Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy

Allen P Kaplan, Dennis Ledford, Mark Ashby, Janice Canvin, James L Zazzali, Edward Conner, Joachim Veith, Nikhil Kamath, Petra Staubach, Thilo Jakob, Robert G Stirling, Piotr Kuna, William E Berger, Marcus Maurer, Karin Rosen

Research output: Contribution to journalArticleResearchpeer-review

390 Citations (Scopus)


Background: Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies. Objectives: We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H1-antihistamines at up to 4 times the approved dose plus H2-antihistamines, leukotriene receptor antagonists, or both. Methods: In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary objective of the study was to evaluate the overall safety of omalizumab compared with placebo. Efficacy (itch severity, hive, and urticaria activity scores) was evaluated at weeks 12 and 24. Results: The overall incidence and severity of adverse events and serious adverse events were similar between omalizumab and placebo recipients; the safety profile was consistent with omalizumab in patients with allergic asthma. At week 12, the mean change from baseline in weekly itch severity score was 28.6 (95 CI, 29.3 to 27.8) in the omalizumab group compared with 24.0 (95 CI, 25.3 to 22.7) in the placebo group (P
Original languageEnglish
Pages (from-to)101 - 109
Number of pages9
JournalThe Journal of Allergy and Clinical Immunology
Issue number1
Publication statusPublished - 2013

Cite this