Xolair (omalizumab) is a prescription medication developed by Novartis and approved for the treatment of allergic asthma and chronic idiopathic urticaria. The therapy is also being investigated for the treatment of angioedema, a skin reaction characterized by frequent swelling of the deeper layer of the skin and mucous membranes. Episodes of angioedema are common in chronic idiopathic urticaria and observed in approximately 40 percent of these patients.

How Xolair works

Xolair’s exact mechanism of action in angioedema is not well-understood. However, it is thought to work through a number of anti-inflammatory pathways.

The therapy is a monoclonal antibody against immunoglobulin E (IgE). IgE is involved in the body’s immune response to a number of parasitic infections, and also plays a role in hypersensitivity observed in various allergic conditions such as asthma, sinusitis, rhinitis (hay fever), chronic urticaria, and allergic reactions to foods and medication. By binding to and neutralizing IgE, Xolair reduces the severity of allergic reactions. One study demonstrated that Xolair has the ability to block or decrease the functions of inflammatory cytokines, which are chemical messengers that promote inflammation.

Xolair in clinical trials

The effectiveness of Xolair in improving the quality of life of patients with angioedema and urticaria has been investigated in several studies.

A Phase 3 trial (NCT01723072) assessed the impact of Xolair on improving patients’ quality of life, compared with a placebo. Results of this study, published in the scientific journal Allergy, showed that Xolair was an effective treatment option for patients with angioedema as it significantly reduced the burden of the disease.

In another study, researchers assessed the effect of Xolair on angioedema and the quality of life of patients with urticaria who also had either hives or angioedema or both. Results of this study, published in the Journal of the European Academy of Dermatology and Venereology, revealed that patients who received Xolair saw a marked reduction in the incidence of angioedema episodes and an improvement in their quality of life.

A randomized, double-blind, placebo-controlled Phase 4 trial (NCT02966314) is evaluating Xolair’s ability to reduce the severity of swelling episodes in patients with idiopathic angioedema (angioedema of an unknown cause). The study, which is currently recruiting participants in Wisconsin, will also assess the effect of Xolair on the quality of life of angioedema patients experiencing recurrent swelling episodes.

Three Phase 3 trials, ASTERIA I (NCT01287117), ASTERIA II (NCT01292473), and GLACIAL (NCT01264939), compared various dosages of Xolair with placebo in patients with chronic idiopathic/spontaneous urticaria. Results showed that higher doses of Xolair (300 mg) resulted in a reduction in the percentage of patients with angioedema. The frequency of angioedema episodes was also reduced.

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