Mucosomal allergen-specific immunotherapy with initial dosing after start of pollen season

Abstract

The present invention relates to mucosal allergen-specific immunotherapy with a seasonal allergen, wherein the therapy is initiated after start of the pollen season of the seasonal allergen. Preferably, the seasonal allergen is provided in solid dosage form and is administered daily. Furthermore, advantageously, the same dose may be used throughout the treatment period since up-dosing is not required.

1 . A solid dosage form suitable formulated for mucosal administration comprising a seasonal allergen composition for use in allergen-specific immunotherapy for preventing or treating allergy to said allergen composition in a subject by mucosal administration, wherein the solid dosage form is administered in a dosage regimen, wherein initial administration is performed within the allergen season of the allergen composition. 
     
     
         2 . A solid dosage form according to  claim 1 , wherein the dosage regimen is a mono-dose regimen. 
     
     
         3 . A solid dosage form according to  claim 1 , wherein the dosage regimen comprises use of only one dose of the allergen composition throughout the entire treatment period. 
     
     
         4 . A solid dosage form according to  claim 1 , wherein the dosage regimen comprises no up-dosing phase. 
     
     
         5 . A solid dosage form according to  claim 1 , wherein the initial administration is performed without up-dosing phase. 
     
     
         6 . A solid dosage form according to  claim 1 , wherein the initial administration is given more than 1 week, more particularly more than 2 weeks, more particularly more than 3 weeks, more particularly more than 4 weeks, more particularly more than 5 weeks, more particularly more than 6 weeks, more particularly more than 10 weeks after the start of the allergen season. 
     
     
         7 . A solid dosage form according to  claim 1 , wherein the dosage form is administered daily. 
     
     
         8 . A solid dosage form according to  claim 1 , wherein the dosage form is administered once or twice daily. 
     
     
         9 . A solid dosage form according to  claim 1 , wherein the duration of the dosage regimen is from 12 months to 48 months, preferably from 24 months to 42 months, more preferably from 30 months to 40 months, and most preferably from 34 months to 38 months. 
     
     
         10 . A solid dosage form according to  claim 1 , wherein the allergen of the seasonal allergen composition is selected from the group consisting of a tree pollen allergen, a grass pollen allergen, a weed pollen allergen, a herb pollen allergen, a seasonal mould allergen and a fungi seasonal allergen. 
     
     
         11 . A solid dosage form according to  claim 1 , wherein the mucosal administration is oral, nasal, vaginal, sublingual, ocular, rectal, urinal, intramammal, pulmonal, otolar (i.e. via the ear) or buccal administration 
     
     
         12 . A solid dosage form according to  claim 1 , wherein the mucosal administration is oromucosal administration. 
     
     
         13 . A solid dosage form according to  claim 1 , wherein the mucosal administration is sublingual administration. 
     
     
         14 . A solid dosage form according to  claim 1 , wherein the solid dosage form is selected from the group consisting of compressed tablets, non-compressed tablets, coated tablets, non-coated tablets, powders, gels, suppositories, capsules and pastes. 
     
     
         15 . A solid dosage form according to  claim 1 , wherein the concentration of major allergen in a mono-dose intended for daily administration is from 0.05 to 50 μg, more preferably from 0.05 μg to 30 μg, more preferably from 0.06 μg to 25 μg, more preferably from 0.07 μg to 20 μg, more preferably from 0.08 μg to 15 μg, more preferably from 0.09 μg to 10 μg and most preferably from 0.1 μg to 7 μg. 
     
     
         16 . A dosage form according to  claim 1 , wherein the allergen composition is selected from the group consisting of an allergen extract, a purified fraction of an allergen extract, a modified allergen, a recombinant allergen and a mutant of a recombinant allergen. 
     
     
         17 . A method of doing allergen-specific immunotherapy for preventing or treating allergy to a seasonal allergen composition, comprising administering by mucosal administration to a subject in need thereof a solid dosage form containing a seasonal allergen, the solid dosage form is administered in a dosage regimen, wherein initial administration to said subject is performed within the allergen season of the allergen composition.