A novel anti-IgE antibody drug ligelizumab allows more than half of patients with chronic spontaneous urticaria to clear symptoms, a phase 2 trial has shown.
Published in the NEJM, the 12-week results for the biologic showed that 51% of the patients treated with ligelizumab had complete control of urticaria, as compared with 26% of the patients treated with omalizumab.
The study also showed a clear dose–response relationship with ligelizumab, and a rapid onset of response for the drug that is administered subcutaneously every four weeks.
The study involved 382 adults with mild-to-moderate chronic spontaneous urticaria that was inadequately controlled with antihistamines and leukotriene-receptor antagonists. Patients were randomised to one of three doses of ligelizumab, omalizumab 300 mg or placebo.
The primary endpoint of complete hives response (weekly hives-severity score of 0) at week 12 was achieved by 43/84 patients taking the middle dose of ligelizumab (72mg) and 22/85 patients taking omalizumab. With the same dose of ligelizumab complete resolution of weekly itch urticaria (zero severity) was achieved by 48% and 44% of patients respectively, compared to 29% and 26% of patients taking omalizumab.
The response with the 72-mg dose of ligelizumab was maintained at week 20, with 51% of the patients having a response, as compared with 34% of those in the omalizumab group
In terms of safety, the rates of adverse events were similar for ligelizumab and omezilzumab, with most common adverse events being injection site reactions, respiratory tract infections and headaches.
The drug has since been reported at the American Academy of Dermatology 2019 meeting to have sustained efficacy in urticaria in follow up to one year and has now started phase 3 trials (PEARL1 and PEARL 2) comparing it with omalizumab in more than 2,000 patients.
The multinational trial included Australian centres such as the Immunology and Allergy Unit, Campbelltown Hospital, NSW and Sinclair Dermatology and the Epworth Hospital, Melbourne.
Omalizumab (Xolair) has been listed on the PBS since September 2017 for the treatment of patients with severe chronic spontaneous urticaria (CSU).