Omalizumab relieved seasonal asthma attacks in youth with moderate to severe disease
Busse WW. N Engl J Med. 2011;364:1005-1105.
New data indicate that omalizumab reduced symptoms and exacerbations in patients with persistent allergic asthma, according to new data from the NIH.
When added to current standard therapy for inner-city children and adolescents, omalizumab (Xolair, Genentech/Novartis) further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma, according to a study published online.
The results indicate that children and adolescents who received omalizumab had a 25% reduction in days with symptoms and a 30% reduction in asthma attacks vs. those who received placebo. Patients who received omalizumab also had a 75% reduction in hospitalizations. The researchers said the spring and fall increases in attacks that typically appear in patients with asthma were nearly eliminated in those participants receiving omalizumab.
The spike in asthma attacks in the fall, which is associated with colds and other viral airway infections, disappeared in the kids in the omalizumab group, William Busse, MD, the principal investigator of the Inner City Asthma Consortium (ICAC) and professor of medicine at the University of Wisconsin-Madison, said in a press release from the National Institute of Allergy and Infectious Diseases. Because the drug specifically targets [immunoglobulin E], which is the antibody responsible for allergies, our observations show the possible interplay between allergies, respiratory viruses and IgE in provoking asthma attacks.
The study enrolled 419 participants aged 6 to 20 years who were diagnosed with moderate to severe allergic asthma lasting more than 1 year. The study was conducted in eight US cities by the ICAC; 60% of the participants were black and 37% were Hispanic.
All patients received standard therapy, and half of the participants were randomly assigned to receive omalizumab and the other half a placebo. Drug or placebo was delivered via an injection under the skin every 2 to 4 weeks for 60 weeks. Participants returned to the clinic every 3 months for evaluation of their symptoms. As needed, their non-trial medications were adjusted according to the NIH asthma treatment guidelines.
Children and adolescents who responded best to omalizumab had positive skin tests for cockroach allergy and high levels of cockroach allergen in their homes, which previous research has shown to be an important cause of asthma-related illness and hospitalization.
Omalizumab is a humanized monoclonal anti-IgE antibody and is approved in the United States for patients aged 12 years and older with moderate to severe persistent allergic asthma.
Disclosure: The study was supported by contracts with the NIAID, grants from the National Center for Research Resources and Novartis Pharmaceuticals.
Dr. Busse reports receiving board membership fees from Centocor and Merck, consulting fees from Boehringer Ingelheim, Teva, Amgen, Pfizer and Genentech; consulting fees and grant support from AstraZeneca, GlaxoSmithKline, MedImmune and Novartis; and grant support from Ception.
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