Real-life experience with omalizumab in chronic spontaneous urticaria.

Chronic spontaneous urticaria (CSU) is a common skin disease. Many patients with CSU do not have a response to therapy with H1 antihistamines, even at high dose. Evidence has shown that omalizumab, a recombinant humanized monoclonal antibody approved as add-on therapy for persistent allergic asthma, is highly effective fot the treatment of CSU. We gave omalizumab at dose of 300 mg once a month for 24 weeks to three patients, with moderate to severe CSU, that were refractory to standard treatment, including high doses of antihistamines, corticosteroid and cyclosporine. This treatment period was followed by a maintenance period. There was dramatic improvement in the primary efficacy variable, the change in mean urticaria activity score (UAS) from baseline to the final week of omalizumab treatment. There was an improvement in quality of life, interference with daily activities and with sleep. Omalizumab diminished clinical symptoms and signs of CSU in patients who remained symptomatic despite standard therapy (licensed doses). The mechanism by which omalizumab works to improve urticaria has not been fully elucidated.