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Original Article


In Vivo and In Vitro Immunological Changes Induced by a Short Course of Grass Allergy Immunotherapy Tablets


C Panizo,1 M Cimarra,2 E González-Mancebo,3 A Vega,4 C Senent,5 S Martín6

1Hospital Nuestra Señora del Prado, Talavera de la Reina, Spain
2Hospital Clínico San Carlos, Madrid, Spain
3Hospital Fuenlabrada, Madrid, Spain
4Hospital Universitario de Guadalajara, Guadalajara, Spain
5Hospital Virgen del Valle, Toledo, Spain
6ALK-Abelló S. A., Madrid, Spain

J Investig Allergol Clin Immunol 2010; Vol. 20(6): 454-462



Background: The fast-dissolving grass allergy immunotherapy tablet (grass AIT), Grazax, has proven effective in grass pollen–induced rhinoconjunctivitis.
Objective: To investigate the immunological and cutaneous changes induced after a short course with grass AIT.

Methods: We performed a randomized, double-blind placebo-controlled trial with 78 patients randomly assigned to receive either grass AIT or placebo in a 2:1 ratio. Treatment lasted at least 8 weeks before the grass pollen season (GPS), and continued until the seasonfinished. Specifi c immunoglobulin (Ig) G4, IgE, and IgE-blocking factor to Phleum pratense were measured at the beginning of the trial and at different intervals during treatment. Immediate and delayed skin tests with P pratense were also performed. Safety endpoints were defined in terms of adverse events reported.

Results: A total of 75 patients completed the trial (50 active and 25 placebo). P pratense IgG4, IgE, and IgE-blocking factor in actively treated patients increased significantly from baseline to the start of the GPS compared to placebo (P>.001, P=.017, and P=.005, respectively). The immediate cutaneous response was reduced during therapy in actively treated subjects, whereas placebo-treated subjects showed a decrease only after the start of the GPS. The delayed response to the intradermal test in grass AIT–treated subjects diminished, although not in a significantly different way from the placebo-treated subjects.

Conclusion: Treatment with grass AIT for grass pollen allergic rhinoconjunctivitis induces immunological changes after only 1 month of treatment.

Key words: Grass pollen allergy. Grass allergy immunotherapy tablet. Immunological changes. Sublingual immunotherapy.