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Omalizumab Therapy for Patients With Severe Asthma FREE

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The full report is titled “Omalizumab in Severe Allergic Asthma Inadequately Controlled With Standard Therapy. A Randomized Trial.” It is in the 3 May 2011 issue of Annals of Internal Medicine (volume 154, pages 573-582). The authors are N.A. Hanania, O. Alpan, D.L. Hamilos, J.J. Condemi, I. Reyes-Rivera, J. Zhu, K.E. Rosen, M.D. Eisner, D.A. Wong, and W. Busse.

Ann Intern Med. 2011;154(9):I-28. doi:10.7326/0003-4819-154-9-201105030-00001
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What is the problem and what is known about it so far?

Asthma is a common disease in which inflammation and constriction of the airways cause symptoms, such as wheezing, coughing, and shortness of breath. In some patients with severe asthma, symptoms persist despite the regular use of inhaled medicines to relax constricted airways (inhaled long-acting β2-agonists [LABAs] or bronchodilators) and to reduce inflammation (inhaled corticosteroids [ICS]). Such patients often require frequent use of a “rescue inhaler” for immediate relief of symptoms and often have acute flares of asthma requiring treatment with steroids given by mouth or by vein.

Why did the researchers do this particular study?

Omalizumab, a medication that blocks the ability of a blood protein to increase airway inflammation and constriction, might help patients with severe asthma. Whether it is helpful in patients with continued symptoms despite ongoing treatment with LABAs and high-dose ICS is not clear.

Who was studied?

850 participants aged 12 to 75 years who had severe asthma causing nighttime awakenings, frequent daytime rescue inhaler use, and at least 1 acute exacerbation of asthma in the past year requiring steroids by mouth or by vein.

How was the study done?

The participants were randomly assigned to receive either omalizumab or a placebo, given as an injection under the skin every 2 or 4 weeks during the 48 weeks of the study. In addition, all participants received treatment with high-dose ICS and LABAs. The researchers measured how often the participants had asthma flares requiring steroids by mouth or by vein, as well as the participants' symptoms, quality of life, and use of rescue inhalers.

What did the researchers find?

During the 48 weeks of the study, participants who received omalizumab had fewer asthma flares requiring steroid therapy by mouth or vein, as well as less use of daytime rescue inhalers, than did the participants who received placebo. The participants who received omalizumab also reported improved asthma symptoms and quality of life compared with the placebo group.

What were the limitations of the study?

Although the researchers saw no difference between the groups in how often bad side effects occurred, the study was too small to confidently assess whether certain rare serious side effects, such as anaphylaxis, blood problems, or cancer, might be increased with the use of omalizumab.

What are the implications of the study?

Omalizumab can improve symptoms and prevent acute asthma flares in some patients with severe asthma despite treatment with LABAs and high-dose ICS.





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