Omalizumab: A Monoclonal Anti-IgE Antibody

Paul P. Belliveau, PharmD

In This Article

Abstract and Introduction


Objectives: To describe allergic asthma and allergic rhinitis pathophysiology and review the pharmacologic, pharmacokinetic, pharmacodynamic, efficacy, and safety data for omalizumab.

Methods: MEDLINE, In-Process & Other Non-Indexed Citations, and EMBASE Drugs & Pharmacology were searched using olizumab, omalizumab, E25, rhuMAb-E25, and anti-IgE. Combinations of rhinitis, asthma, and IgE captured information on disease pathophysiology.

Results: Omalizumab is a monoclonal antibody targeting the high-affinity receptor binding site on human immunoglobulin (Ig)E. Bound IgE is not available for basophil binding, degranulation is attenuated, and allergic symptoms are reduced. In asthma trials, omalizumab reduced inhaled corticosteroid and rescue medication requirements and improved asthma control and asthma quality of life in moderate to severe allergic asthmatics with disease poorly controlled by inhaled corticosteroids. In trials of patients with poorly controlled moderate to severe seasonal allergic rhinitis (SAR), omalizumab reduced the severity of exacerbations and rescue medication use, and improved rhinitis-related quality of life. Benefits were also observed in trials utilizing combinations of immunotherapy and omalizumab for SAR and in trials of perennial allergic rhinitis (PAR). Omalizumab has been well tolerated. Although malignant neoplasms have been observed in treated patients, they were likely not related to omalizumab therapy.

Conclusions: Omalizumab has demonstrated efficacy in children, adults, and adolescents with uncontrolled moderate to severe allergic asthma and allergic rhinitis. Long-term safety beyond 52 weeks needs continued evaluation.


Diseases such as asthma and allergic rhinitis have a significant societal impact. These conditions affect a substantial population of patients and impose a burden in terms of treatment costs, productivity loss, and reduced quality of life.[1,2,3,4,5] Although medications are available to treat these conditions, some focus only on symptom relief, others are nonspecific in their mechanism of action (and, therefore, produce substantial side effects), and none provide symptom relief in all patients.[6,7,8,9] Because of IgE's role in the manifestation of these conditions (see discussion below), there has been interest in developing therapies that specifically target this immunoglobulin to treat allergic asthma and allergic rhinitis. The recent introduction of the monoclonal anti-IgE antibody omalizumab (Xolair, Genentech, South San Francisco, California) provides clinicians with an additional unique option for treating these conditions. This review will present information on the pathophysiology of allergic asthma and allergic rhinitis and describe the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy data, and safety profile for omalizumab. The focus of this review is a function of the fact that most published information with omalizumab addresses its use for these conditions. However, future applications for anti-IgE therapy are likely forthcoming for other IgE-mediated conditions such as food allergies and atopic dermatitis.[10,11] In particular, recent information suggests that anti-IgE therapy can prevent the manifestations of inadvertent peanut exposure in patients with peanut allergy.[11]


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