Treatment of allergic asthma with monoclonal anti-IgE antibody.

Background Immune responses mediated by IgE are important in the pathogenesis of allergic asthma. A recombinant humanized monoclonal antibody (rhuMAb-E25) forms complexes with free IgE and blocks its interaction with mast cells and basophils. We studied the efficacy of rhuMAb-E25 as a treatment for moderate-to-severe allergic asthma. Methods After a 4-week run-in period, we randomly assigned 317 subjects (age range, 11 to 50 years) who required inhaled or oral corticosteroids (or both) to receive either placebo or one of two regimens of rhuMAb-E25: high-dose rhuMAb-E25 (5.8 μg per kilogram of body weight per nanogram of IgE per milliliter) or low-dose rhuMAb-E25 (2.5 μg per kilogram per nanogram of IgE per milliliter) intravenously on days 0 (half a dose), 4 (half a dose), and 7 (full dose) and then once every 2 weeks thereafter for 20 weeks. For the first 12 weeks of the study, the subjects continued the regimen of corticosteroids they had received before enrollment. During the following eight weeks, the...

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