WEDNESDAY, March 16 (HealthDay News) -- The injectable
medication Xolair reduced asthma symptoms in inner city children
with the respiratory condition, and almost eliminated seasonal
peaks in asthma attacks, new research shows.
When added to standard asthma treatments, Xolair (omalizumab)
decreased the amount of inhaled steroid needed to maintain asthma
control, according to the study, which is published in the March 17
issue of the
New England Journal of Medicine.
"Omalizumab improves asthma control on top of guidelines-based treatment," said study co-author Dr. William Busse, a professor of medicine at the University of Wisconsin School of Medicine in Madison. "There was less need for other medications, a reduction of symptoms and reduction of the seasonal exacerbations of asthma. Omalizumab almost totally eliminated these attacks."
But, he added, it's too soon to make treatment recommendations
based on these findings. "I think we have to be very cautious,
given the limited aspect of our study. It's still a small study,
with just 200 people in each group," he explained.
And, he noted, Xolair is an expensive medication, costing about
$1,000 a month. Injection of the drug also requires a doctor
Omalizumab targets the antibody immunoglobulin E (IgE), a
substance that is responsible for allergic symptoms and many asthma
exacerbations. It is given by injection, usually once every two to
four weeks, according to Novartis, the drug manufacturer.
Omalizumab is currently only approved for people over the age of
The U.S. Food and Drug Administration is currently conducting a
long-term safety review of omalizumab, because there have been
reports of an increased risk of heart attack, abnormal heart
rhythms, heart failure and stroke in people taking the drug. Final
results of this review aren't expected until 2012, and, in the
meantime, the medication remains on the market.
The current analysis included 419 children with asthma from
eight different urban areas across the United States. The children
were between the ages of 6 and 20, and most had moderate to severe
asthma. Sixty percent of the children were black and 37 percent
All of the children were being treated for their asthma symptoms
based on the guidelines from the National Asthma Education and
Prevention Program. Study participants and their caregivers
received education about controlling environmental asthma and
allergy triggers, such as dust mites and cockroaches. They were
also given mattress covers, pest traps and a new vacuum
Half of the group was randomly selected to receive omalizumab
injections once every two to four weeks (dosage varied by weight
and disease severity), or a placebo injection. The study lasted 60
At the start of the study, the children were having asthma
symptoms an average of 1.96 days during a two-week period. Those
who received omalizumab saw the duration of their symptoms drop to
1.48 days per two week period, a reduction of 24.5 percent,
according to the study.
Those taking long-term preventive medications were able to
reduce the amount of medication without experiencing an increase in
symptoms. The treatment group had a 75 percent reduction in the
number of hospitalizations compared to the placebo group.
And, the exacerbations in the omalizumab group were reduced --
30.3 percent vs. 48.8 in the placebo group. The omalizumab group
also didn't experience seasonal peaks in their asthma symptoms,
which normally happens in the spring and the fall.
No differences in concern related to safety were noted between
the two groups, the researchers reported. One patient in the
omalizumab group developed anaphylaxis -- a life-threatening
allergic reaction that has previously been linked to the drug --
compared to six patients in the placebo group who developed
One of the study's key findings, according to Busse, is the fact
that allergies play a significant role in the development of asthma
attack. He said that wasn't unknown, but that it was surprising to
see how much of an effect reducing IgE levels had on asthma.
"Allergies play a very important role in bringing about asthma
attacks, and omalizumab allowed us to reduce the allergic process,"
Funding for the study was provided by the National Institutes of
Health, Novartis, Dey Pharma (they provided Epi-Pens to treat
serious allergic reactions), and SC Johnson (which provided pest
"Clearly, this is a very well-conducted study, but it is just one study. More research needs to be done, and we need to know more about safety," said Dr. Deepa Rastogi, an attending physician in the division of respiratory and sleep medicine at Children's Hospital at Montefiore Medical Center in New York City.
She added that this study reinforces treatment guidelines, and
emphasizes the need for good allergen control wherever possible. If
you can't control exposure to environmental allergens, allergy
prevention medications are often recommended, she said.
Learn more about managing asthma and allergy triggers from the
American Academy of Allergy, Asthma and
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