Xolair Benefitial In Treating Children With Allergic Asthma
Data presented today at the American College of Allergy, Asthma & Immunology (ACAAI) show that Xolair (Omalizumab) for Subcutaneous Use significantly reduced asthma attacks in children aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids. The study further defines the safety profile of Xolair in this patient population.
The Phase III study showed that children treated with Xolair demonstrated a 31% reduction in clinically significant asthma exacerbations compared to children treated with placebo at 24 weeks. After a year of treatment, children treated with Xolair suffered 43% fewer clinically significant asthma exacerbations than those receiving placebo.
Xolair is a biologic treatment currently approved for people 12 years of age and above with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. It is the only approved therapy which blocks IgE (immunoglobulin E), a major component of allergic asthma. Genentech, co-marketer of Xolair, plans to submit these data to the US Food and Drug Administration (FDA) seeking to expand the current labeled indication for Xolair.
"Asthma is a life-threatening disease that can have serious health consequences in children. There are many children whose allergic asthma symptoms are just not adequately controlled despite optimal dosing with standard of care inhaled corticosteroid treatment," said principal investigator Bob Lanier, MD, Medical Director of the North Texas Institute for Clinical trials and Clinical Professor of Pediatrics at the University of North Texas Health Science Center. "In the Phase III study, children treated with Xolair experienced significantly fewer asthma exacerbations, or worsening attacks."
Asthma is the leading serious chronic illness of children in the US, affecting an estimated nine million children under the age of 18; of these children, 2.5 million suffer from allergic asthma, the most common type overall. Allergic asthma causes airway obstruction and inflammation, and can be triggered by allergens such as dust mites, pet dander, mold and cockroaches.
Among children aged five to 17, asthma is a leading cause of school absenteeism from a chronic illness, accounting for an annual loss of more than 12.8 million school days, and is the third leading cause of hospitalization for children under the age of 15.
Phase III Xolair Pediatric Study Results
The pivotal Phase III double-blind, randomized placebo-controlled study evaluated children aged six through 11 with moderate-to-severe allergic asthma uncontrolled despite inhaled corticosteroid (ICS) therapy. For eight weeks, ICS doses were optimized and baseline measures established in all study participants; 628 children still symptomatic after reaching optimized ICS dosing were randomized to receive add-on Xolair therapy or placebo. The study comprised a 24-week fixed-dose ICS phase, followed by a 28-week phase in which ICS doses could be reduced, and a 16-week safety follow-up period.
The study met its primary endpoint with Xolair-treated patients demonstrating a 31% reduction in clinically significant asthma exacerbations compared to patients treated with placebo at 24 weeks. The study also showed further support of the safety profile in a pediatric population aged six through 11. Adverse events were similar between groups and most (91%) were mild or moderate, with the most common being nasopharyngitis, sinusitis and upper respiratory tract infection. Two patients who were treated with Xolair withdrew from the study due to headache or bronchitis.
"We're encouraged by the Phase III clinical results that showed Xolair significantly reduced asthma exacerbations in children whose symptoms cannot be controlled with standard therapy," said John J. Orloff, MD, Head of US Medical and Drug Regulatory Affairs, North America at Novartis Pharmaceuticals Corporation. "Xolair represents a potentially important new approach to treating pediatric patients aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids."