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LOS ANGELES -- Omalizumab (Xolair) plus guideline-based asthma treatment reduced rates of cold symptoms in asthmatic children compared with kids who were treated based on guidelines alone, researchers reported here.

For the Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE) study, 478 inner-city asthmatic children, ages 6 to 17, were randomized to either guideline-based asthma care, or add-on fluticasone boost, or add-on omalizumab, reported , of the University of Wisconsin School of Medicine and Public Health in Madison, and colleagues.

They performed a total of 6,117 assessments on the participants, and 18% symptomatic illnesses were detected. Rates of symptoms were 27% lower in the add-on omalizumab group compared with guideline-based care alone. The fluticasone boost did not appear to have an effect on rates of cold symptoms, they reported at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

"The idea for this study was to try and ramp up asthma therapy before kids go to school," Gern said during an AAAAI press conference.

Omalizumab is a monoclonal antibody that received FDA approval in 2003 for the treatment of moderate to severe persistent allergic asthma, and then again in 2014 for chronic idiopathic urticaria in adults and adolescents who remain symptomatic despite H1 antihistamine treatment.

Children were screened for cold symptoms with scoring sheets every week over the course of the 2012 or 2013 cold seasons. Cold symptoms, runny nose, stuffy nose, sneezing, cough, or sore throat, were compared with baseline measures.

The cohort was 59% African American, 34% Hispanic, 8% white, and 55% had an annual household income below $15,000.

Everyone participated in a run-on period of 4 to 9 months of only guideline-based care to gather baseline measures. Among patients in the omalizumab group, the adjusted prevalence of rhinovirus was nearly 30% lower (odds ratio 0.7, 95% CI 0.55-0.87, P=0.0017).

Gern said that they were unable to detect whether the omalizumab reduced the number of infections or shortened the duration of the subsequent infections.

When looking at the patients who had more severe asthma, and were on medications in the (nearly 40%), Gern's group discovered that the viral load was 32% lower in the omalizumab group compared with the placebo group.

And among the 60% of participants who were on medications consistent with treatment steps 2-4, the viral load was only 26% lower among the omalizumab group compared with the placebo group.

"This study was unique in that we had very good virology. Kids gave a sample of nasal mucus every week," Gern said. "We had freezers full of snot, and each of those samples was evaluated for respiratory viruses."

The authors also reported that cold symptom reduction rates among children in the omalizumab group were similar between children with moderate versus severe persistent asthma.

"This isn't an at-home treatment; it's too expensive, but this gives us some insights," Gern stated. "But I think what it's telling us is that if you treat allergic inflammation, you may have secondary effects to boost interferon production and reduce viral morbidity across the board, not just exacerbations."

"By preventing allergy in kids, we might see less viral morbidity," Gern added. "My long-term goal is to see how we can prevent allergic sensitization, and prevent secondary viral morbidity."

In commenting on the study,, of Children's Mercy in Kansas City, Mo., called the results "exciting...this new mechanism for this biologic."

But Portnoy, who was not involved in the research, questioned the authors' conclusion that "these findings indicate that IgE contributes to the frequency and/or duration of upper respiratory illnesses in this population."

Omalizumab has a mechanism that doesn't involve IgE antibodies, Portnoy noted, adding that "we know that because people who have chronic hives respond to omalizumab."

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