Omalizumab generally was well tolerated in several clinical trials. The most frequent adverse effect was injection-site reactions (e.g., redness, stinging, bruising, and induration), but these reactions also were seen at comparable frequencies with placebo. Low titers of antibodies against omalizumab developed in 1 of 1723 treated patients, whereas anaphylaxis was seen in 0.1% of treated patients. Malignancies of various types were observed in 20 of 4127 patients taking omalizumab, a higher frequency than the 5 malignancies in 2236 patients taking other asthma and allergy drugs; additional study is needed to clarify this risk.

Monospecific anti-lgE antibody (Omalizumab)

No allergen-induced

Neutralization activation of:

of serum IgE mast cells basophils (other cells?)


FIGURE 27-3 Mechanism of Action of Omalizumab. Omalizumab is a monospecific anti-lgE antibody. Specific B lymphocytes produce IgE antibodies. The Fc region of IgE heavy chains binds with high affinity to receptors (FceRI) in the plasma membranes of mast cells and basophils (and other cells). Allergen interacts with the antigen-binding site of cell-bound IgE, causing FceRI cross-linking and cell activation. Omalizumab neutralizes the free IgE in the serum by binding to the Fc regions of the heavy chains to form high-affinity IgE-anti-IgE complexes. This prevents the IgE from binding to FceRI, thereby blocking allergen-induced cell activation.

USE IN ASTHMA Omalizumab is indicated for adults and adolescents >12 years of age with allergies and moderate-to-severe persistent asthma. In this population, omalizumab has proven to be effective in reducing the dependency on inhaled and oral corticosteroids and in decreasing the frequency of asthma exacerbations. Omalizumab is not an acute bronchodilator and should not be used as a rescue medication or as a treatment of status asthmaticus.

Based on its mechanism of action, omalizumab has been used in the treatment of other allergic disorders, such as nasal allergy and food allergy, but large-scale clinical trials are limited to asthma.

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