diagnosed CSU in Optum EHR

In Optum EHR, the age- and sex-standardized incidence rate (95% CI) among adults and pediatric patients during the identification period was 0.039 (0.039–0.039) and 0.066 (0.065–0.067) per 100 person-years, respectively, while the prevalence (95% CI) was 0.120% (0.119–0.120) and 0.193% (0.191–0.195), respectively.

The yearly incidence rate per 100 person-years (95% CI) ranged from 0.031 (0.030–0.032) in 2012 to 0.034 (0.033–0.035) in 2018 among adults and from 0.057 (0.056–0.059) in 2012 to 0.066 (0.064–0.079) in 2018 among pediatric patients (Fig. 2a). The yearly prevalence (95% CI) ranged from 0.052% (0.051–0.052) in 2012 to 0.108% (0.107–0.109) in 2018 among adults and from 0.087% (0.085–0.090) in 2012 to 0.190% (0.186–0.194) in 2018 among pediatric patients (Fig. 2b).

Fig. 2.

Fig. 2

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Yearly age- and sex-standardized a incidence rate and b prevalence of diagnosed CSU in Optum EHRa. CSU chronic spontaneous urticaria, EHR Electronic Health Record, US United States. aIncidence rate and prevalence in Optum EHR were standardized by age and sex as compound strata, based on population values from the US census data

Standardized Incidence Rate and Prevalence of Diagnosed CSU in Optum CDM

The age-standardized incidence rate (95% CI) of CSU among the adult and pediatric populations during the identification period in Optum CDM was 0.094 (0.093–0.095) and 0.109 (0.107–0.111) per 100 person-years, respectively, while the prevalence (95% CI) was 0.277% (0.275–0.279) and 0.304% (0.300–0.308), respectively. The sex-standardized combined (adult and pediatric) incidence rate and prevalence (95% CI) were 0.096 (0.096–0.097) per 100 person-years and 0.283% (0.281–0.284), respectively.

The yearly age-standardized incidence rate (95% CI) per 100 person-years ranged from 0.088 (0.086–0.0901) in 2012 to 0.069 (0.068–0.071) in 2018 among adults and from 0.112 (0.108–0.117) in 2012 to 0.110 (0.105–0.115) in 2018 among pediatric patients. The yearly sex-standardized combined (adult and pediatric) incidence rate per 100 person-years varied from 0.092 (0.091–0.094) in 2012 to 0.071 (0.070–0.072) in 2018 (Fig. 3a).

Fig. 3.

Fig. 3

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Yearly age- and sex-standardized a incidence rate and b prevalence of diagnosed CSU in Optum CDMa. CDM Clinformatics Data Mart, CSU chronic spontaneous urticarial. aIncidence rate and prevalence in Optum CDM were standardized by age (pediatric and adult populations separately) and sex as a separate stratum (combined adult and pediatric population)

The yearly age-standardized prevalence (95% CI) ranged from 0.189% (0.186–0.192) in 2012 to 0.175% (0.172–0.177) in 2018 among adults and from 0.216% (0.210–0.223) in 2012 to 0.258% (0.251–0.265) in 2018 among pediatric patients. The yearly sex-standardized combined (adult and pediatric) prevalence (95% CI) varied from 0.192% (0.189–0.195) in 2012 to 0.178% (0.175–0.180) in 2018 (Fig. 3b).

Standardized Incidence Rate and Prevalence of Diagnosed CSU in MarketScan

In MarketScan, the age-standardized incidence rate (95% CI) of CSU among adults and pediatric patients during the identification period was 0.102 (0.097–0.107) and 0.097 (0.096–0.098) per 100 person-years, respectively, while the prevalence (95% CI) was 0.256% (0.248–0.265) and 0.264% (0.261–0.266), respectively. The sex-standardized combined (adult and pediatric) incidence rate and prevalence (95% CI) were 0.088 (0.087–0.088) per 100 person-years and 0.244% (0.243–0.245), respectively.

The yearly age-standardized incidence rate (95% CI) per 100 person-years ranged from 0.060 (0.059–0.061) in 2012 to 0.056 (0.055–0.0657) in 2017 among adults and from 0.084 (0.082–0.085) in 2012 to 0.101 (0.098–0.104) in 2017 among pediatric patients. The yearly sex-standardized combined (adult and pediatric) incidence rate (95% CI) per 100 person-years varied from 0.072 (0.071–0.073) in 2012 to 0.071 (0.070–0.072) in 2017 (Fig. 4a).

Fig. 4.

Fig. 4

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Yearly age- and sex-standardized a incidence rate and b prevalence of diagnosed CSU in MarketScana. CSU chronic spontaneous urticarial. aIncidence rate and prevalence in MarketScan were standardized by age (pediatric and adult populations separately) and sex as a separate stratum (combined adult and pediatric population)

The yearly age-standardized prevalence (95% CI) ranged from 0.142% (0.140–0.145) in 2012 to 0.171% (0.168–0.174) in 2017 among adults and from 0.162 (0.159–0.164) in 2012 to 0.244 (0.240–0.249) in 2017 among pediatric patients. The yearly sex-standardized combined (adult and pediatric) prevalence (95% CI) varied from 0.150% (0.149–0.151) in 2012 to 0.191% (0.189–0.193) in 2017 (Fig. 4b).

Discussion

The present study provides population-based standardized epidemiological estimates (age- and/or sex-standardized incidence rate and prevalence) for diagnosed CSU among adult and pediatric populations using data from three large nationwide US databases: Optum EHR, Optum CDM, and MarketScan and a validated algorithm to identify patients diagnosed with CSU [12].

The study also reports for the first time, to the best of our knowledge, standard incidence rate of diagnosed CSU in the USA, with period estimates among adults ranging from 0.039 to 0.102 per 100 person-years in the three databases. The annual incidence rate ranged from 0.031 in 2012 to 0.069 per 100 person-years in 2018 across the three databases. The results are comparable to a population-based study from Italy (individuals aged ≥ 15 years) with the annual incidence rate ranging from 0.010 in 2002 to 0.130 in 2013 per 100 person-years [13]. However, another population-based study in Korea (individuals aged ≥ 20 years) reported a higher adjusted incidence rate, ranging from 0.102 in 2006 to 0.243 in 2014 per 100 person-years [14].

Our study reports the standardized period prevalence of diagnosed CSU among adults from 0.120% to 0.277% across three databases, which is similar to the prevalence estimates from a recent cross-sectional analysis of EHRs in the USA (0.230%) [3]. Comparatively, other claims-based studies conducted more than 10 years ago in the USA reported lower prevalence estimates (0.08–0.11%) [4, 5]. Another study that used a large national representative cohort (NHWS) reported the prevalence of diagnosed CSU in the USA as 0.40%. This was consistent with the prevalence estimates in Brazil (0.41%) and five European countries (0.50%) reported using NHWS data from those geographies [6, 15, 16]. These studies conducted more than 10 years ago have used CU as a proxy for CSU. A more recent NHWS study in the USA that identified diagnosed CSU reported the annual prevalence of CSU as 0.78% [17]. Some studies conducted in China have also reported a higher standardized prevalence of diagnosed CSU (1.29–2.7%). However, a comparison may not be feasible as these are unadjusted estimates based on children, adolescent, and adult populations [18, 19].

The annual standardized prevalence of diagnosed CSU among adults across three databases increased from 0.052% in 2012 to 0.191% in 2018. These trends were similar to those in population-based studies that reported an increase in the yearly prevalence of CSU in Korea (0.16% in 2006 to 0.45% in 2014) and Italy (0.02% in 2002 to 0.38% in 2013) [13, 14].

The standardized period prevalence of diagnosed CSU among pediatric patients ranged from 0.193% to 0.304% across the three databases. Comparatively, a claims-based study reported a lower prevalence of 0.138% in the USA [5], whereas a physician survey-based study reported a higher annual prevalence of diagnosed CSU among pediatric patients from five European countries (0.75%) [20]. The prevalence of CSU among adolescents in China (2.7%) and Israel (0.6%) was higher compared with that observed in this study, indicating geographic variability and also potentially differences in study design or population definition [19, 21].

The prevalence of CSU in the present study was higher among pediatric patients than among adults across all databases. This trend was reported in another US claims-based study, with slightly higher prevalence (0.138%) among patients aged ≤ 11 years than among those aged 12–24 years (0.065%), 25–64 years (0.130%–0.119%), and ≥ 65 years (0.097) [5].

Overall, our study findings are similar to previous epidemiological estimates obtained from database studies [3–5] and lower than estimates reported from studies that used population-based surveys [6, 15, 16]. The variability in the incidence and prevalence estimates could be attributed to the heterogeneity of the studied populations and differences in diagnostic criteria, methods (some studies report unadjusted estimates), and data sources.

One of the key strengths of the current study was the inclusion of both claims data and EHRs identified using three healthcare databases with large sample sizes representative of the US national population [22]. In addition, epidemiological estimates for CSU were adjusted for variation in age and sex, unlike previous studies on CSU in the USA, which reported only crude estimates [4–6]. The present study provided prevalence, and incidence estimates for the entire study period as well as yearly estimates, which allowed for identification of any epidemiological trends.

Nonetheless, this study has certain limitations that need to be considered when interpreting the results. Optum EHR data represents only individuals who seek medical care and excludes those who do not visit healthcare facilities or who use alternative forms of healthcare [23, 24]. Similarly, MarketScan consists of data from individuals with private insurance sponsored by the employers, and mostly, the employers who contribute to MarketScan data represent large companies, with weaker representation from small-/medium-sized employers [9, 11, 25]. Other limitations include the possibility of coding errors in these databases, which might lead to under/overestimations or misclassification of the disease [26–28].

Conclusion

Our study provides robust evidence on the incidence and prevalence of diagnosed CSU using large datasets representative of US national population. The findings of this study indicate a general increasing trend in the incidence and prevalence of CSU among the US population, with higher rates among pediatric patients than among adults. These results underscore the need for continued research in this area to understand the impact of CSU on patients and to improve the patient care pathway.

Acknowledgements

We would like to thank the participants and contributors to this study.

Medical Writing/Editorial Assistance

Medical writing/editorial support was provided by Mukhtar Ahmad Dar, Novartis Healthcare Pvt. Ltd., Hyderabad, India.

Author Contributions

All authors contributed to the study conception, design, data collection, and analysis. Manuscript preparation was performed by Yvonne Geissbühler and Maria-Magdalena Balp. All authors critically revised the manuscript and approved the final manuscript for submission.

Funding

This research and the journal rapid service fee was funded by Novartis Pharma AG, Basel, Switzerland.

Data Availability

All data generated or analyzed during this study are included in this article and available from the corresponding author on reasonable request.

Declarations

Conflict of Interest

Yvonne Geissbühler and Maria-Magdalena Balp are employees of Novartis Pharma AG, Basel, Switzerland. Aine Mcconnon, Justin Gomme, and Sarah Jane McKenna were employees of Novartis Business Services Center, Dublin, Ireland, at the time of the analysis. Ravneet Kaur Kohli is an employee of Novartis Healthcare Pvt. Ltd., Hyderabad, India. Weily Soong was a speaker for AbbVie, Amgen, AstraZeneca, GSK, Pfizer, Regeneron, and Sanofi; a consultant for AbbVie, Amgen, AstraZeneca, Novartis, Pfizer, Regeneron, and Sanofi; and has received research funding from AbbVie, Allakos, Amgen, AstraZeneca, Escient, Incyte, Leo, Novartis, Pfizer, Regeneron, and Sanofi.

Ethical Approval

The databases are compliant with the Health Insurance Portability and Accountability Act. As data used in this study are commercially available and de-identified, institutional review board approval was not required. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki of 1964 and its later amendments or comparable ethical standards.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

All data generated or analyzed during this study are included in this article and available from the corresponding author on reasonable request.

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