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Asthma is a heterogeneous disease of airway inflammation that affects more than 25 million patients in the United States alone (https://www.aafa.org/asthma-facts/). Although mild asthma can frequently be controlled with inhaled corticosteroids and other medications, more severe asthma can require treatment with a biologic such as Xolair. IgE has been shown to play a role in asthma and other diseases, and blocking IgE with Xolair has been shown to be beneficial.
Xolair is an anti-IgE monoclonal antibody that has been approved for the treatment of allergic asthma since 2003. Xolair uses a personalized dosing approach for the treatment of asthma, which takes into account a patient’s body weight and baseline IgE levels. A dosing table was created to identify the Xolair dose and regimen based on a patient’s body weight and IgE levels at baseline. The dosing table was designed to deliver a dose of 0.016 mg/kg/(IU/mL) every four weeks to achieve a target free IgE level of 25 ng/mL (see figure). The dosing table was expanded in Europe using a modeling and simulation approach.
This allows us to create a personalized approach for each patient, ensuring we do not administer more medication than is needed.
Xolair has been studied in other diseases using a similar personalized dosing approach as was used in asthma. This has led to successful Phase 3 trials in nasal polyps and allergic rhinitis, as well as several literature reports of successful use in food allergy.
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