Omalizumab for Chronic Urticaria

Summary and Comment |
January 26, 2015

Omalizumab for Chronic Urticaria

  1. Mark V. Dahl, MD

Another controlled study finds omalizumab effective for treatment of patients with chronic hives.

  1. Mark V. Dahl, MD

The FDA and the European Medicines Agency approved omalizumab for chronic idiopathic urticaria (CIU) based on three studies of CIU refractory to H1 antihistamines. Two studies were reported earlier, but investigators have now published results of the third, longer-duration study. Omalizumab is a humanized IgE monoclonal antibody that reduces mast cell and basophil degranulation mediated by IgE and the high affinity IgE receptor.

In this phase III, multicenter, 40-week, double-blind, randomized, placebo-controlled study, 319 patients who remained symptomatic despite H1 antihistamines at approved doses were randomized to omalizumab at one of four doses: 0 (placebo), 75 mg, 150 mg, or 300 mg every 4 weeks for 24 weeks. Patients recorded outcomes including itch severity, number of hives, size of largest hive, sleep interference, activity interference, rescue medication use, and presence of angioedema. Primary and secondary endpoints were evaluated at week 12; treatment and scoring continued for 24 weeks. When omalizumab was stopped, patients continued to score signs and symptoms for 16 additional weeks. An additional H1 antihistamine was allowed after week 12.

Mean weekly itch severity scores decreased significantly with treatment versus placebo from baseline to week 12 (P=0.00001). Improvement was dose related, generally appeared by week 1 and was obvious by week 2, remaining relatively stable through week 24. The 300-mg dose was better than smaller doses. The most common adverse effects were injection-site reactions, headaches, and arthralgias. No severe effects were attributed to omalizumab.


Not all patients experienced complete control, but complete response (no hives at week 12) was four times more common among omalizumab recipients than nonrecipients. Omalizumab is a welcome additional treatment. It will not replace first-line nonsedating and sedating H1 antihistamines. Some patients will be best treated with cyclosporine, prednisone, montelukast, or other agents. The side effect profile of omalizumab compares favorably with some of these treatments, but its cost will be greater.

Editor Disclosures at Time of Publication

  • Disclosures for Mark V. Dahl, MD at time of publication Consultant / Advisory board Makucell, Inc.; Castle Diagnostics, Inc.; Up To Date; Ulthera, Inc.; Biohealth, Inc. Equity Elorac, Inc.; Makucell, Inc. Editorial boards UpToDate


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