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Cedar Pollen Allergy Responds to Omalizumab: Presented at AAAAI
By Jill Stein
DENVER, CO -- March 9, 2003 -- Omalizumab is an effective treatment for seasonal allergic rhinitis (SAR) associated with Japanese cedar pollen, according to data presented here March 8th at the 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
Omalizumab is a humanised monoclonal anti-immunoglobulin antibody.
Dr. Takeru Ishikawa, with Kumamoto University in Osaka, Japan, reported results in 98 patients who had been randomised to omalizumab or placebo administered subcutaneously every 2 to 4 weeks.
All patients had moderate to severe SAR associated with Japanese cedar pollen for at least 2 years and had at least four moderate to severe symptoms out of eight possible symptoms (sneezing, itchy nose, runny nose, stuffy nose, itchy eyes, watery eyes, red eyes and itchy throat).
The first dose was administered approximately one month before the expected scattering of Japanese cedar pollen.
The two treatment groups were similar with respect to age, sex, duration of allergy, specific IgE for Japanese cedar pollen, and baseline serum total IgE.
The primary study end point was the daily nasal symptom medication score defined as the sum of the daily nasal severity score plus daily medication score.
Results showed that the average daily nasal symptom medication score during the pollen period was significantly lower in the omalizumab group (2.301) than in the placebo group (3.884, p<0.001).
In addition, the average daily ocular symptom medication score in the omalizumab group (0.888) was significantly lower than that in the placebo group (1.992) (p less than 0.001).
The frequency of overall adverse drug reactions and injection site reactions was higher in the omalizumab group compared with placebo group (p=0.0282). The frequency of injection site reactions was 25 percent (12/48) in the omalizumab group and 10 percent (5/50) in the placebo group. Importantly, there were no obvious drug -related serious adverse events.
Dr. Ishikawa said that the results support a role for omalizumab in the management of SAR associated with Japanese cedar pollen.
About 17% of the Japanese population, or 20 million people, have SAR associated with Japanese cedar pollen. The figure is expected to increase, Dr. Ishikawa said.
The study was sponsored by Novartis Pharma K. K. in Tokyo.
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