Xolair Relieves Kids' Seasonal Asthma Attacks: Study
Study Findings Met With Skepticism Because of Cost, Other Factors
Xolair: Study Details
Busse, with his co-researchers from the Inner City Asthma Consortium, randomly assigned 419 children and young adults, aged 6 to 20, with allergic asthma to get either injections of the drug or placebo. At the time of assignment to the groups, 73% had either moderate or severe disease.
About 97% of both groups were either African-American or Hispanic.
Busse tells WebMD it's long been known that inner-city children with asthma often have more severe disease than children living outside of urban areas, and they often have co-existing allergies to dust mites, cockroaches, and other allergens.
Both groups got education about controlling these environmental allergens and were given bedding covers, pest traps, and a vacuum cleaner.
Research has shown that hospitalization rates go up about two weeks after children with allergic asthma return to school in the fall, as they catch respiratory infections, triggering worse asthma attacks, Busse says.
In the study, the researchers followed the participants for 60 weeks, evaluating whether the drug reduced symptoms of asthma.
Before the study started, Busse says, the children's asthma was controlled with a variety of other medications, and then Xolair was added on.
Children got the injections either every two weeks or every four weeks, for a total of either 15 or 30 injections.
Besides the reduction in symptom days and attacks, children on the drug were less likely to be hospitalized. Although 1.5% of children on the drug were hospitalized during the study, 6.3% of children in the placebo group were.
Overall, adverse events affected the placebo group more. One in the Xolair group and six in the placebo group had anaphylaxis.
The typical seasonal spike in asthma wasn't seen in the drug group in the fall and summer, but nearly doubled in the placebo group during those times.
The study results suggest that in these children allergy plays an important role in their asthma, Busse says, with an interaction between allergy and viral infections possibly triggering the asthma attacks, a link others have suggested.
Controlling the allergies, Busse says, didn't result in fewer colds, but in his study did result in fewer asthma attacks. "We don't know exactly why," he says, although reducing inflammation may help explain the findings.
Although the drug is expensive, Busse points to the reduction in hospitalization costs as a benefit.
The study was funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and by Novartis.
Busse reports receiving board membership fees from Centocor and Merck, consulting fees from Genentech, and consulting fees and grant support from Novartis and other pharmaceutical companies.
Asthma Drug Xolair: Second View
Mosenifar reviewed the study for WebMD but was not involved in it. He has no disclosures relevant to the topic.
Although the study is scientifically sound, he says, "I'm a little skeptical about this. This drug has been around for seven or eight years.'' He cites concerns about anaphylaxis, cancers, and expense.
"Certainly this drug plays a role in allergic asthma, that is not new," he tells WebMD. "The nuance in this is that the allergy component is diminished [with Xolair]."
Although the population studied is definitely at higher risk of allergy and asthma, Mosenifar says ''there are better ways of dealing with this issue -- and that is environmental cleaning and household cleaning, which the authors imply have limitations. But I think they are very important."
As an alternative, he would suggest spending the money on basic measures -- dust mite-resistant pillow cases and control of pests such as cockroaches -- with the goal of preventing the initial elevation of IgE antibodies that sets the allergic ''cascade'' into action.