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Chronic Spontaneous Urticaria and the Need for Anti-IgE Therapy
Chronic spontaneous urticaria (CSU), with or without spontaneous angioedema, is a condition that can severely impact quality of life. It is believed to affect 0.5–1% of the global population at any given time. For many patients, antihistamines effectively manage their symptoms. However, a significant number of people with CSU do not respond to antihistamines, leaving them in search of alternative treatments.
For these patients, anti-IgE therapy represents the next stage of treatment. This approach specifically targets IgE, the key mediator in the allergic response, which is responsible for triggering the release of histamine, which in turn leads to a cascade effect resulting in the red, itchy wheals of an urticarial rash.
Omalizumab, commonly known by its brand name Xolair, is a leading anti-IgE therapy that works to block circulating IgE from binding to mast cells. This prevents the release of histamine, effectively reducing allergic symptoms.
Omalizumab: Approved and Effective
Omalizumab has been approved in the UK for patients as young as six years old with severe, persistent allergic asthma that remains uncontrolled by oral or injectable corticosteroids. It has also been approved for use in patients over 12 years of age with chronic spontaneous urticaria, where antihistamines alone are insufficient.
The drug was first approved by the FDA in the United States in 2003, followed by approval from the European Medicines Agency in 2005. Since then, it has been widely recognised as a safe and effective treatment.
A biosimilar drug to Xolair, called Omlyclo is also available for patients who want an alternative. Omlyclo has equivalent clinical efficacy to Xolair.
Safety and Administration of Omalizumab
Clinical trials have shown that Omalizumab is generally well-tolerated, with no significant increase in the overall incidence or severity of adverse events compared to the placebo (Kaplan et al 2013). The treatment has proven particularly effective in reducing the signs and symptoms of chronic spontaneous urticaria in patients who have not found relief with antihistamines.
Omalizumab is administered as an injectable treatment once every four weeks over a six-month course. Each monthly dose is divided into two syringes, with two injections made one after the other into the abdomen. The first three doses are administered in the clinic by your doctor and, if all goes well, the remaining three doses can be self-administered at home.
Expert Care at the London Allergy Clinic with Dr Gururaj Arumugakani
Dr Arumugakani began treating patients with omalizumab for chronic spontaneous urticaria before the therapy received European licensing approval for that indication — putting him among the earliest clinical adopters in the UK.
His published research, based on a cohort of 357 patients treated over ten years at St James's University Hospital in Leeds, demonstrated that personalising omalizumab doses to the individual — rather than keeping all patients on the same fixed regimen — allowed 22% of partial responders to achieve full symptom control who would otherwise have remained undertreated. This personalised approach, which his team helped pioneer, is now consistent with international urticaria guidelines.
Beyond omalizumab, Dr Arumugakani has been sub-principal investigator in phase 2a and phase 3 clinical trials of next-generation biological treatments for urticaria — therapies that are only now entering routine practice. He also contributed to developing the home administration model, which allows most patients to self-inject after their first clinic doses, making ongoing treatment significantly easier to manage.
This level of direct research involvement is rare in a private clinic setting. Patients seeking omalizumab treatment in London — including those travelling from the United States and internationally — benefit from expertise built not just in consultation rooms, but in clinical trials and published research.
