Abstract

Seasonal allergic rhinitis (SAR) induced by Japanese cedar pollens is a substantial problem in Japan. Omalizumab, a novel humanized monoclonal anti-immunoglobulin E (IgE) antibody, has already been proven to reduce symptoms associated with SAR. To investigate the safety and efficacy of omalizumab in the treatment of patients with Japanese cedar pollen-induced SAR compared to placebo or anti-allergic drug, two randomized, double-blind studies were conducted in Japan. Omalizumab (150, 225, 300, or 375 mg) or placebo was administered subcutaneously every 2 or 4 weeks based on serum total IgE and body weight at baseline. IPD was administered 300 mg per day through the season. Primary and all secondary efficacy variable scores were significantly lower in the omalizumab group than in the placebo group (P < .01) and IPD, Th2 cytokine inhibitor group (P < .01). Omalizumab was effective and safe in the treatment of SAR induced by Japanese cedar pollens. And the methods of increasing effects by combining omalizumab with antibody-specific immunotherapy are being considered. These strategy is more effective than immune-therapy alone.

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