Similar biological activity in skin prick test for Oralair® (8200 BAU) and Grazax® (6200 BAU) reinforces effective SLIT dosing level

In Europe, allergen extracts are standardized based on skin prick wheal size in 20–30 allergic subjects. To understand the biological activity of clinically effective Sublingual immunotherapy, we used this method to determine the biological activity of solution and tablet Timothy grass pollen (TIM)...

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Vydáno v:Allergy (Copenhagen) Ročník 71; číslo 12; s. 1782 - 1786
Hlavní autoři: Larenas Linnemann, D. E. S., Singh, J., Rosario, N., Esch, R., Matta, J. J., Maspero, J., Michels, A., Mösges, R.
Médium: Journal Article
Jazyk:angličtina
Vydáno: Denmark Blackwell Publishing Ltd 01.12.2016
Témata:
Administration, Sublingual
allergen extract
allergen immunotherapy
Allergens - administration & dosage
allergic rhinitis
Allergies
Antigens, Plant - administration & dosage
Biological activity
Diagnostic tests
Humans
Immunotherapy
Plant Extracts - administration & dosage
Rhinitis, Allergic, Seasonal - diagnosis
Rhinitis, Allergic, Seasonal - immunology
Rhinitis, Allergic, Seasonal - therapy
Skin Tests
Sublingual Immunotherapy
timothy grass pollen
Treatment Outcome
allergen extract
allergic rhinitis
sublingual immunotherapy
allergen immunotherapy
timothy grass pollen
ISSN:0105-4538, 1398-9995
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Shrnutí:In Europe, allergen extracts are standardized based on skin prick wheal size in 20–30 allergic subjects. To understand the biological activity of clinically effective Sublingual immunotherapy, we used this method to determine the biological activity of solution and tablet Timothy grass pollen (TIM) extracts, compared to an FDA‐approved extract (Reference) of 10 000 BAU/ml. Blinded, quadruplicate skin prick tests with concentrate and three serial half‐log dilutions allowed the construction of a semilogarithmic regression line per extract. Bioequivalent allergy units (BAU) values were obtained from the comparison with reference. Extracts and dilutions showed a neat linear dose response (all: R2 > 0.98) in 33 rhinitis patients. Relative potencies: Staloral® 12 000 BAU/ml, Soluprick® 10 300 BAU/ml, Oralair® 8200 BAU, and Grazax® 6200 BAU. Even though all extract concentrates differed in wheal size (P = 0.01–0.001), Grazax® producing a 25% smaller wheal size than Oralair®, and the biological activity of these clinically effective TIM tablets led in the same range (6200–8200 BAU; 0.92–1.23 cm2). SLIT dose‐finding studies for other pollens might start with allergen extracts producing 1.1 cm2 wheal surface.
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ISSN:0105-4538
1398-9995
DOI:10.1111/all.12998