Those unmet therapeutic needs and the arrival of the first targeted oral treatment

Constant itching, hives that appear suddenly and an unpredictable course that disrupts sleep, work and social relationships. This is the uncomfortable reality for thousands of people living with chronic spontaneous urticaria (CSU), an inflammatory skin condition that mainly affects women and is most common between the ages of 20 and 40. Unlike common urticaria, which is generally associated with allergic reactions, the chronic spontaneous form occurs without any identifiable trigger. The symptoms – itchy welts, redness and swelling that appear on the face, hands and feet, and sometimes even affect the throat – persist for at least six weeks and can last for months or years.

The unpredictable nature of the condition is one of the most difficult aspects to manage. Symptoms appear suddenly, making it difficult to plan daily activities. The result is a burden that is not only physical but also psychological. Many patients report sleep disturbances, anxiety, depression and reduced productivity at work, with significant consequences for their personal and professional lives.

“Living with chronic spontaneous urticaria,” comments Elena Radaelli , President of ARCO (Association for Research and Treatment of Urticaria), “means dealing every day with a complex and often underestimated condition that can have a profound impact on quality of life. Many patients still feel misunderstood and struggle to find adequate answers.”

Despite the availability of established treatments, unmet therapeutic needs remain high. H1 antihistamines are, in fact, the first-line treatment, but more than half of patients continue to experience significant symptoms despite treatment. For these patients, achieving adequate control of the condition remains a major clinical challenge. It is precisely to address these unmet needs that the European Commission has approved remibrutinib for the treatment of adults with chronic spontaneous urticaria that is not controlled by H1 antihistamines. This is the first targeted oral therapy (taken twice daily) authorised in the European Union for this indication.

The drug is a selective inhibitor of Bruton’s tyrosine kinase (BTK), a protein involved in the immunological mechanisms that lead to the release of histamine. Histamine is one of the main substances responsible for the onset of itching, hives and swelling. By blocking this signalling pathway, remibrutinib therefore acts directly on the biological processes underlying the disease.