“The increased number of asthma attacks we typically see in the fall and spring nearly was eliminated in the children and adolescents who received the drug,” said Dr. Rebecca Gruchalla, chief of allergy and immunology at UT Southwestern and a co-author of the study appearing online and in the March 17 issue of the New England Journal of Medicine.
|Dr. Rebecca Gruchalla found that adding omalizumab to treatment led to a 30 percent reduction in asthma attacks for children with allergic asthma.|
Researchers at UT Southwestern and eight other academic medical institutions found that Xolair (omalizumab) improved asthma control, nearly eliminated seasonal exacerbations and reduced the need for controller medication when used in concert with National Institutes of Health-based treatment guidelines. Omalizumab binds to and inactivates IgE antibodies, which are the fuel in the immune system that perpetuates the asthmatic reaction.
This therapy is already being used successfully in adults and adolescents who have allergic asthma.
“While these children typically are exposed to multiple allergens that are difficult if not impossible to control, their asthma improved dramatically when we added omalizumab to therapy,” said Dr. Gruchalla. “Those who received the drug experienced 25 percent fewer days with symptoms and a 30 percent reduction in asthma attacks.”
More than half of the 20 million people diagnosed with asthma in the U.S., including 2.5 million children, have been diagnosed with allergic asthma. Inner-city children and adolescents are known to have a high prevalence of severe asthma.
The study was conducted by the Inner-City Asthma Consortium (ICAC), a five-year, $56- million NIH-sponsored project to investigate novel treatments and causes of asthma in urban children. Dr. Gruchalla has led the Dallas-based ICAC arm for eight years.
The study involved 419 children and young adults between the ages of 6 and 20 with persistent moderate-to-severe allergic asthma, a complex disease of the airways that is characterized by variable and recurring symptoms, airflow obstruction, bronchial hyperresponsiveness and underlying inflammation. Of the participants, 60 percent were African-American; Hispanics accounted for another 37 percent. More than half were 6- to 11-year-old males.
The participants, from eight cities across the U.S., received care based on NIH guidelines for 60 weeks. Each participant randomly was assigned to receive either injected omalizumab or a placebo every two to four weeks. Their regular asthma medications were periodically adjusted as needed.
Another interesting finding from the study, Dr. Gruchalla said, was that participants who had positive skin tests for cockroach allergy and who had high levels of cockroach allergen in their residences showed the best response to omalizumab. Exposure to these allergens has been shown previously to be an important cause of asthma-related illness and hospitalization in children.
“Since ridding inner-city environments of indoor allergens, including cockroach allergen, is a monumental, if not impossible task, the use of an agent such as omalizumab may circumvent the need to eradicate these allergens,” she said.
In addition to UT Southwestern’s participation, researchers from the University of Wisconsin-Madison; University of Arizona; Boston University; Children’s Memorial Hospital in Chicago; Rainbow Babies and Children’s Hospital in Cleveland; Children’s National Medical Center in Washington, D.C.; National Jewish Medical and Research Center in Denver; Columbia University College of Physicians and Surgeons; National Institute of Allergy and Infectious Diseases; and Rho Federal Systems Division contributed to the study.
The National Institute of Allergy and Infectious Diseases, the National Center for Research Resources, Novartis Pharmaceuticals, Dey Pharma and SC Johnson supported the study.
Visit http://www.utsouthwestern.org/allergy to learn more about UT Southwestern’s clinical services for asthma and allergies.
Media Contact: Kristen Holland Shear