Several large-scale, double-blind, randomized, placebo-controlled clinical
trials of the anti-immunoglobulin E (IgE) monoclonal antibody, rhuMAb-E25 (
omalizumab) have demonstrated the benefits of this agent in patients with m
oderate to severe allergic asthma who remain symptomatic despite treatment
with systemic or inhaled corticosteroids. The trials have consistently show
n that administration of omalizumab is associated with fewer asthma exacerb
ations per patient despite significant reductions in corticosteroid dose, s
table symptom control despite concomitant reductions in rescue medication u
se, and improvement in quality of life compared with placebo. In addition,
anti-IgE (omalizumab) has been shown to be safe and well tolerated.