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. 2025 Oct;15(10):2925-2946.
doi: 10.1007/s13555-025-01498-9. Epub 2025 Aug 8.

The Urticaria Voices Study: Physicians' Perspectives on the Real-World Patient Burden, Treatments, and Outcomes in Chronic Spontaneous Urticaria

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

The Urticaria Voices Study: Physicians' Perspectives on the Real-World Patient Burden, Treatments, and Outcomes in Chronic Spontaneous Urticaria

Karsten Weller et al. Dermatol Ther (Heidelb). 2025 Oct.

Abstract

Introduction: Chronic spontaneous urticaria (CSU) significantly impacts patients' quality of life (QOL). Understanding physicians' perspectives and treatment approaches for CSU is crucial for optimizing the outcomes. We describe the CSU management challenges and treatment perceptions reported by physicians in the Urticaria Voices study.

Methods: This is a multinational cross-sectional online survey involving patients with CSU and CSU-treating physicians from seven countries (USA, Canada, UK, Germany, France, Italy, and Japan). The reported analyses assessed prescribing patterns, treatment satisfaction, and disease management challenges for physicians. Data were analyzed descriptively.

Results: Overall, 862 physicians (517 dermatologists; 345 allergists) participated in the study. Fifty-two percent perceived CSU as serious and 65% reported that CSU negatively impacts patients' life, particularly mental well-being (mean [SD], 8.2 [1.7]; 10-point scale). Key challenges included treatment-related issues (approx. 66%) and diagnosis (39%). Globally, 56% of physicians adhered to guidelines, 19% followed therapeutic protocols, and approximately 30% did not adhere to any guideline. Physicians reported that 80% of patients were on H1-antihistamines (H1-AH; second-generation H1-AH [sgH1-AH], 57%; first-generation H1-AH, 23%), 29% on steroids, and 21% on omalizumab. Overall, 67% of physicians were satisfied with omalizumab and 33% with sgH1-AH. For patients inadequately controlled on H1-AH, physicians doubled (21%) or quadrupled (32%) H1-AH dose or added omalizumab (11%) or another sgH1-AH (10%). Key treatment goals were improving patients' QOL (81%) and being free of itch and hives (75%); approximately, half of the physicians (51%) reported success in achieving complete symptom control. Unmet needs included better understanding of CSU etiology (48%), better access to treatments (47%), and reduced administrative barriers for prescribing biologics (45%).

Conclusion: Improving patients' QOL and diagnosis- and treatment-related challenges is critical in CSU management from physicians' perspective. Despite higher satisfaction with omalizumab, predominant use of sgH1-AH and reluctance to escalate to omalizumab indicate areas for improving treatment strategies in CSU care. Notably, reluctance to escalate to biologics may be partly due to limited availability and barriers to access in certain countries, which must be addressed to optimize care globally.

Keywords: Chronic spontaneous urticaria; Disease burden; Real-world data; Treatment outcomes; Treatment patterns.

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Conflict of interest statement

Declarations. Conflicts of Interest: Karsten Weller reports grants from Novartis, Sanofi, and Takeda outside the submitted work and personal fees from Biocryst, Biomarin, CSL Behring, Novartis, Moxie, Takeda outside the submitted work. Tonya A. Winders receives funds for unbranded disease awareness & education from Novartis, AstraZeneca, Sanofi-Regeneron, Amgen, Roche & Genentech outside of the submitted work. Jessica McCarthy is an employee of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, 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. 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 Medicine, 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. Ethical Approval: This study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki and adhered to the Guidelines for Good Pharmacoepidemiology Practices of the International Society for Pharmacoepidemiology 2016 and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines [16]. Legal and regulatory requirements, and criteria of a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study were further fulfilled and the ENCePP Code of Conduct was followed [17]. All study materials, including the translated questionnaire, underwent review by a recognized institutional review board (IRB) globally. This study was reviewed and approved by Pearl IRB (approval number 21-IPSO-157A), which granted an exemption from ongoing oversight based on the nature of the study involving anonymous, self-administered online surveys with no intervention or collection of sensitive personal health information. The Pearl IRB provided global oversight, granting an exemption while ensuring adherence to ethical standards across countries. In addition, local/ethics committee approval was sought and received in Japan (and France). IRB/ethical approval was sought for this study based on the rationale that while the study included “living people” who completed the quantitative internet-based survey, no articles or substances were tested. An exemption from ongoing oversight was sought after and obtained from an IRB, who reviewed and granted international approval. Informed opt-in consent was requested from respondents prior to the initiation of fieldwork. Irrespective of the sample origin, all participants electronically acknowledged receipt of their informed consent forms before initiating the survey. All physicians read and signed informed consent forms electronically before survey participation. The informed consents were approved by IRB/EC and complied with the Declaration of Helsinki as well as regulatory requirements. Adherence to research and regulatory standards ensured that the rights, safety, and well-being of patients in noninterventional studies were protected, in line with the principles originating from the Declaration of Helsinki.

Figures

Fig. 1
Fig. 1
Physician’s perspective about the disease and available treatments. Question to physicians: Please indicate to what extent you agree or disagree with these statements. al do not need to ask my patient if their CSU causes them to suffer because if they are, they will tell me. bI am worried that if I prescribe a biologic after trying the maximum recommended dose of the first antihistamine, others may think that I am not doing the right thing. Measures of parameters were collected on a 6-point scale, with number 1 denoting completely disagree and 6 denoting completely agree. CSU chronic spontaneous urticarial, H1-AH H1-antihistamine
Fig. 2
Fig. 2
Percentage of physicians, who have rated CSU impact on individual target life domains with 8 or higher. Question to physicians: To the best of your knowledge, please estimate the extent to which each of the following life domains are negatively affected in your patients with inadequately (poorly) controlled CSU. Measures of parameters were collected on a 10-point scale, with number 1 denoting a low score and 10 denoting a high score. Top 3 box results refer to the percentage of physicians choosing a high score of 8, 9, or 10. CSU chronic spontaneous urticarial, UK United Kingdom, USA United States of America
Fig. 3
Fig. 3
Physician’s challenges when diagnosing and treating patients. Question to physicians (open ended): In your experience, what are the most common challenges you face when diagnosing and treating patients with CSU? aDiagnosis-related challenges include finding a cause, late or misdiagnosis, unclear symptoms. bDisease is difficult to explain to patients, inaccurate patient history, raise awareness about autoimmune phenomena. cIncludes poor effectiveness of treatments and management of symptoms, poor response rate, lack of long-term control. dIncludes difficulties with access to effective treatments and selecting suitable treatments. eChallenges include patient compliance, restrictions to increase dose, patients on steroids. CSU chronic spontaneous urticaria
Fig. 4
Fig. 4
Physicians’ methods to assess and monitor patients with CSU with or without PROMs. Question to physicians: How else, if at all, do you assess and monitor your CSU patients’ symptoms and treatment outcomes? CSU chronic spontaneous urticarial, PROM patient-reported outcome measure
Fig. 5
Fig. 5
(i) Current CSU treatments used by physiciansa; (ii) Second-line treatment given directly after failure of licensed sgH1-AHb. aPhysicians may have prescribed > 1 type of treatment at a time. bTop 5 second-line therapies. (i) Question to physicians: Thinking about all your patients with CSU, please indicate what percentages are on the following therapies? (ii) Question to physician: In general, what would be your immediate next step for patients with CSU to whom you have already prescribed the recommended licensed dose of a second-generation H1-AH but who continue to be poorly uncontrolled and have moderate/severe activity? CSU chronic spontaneous urticarial, fgH1-AH first-generation H1-antihistamine, H1-AH H1 antihistamine, sgH1-AH second-generation H1-antihistamine, UK United Kingdom, USA United States of America
Fig. 6
Fig. 6
Proportion of physicians who expressed high satisfaction with current CSU treatment options by country. Question to physician: Regarding the clinical benefits and achieving your treatment objectives, how satisfied are you with the treatments you have prescribed for your chronic urticaria patients? The figure presents data of the top 3 box, which refers to the percentage of physicians choosing scores of high satisfaction: 8, 9 or 10 of 10 (in line with top 3 boxes). CSU chronic spontaneous urticaria, fgH1-AH first-generation H1-antihistamine, sgH1-AH second-generation H1-antihistamine, UK United Kingdom, USA United States of America
Fig. 7
Fig. 7
Percentage of physicians who rank (i) treatment goal and (ii) unmet need categories in CSU with high level of importancea. (i) Question to physicians: Please score the following treatment expectations according to how important they are for the management of your patients’ CSU. (ii) Question to physicians: Please read the list and select what you believe could improve the lives of people living with CSU. aMeasures of parameters were collected on a 10-point scale, with 1 denoting not at all important and 10 denoting extremely important. Top 3 box results refer to the percentage of physicians choosing a high score of 8, 9, or 10. CSU chronic spontaneous urticarial, QOL quality of life, UK United Kingdom, USA United States of America
Fig. 8
Fig. 8
Physicians’ perceived barriers to achieving complete CSU symptom control. Question to physician (open-ended): What are your main barriers to achieving complete control in your patients with CSU? CSU chronic spontaneous urticaria
See this image and copyright information in PMC

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