Ligelizumab for the treatment of chronic spontaneous urticaria

Due to daily hives with itch, sleeplessness, and unforeseen development of angioedema, chronic spontaneous urticaria significantly impairs quality of life, often for years. Its management is challenging. In most cases, H1-antihistamines are not effective. Although the disease is not characterized by specific IgE antibodies against allergens, the last decade demonstrated that neutralizing IgE by using the monoclonal anti-IgE antibody Omalizumab is safe and effective. Nevertheless, symptoms are not controlled by Omalizumab in approximately one-fourth of patients.

This review is focused on Ligelizumab (QGE031), a next-generation non-triggering fully human monoclonal antibody, with higher affinity to IgE compared to Omalizumab.

In chronic spontaneous urticaria, subcutaneous Ligelizumab once per month for five months has shown a clear dose-response relationship with respect to symptoms. Superiority over Omalizumab was noted whereas the safety profile was similar. Most common side effects were injection site reactions. In the near future, results from phase 3 trials, two of them including more than 1000 patients each, are awaited. Having a higher affinity to IgE and being more effective than Omalizumab, Ligelizumab has the potential to free chronic urticaria patients from year-long daily annoying symptoms that did not respond to standard therapy as recommended by current guidelines.