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| |  Grass Allergen Tablet Reduces Rhinoconjunctivitis Symptoms in Children: Presented at AAAAI By Maggie Schwarz PHILADELPHIA -- March 20, 2008 -- Immunotherapy with lyophilisate grass allergen tablet is safe and effective in reducing rhinoconjunctivitis symptoms in children, researchers announced here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Albrecht Bufe, MD, University Professor, Ruhr University, Bochum, Germany, presented results of a phase 3 trial in which the grass allergen tablet was compared with placebo in 253 children aged 5 to 16 years who had grass-pollen-induced rhinoconjunctivitis with or without asthma. The trial was a randomized, double-blind, parallel-group study performed in 26 centers in Germany. Subjects received the tablet for 8 to 23 weeks prior to and during the grass pollen season. Of the 253 participants, 103 had a history of seasonal asthma. All participants also had a positive skin prick test to grass pollen and positive immunoglobulin E against grass pollen. Analysis of the average rhinoconjunctivitis symptom score revealed a statistically significant improvement for the lyophilisate group versus placebo (P = .0195). The lyophilisate group had a relative median symptom score reduction of 24% versus placebo. Using a threshold of 30 rather than 10 grains per cubic meter to define the grass pollen season, statistically significant reductions were observed as well (P = .0071), with a median reduction of 28%. Rescue medication was used 34% less (median rate) in the lyophilisate group compared with the placebo group. Using the revised threshold described above, statistically significant median reductions were still observed (P = .0016). Regarding asthma symptoms, the average asthma symptom score showed a statistically significant improvement in the lyophilisate group versus placebo (P = .0344). The lyophilisate group had a relative median reduction of asthma symptoms of 64%. The number of subjects in need of asthma rescue medication during the grass pollen season was lower in the lyophilisate group (20 subjects, 17%) than in the placebo group (30 subjects, 25%). Lyophilisate provided a significant reduction in rhinoconjunctivitis symptoms and in rhinoconjunctivitis rescue medications. In the lyophilisate group, asthma symptom scores were lower, as was the median number of days with asthma symptoms. The number of patients in need of asthma rescue medication was also reduced. A total of 199 related adverse events were reported by 67 (53%) subjects in the lyophilisate group and 37 (29%) subjects in the placebo group. The majority of related adverse events were local reactions primarily within the mouth or throat, and were mild or moderate in severity and transient in nature. No serious treatment-related adverse events were reported. Dr. Bufe concluded that immunotherapy with lyophilisate in children is effective and well tolerated. This study was funded by ALK-Abelló A/S, Hoersholm, Denmark.
[Presentation title: Phase III Trial With Grass Allergen Tablet for Sublingual Immunotherapy in Children. Abstract 492]
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