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Real-world data offer new insights into chronic urticaria care

In her PhD research project aimed at improving urticaria care in daily clinical practice, Reineke Soegiharto (UMC Utrecht) showed that some patients with urticaria develop long-term disease that can be predicted early based on the clinical characteristics. She also demonstrated that omalizumab is a safe and effective treatment for chronic urticaria and angioedema. The findings may help physicians identify patients at risk of long-term disease earlier and support more personalized treatment strategies.

Urticaria (or hives), a skin disease characterized by recurring itchy hives and swelling of the skin, affects many people at some point in their lives. It is estimated that 0.3-0.5 percent of the population in Western Europe present to their general practitioner (GP) with urticaria. In most cases, symptoms disappear within days or weeks. However, in about 1 in 6 patients (17 percent), symptoms persist for months or even years. This chronic form of urticaria can have a major impact on quality of life, including sleep disturbances, fatigue, reduced work and school productivity and psychosocial problems.

Reineke Soegiharto, MD PhD

The research by PhD candidate Reineke Soegiharto, MD was based on both Dutch GP data and international real-world clinical data. She performed her research at the Department of Dermatology & Allergology at UMC Utrecht, a recognized international chronic urticaria Center of Reference and Excellence within the European GAL²EN Network. Reineke and colleagues investigated how chronic urticaria develops and how patients respond to treatment in daily practice. In total, data from more than 16,000 patients in general practice and over 2,300 patients treated with a biologic in specialized urticaria centers across 10 countries were analyzed.

Early indicators of prolonged disease

A key finding was that certain characteristics at the first presentation to the GP may predict a prolonged disease course. Older age, higher body mass index (BMI), and early use of prednisolone were associated with a higher likelihood of developing chronic urticaria and experiencing symptoms for more than one year. According to the researchers, recognizing these indicators early may help healthcare professionals intervene sooner, for example by optimizing antihistamine treatment or referring patients to a specialist at an earlier stage.

Strong real-world evidence for omalizumab

The studies also provide valuable long-term data on the monoclonal antibody omalizumab, a biologic therapy often used when antihistamines do not sufficiently control symptoms. While formal clinical trials have already demonstrated the efficacy and safety of omalizumab, evidence from everyday clinical practice remained limited.

The analysis of the international data set by Reineke Soegiharto showed that omalizumab was highly effective in daily practice: 80 percent of patients achieved good disease control or became symptom-free, often within the first month of treatment. The treatment also proved to be safe, with no serious side effects reported. Although one-third of patients experienced mild side effects such as fatigue or headache, only a small proportion discontinued treatment because of these complaints.

Broader implications for patient care

Importantly, the Soegiharto and co-workers demonstrated that omalizumab is also effective and safe in patient groups for whom access or reimbursement is still limited in many countries, including patients with chronic inducible urticaria and patients suffering primarily from recurrent angioedema. These findings support broader access to treatment and underline the importance of individualized care.

Reineke Soegiharto concluded: “Real-world data are essential for improving care for patients with chronic urticaria, particularly now that new therapies are emerging. By better understanding which patients are at risk of severe or prolonged disease and how treatments perform outside clinical trials, we may be able to tailor treatment more effectively to individual patients in the future.”

PhD defense

Reineke Soegiharto (1995, Leiden) defended her PhD thesis on May 27, 2026 at Utrecht University. The title of her thesis was “Beyond the wheals: mapping the road of chronic urticaria from primary to specialized care – real-world insights into the course and care of chronic urticaria.” Supervisor was Prof. André Knulst, MD PhD (Department of Rheumatology & Clinical Immunology, UMC Utrecht). Co-supervisors were Heike Röckmann, MD PhD (Department of Rheumatology & Clinical Immunology, UMC Utrecht) and Juul van den Reek, MD PhD (Department of Dermatology, Radboudumc). In May 2025, Reineke started working as a resident in dermatology at UMC Utrecht.

Previous articles on this subject

  • November 3, 2023
    Omalizumab also highly effective in chronic urticaria in real world setting
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