Chronic spontaneous urticaria – the impact on patient quality of life, ongoing developments in treatments and the importance of greater awareness
Ella Day | October 3, 2025 | Feature | Medical Communications, Research and Development | Dermatology, Immunology, acute urticaria, chronic spontaneous urticaria, dermatology, immunology
Pharmafile talks to Martin Metz, Professor of Dermatology about chronic spontaneous urticaria (CSU), a debilitating dermatological condition. He discusses its impact on patient quality of life, ongoing developments in treatments and the importance of greater awareness of the condition.
Pharmafile: Can you give us an overview of CSU?
Martin Metz (MM): CSU is quite a common disease, with a prevalence of about 1%. The most common symptoms are itchy wheals or hives. About 50% patients also have angioedema, which is swelling – typically of the eyelid or the lip, but it can occur anywhere on the body.
Acute urticaria is probably the most common dermatological disease, with a prevalence of 4-5%. CSU develops when acute urticaria persists for longer than six weeks. It’s called spontaneous because these signs and symptoms occur randomly and without triggers. The wheels last usually for a few hours, and return daily.
Patients really suffer a lot, mainly because of itchiness. The angioedema – if it occurs – place an extra burden on these patients because they look unpleasant and patients worry that the swelling could cause suffocation. It doesn’t, but if your tongue is three times the size it usually is, patients are understandably concerned.
The causes of CSU are mainly autoimmune in nature. It can affect anyone of any age, mainly between the ages of 30 and 50. It affects women twice as much as men.
Pharmafile: Does CSU have any known causes or triggers?
MM: There are two main autoimmune mechanisms which are important: type 1 autoimmunity or autoallergy and type 2b autoimmune patients. They each activate the muscles in different ways, but they both degranulate them, leading to the same signs and symptoms. Therefore, it’s difficult to determine which patients have which mechanism just by looking at them.
Pharmafile: What are the guidelines for current treatments?
MM: The current guidelines follow a three-step treatment algorithm. The standard therapy and first-line treatment are second-generation antihistamine in standard dose or up-dose if needed. Upward doses are not approved anywhere in the world, but they work and are safe, and so are recommended in the guidelines. With a standard dose, we get about 10% of the patients under control, and if they are up-dosed, that number can rise to 40%.
For patients who are resistant to this standard therapy, the next step is anti-IgE treatment, referred to as Omalizumab. This helps approximately 20% of patients, but a remaining 40% still don’t respond adequately. In this case, the guidelines recommend cyclosporine treatment, which we really try to avoid because of associated problems and it being an off-label treatment.
In some parts of the world, including the US, dupilumab is now also approved for the treatment of CSU, and we anticipate approval in Europe soon. Additionally, we hope that remibrutinib, a BTK inhibitor therapeutic, will be approved soon.
Pharmafile: What factors are limiting current treatments, and how can these be addressed?
MM: There are various factors that are limiting current treatments, the biggest being the healthcare professionals (HCPs) themselves. Not all HCPs understand how severe this disease is, or that it requires effective treatment. Many still prescribe antihistamines, but if they don’t work, patients are left with no other choice than to just learn to live with the condition.
Another problem is that not all patients respond adequately to treatment. After three months of treatment – a time frame that physicians deem appropriate to determine a response – there still remains a largely resistant population.
Pharmafile: How does CSU impact patient quality of life?
MM: There’s a huge impact on their quality of life due to itchiness, the unpredictability and disruptive nature of symptoms, and the frequent therapeutic inefficiency. A recent study of more than 260,000 patients with CSU showed that the rate of suicide is more than twofold higher among patients compared to those without CSU. I think this clearly shows the true impact this disease has on patients’ quality of life.
Pharmafile: How does treatment with BTK inhibitors differ from current therapies?
MM: Type 2b autoimmune patients are typically resistant to current therapies, so the key difference is that BTK inhibitors can work for CSU patients with both types of autoimmunity.
Another difference is connected to the mode of action. BTK inhibitors need to be administered via a monthly injection, whereas remibrutinib is a small-molecule oral treatment that patients take daily in tablet form.
Additionally, BTK inhibitors could be involved in the production of autoantibodies relevant to the disease, which could impact the success of the treatment or could reduce remission rates in some patients.
Pharmafile: What other research pipelines for new therapies?
MM: As mentioned earlier, dupilumab has been approved in four countries worldwide and will hopefully receive approval in other countries soon. Perhaps the most exciting development involves a drug that starves mast cells, which are integral to the disease, thereby reducing their numbers in the skin. A phase 2 trial has demonstrated very good efficacy, although there are some tolerability issues. A phase 3 trial is currently ongoing, so it will be a while before this drug can be put forward for approval.
Pharmafile: How do you see treatments for CSU advancing over the next five years?
MM: I think the biggest advances in CSU treatment are happening right now, with the development of two new treatment options, in addition to anti-IgE treatment with remibrutinib and dupilumab. Over the coming years we will be able to focus on better defining our patient population in order to ascertain which patients will most benefit from these treatments. Ideally, we’ll get to the point where we’ll be able to use precision medicine to indicate which treatment will be most effective for individual patients, and thereby improve how the condition is managed.
In conclusion, I do want to emphasise again the need for greater awareness of this condition. As more HCPs acknowledge the vital importance of providing comprehensive treatment for patients with CSU, treatment options should become more widely available to patients, thereby improving their quality of life.
Martin Metz is Professor of Dermatology and Deputy Head of the Institute of Allergology at the Charité – Universitätsmedizin Berlin, Germany and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology. His main scientific areas of interest are mast cell biology, neuroimmunology, inflammation and innate immunity.
This article featured in: October 2025 – The Pharmafile Brief
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