Chronic Spontaneous Urticaria (CSU) in Chinese Patients: Real-World Evidence of Disease Control and Treatment Patterns from the Urticaria Voices Study

Abstract

Introduction

Chronic spontaneous urticaria (CSU), characterized by recurring itchy wheals (hives) and/or angioedema lasting > 6 weeks without identifiable triggers, affects 1.29% of China’s population. China ranks second globally in urticaria disability-adjusted life years (DALYs), thus understanding real-world outcomes is important. We hypothesized that, despite ongoing treatment, a substantial proportion of Chinese patients with CSU experience inadequate disease control and impaired quality of life (QoL), with gaps between their treatment expectations and perceived achievability of optimal control. This study assessed patient-reported burden, treatment patterns, and unmet needs in these patients.

Methods

This was a cross-sectional study using 40-min online surveys. Patients were recruited through online panels. Eligibility included adults ≥ 18 years with physician-confirmed CSU diagnosis, actively treated. Descriptive analysis was stratified by disease control and treatment type.

Results

A total of 400 patients with CSU (mean age 35.09, [SD 7.24] years; 45% female) participated; 2% reported symptom onset < 1 year pre-study, 71% between 1 and 5 years, and 27% > 5 years (mean disease duration 5.31 [SD 4.89]). On the basis of the Urticaria Control Test (UCT), 35% of participants had inadequately controlled disease (UCT < 12), whereas Patient Global Impression of Severity (PGI-S) self-assessment suggested better perceived control (92% mild/no symptoms). Most diagnoses were made by dermatologists (94%); 57% of patients reported no fixed follow‑up schedule. Among inadequately controlled patients, 90% reported sleep disturbance during exacerbations. Most patients (82%) used second-generation antihistamines; one-third used Traditional Chinese Medicine. Complete symptom control was the top treatment goal (mean importance: 8.5/10), yet only 16% believed it achievable (9% of inadequately controlled).

Conclusions

One-third of treated patients with CSU reported inadequate disease control impacting QoL. The disconnect between high priority for complete control and low perceived achievability, alongside irregular follow-ups, highlights limitations in current therapies and care delivery. These findings underscore the need for more effective treatments and structured, patient-centered management pathways to optimize CSU care in China.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1007/s13555-026-01856-1.

Key Summary Points

Why carry out this study?

Despite China ranking second globally in urticaria-related disability-adjusted life years (DALYs) and having more than 18 million patients with CSU, real-world data on disease control, treatment patterns, and patient experiences in routine Chinese clinical practice are limited, making this study the first to provide comprehensive patient-reported data in this population.

One-third (35%) of actively treated patients with CSU in China report inadequate disease control on the basis of Urticaria Control Test (UCT < 12), among whom 90% experience sleep disturbance during exacerbations, 39% report feeling moody, 28% rate their professional life impact as moderate to severe (≥ 5 on a 10-point scale), and only 2% feel able to achieve their full life potential.

What was learned from the study?

While 84% of patients rate complete symptom control as highly important (> 8/10), only 16% believe it achievable with current treatments, and 50% of inadequately controlled patients identify “better treatment access” as essential for improving their lives—yet 57% of the participating patients lacking structured follow-up schedules, suggesting misalignment between patient needs and existing healthcare infrastructure.

Traditional Chinese Medicine was used by 38% of all patients with CSU (9% currently using and 29% in the past) in addition to conventional pharmaceutical treatment, indicating patients’ active search for complementary therapeutic approaches in managing CSU.

Despite physician recommendations for advanced therapies in 28% of patients (36% among inadequately controlled), actual utilization remains at only 7%, with 51% of those who escalated antihistamine doses experiencing new side effects including drowsiness (20%).

Introduction

Chronic spontaneous urticaria (CSU) is a debilitating skin condition characterized by recurring itchy wheals (hives) and/or angioedema lasting more than 6 weeks without identifiable external triggers [1]. In China, CSU affected approximately 1.29% of the population in 2022, representing more than 18 million patients nationally [1]. China ranks as the second country globally in urticaria-related disability-adjusted life years (DALYs), highlighting a substantial public health burden [2]. Despite the availability of various therapeutic options, including antihistamines and advanced therapies, treatment outcomes in real-world Chinese settings remain understudied.

Previous studies have focused primarily on clinical efficacy in controlled trials, with limited data on actual patient experiences, treatment accessibility, and economic burden in routine practice. Patient perspectives are essential, as they reveal treatment barriers, adherence challenges, and quality of life impacts that clinical trials cannot capture. Understanding these real-world perspectives is crucial for healthcare optimization at multiple levels, as they can illuminate gaps in current care provision, offer insights for improving patient care at the individual level, and inform policy decisions nationally, including reimbursement strategies that can directly impact treatment access and affordability.

To address these knowledge gaps, it is essential to understand current treatment pathways and their real-world effectiveness. Chinese guidelines [3] on treatment recommendations were locally adapted from international treatment guidelines (2022 version). These recommend second-generation H1-antihistamines (sg-H1-AH) as first-line therapy, with dose escalation up to four times the standard dose, if necessary, followed by biologic treatment and ciclosporin [4]. It should be noted that the international guidelines were updated in early 2026, with more specific recommendations including omalizumab as an add-on treatment after H1-antihistamines, as well as newer options such as dupilumab and remibrutinib, with ciclosporin being reserved for cases unresponsive to licensed treatments [5]. Despite available treatments, many patients continue to experience inadequate disease control [6].

This study aimed to investigate the real-world experiences of patients with CSU in China, examining disease control patterns, healthcare utilization, treatment satisfaction, impact on quality of life, financial burden (both insurance covered and out-of-pocket expenses), and the gap between patient expectations and current treatment outcomes.

By capturing comprehensive patient-reported outcomes across these dimensions, this study provides the first large-scale assessment of CSU management gaps in China. These findings are particularly timely as China expands its chronic disease coverage [7] and evaluates novel therapeutic options [8] that could address current treatment barriers [9], including the need for more accessible and acceptable treatment modalities.

Methods

Study Design and Population

This study consisted of an internet-based cross-sectional observational study conducted using a structured 40-min online survey. Patients with CSU in China were recruited through multiple channels, including referrals from healthcare professionals (e.g., physicians, nurses, pharmacy staff), patient communities (e.g., support groups, online forums), and patient recruitment panels managed by third-party vendors. These panels consist of preregistered individuals who have previously consented to participate in online research studies. The panels provided representative coverage of all major Chinese regions (North China, East China, South Central China, Southwest China, Northwest China, Northeast China). No gender-based recruitment quotas were applied.

A comprehensive questionnaire was used (see Supplementary Table S1 for the complete screening criteria) to identify respondents meeting the following qualifying criteria: self-reported physician-confirmed diagnosis of CSU, 18 years of age or older, currently receiving a physician-prescribed medical treatment for chronic urticaria, not currently part of a clinical trial for chronic urticaria, and not employed by a pharmaceutical or market research company. While direct medical record verification was not feasible, multiple validation questions were used to confirm diagnosis consistency, including visual symptom identification tests and temporal consistency checks (see Supplementary Table S2 for validation methods). The screening process captured patient characteristics including disease severity levels, treatment stages, and all major Chinese regions.

The data collection was conducted between August 2025 and October 2025. All participants recruited who completed the questionnaire for this study were remunerated for the time spent on this study as per fair market value.

This study was designed, implemented, and reported in accordance with the Guidelines for Good Pharmacoepidemiology Practices (GPP) of the International Society for Pharmacoepidemiology (ISPE 2015), the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines [10], and with the ethical principles laid down in the Declaration of Helsinki of 1964 and its later amendments.

Study materials (protocol, questionnaire, informed consent form) were reviewed and approved by the Tsinghua University Science and Technology Ethics Committee (protocol: CLOU064A2008; Institutional Review Board [IRB] ID: THU-01-2025-1009-R1). Moreover, the study was also reviewed and granted exemption by Pearl IRB (protocol: CLOU064A2008; IRB ID: 2025-0469). All participants had to review and electronically confirm their agreement with the informed consent form prior to being able to participate in the study. No personal identifiers were recorded, and all results are reported in an aggregate form.

Data Collection

Participants completed an internet-based 40-min self-completion questionnaire in (simplified) Chinese covering disease characteristics and duration, healthcare utilization patterns (including specialist consultations before and after diagnosis, visit frequency), current and previous treatments, disease control using validated instruments, quality-of-life impact across multiple domains including sleep impact, treatment satisfaction and expectations, and financial burden (insurance-covered and out-of-pocket expenses).

Disease control in patients was assessed with the Urticaria Control Test (UCT) [11], a validated 4-item questionnaire evaluating control over the past 4 weeks, each weighing 4 points with a maximum of 16 points overall. Patients scoring 16 are classified as completely controlled, those scoring 12–15 as well controlled, and those scoring under 12 as inadequately controlled. Recent symptom severity was captured using the Patient Global Impression of Severity (PGI-S) tool [12], which looked at the last 7 days and has five categories of symptom severity: no symptoms, mild, moderate, severe, and very severe symptoms. Both instruments were included to capture different temporal aspects of disease control, allowing for examination of potential recall bias and temporal variations. Sleep impact was evaluated using study-specific questions addressing sleep initiation, nighttime awakening frequency, and daytime dysfunction (fatigue, concentration), rather than validated sleep-specific patient-reported outcome (PRO) instruments.

Key outcomes including life domain impacts, treatment goal importance, and ability to reach full potential were assessed using 10-point scales (1, not at all/lowest impact; 10, extremely/highest impact).

The survey also assessed patients’ recall of whether and which Patient-Reported Outcome Measures (PROMs) were used by their physicians during clinical visits, their preferences for disease monitoring tools, and their perspectives on the adequacy of current disease assessment practices in their care.

Statistical Analysis

Descriptive statistics were performed for all primary and secondary endpoints, with continuous variables reported as means (standard deviations) and categorical variables as frequencies (percentages). No sample size calculation was performed as this was a descriptive study. Subgroup analyses were conducted primarily by disease control status (UCT scores: complete control = 16, well-controlled = 12–15, inadequately controlled < 12). Statistical significance was assessed using two-tailed t-tests (p < 0.05). No data imputation was performed; complete case analysis was carried out. Comparisons between subgroups were performed using column proportion tests at 95% confidence level.

Results

Patient Demographics and Disease Characteristics

The study enrolled 400 patients with CSU with a mean age of 35.09 (SD 7.24) years (45% female, 55% male). A majority of patients (71%) reported symptom onset 1–5 years prior to study participation, while 2% reported symptom onset < 1 year prior and 27% > 5 years prior, with a mean disease duration of 5.31 (SD 4.89) years (Table 1). Similarly, 71% of patients reported 1–5 years since diagnosis, with 3% reporting under 1 year and 14% reporting > 6 years (12% reported > 10 years), with mean value of 5.16 (SD 4.87). The most reported comorbidities by the patients were hypertension (14%), sinusitis (13%), and obesity (11%). On the basis of UCT scores, 35% of patients had inadequately controlled disease (UCT < 12), while Patient Global Impression of Severity (PGI-S) self-assessment showed that 92% perceived to have had—in the 7 days prior to study participation—mild or no symptoms.

Table 1.

Patient characteristics and demographics

	All CSU (N = 400)
Age (years), mean (SD)	35.09 (7.24)
Gender, n (%)
Female	181 (45)
Male	219 (55)
Geographic region, n (%)
South Central China	112 (28)
East China	94 (24)
North China	76 (19)
Southwest China	46 (12)
Northeast China	42 (11)
Northwest China	30 (8)
Years since onset, mean (SD)	5.31 (4.89)
Years since diagnosis, mean (SD)	5.16 (4.87)
Angioedema experienceda, n (%)	26 (7)
Disease control status based on Urticaria Control Test (UCT)b, n (%)
Complete control (score = 16)	58 (15)
Adequate control (score = 12–15)	202 (51)
Inadequate control (score < 12)	140 (35)

SD standard deviation

^aRefers to patients who have ever experienced angioedema during their disease course, not limited to those with active angioedema at the time of study enrollment

^bDisease control categories were derived from the UCT, a validated multi-item questionnaire assessing disease control over the previous 4 weeks

Disease Control

Objective disease control metrics differ from self-reported symptom perception. Among the participating patients, based on UCT, 140 patients with CSU (35%) were classified as inadequately controlled, 202 (51%) as well controlled, and 58 (15%) as fully controlled. In contrast, on the basis of PGI-S self-reported perception of symptom severity, 206 (52%) patients with CSU have experienced no symptoms in the 7 days prior to the survey, 160 (40%) mild, 32 (8%) moderate, 2 (1%) severe, and none with very severe symptoms.

Healthcare Utilization and Economic Burden

Dermatologists were the most frequently consulted specialists before diagnosis (70% of patients), followed by internal medicine specialists (25%), allergists (23%), and primary care physicians (20%). Initial diagnosis was established by dermatologists in 94% of cases. Following initial diagnosis, 86% of patients were seen by at least one additional dermatologist, with 41% seeing two additional dermatologists and 13% seeing three to five physicians. Healthcare engagement patterns revealed that 57% of patients reported no fixed visit schedule, rising from 52% (n = 285) among those diagnosed 1–5 years ago to 82% (n = 49) in those with ≥ 10 years disease duration.

Mean out-of-pocket expenses reached 876.13 CNY (approximately $129 USD) per month on CSU-related expenses reported by patients with CSU. These expenses included prescription medicine, doctor fees, alternative practitioners, dietician, complementary medicines, counseling, and Traditional Chinese Medicine (TCM). Other areas included non-prescribed medicines, travel costs, non-medical products, and special clothing. Patients reported CSU-related expenses covered by insurance amounted to a mean of 127.07 (SD 179.23) CNY, approximately 19 USD per month, increasing to a mean 157.08 (SD 222.27) CNY for inadequately controlled patients, approximately 23 USD.

Treatment Patterns and Outcomes

Figure 1 summarizes current treatment patterns. Sg-H1-AHs were used by 326 (82%) patients overall and by 106 (76%) of the inadequately controlled ones. Treatment modification was common: 71% of patients reported switching between different antihistamine types at least once, rising to 80% among inadequately controlled patients (Table 2). Dose escalation of current antihistamines once or more was reported by 63% of the patients overall and 78% in inadequately controlled. Among those who escalated, one dose increase was reported by 51% of all patients, two increases by 11%, and three or more increases by 1%. Of those who escalated doses, 51% experienced new side effects: 20% reported increased drowsiness and 31% developed other side effects. Despite dose escalation attempts, only 19% of all patients with CSU who escalated (13% of those currently inadequately controlled) reported achieving “complete improvement” from their past dose escalation (which was based on patient self-assessment without a standardized definition provided in the survey) (Table 2).

Fig. 1.

Current treatment utilization among patients with CSU. Fg-H1-AH first-generation H1-antihistamines, sg-H1-AH second-generation H1-antihistamines, TCM Traditional Chinese Medicine (including Lei-Gong-Teng with or without any H1-AH). All treatment categories except sg-H1-AH and fg-H1-AH monotherapy may include use with or without concomitant H1-antihistamines, as assessed in the original questionnaire. Biologics were queried as “biologics (e.g., omalizumab)” but respondents could report any biologic therapy, including potential off-label use. Traditional Chinese Medicine was assessed as both a general category and specific agents (Glycyrrhizin, Lei-Gong-Teng/Tripterygium), with Lei-Gong-Teng also assessed as monotherapy. Patients could receive multiple concomitant treatments; percentages reflect the proportion of patients receiving each treatment and are not mutually exclusive. Inadequate control defined as UCT < 12

Table 2.

Treatment patterns and outcomes in patients with CSU

	All patients with CSU (N = 400)	Patients with Inadequately controlled CSU (N = 140)	Patients with Adequately controlled CSU (N = 260)
Current treatment regimena, n (%)
sg-H1-AH monotherapy	326 (82)	106 (76)	220 (85)
Combination of different H1-AHs	53 (13)	28 (20)	25 (10)
fg-H1-AH monotherapy	34 (9)	7 (5)	27 (10)
Biologics (e.g., omalizumab)	26 (7)	14 (10)	12 (5)
H1-AH dose escalationb, n (%)
Patients with any H1-AH dose escalation	231 (63)	94 (78)	137 (56)
Outcomes of dose escalationb, n (%)
Achieved complete improvement	45 (19)	12 (13)	33 (24)
Developed new side effects	72 (31)	26 (28)	46 (34)
Experienced more drowsiness	46 (20)	24 (26)	22 (16)

Inadequate control defined as UCT <12, Adequately controlled as UCT 12–16

fg-H1-AH first-generation H1 antihistamine, H1-AH H1 antihistamine, sg-H1-AH second-generation H1 antihistamine

^aPatients could receive multiple concomitant treatments; percentages reflect the proportion of patients receiving each treatment and are not mutually exclusive. All treatment categories except sg-H1-AH and fg-H1-AH monotherapy may include use with or without concomitant H1−antihistamines, as assessed in the original questionnaire

^bPercentages calculated among patients currently on antihistamines (N = 366 for all CSU, N = 121 for inadequately controlled)

^bPercentages calculated among patients who underwent dose escalation (N = 231 for all CSU, N = 94 for inadequately controlled)

Biologic usage—queried generally as biologics without specification of particular agents—remained minimal: 26 (7%) patients currently receiving biologics, (14 [13%] among inadequately controlled patients), even though 73 (28%) patients reported that biologics were recommended to them by their physicians (34 [36%] in inadequately controlled) (Table 2). Main reasons reported by patients for refusing biologics when recommended by their physicians included concerns about side effects (58%), concerns about lowering immune system (44%), and feeling they did not have enough information about biologics to make an informed decision (32%).

Traditional Chinese Medicine use was reported in part of the population (115 [29%] had used, 37 [9% currently using]), in conjunction with conventional treatments, potentially reflecting both patient preference for integrated approaches and inadequate symptom control requiring supplementary therapies.

Quality-of-Life Impact

CSU significantly affected multiple quality-of-life domains (Fig. 2). Areas where patients experienced significant burden include:

• Sleep: during symptom exacerbations, 79% of patients experienced sleeping problems, rising to 90% among inadequately controlled patients. Nighttime awakening occurred two to three times per week in 46% of all patients (62% of inadequately controlled), while 48% reported trouble falling asleep sometimes or often (68% of inadequately controlled). Additionally, 73% of patients reported that lack of sleep affected their daily life in terms of fatigue or concentration, with this proportion increasing to 85% among those with inadequate disease control.

• Mental and emotional well-being: during periods of worst symptoms, patients reported a mean impact score of 3.87 (SD 1.62) on a 10-point scale (1, not at all negatively affected; 10, extremely negatively affected), with scores rising to 4.48 (SD 1.61) among those with inadequate disease control. The most frequent negative emotions during these periods included feeling moody (31% overall, 39% inadequately controlled). Social anxiety was reported by 15% of patients overall, increasing to 22% among those with inadequate disease control.

• Social life and intimate relationships: during peak symptom periods, patients reported a mean impact score of 3.82 (SD 1.77) on social life and intimate relationships on a 10-point scale, rising to 4.42 (SD 1.78) among those with inadequate control.

• Professional and academic life: at worst symptom presentation, patients reported a mean impact score of 3.28 (SD 1.86) on professional and academic functioning on a 10-point scale, with scores rising to 3.44 (SD 1.78) among those with inadequate control.

• Life potential: patients rated their ability to achieve full life potential at a mean of 3.32 (SD 1.34) on a 10-point scale (1, completely able; 10, not able at all), worsening to 3.71 (SD 1.21) among inadequately controlled patients. Moderate impact (scores 4–7) affected 46% of all patients versus 61% of inadequately controlled patients. Only 8% felt completely able to reach their full potential living with CSU, decreasing to just 2% among those with inadequate disease control.

Fig. 2.

Patient-reported impact of CSU across life domains during worst symptoms. Impact scores based on 10-point scale: 1, not at all negatively affected; 10, extremely highly negatively affected. Data shown as mean for adequately controlled (n = 260) and inadequately controlled subgroups (n = 140). Inadequately controlled defined as UCT < 12, adequately controlled as UCT 12–16. Patients rated impact retrospectively at worst symptom severity

Treatment Expectations and Unmet needs

Complete symptom control was rated the highest priority by patients with CSU (mean importance 8.5/10, where 10 = extremely important), followed closely by being free of itch and hives (8.2/10) and having no more visible skin signs (8.1/10). Despite these expectations, only 16% believed it achievable with current treatments (decreasing to 9% among inadequately controlled patients). This gap between expectation and reality was consistent across all disease control levels.

Key unmet needs identified included: 44% of patients (49% among inadequately controlled) reported the need for more information regarding treatments. Treatment access emerged as the second-highest priority: 42% of patients identified that better access to treatments would improve their lives; rising to 50% among inadequately controlled patients with CSU (Fig. 3).

Fig. 3.

Patient-identified unmet needs in CSU (top 6 responses by frequency)

Discussion

This study of 400 patients with CSU in China reveals important gaps in CSU management across China: while 35% of patients met objective criteria for inadequate disease control despite active treatment, more than 80% believe complete symptom control is unachievable with current therapies. More remarkably, 92% perceive their symptoms as mild or absent despite objective evidence of poor control. This discordance between validated measures and patient perception, combined with minimal utilization of advanced therapies despite clear clinical need for treatment escalation, highlights fundamental challenges in CSU management that extend beyond treatment efficacy alone.

Notably, our study population was 45% female, contrasting with the well-established global female predominance in CSU. The CURE registry analyses consistently demonstrate female-to-male ratios of 1.5–2:1, with women experiencing greater disease burden and poorer urticaria control, particularly in midlife [13]. This female predominance has been documented across diverse populations including Japan [14] and in systematic reviews [15]. Our finding of male predominance in the current survey participants may reflect differences in disease presentation, healthcare-seeking behaviors, or diagnostic patterns specific to our survey respondents. Cultural factors influencing healthcare utilization—with Chinese male individuals potentially more likely to seek medical attention for visible skin conditions—or differences in hormonal and environmental factors affecting CSU manifestation could contribute to this pattern. Additionally, the use of mixed recruitment channels and online recruitment methods may have introduced selection bias, though further research is needed to determine whether this represents a true epidemiological difference or methodological artifact. This contrast with the greater burden typically observed in women globally [13] warrants further investigation into population-specific factors influencing CSU epidemiology.

Another notable finding is the markedly low angioedema prevalence in our cohort (7%) compared with 29% reported in Asian populations [19]. This substantial discrepancy likely reflects under-recognition rather than true absence, as patients may not identify facial or lip swelling as part of their CSU manifestation. This aligns with our broader findings of limited disease awareness and the expectation–reality gap, where patients minimize or fail to recognize key disease features. The under-reporting of angioedema has important clinical implications, as unrecognized angioedema may delay appropriate treatment escalation and contribute to the documented discordance between objective disease burden and patient perception.

The discrepancy between UCT scores and PGI-S assessments represents a critical finding with multiple implications. While methodological factors, including different recall periods for the questionnaires (4 weeks UCT, 7 days PGI-S) contribute to the discrepancy, this cannot fully explain the gap between objective inadequate disease control and subjective symptom perception. This may reflect tendencies toward symptom minimization in Chinese populations [16], or to communication gaps where patients may not effectively convey the severity of their conditions. Additionally, limited disease awareness in the general population may contribute to delayed treatment-seeking and symptom normalization, though this requires further investigation in the Chinese context.

Our findings reveal a substantial proportion of patients who are currently inadequately controlled by H1-antihistamines on the basis of UCT scores: 71% of patients had switched between antihistamines (80% among inadequately controlled patients) and 63% had experienced dose escalation (78% among inadequately controlled), yet only 19% reported achieving complete improvement from their dose escalation attempts. This apparent paradox—reporting complete improvement from past dose escalation while currently meeting criteria for inadequate control—primarily reflects the temporal disconnect between historical treatment response and current disease status. The UCT assessed control over the 4 weeks prior to survey completion, while dose escalation improvements could have occurred months or years earlier. This finding underscores the nonlinear nature of CSU, where initial treatment response may not persist over time. In addition, the subjective nature of patient-reported improvement, as “complete improvement” was not defined in our survey, may have contributed to varied interpretations, and 51% of dose escalators experienced side effects (20% drowsiness, 31% other), likely limiting further optimization. These treatment patterns align with the CURE registry findings showing that fewer than 10% of patients achieve complete control with H1-antihistamine escalation [17], confirming widespread H1-antihistamine therapy failure across diverse populations.

The subsequent treatment escalation gap is particularly concerning because despite physicians recommending biologics to 28% of patients (36% for inadequately controlled), actual uptake remained low. This gap between recommendation and implementation, consistent with CURE’s finding that 28.6% of patients with UCT < 12 did not receive indicated treatment escalation (including escalation to up-dosed antihistamines or biologics) [17], suggests potential barriers beyond clinical decision-making.

Multiple interconnected barriers prevent treatment optimization. Patient-level related factors include injection aversion (consistent with findings that 75% preferred oral options in the CHOICE CSU2 study [18]), safety concerns, and information gaps.

System-level barriers, including out-of-pocket costs averaging 876 CNY monthly (approximately sevenfold higher than insurance coverage), with significant regional variation in coverage affecting treatment accessibility across different Chinese provinces, irregular follow-up patterns (57% without scheduled visits), and limited specialist availability, appear equally important. The substantial Traditional Chinese Medicine usage rate (38% tried, 9% continuing) may reflect unique Chinese healthcare-seeking patterns and self-management strategies in the absence of structured care, particularly given that 57% of patients lack scheduled follow-up visits. Notably, 42% of all patients—and half of those inadequately controlled—identified better treatment access as key to improving their lives, representing a clear call for healthcare system improvements. This convergence of patient-identified needs with objective treatment gaps suggests that novel oral therapies addressing both efficacy and accessibility could transform CSU management.

The profound sleep disruption affecting 79% of patients with inadequately controlled CSU, with 85% reporting daytime dysfunction, represents an underrecognized disease burden that extends into multiple life domains: sleep impairment creates a vicious cycle, potentially worsening urticaria through stress-immune interactions while diminishing coping capacity and straining emotional well-being. Although first-generation sedating antihistamines may help alleviate nocturnal symptoms, their associated daytime drowsiness may worsen fatigue and concentration difficulties, making them suboptimal for long-term CSU management.

This comprehensive burden—with only 8% of patients feeling able to achieve their full life potential (2% among inadequately controlled)—is compounded by a fundamental expectation–reality gap: while patients universally prioritize complete symptom control (8.5/10 importance overall), only 16% believe it achievable with current treatments. This disconnect, alongside irregular monitoring (with low patient awareness of disease chronicity potentially contributing to irregular follow-up) and unmet information needs, underscores the need for comprehensive treatment approaches that address both symptom and patient expectations through structured follow-up protocols and enhanced patient education.

These findings have important implications for healthcare policy and clinical practice in China. Three priority areas emerge for improving CSU management: (1) addressing the expectation–reality gap through enhanced patient education and shared decision-making; (2) improving treatment accessibility through streamlined pathways and enhanced reimbursement; and (3) developing convenient oral alternatives aligning with patient preferences. While interventional studies are needed to quantify potential impact, the convergence of inadequate control, treatment escalation barriers, and patient preferences for convenient oral therapies provides evidence-based guidance for healthcare system improvements.

Strengths

This study has several notable strengths. Our comprehensive screening questionnaire incorporated multiple validation questions, red herring items, and consistency checks (Supplementary Table S2) specifically designed to ensure accurate CSU diagnosis and minimize misclassification with other conditions such as atopic dermatitis. The study achieved broad geographic representation across six major Chinese regions, enhancing generalizability of findings. These recent data (collected in 2025) fill a critical knowledge gap in understanding CSU management in China, the world’s most populous country, with more than 18 million affected individuals. Furthermore, the study design was informed by the global Urticaria Voices framework [14], enabling meaningful international comparisons and contributing to worldwide insights on CSU burden and management patterns.

Limitations

The cross-sectional design precludes causal inference and cannot capture treatment trajectories or long-term outcomes. Online recruitment may underrepresent elderly, rural, or digitally disadvantaged populations, potentially underestimating access barriers. Self-reported physician diagnosis without medical record verification remains a limitation, though our comprehensive screening questionnaire with multiple validation questions, red herring items, and consistency checks were designed to minimize misclassification. Recall bias may affect reported disease duration and treatment history. In addition, key terms such as “complete improvement” and “treatment access” were not defined in the survey, allowing for subjective interpretation, which combined with the temporal disconnect between past treatment responses and current disease assessment, may help explain the discordance between patient-reported historical improvement and current validated disease control measures. The term “treatment access” could encompass financial, geographic, institutional, or insurance-related barriers depending on individual patient interpretation. Cultural differences in symptom reporting and healthcare communication may have influenced patient responses, potentially affecting patients’ answers given the nature of self-reported outcomes.

Despite these limitations, this study provides valuable real-world insights into CSU management gaps in China, highlighting areas requiring policy intervention.

Conclusions

This real-world study illustrates the current state of CSU management in China from the patients’ perspective, documenting significant unmet needs in disease control and treatment access. Despite 35% of patients experiencing inadequately controlled disease in the previous 4 weeks at study completion while on active treatment, advanced therapy utilization remained low, at only 7% of patients currently using them. Notably, 50% of inadequately controlled patients identified treatment access as essential for improving their lives. The disconnect between patient priorities for complete control and low perceived achievability with current treatments is particularly concerning given that more than half of these patients with active chronic disease lack routine follow-up schedules, missing key opportunities for treatment optimization. This irregular monitoring, combined with high alternative medicine usage, highlights systemic challenges in current care delivery that perpetuate inadequate control.

Priority interventions should include implementing structured monitoring protocols to ensure patients with active CSU receive regular assessment and timely treatment escalation and developing patient education programs that align treatment expectations with achievable outcomes.

The substantial disease burden documented here—affecting sleep, mental health, social life, and productivity, with only 8% feeling able to achieve full life potential—combined with patient preference for convenient oral therapies and current access limitations, provides evidence for new treatment approaches. As China continues healthcare reforms aimed at improving chronic disease management, addressing the identified gaps in CSU care through accessible, effective treatments aligned with patient preferences could serve as a model for managing other chronic conditions. Future research should evaluate interventions targeting these specific gaps and assess the impact of novel therapeutic options on real-world outcomes.

Supplementary Information

Below is the link to the electronic supplementary material.

Author Contributions

All authors contributed to the study conception and design. Cristina Constantinescu led data collection and analysis and contributed to study design, execution, and results interpretation. Angie Li provided consultancy services and obtained Tsinghua University Ethics Committee approval for China implementation. Tara Raftery, Nadine Chapman-Rothe, Pallavi Saraswat, and Ruixin Tan led study design, execution, and results interpretation. Bin Yang and Zuotao Zhao provided clinical expertise. Yi Li contributed patient advocacy perspectives. Jessica McCarthy, Ravneet Kaur Kohli, and Guojiao You supported study design and interpretation. All authors approved the final version.

Funding

Sponsorship for this study and Rapid Service Fee were funded by Novartis Pharma AG, Basel, Switzerland.

Data Availability

The datasets generated and/or analyzed during the current study are not publicly shared. However, they can be available from the corresponding author on reasonable request.

Declarations

Conflict of Interest

Zuotao Zhao, Yi Li and Bin Yang have no COIs to disclose. Tara Raftery is an employee of Novartis Ireland Ltd, Dublin, Ireland, and reports holding shares of Novartis Pharma AG, Basel, Switzerland. Nadine Chapman-Rothe is an employee of Novartis Pharma AG, Basel, Switzerland, and reports holding shares of Novartis Pharma AG. Pallavi Saraswat is an employee of Novartis Healthcare Pvt Ltd, Hyderabad, India, and reports holding shares of Novartis Pharma AG, Basel, Switzerland. Jessica McCarthy is an employee of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, and reports holding shares of Novartis Pharma AG, Basel, Switzerland. Ravneet Kohli is an employee of Novartis Healthcare Pvt Ltd, Hyderabad, India. Cristina Constantinescu is an employee of Ipsos, a consulting company that received funding from Novartis for the design and execution of this study. Angie Li is an employee of Ipsos China, a consulting company that received funding from Novartis for communication of study affairs in China. Guojiao You is an employee of Beijing Novartis Pharma Co., Ltd, Shanghai, China, and reports holding shares of Novartis Pharma AG, Basel, Switzerland. Ruixin Tan is an employee of Beijing Novartis Pharma Co., Ltd, Shanghai, China, and reports holding shares of Novartis Pharma AG, Basel, Switzerland.

Ethical Approval

This study was designed, implemented and reported in accordance with the Guidelines for Good Pharmacoepidemiology Practices (GPP) of the International Society for Pharmacoepidemiology (ISPE 2015), the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines (Vandenbroucke et al. 2014) [10], and with the ethical principles laid down in the Declaration of Helsinki of 1964 and its later amendments. Study materials (protocol, questionnaire, informed consent form) were reviewed and approved by the Tsinghua University Science and Technology Ethics Committee (Protocol: CLOU064A2008; Institutional Review Board [IRB] ID: THU-01-2025-1009-R1). Moreover, the study was also reviewed and granted exemption by Pearl IRB (Protocol: CLOU064A2008; IRB ID: 2025-0469). All participants had to review and electronically confirm their agreement with the informed consent form prior to being able to participate in the study. No personal identifiers were recorded, and all results are reported in an aggregate form.