Data from seven clinical studies demonstrate that in patients with severe allergic asthma who require treatment with oral corticosteroids – indicating that they have a more severe form of the disease – Xolair ( Omalizumab ), a humanized therapeutic antibody, significantly reduced the rate of severe asthma attacks and emergency medical visits.

Xolair is the first approved therapy designed to target the antibody IgE, a key underlying cause of the symptoms of allergy related asthma.

A further analysis of results from two of the studies shows that Xolair improved asthma control in patients with moderate to severe allergic asthma, and reduced their reliance on bursts of oral corticosteroid to manage acute asthma exacerbations.
The need for steroid bursts is an important indicator of asthma control, and high use of systemic steroids, coupled with frequent asthma exacerbations, is associated with increased complications including hospital visits and steroid side-effects.

Ulrich Wahn of the Charité Virchow-Klinikum in Berlin, Germany, and President of the European Academy of Allergology and Clinical Immunology ( EAACI ), said that anti-IgE therapy could prove a valuable addition to current treatment options. " In some cases it is impossible to control the symptoms of severe allergic asthma, even with recommended treatment regimens. For such patients, asthma can have serious impact on their health and affect their quality of life on a daily basis. These data demonstrate that Xolair offers the potential to achieve a significant improvement in control, and to improve the lives of patients who continue to suffer from this debilitating disease."

Xolair offers a novel therapeutic approach to the control of asthma by targeting a root cause of allergic disease. It blocks the action of the IgE antibody, responsible for initiating the cascade of inflammatory symptoms such as airway constriction, mucous production, wheezing and shortness of breath. Xolair is effective even in the most difficult-to-treat patients whose condition remains poorly-controlled despite receiving the best available therapy.

Data were analyzed from seven controlled trials of Xolair in severe allergic asthma patients, 93% of whom met GINA 2002 criteria for severe persistent asthma.
A total of 446 patients were receiving maintenance oral corticosteroids, indicative of more severe disease, while 3,862 were not. The severe exacerbation rate ( i.e. where lung function measured by PEF or FEV1 was less than 60% of personal best, requiring systemic corticosteroids ) and the rate of emergency visits ( i.e. hospital admissions, emergency room visits and unscheduled doctor's visits ) were calculated during the treatment phase.

The results demonstrated that adding Xolair to current therapy offered an improved level of asthma control, reducing the severe exacerbation rate by 59.2% compared to control ( p=0.008 ) and the rate of emergency visits by 55.9% ( p=0.014 ) in patients treated with oral steroids. In patients not receiving oral steroids, similar but slightly smaller reductions were seen in severe exacerbations ( 56.9%, p<0.0001 ) and emergency visits ( 44.7%, p=0.0005 ).

Xolair significantly reduced the asthma exacerbation rate by 37.2% compared to control in patients receiving oral steroids ( p=0.001 ), and by 38.8% in those not receiving oral steroids ( p<0.0001 ).
The reduction was greatest in absolute terms in the group receiving steroids as they had higher exacerbation rates, an indication of more severe disease.
Individual publications of the studies included in the analysis, including three studies of one year's duration, reported excellent tolerability.

Further data from two of the studies assessed the impact of add-on Xolair on the need for bursts of systemic steroids in patients with moderate to severe allergic asthma.
Combined data from two randomised 28-week, double-blind, placebo-controlled studies involving 824 patients demonstrated that patients taking placebo were 1.4 times more likely to use steroid bursts to control their disease than those in the Xolair group ( p=0.011 ). This figure rose to 2.2 times in the most difficult to control group of severe patients with an FEV1 of less than 60% ( p=0.0002 ).

Source: World Allergy Congress, 2005


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