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SAN FRANCISCO -- Among children whose asthma was poorly controlled with inhaled corticosteroids, treatment with omalizumab (Xolair) was associated with fewer hospitalizations and unscheduled doctor's visits in a 52-week study, but was not tied to fewer asthma-related emergency department (ED) visits, researchers reported here.
During the total 52-week treatment period, the percentage of patients with asthma-related unscheduled healthcare visits was significantly lower in the omalizumab group versus the placebo group, reported , of the University of North Texas Health Science Center in Benbrook, and colleagues. Specifically:
- Asthma-related hospital admissions: 4.4% vs 9.4% (P=0.024)
- Asthma-related unscheduled doctor visits: 28.4% vs 37.5% (P=0.032)
- Any asthma-related ED visit (33.6% vs 46.9% (P=0.003)
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
However, findings from the post hoc analysis of a phase III, placebo-controlled trial showed that the percentage of patients with asthma-related ED visits was not significantly different between patients receiving omalizumab and placebo (5.7% versus 8.3%, P=0.246), Lanier reported in a presentation at the American College of Allergy, Asthma & Immunology annual meeting.
Nonetheless, the results suggest that treatment with the pricey biologic drug can actually save healthcare dollars for kids with poorly controlled asthma, he noted.
Omalizumab was for the treatment of children, ages 6 to 11 years, with allergic asthma who were inadequately controlled despite regular treatment with 200 μg/day or more of fluticasone propionate or equivalent, with or without rescue inhalers.
It has been approved since 2003 for use in older children and adults with poorly controlled asthma despite treatment with conventional inhaled corticosteroids.
"The question was, 'Would we see a reduction in hospital admissions by putting children on omalizumab?' And the answer was 'yes.' We were able to reduce hospital admissions by over half," Lanier told 鶹ý. "When you think about the cost of a hospital admission -- not only in terms of direct costs, but school loss and time loss -- that is very significant."
The children, ages 6 t0 12 years, were treated with either placebo or omalizumab (75 to 375 mg) subcutaneously every 2 to 4 weeks for 52 weeks. Dose and frequency were determined from dosing tables using baseline serum IgE levels and body weight. Inhaled corticosteroid therapy was constant during the first 24 weeks of the study, but investigators could modify this corticosteroid dosage after this time.
The researchers concluded that continuing omalizumab for 52 weeks or longer may help reduce asthma-related utilization of health care services in younger children.
Lanier told 鶹ý that he believes third-party payers will be receptive to covering the drug for use in younger patients with difficult-to-treat asthma.
"Even though this drug has only recently been approved for use in younger children, we have been able to get compassionate approval in recent years. I am passionate about this because the kids I have treated have just done so well," he said.
Disclosures
The study was funded by Genentech and Novartis Pharma AG.
Lanier disclosed relevant relationships with Genentech and Novartis.
Primary Source
American College of Allergy, Asthma & Immunology
Lanier B, et al "Omalizumab reduces health care resource use in children" ACAAI 2016; Abstract P147.