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- W2046004593 abstract "Ragweed allergy immunotherapy tablet (AIT) efficacy trials suggest 12 Amb a 1-U as the optimal dose for patient self-administration at home. A large trial was conducted to supplement and support the safety profile. Adults with ragweed pollen–induced ARC with/without asthma were randomized 2:1 to 28 days’ treatment with ragweed AIT 12 Amb a 1-U or placebo. The trial occurred outside ragweed season. Dose 1 of study medication was administered at the physician’s office; subsequent doses were taken at home. The primary objective was to characterize the adverse event (AE) profile of AIT 12 Amb a 1-U. 610 subjects were randomized to AIT 12 Amb a 1-U and 304 to placebo. 240 (39.4%) and 64 (21.1%) subjects receiving AIT and placebo respectively reported treatment-related AEs; the most common were local application-site reactions in the mouth, throat, and ear. Of these treatment-related AEs, approximately 96% were mild or moderate in severity. No serious treatment-related AEs were reported with AIT treatment. 2.8% of AIT subjects discontinued due to treatment-related AEs vs 0.7% receiving placebo (P=0.029). Two systemic allergic reactions developed: one subject receiving active treatment self-administered epinephrine appropriately, and proceeded to the ER; one subject receiving placebo with history of latex hypersensitivity presumably reacted to inadvertent latex exposure. No new safety signals emerged. In this study, AEs observed with ragweed AIT 12 Amb a 1-U were primarily local application-site reactions and were predominantly mild or moderate in severity. Ragweed AIT may hold potential for more convenient at-home allergy immunotherapy dosing." @default.
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- W2046004593 date "2013-02-01" @default.
- W2046004593 modified "2023-10-16" @default.
- W2046004593 title "Characterizing the 12 Amb a 1-U Ragweed Allergy Immunotherapy Tablet Adverse Event Profile in Adults with Ragweed-Induced Allergic Rhinoconjunctivitis" @default.
- W2046004593 doi "https://doi.org/10.1016/j.jaci.2012.12.1066" @default.
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