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| |  Grass Allergy Immunotherapy Tablet Safe, Effective in Children: Presented at AAAAI By Carole VanSickle Ellis NEW ORLEANS -- March 3, 2010 -- The grass allergy immunotherapy tablet (AIT) has shown efficacy and tolerability in children with allergic rhinoconjunctivitis (ARC) in the first successful phase 3 trial in North America, according to researchers at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Michael Blaiss, MD, University of Tennessee Health Science Center, Memphis, Tennessee, and colleagues revealed on March 2 that their phase 3 trial of this protocol conducted in North America had completed the first successful phase. In the study, 345 children with grass pollen ARC received either a once-daily treatment with grass AIT or placebo. The team started recruitment in 2008 in sites throughout the United States and Canada and observed the children throughout the 2008 grass pollen season (GPS) to establish a history of allergy to grass pollen. The patients started treatment >8 weeks before the 2009 GPS and then continued throughout the season. All patients kept electronic diaries daily of rescue medications and symptoms. Primary efficacy endpoints comprised a total combined daily symptom score (DSS) and a daily medication score (DMS). The study’s secondary endpoints were individual DSS, DMS, and the Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Adverse events (AEs) were used to assess safety, whereas specific immunoglobulin (Ig)G4- and IgE-blocking factors were used for immunological endpoints. Overall, the AIT group had a statistically significant improvement of 26% (P = .001) in total combined score, compared with the placebo group. For the AIT group, DSS was 25% (P = .002), and the RQLQ improved by 18%. AEs tended to be application-site reactions, with no reports of anaphylactic shock. “This was the first successful phase 3 trial in North America investigating grass AIT in children,” said Dr. Blaiss. The results indicate that once-daily administration of grass AIT before and during the GPS is “clinically effective, is well-tolerated, and may be a new therapeutic modality for children with grass pollen allergy,” he concluded. [Presentation title: Efficacy and Safety of Grass Allergy Immunotherapy Tablet (AIT) in a North American Pediatric Population. Abstract L10]
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