Washington, DC- Many inner-city children may be prone to asthma attacks in the fall, and a new study shows that starting injections of the drug omalizumab, before the school year begins, significantly reduces the number of flare-ups of asthma.
The study is entitled, “Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE)
” and the first author is Stephen J. Teach, MD, MPH
, Chair of the Department of Pediatrics at Children’s National Health System and the George Washington University School of Medicine and Health Sciences. Dr. Teach is also the Principal Investigator and Director of IMPACT DC (Improving Pediatric Asthma in the District of Columbia).
The study, published in the Journal of Allergy and Clinical Immunology, reports a clinical trial conducted by the Inner-City Asthma Consortium (ICAC), an asthma research program supported by the National Institutes of Allergy and Infectious Diseases (NIAID). The report focused on at-risk patients, age 6 to 17 years old, who received medication in the 4-to-6 weeks before school started.
The analysis revealed an overall reduction in the proportion of children experiencing the flare-ups, also known as exacerbations, in the first 90 calendar days of the school year.
“Our study showed that an effective, preventative strategy for fall exacerbations can be achieved with targeted, seasonal treatment using omalizumab, suggesting a model shift for managing high risk patients,” said Dr. Teach.
Children who had experienced exacerbations in the several months before school started benefited the most from omalizumab treatment. Within this group, omalizumab reduced the risk of exacerbation by more than 80 percent: about 36.3 percent of children who received a placebo had at least one fall attack, compared to only 6.4 percent of children who received omalizumab.
“We were able to reduce flare-ups of asthma during the fall period quite dramatically,” he added. “This work is also very exciting because it suggests how the drug altered children’s response to viral infections. Now, we understand more about the underlying mechanism of virally triggered exacerbations, and most importantly, the kids did great.”
Asthma exacerbations disrupt quality of life and reduce school attendance. Asthma is the leading cause of childhood hospitalization and missed school days in the U.S., and disease severity is disproportionately high among children living in inner-city communities. During the fall, children sensitive to asthma attacks are “faced with an almost triple hit of allergen sensitivity, indoor allergen exposure, and infections with the rhinovirus (the common cold),” Dr. Teach said.
The trade names of omalizumab include Xolair, Roche/Genentech, and Novartis. Omalizumab received approval from the U.S. Food and Drug Administration in 2013 for treating patients 12 years and older with moderate to severe allergic asthma. Its primary use is for patients with severe, persistent allergic asthma.
The findings of the study showed that short-term treatment with omalizumab was most effective at preventing additional exacerbations in children who had experienced an exacerbation earlier that year. Researchers also found the preventative effects of omalizumab may be due to the suppression of both allergic and virus-associated inflammation.
“Perhaps the most exciting result from PROSE is that it demonstrates how clinicians can individualize care for young patients with certain high-risk clinical profiles; this is important to further advance asthma care,” said Dr. Teach.
Dr. Teach led an innovative study published earlier this year in the Journal of Allergy and Clinical Immunology
that showed asthma flare-ups vary by season, particularly in the fall.
Dr. Teach said clinicians should continue to optimize medication before the fall season to minimize youths’ exposure to asthma triggers. As a result, many asthma flare-ups can be prevented, Dr. Teach said. “You can’t really prevent kids from catching the common cold, but you can minimize its interplay with the allergic response.” Contact:
Lauren Lytle at 202-476-4500.