Omalizumab for Chronic Urticaria

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

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 outcome…

Reviewing Author

Mark V. Dahl, MD

Disclosures

Consultant / Advisory board Ulthera, Inc.; AuBio LifeSciences, LLC; Paris Therapeutics

Equity Elorac, Inc.; Makucell, Inc.; Paris Therapeutics

Editorial boards UpToDate

Leadership positions in professional societiesNational Rosacea Society (Chairman, Medical Board)