Xolair Relieves Kids' Seasonal Asthma Attacks: Study
Study Findings Met With Skepticism Because of Cost, Other Factors
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Asthma Drug Xolair: Background continued...
In clinical trials, about one in 1,000 people reported anaphylaxis. Malignances have been another issue. In clinical trials, 0.5% of people on the drug reported cancers of the skin, breast, and other sites, compared to 0.2% of people on placebo.
In 2009, the FDA began to evaluate findings from an ongoing study of Xolair that suggests a link with heart disease and cerebrovascular problems, although it has not yet suggested any changes based on the interim findings.
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.