Maintenance dosing for sublingual immunotherapy by prominent European allergen manufacturers expressed in bioequivalent allergy units.
BACKGROUND
Sublingual immunotherapy (SLIT) has become established in Europe, and its efficacy is being evaluated in the United States. The doses used for SLIT in Europe today are difficult to evaluate, because each manufacturer expresses the potency of its extracts differently.


OBJECTIVE
To compare in vitro European SLIT maintenance solutions against US licensed standardized allergenic extract concentrates and to determine the monthly SLIT doses delivered expressed in bioequivalent allergy units ([B]AU).


METHODS
We studied Dermatophagoides pteronyssinus, timothy grass pollen, cat (hair) and short ragweed pollen allergen extracts. The SLIT maintenance solutions of 4 leading European manufacturers and standardized concentrate extracts of 3 US manufacturers were analyzed with the following assays: protein content, relative potency (immunoglobulin E [IgE]-binding enzyme-linked immunosorbent assay [ELISA] inhibition) and major allergen content. The relative monthly allergen dose in (B)AU was calculated for each recommended SLIT schedule.


RESULTS
Relative potency was approximately 10 times higher for US concentrate standardized extracts-which are meant to be diluted-than for European SLIT maintenance solutions of D pteronyssinus and timothy grass pollen. For cat (hair) and short ragweed pollen, the difference was less. Measurements of relative potency and major allergen content correlated well. In our assays, European mite extracts contain a very low quantity of Der p 2 compared with US mites.


CONCLUSIONS
Recommended SLIT doses in Europe vary widely among the manufacturers, but are consistently lower (Eur1) or higher (Eur4) over all four allergens tested. SLIT efficacy probably depends on additional factors apart from the exact dose. SLIT dose finding studies should be done for each product.
Hospital Médica Sur, Mexico City, Mexico.
Désirée
D
Larenas-Linnemann
Robert
R
Esch
Greg
G
Plunkett
Shannon
S
Brown
Daniel
D
Maddox
Charles
C
Barnes
Derek
D
Constable
D000286:Administration, Sublingual; D000485:Allergens / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000818:Animals; D003888:Desensitization, Immunologic / Q000592:standards; D054796:Drug Dosage Calculations; D005060:Europe; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology*; D007221:Industry / Q000592:standards; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D013810:Therapeutic Equivalency; D014481:United States
D000485:Allergens; D004364:Pharmaceutical Preparations