Publications

Background: Chronic spontaneous urticaria (CSU) is defined byitchy hives, angioedema, or both for at least 6 weeks. Omalizumab, an anti-IgE antibody that affects mast cell and basophil function, is a promising new treatment option. As of now, however, the efficacy and safety of different doses of omalizumab used in clinical trials for CSU have not been systematically analyzed and summarized.

Objective: We sought to assess the efficacy and safety of different doses of omalizumab for the treatment of CSU in ameta-analysis of clinical trial results.

Methods: Suitable trials were identified by searching PubMed,Medline, Embase, and Web of Science databases and with thehelp of omalizumab’s manufacturers. Only double-blind, randomized, placebo-controlled studies with omalizumab-treated versus placebo-treated patients with CSU were included in this analysis.

Results: We identified 7 randomized, placebo-controlled studies with 1312 patients with CSU. Patients treated with omalizumab(75-600 mg every 4 weeks) had significantly reduced weekly itch and weekly wheal scores compared with the placebo group. Omalizumab’s effects were dose dependent, with the strongest reduction in weekly itch and weekly wheal scores observed with 300 mg. Rates of complete response were significantly higher inthe omalizumab group (relative risk, 4.55;P< .00001) and dosedependent, with the highest rates in the 300-mg group. Rates ofpatients with adverse events were similar in the omalizumab and placebo groups.

Conclusion: This meta-analysis provides high-quality evidencefor the efficacy and safety of omalizumab in patients with CSU and for treating these patients with 300 mg of omalizumab every 4 weeks. (J Allergy Clin Immunol 2016;137:1742-50.)