Omalizumab efficacy supported by database of patients with difficult-to-treat CIU


Published Online: June 8, 2015

Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) suffer with bothersome itchy wheals and/or angioedema for at least 6 weeks.1 Despite the use of conventional treatment with antihistamines, sometimes with doses as high as 4 times the approved dose, these patients continue to suffer with symptoms that disrupt their daily life. The cause of CIU is not known, making treatment and control of symptoms difficult. In 2014, omalizumab, an antibody to immunoglobulin E (IgE) was approved for use in patients with difficult-to-treat CIU.2

In a recent publication in The Journal of Allergy and Clinical Immunology: In Practice, Casale et al used data from three studies to compare the benefit of once-monthly omalizumab injection in patients with disease not responding to other treatments. The studies included patients with difficult-to-treat CIU symptoms, and supported the approval of omalizumab for the treatment of CIU in patients at least 12 years old who continue to suffer with symptoms despite antihistamine use.2 The nearly 1,000 patients included represent the largest database to date of patients with difficult-to-treat CIU. In these studies, patients had received different treatment before and during the study for their CIU symptoms. Two of the studies (ASTERIA I and ASTERIA II) included patients who had not responded to treatment with approved doses of antihistamines. The third study (GLACIAL) included patients with continued symptoms even though they had been treated with antihistamines at up to 4 times the approved dose and may have received other therapies (eg H2 or leukotriene blockers) for the management of their symptoms. In all studies, patients were permitted to continue taking their regular therapies for their CIU symptoms while participating in the study. Casale and colleagues primarily evaluated the reduction in itch score as well as the safety of omalizumab in this large group of patients.

The data analyzed for this publication showed that patients receiving omalizumab and standard doses of antihistamines as well as those patients receiving omalizumab and more intense treatment for their CIU symptoms experienced a similar improvement in those symptoms when they received the 300-mg dose of omalizumab. Up to 40% of patients had complete remission of symptoms and at least 50% of patients had well-controlled disease at week 12 of therapy. Omalizumab was well tolerated by patients.

The results of this analysis support the use of omalizumab in patients with difficult-to-treat symptoms of CIU/CSU irrespective of previous treatments. All patients responded similarly to the dosing of omalizumab.


The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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