Allergy specialist Marcus Maurer and his team at Charité in Berlin, Germany recently published this finding. The new drug is called ligelizumab. It is a so-called monoclonal antibody that binds to immunoglobulin E (IgE). IgE is one of the factors involved in the symptoms of patients with chronic urticaria.
A group of 382 patients received either subcutaneously injected ligelizumab or omalizumab (also a monoclonal antibody against IgE), which is already available for the treatment of urticaria, or a placebo (a preparation with no active ingredient). The team also investigated various doses of ligelizumab and single-dose versus multiple-dose treatment.
The doctors monitored the symptoms of the study patients every week: skin rash (itchy hives) and angioedema, or swelling of the skin and mucosa. If these symptoms occur repeatedly over a period of more than six weeks without a clear trigger, it is referred to as chronic spontaneous urticaria (CSU).
In over half of the patients who received ligelizumab at a dose of 72mg, the rash disappeared completely; a higher dosage did not lead to better results. Only one in four patients who received omalizumab remained symptom-free. There was no change at all in the symptoms of the patients who received the placebo.
“This is a very important study because it shows that, in the treatment of patients with chronic urticaria, ligelizumab is more effective than omalizumab, the only previously approved medication for this disease other than antihistamines”, says Maurer.
The research team is currently in the final phase of preparing the drug for approval. This involves two phase III trials, each of which will include more than 1,000 patients from many different clinics. Maurer expects the initial results to be available in the coming year.
Maurer M et al. “Ligelizumab for chronic spontaneous urticaria” in the New England Journal of Medicine Aug 2019. doi: 10.1056/NEJMoa1900408