Omalizumab for Inadequately Controlled Severe Asthma

Omalizumab (Xolair), a recombinant monoclonal antibody that inactivates free IgE, is approved for use in patients older than 11 years with moderate-to-severe asthma that is not controlled by inhaled corticosteroids (ICS). In a double-blind, placebo-controlled randomized trial, U.S. investigators evaluated the efficacy and safety of add-on omalizumab among 850 asthma patients (age range, 12–75) who had inadequate symptom control while using both high-dose ICS and long-acting β₂-agonists (LABAs). Omalizumab was delivered subcutaneously every 2 or 4 weeks in doses that were based on weight. All patients had positive skin tests to a perennial aeroallergen. The trial, which excluded patients with histories of intubation secondary to asthma, was …