SUMMARYObjective: Omalizumab (Xolair), is a recombinant humanised monoclonal anti-immunoglobulin E (IgE) antibody, for the treatment of allergic asthma. This review describes how the correlation between clinical outcomes and a suitable surrogate marker (free serum IgE) led to the development of an individualised dosing strategy for omalizumab. It also demonstrates how subsequent studies using this dosing strategy were able to achieve low levels of IgE and clinical benefit. * Xolair is a registered trade name of Novartis Pharma AG, Basel, Switzerland and Genentech, South San Francisco, California, USAData sources: Published articles and data on file (Novartis PharmaAG, Genentech).Results: Studies in patients with IgE-mediated diseases of the airways have shown that clinical benefit with omalizumab is observed when free IgE levels in serum are reduced to 50ng/ml (20.8 IU ml−1) or less (target 25 ng ml−1 (10.4IU ml−1)). The ability of omalizumab to reduce free IgE levels to such levels is dependent on dose, ...
1 December 2004 in Proceedings of the American Thoracic Society
Bronchial asthma and allergic rhinitis are among the most common diseases of modern society and to an increasing degree a major cause of illness, hospitalization, loss of productivity, and death. Despite improvements in drug therapy over the years, the incidence is still increasing. Inhaled and intranasal corticosteroids are the drugs of choice in the therapy of asthma and allergic rhinitis. Inhalation and intranasal use result in better, target-specific delivery of corticosteroids. Higher concentrations at the site of action and minimized systemic exposure provide improved therapeutic ratios. However, there is still considerable concern over the risk of systemic side effects. It is the goal of inhaled and intranasal corticosteroid therapy to produce long-lasting therapeutic effects at the site of action and minimize systemic side effects with high clearance, low oral bioavailability and high plasma protein binding. This article reviews the pharmacokinetic and pharmacodynamic properties of corticosteroids used in asthma and allergic rhinitis.
1 April 2003 in The Journal of Clinical Pharmacology