Assessing the Risk of Omalizumab Add-on Therapy for Chronic Idiopathic Urticaria during the COVID-19 Pandemic.

Amid the current COVID-19 pandemic, there is concern for increased risk of infection while on immunomodulatory therapy. Omalizumab, a monoclonal antibody, is an add-on therapy for the treatment of chronic idiopathic urticaria (CIU) when first line therapy alone fails to achieve appropriate response. Current understanding of the response to COVID-19 infection is largely varied and actively under investigation. In the context of a pandemic, it is important to consider the safety profile of omalizumab as it modulates the immune system. We reviewed data from pivotal Phase III clinical trials investigating omalizumab use in CIU patients with a focus on reported respiratory-related adverse events (AEs) to assess these risks. Results from three phase III trials show that omalizumab adjunct therapy does not significantly increase infection risk and severity.