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. 2025 Aug;15(8):2201-2215.
doi: 10.1007/s13555-025-01461-8. Epub 2025 Jun 22.

Urticaria Voices: Real-World Treatment Patterns and Outcomes in Chronic Spontaneous Urticaria

Jonathan A Bernstein  1   2 , Tonya A Winders  3 , Jessica McCarthy  4 , Pallavi Saraswat  5 , Nadine Chapman-Rothe  6 , Tara Raftery  7 , Karsten Weller  8
Affiliations

Urticaria Voices: Real-World Treatment Patterns and Outcomes in Chronic Spontaneous Urticaria

Jonathan A Bernstein et al. Dermatol Ther (Heidelb). 2025 Aug.

Abstract

Introduction: Chronic spontaneous urticaria (CSU) is characterized by itchy wheals/hives and/or angioedema lasting longer than 6 weeks. Herein, we describe patients' perspectives from the global Urticaria Voices study reporting treatment patterns, disease burden, treatment satisfaction, and expectations.

Methods: This global, cross-sectional online survey was conducted from February to September 2022 in patients with CSU. Eligible patients had a self-reported clinician-provided diagnosis of CSU. Data were analyzed descriptively and reported as percentages (n/N), means (standard deviation [SD]), or 95% confidence intervals.

Results: Overall, 582 patients with CSU were included in this analysis (62% women; mean [SD] age: 42.0 [11.9] years). At the time of the survey, patients reported taking 2.9 (2.6) concomitant therapies; most patients (79%) were prescribed H1-antihistamines (H1-AH), of which 42% took first-generation H1-AH and 52% took second-generation H1-AH. Since the initiation of their first prescribed treatment (6.3 [8.2] years), 80% of patients reported H1-AH switching (2.3 times on average), 62% of whom reported up-dosing (2.9 times on average). In addition, 50% reported currently using glucocorticoids (cream: 72.1%; oral: 48.3%; injection: 25.5%) and 33% reported using any biologic (omalizumab: 26%; dupilumab: 16%): montelukast (18%), doxepin (16%), or ciclosporin (16%). Apart from their prescribed treatments, patients reported currently using additional services (dietetic consultations: 21%, psychological support: 19%) and self-care strategies (e.g., using topical creams, avoiding certain clothing and foods) for CSU management. Most patients (65%) reported that their current treatments did not adequately control their CSU symptoms. Overall, 37% of patients reported experiencing stress due to the unpredictable nature of the disease.

Conclusions: Despite H1-antihistamine switching and up-dosing, most patients (84%) had inadequately controlled disease. Approximately one-quarter of inadequately controlled patients were escalated to more effective treatments such as biologics. These results suggest a need for additional treatment options for patients with inadequately controlled CSU to provide sustained symptom relief.

Keywords: Chronic spontaneous urticaria; Disease burden; Disease control; H1-Antihistamines; Patients’ perspectives; Real-world evidence; Treatment patterns; Treatment satisfaction and expectations; Urticaria voices.

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Conflict of interest statement

Declarations. Conflict of Interest: Jonathan A. Bernstein reports grants from Novartis, AstraZeneca, Sanofi-Regeneron, Amgen, Roche, Allakos, Celldex, CSL Behring, Takeda/Shire, BioCryst, Pharming, Ionis, BioMarin, Intellia, Astria, Aretrea, Pharvaris, Blueprint Medicines, Cogent, Telios, Yuhan, Evoimmune, Incyte/Escient, Jasper, Eli Lilly, Allergy Therapeutics, and Genentech outside the submitted work; personal fees from Novartis, AstraZeneca, Sanofi‑Regeneron, Amgen, Roche, Allakos, Celldex, CSL Behring, Takeda/Shire, BioCryst, Pharming, Ionis, BioMarin, and Genentech outside the submitted work. Tonya Winders receives funds from unbranded disease awareness and education from Novartis, AstraZeneca, Sanofi-Regeneron, Amgen, Roche, and Genentech outside the submitted work. Jessica McCarthy is an employee of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 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. Nadine Chapman-Rothe is an employee of Novartis Pharma AG, Basel, Switzerland, and reports holding shares of Novartis Pharma AG. Tara Raftery is an employee of Novartis Ireland Ltd, Dublin, Ireland, and reports holding shares of Novartis Pharma AG. Karsten Weller reports grants from Novartis, Sanofi, and Takeda outside the submitted work and personal fees from BioCryst, BioMarin, CSL Behring, Novartis, Moxie, and Takeda outside the submitted work. Ethical Approval: This study was conducted in accordance with legal and regulatory requirements and fulfilled the criteria of the “European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study” and followed the “ENCePP Code of Conduct,” as previously described [23]. All participants of the survey provided written informed consent forms, approved by the corresponding institutional review board/ethics committee (IRB/IEC) and in accordance with the Declaration of Helsinki and other relevant regulatory requirements. An exemption from ongoing oversight was obtained from the Pearl IRB, who reviewed and granted international approval of an exemption [23]..

Figures

Fig. 1
Fig. 1
Patient-reported disease control with H1-antihistamines. Analysis conducted in patients who were on H1-AH (460 of 582 [79%]) from the pooled dataset; country-specific results are published elsewhere; 23.7% of patients (138 of 582) were exclusively on H1-AH and 65.5% of patients (381 of 582) received mixed treatments. CSU, chronic spontaneous urticaria; H1-AH, H1-antihistamine; n, number of patients; SD, standard deviation; UCT, Urticaria Control Test
Fig. 2
Fig. 2
CSU control in patients using glucocorticoids. These data are based on UCT, thus caution should be exercised while interpreting these data, as most patients in this study received glucocorticoids only once or for a short term to manage exacerbations. As UCT spans a period of 4 weeks, it is important to note that the disease control data may not have been accurate because of glucocorticoid treatment. The percentages are based on the total number of patients in each category; each category is based on the route of administration and are analyzed independently and not as subcategories of “any glucocorticoids.” a In combination with other treatments for CSU. CSU, chronic spontaneous urticaria; N, number of patients; UCT, Urticaria Control Test
Fig. 3
Fig. 3
Impact of CSU on patients’ mental and emotional well-being. Data based on responses to the survey question: “Please indicate how you feel about living with chronic urticaria from the list below.” CSU, chronic spontaneous urticaria; N, total number of patients; n, number of patients in each subgroup; UCT, Urticaria Control Test
Fig. 4
Fig. 4
Satisfaction with current treatment(s) in patients with CSU. Base: all patients with CSU giving a low satisfaction score (n = 93). CSU, chronic spontaneous urticaria; SD, standard deviation; QoL, quality of life; UCT, Urticaria Control Test
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