Effect of Omalizumab on Symptoms of Seasonal Allergic Rhinitis: A Randomized Controlled Trial
2001
ContextSeasonal allergic rhinitis is a common IgE-mediated disorder that produces
troublesome symptoms. A recombinant humanized monoclonal anti-IgE antibody
(omalizumab) forms complexes with free IgE, blocking its interaction with
mast cells and basophils and lowering free IgE levels in the circulation.ObjectiveTo assess the efficacy and safety of omalizumab for prophylaxis of symptoms
in patients with seasonal allergic rhinitis.DesignRandomized, double-blind, dose-ranging, placebo-controlled trial conducted
from July 25 through November 21, 1997.SettingTwenty-five outpatient centers throughout the United States.PatientsFive hundred thirty-six patients aged 12 to 75 years with at least a
2-year history of moderate to severe ragweed-induced seasonal allergic rhinitis
and a baseline IgE level between 30 and 700 IU/mL.InterventionsPatients were randomly assigned to receive omalizumab, 50 mg (n = 137),
150 mg (n = 134), or 300 mg (n = 129), or placebo (n = 136) subcutaneously
just prior to ragweed season and repeated during the pollen season every 3
weeks in patients with baseline IgE levels of 151 to 700 IU/mL (4 total treatments)
and every 4 weeks in patients with baseline IgE levels of 30 to 150 IU/mL
(3 total treatments).Main Outcome MeasuresSelf-assessed daily nasal symptom severity scores (range, 0-3), rescue
antihistamine use, and rhinitis-specific quality of life during the 12 weeks
from the start of treatment.ResultsNasal symptom severity scores were significantly lower in patients who
received 300 mg of omalizumab than in those who received placebo (least squares
means, 0.75 vs 0.98, respectively; P = .002). A significant
association was observed between IgE reduction and nasal symptoms and rescue
antihistamine use. Rhinitis-specific quality of life scores were consistently
better in patients who received 300 mg of omalizumab than in those who received
lower dosages or placebo and did not decline during peak season. The frequency
of adverse events was not significantly different among the omalizumab and
placebo groups.ConclusionOmalizumab decreased serum free IgE levels and provided clinical benefit
in a dose-dependent fashion in patients with seasonal allergic rhinitis.
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