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Chronic spontaneous urticaria (CSU) is defined as presence of hives (and often angioedema) on most days of the week for longer than 6 weeks with no apparent cause. Although the pathogenesis is unclear, as many as half of patients with CSU have autoantibodies directed against immunoglobulin E (IgE) receptors on mast cells. In an industry-sponsored study, researchers compared ligelizumab, a new anti-IgE monoclonal antibody that is not yet FDA-approved, to currently approved omalizumab (Xolair) in 382 adult patients whose CSU was uncontrolled with antihistamines.
Patients were randomized to monthly subcutaneous injections of ligelizumab, omalizumab, or placebo. All patients were treated with H1-antihistamines, and many used H2-antihistamines an…