Anti-immunoglobulin E (anti-IgE) (omalizumab), a humanized monoclonal anti-
IgE antibody that binds to circulating IgE, has been studied in several lar
ge double-blind, randomized, placebo-controlled clinical trials to determin
e its pharmacokinetic characteristics, efficacy, and safety in ragweed- or
birch pollen-induced seasonal allergic rhinitis (SAR). The consequences of
readministering omalizulab after a lapse of time have also been studied. Th
ese studies have confirmed that serum-free IgE declines in a dose-related m
anner with such treatment and that omalizumab-induced declines In IgE corre
late with symptom improvement. Whether omalizumab is administered intraveno
usly or subcutaneously, its pharmacokinetics do not differ. A Phase II dose
-ranging study demonstrated that the optimum efficacious dose of omalizumab
for the treatment of seasonal allergic rhinitis is 300 mg administered sub
cutaneously. The dosing frequency, in terms of whether the antibody is admi
nistered every 3 or 4 wk, is based on the patient's baseline IgE level. Wit
h adequate dosing, nasal and ocular symptoms are significantly reduced, and
quality of life is significantly improved. Omalizumab is safe and well tol
erated and can be safely readministered in subsequent pollen seasons.