PMID- 22018618
OWN - NLM
STAT- MEDLINE
DCOM- 20111212
LR  - 20111024
IS  - 1534-4436 (Electronic)
IS  - 1081-1206 (Linking)
VI  - 107
IP  - 5
DP  - 2011 Nov
TI  - Maintenance dosing for sublingual immunotherapy by prominent European allergen 
      manufacturers expressed in bioequivalent allergy units.
PG  - 448-458.e3
LID - 10.1016/j.anai.2011.07.001 [doi]
AB  - 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. OBJECTIVES: 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. CONCLUSION: 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.
CI  - Copyright (c) 2011 American College of Allergy. Published by Elsevier Inc. All 
      rights reserved.
FAU - Larenas-Linnemann, Desiree
AU  - Larenas-Linnemann D
AD  - Hospital Medica Sur, Mexico City, Mexico.
FAU - Esch, Robert
AU  - Esch R
FAU - Plunkett, Greg
AU  - Plunkett G
FAU - Brown, Shannon
AU  - Brown S
FAU - Maddox, Daniel
AU  - Maddox D
FAU - Barnes, Charles
AU  - Barnes C
FAU - Constable, Derek
AU  - Constable D
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110830
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Allergens)
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Administration, Sublingual
MH  - Allergens/administration & dosage/*pharmacokinetics
MH  - Animals
MH  - *Desensitization, Immunologic/standards
MH  - Drug Dosage Calculations
MH  - Europe
MH  - Humans
MH  - Hypersensitivity/*drug therapy/epidemiology/*immunology
MH  - Industry/standards
MH  - Pharmaceutical Preparations/*administration & dosage
MH  - Therapeutic Equivalency
MH  - United States
EDAT- 2011/10/25 06:00
MHDA- 2011/12/14 06:00
CRDT- 2011/10/25 06:00
PHST- 2011/03/08 00:00 [received]
PHST- 2011/06/11 00:00 [revised]
PHST- 2011/07/06 00:00 [accepted]
PHST- 2011/10/25 06:00 [entrez]
PHST- 2011/10/25 06:00 [pubmed]
PHST- 2011/12/14 06:00 [medline]
AID - S1081-1206(11)00506-0 [pii]
AID - 10.1016/j.anai.2011.07.001 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2011 Nov;107(5):448-458.e3. doi: 
      10.1016/j.anai.2011.07.001. Epub 2011 Aug 30.