查看文章

Background Patients with severe asthma are often inadequately controlled on existing anti‐asthma therapy, constituting an unmet clinical need.

Objective This randomized, double‐blind, placebo‐controlled trial evaluated the ability of omalizumab, a humanized monoclonal anti‐IgE antibody, to improve disease control sufficiently to enable inhaled corticosteroid reduction in patients with severe allergic asthma.

Methods After a run‐in period when an optimized fluticasone dose (1000 μg/day) was received for 4 weeks, patients were randomized to receive subcutaneous omalizumab [minimum 0.016 mg/kg/IgE (IU/mL) per 4 weeks; n=126] or matching placebo (n=120) at intervals of 2 or 4 weeks. The study comprised a 16‐week add‐on phase of treatment followed by a 16‐week fluticasone‐reduction phase. Short‐/long‐acting β₂‐agonists were allowed as needed.

Results Median reductions in …