Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents - 10/08/11
, Jennifer Maloney, MD b, c, Hendrik Nolte, MD, PhD b, d, Sandra Gawchik, DO e, Ruji Yao, PhD b, David P. Skoner, MD f, g
Reprint requests: Michael Blaiss, MD, 7205 Wolf River Blvd, Germantown, TN 38120.Abstract |
Background |
Allergy immunotherapy tablet (AIT) treatment might be a safe and convenient form of specific immunotherapy but it has not been investigated in North American children and adolescents.
Objective |
We sought to investigate the efficacy and safety of timothy grass AIT treatment in North American children/adolescents with grass pollen–induced allergic rhinoconjunctivitis (ARC) with or without asthma.
Methods |
Three hundred forty-five subjects (5-17 years old) were randomized to once-daily grass AIT treatment (2,800 bioequivalent allergen units, 75,000 standardized quality tablet, approximately 15 μg of Phl p 5) or placebo approximately 16 weeks before the 2009 grass pollen season (GPS). Treatment continued through the GPS. Daily symptoms and allergy rescue medication use were recorded. The primary end point was the total combined score (TCS) of the daily symptom score (DSS) and daily medication score (DMS) for the entire GPS. DSS, DMS, Rhinoconjunctivitis Quality of Life Questionnaire score, and Phl p 5–specific IgG4 and IgE-blocking factor levels were secondary end points. Safety was assessed through adverse events.
Results |
Eighty-nine percent of subjects were multisensitized. TCS, DSS, DMS, and Rhinoconjunctivitis Quality of Life Questionnaire score versus placebo improved 26% (P = .001), 25% (P = .005), 81% (P = .006), and 18% (P = .04). Phl p 5–specific IgG4 and IgE-blocking factor levels were significantly higher at the peak and end of the GPS (P < .001). Treatment was well tolerated. Adverse events were generally mild and transient. Although no investigator-assessed systemic allergic reactions were reported, 1 grass AIT–treated subject experienced an event indicating a systemic reaction (lip angioedema, dysphagia, and cough).
Conclusions |
Use of once-daily timothy grass AIT treatment effectively treats timothy grass (cross-reactive with Festucoideae grasses) pollen–induced ARC in North American children 5 years and older. Given its convenient administration, lack of dose build-up requirement, safety profile, and efficacy, AIT treatment might become an important addition to the North American ARC treatment armamentarium.
Le texte complet de cet article est disponible en PDF.Key words : Allergy immunotherapy tablet, allergic rhinoconjunctivitis, specific immunotherapy, grass pollen, children, sublingual immunotherapy
Abbreviations used : AE, AIT, ARC, DMS, DSS, GPS, RQLQ, TCS
Plan
| Supported by Merck & Co. |
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| Disclosure of potential conflict of interest: M. Blaiss has provided consultant and speaker services for Alcon, AstraZeneca, Genentech, GlaxoSmithKline, ISTA, Merck, Nycomed, Proctor & Gamble, Sanofi-Aventis, Sepracor, Teva, UCB, and Vectura and has provided legal consultation and expert witness testimony in rhinitis and asthma-related cases. J. Maloney, H. Nolte, and R. Yao are employees of Merck Research Laboratories. S. Gawchik has received grant support from Alcon, ALK-Abelló, AstraZeneca, Curalogic, GlaxoSmithKline, Greer, Johnson & Johnson, MAP, MEDA, Merck, Novartis, PDZ Biopharm, Sanofi-Aventis, Sepracor, Skye Pharma, Symbio, and Teva; has served as a consultant for AstraZeneca, Merck, and Teva; and has provided speaker services for AstraZeneca, GlaxoSmithKline, Merck, Sepracor, and Teva. D. P. Skoner is on the speakers’ bureau for AstraZeneca, GlaxoSmithKline, Merck, Novartis, and Teva; has consulted for Merck; and has received research support from Novartis and Schering-Plough. |
Vol 127 - N° 1
P. 64 - janvier 2011 Retour au numéro
Article précédent
- Three years of specific immunotherapy may be sufficient in house dust mite respiratory allergy
- Ana I. Tabar, Esozia Arroabarren, Susana Echechipía, Blanca E. García, Santiago Martin, María J. Alvarez-Puebla
- Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults
- Harold S. Nelson, Hendrik Nolte, Peter Creticos, Jennifer Maloney, Jiangming Wu, David I. Bernstein
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