ASTERIA IIstudy results were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2013 Annual Meeting and were simultaneously published in the New England Journal of Medicine. The global, multicenter, randomized, double-blind, placebo-controlled study shows the immunoglobulin E monoclonal antibody currently approved for allergic asthma also diminishes the clinical symptoms of chronic urticaria. The trial enrolled 323 patients with a history of at least 6 months of chronic idiopathic urticaria. Patients had itchy hives for at least 8 consecutive weeks despite the use of H1-antihistamines.
A post hoc analysis showed that over 40% of the patients that were on the high dose were completely hive and angioedema free at the end of the 12-week treatment period. Specifically, the post hoc analysis showed that at the end of treatment, 53% of patients receiving the high dose were completely free of hives compared with 23% in the 150-mg group, 18% in the low-dose group, and 10% in the placebo group.
The indication for Xolair does not require a failure of a Leukotriene inhibitor.
Kaplan AP, Joseph K, Maykut RJ, Geba GP, Zeldin RK. Treatment of chronic autoimmune urticaria with omalizumab. J Allergy Clin Immunol 2008;122:569-573
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Maurer M, Altrichter S, Bieber T, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol 2011;128(1):202.e5-209.e5.
Marcus Maurer, M.D., Karin Rosén, M.D., Ph.D., Hsin-Ju Hsieh, Ph.D., Sarbjit Saini, M.D., Clive Grattan, M.D., Ana Gimenéz-Arnau, M.D., Ph.D., Sunil Agarwal, M.D., Ramona Doyle, M.D., Janice Canvin, M.D., Allen Kaplan, M.D., and Thomas Casale, M.D. Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. N Engl J Med 2013; 368:924-935