Omalizumab, a recombinant humanized
monoclonal antibody, is the first therapeutic agent specifically targeting
immunoglobulin E (
IgE). It has been investigated extensively in the treatment of patients with allergic diseases and is approved in the United States for the treatment of patients with moderate-to-severe persistent
asthma. In this setting,
omalizumab reduced the frequency and incidence of
asthma exacerbations and
asthma control was well maintained, even though patients significantly reduced their dose of inhaled
corticosteroid. Importantly,
omalizumab has been shown to reduce
asthma exacerbations in high-risk patients (e.g., with previous intubation and hospitalization) and to reduce the level of severe
asthma exacerbations (those resulting in
emergency treatment and hospitalization). Responder analysis shows that
omalizumab provides the greatest benefit in patients with more severe
asthma, and this has been confirmed by recent studies establishing the efficacy of
omalizumab in patients whose
asthma is poorly controlled despite receiving the best standard care in medication.
Omalizumab also has proved to be effective in patients with seasonal and
perennial allergic rhinitis and to improve quality of life for patients with
asthma or
rhinitis. As expected with a systemic
anti-IgE agent,
omalizumab was shown to be effective in the treatment of patients with concomitant
asthma and
allergic rhinitis. The efficacy of
omalizumab in a range of allergic diseases reaffirms the importance of
IgE in the pathogenesis of these conditions and establishes the potential benefit to be obtained by inhibiting
IgE, especially in patients with more severe and comorbid allergic diseases.