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.