A study shows that omalizumab (Xolair®, Genentech, Novartis) used in combination with standard care four to six weeks before the start of the school year helps to prevent asthma exacerbations in inner-city children and teenagers come fall. The paper reporting the clinical trial’s results is titled “Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations” and was published in The Journal of Allergy and Clinical Immunology.
Based on previous clinical trials, researchers hypothesized that a short-term targeted therapy can potentially prevent asthma exacerbations at the same time as exposure to the treatment is reduced. Xolair was approved by the U.S. Food and Drug Administration (FDA) in 2003 for the treatment of allergic asthma patients with moderate to severe asthma whose symptoms are not fully managed by inhaled corticosteroid therapy.
Genentech’s three-arm multicenter clinical trial, called “Preventative Omalizumab or Step-up Therapy for Fall Exacerbations (PROSE),” aimed to compare omalizumab to placebo and omalizumab to inhaled corticosteroid (ICS). The study enrolled 478 children, ages 6 to 17, with recent asthma exacerbations and from inner-city neighborhoods. They were randomly divided into treatment with omalizumab, placebo, or an inhaled corticosteroid boost.
Results show that the exacerbation rate come the start of school in the fall was significantly lower in the omalizumab group compared to the placebo group, with an incidence of 11.3% and 21% respectively. No significant difference was observed between omalizumab and the ICS group. In a prespecified subgroup analysis, among participants with an exacerbation during the run-in phase of the trial, omalizumab was more effective than placebo (6.4% vs. 36.3%) and the inhaled corticosteroid therapy (2% vs 27.8%). Furthermore, omalizumab provoked an INF- α increase, a response associated with immunosuppression, and in the omalizumab group, this improvement correlated positively with fewer exacerbations. Researchers registered rare and similar adverse effects across the study groups.
Researchers concluded that, “adding omalizumab before return to school to ongoing guidelines-based care among inner-city youth reduces fall asthma exacerbations, particularly among those with a recent exacerbation. Our study shows that an effective, preventative strategy for fall exacerbations can be achieved with targeted, seasonal treatment using omalizumab, suggesting a paradigm shift for managing high-risk patients,” Dr. Stephen J. Teach, of Children’s National Health System in Washington, D.C., said in a press release.