Efficacy and Safety of Timothy Grass Allergy Immunotherapy Tablets in North American Children and Adolescents

Abstract

M Blaiss, J Maloney, H Nolte, S Gawchik, R Yao, SP Skoner. J Allergy Clin Immunol. 2011;127(1):64–71, 71.e1–71.e4 To investigate the efficacy and safety of timothy grass allergen immunotherapy (AIT) treatment using sublingual tablets in children and adolescents with grass pollen–induced allergic rhinoconjunctivitis (ARC). Three hundred forty-five subjects, aged 5 to 17 years, with a clinical history of physician-diagnosed grass pollen–induced ARC with or without asthma were studied. This was a double-blind, randomized, placebo-controlled, parallel-group, multicenter, phase III study. Subjects were randomly assigned (1:1) to once-daily sublingual grass AIT treatment (2800 bioequivalent allergen units; 15 μg of Phlp5) or placebo. Treatment began ∼16 weeks before …