CME Review ArticleComparison of allergen immunotherapy practice patterns in the United States and Europe
Section snippets
INTRODUCTION
The practice of allergen specific immunotherapy (SIT) has been used in the treatment of allergic rhinitis and asthma in Europe and the United States for many years, since the first description by Noon in 1911, almost a century ago.1 In the 1900s, research focused on desensitizing patients with seasonal allergic rhinitis with pollen extract injections was conducted on both sides of the Atlantic, beginning with Noon and Freeman in London, England, and Lowdermilk in Galena, Kansas. Despite similar
Standardization and Regulation in the United States
In the United States, allergen extracts are regulated by the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). The specific regulations regarding allergen extract are primarily found in part 680 of Title 21 of the Code of Federal Regulations.4 US allergen extracts are manufactured in 2 forms: standardized and nonstandardized. Nonstandardized extracts have no US standard of potency and report content as either weight/volume, which is the weight of the
SIMILARITIES
Similarities between European and US allergists likely lie in the perception of SIT as a disease-modifying agent and the established practice guidelines that provide recommendations. Although there may be an ongoing debate between Europe and US allergists regarding the number of allergens to include in an allergen extract formulation, there is virtually no disagreement that this treatment can provide long-lasting clinical improvement after discontinuation and potentially prevent the progression
CONCLUSIONS
Significant differences and similarities exist in the allergen immunotherapy practice patterns of US and European allergy specialists. The differences lie primarily in the availability of allergen extracts and how these extracts are formulated, and both of these factors are influenced by regulatory guidelines. In Europe, extract manufacturers prepare the final finished allergen formulation, often provided as named-patient products, whereas this role is played by allergy specialists in the
ACKNOWLEDGMENTS
We acknowledge the following: Greg Plunkett, PhD, Robert Esch, PhD, Derek Constable, PhD, and Donald W. Aaronson, MD, JD, MPH.
CME Examination
1-5, Cox LS. 2009;103:451-460.
CME Test Questions
- 1.
An allergen extract standardization procedure that establishes extract potency by comparison with pooled sera from an allergic population, such as the ID50EAL method:
- a.
can determine if a relevant allergen is missing
- b.
provides information about the overall allergenicity of the extract
- c.
will ensure that the allergen extracts with the same labeled potency have similar compositions
- d.
correlates with the weight of the source material extracted with a given volume of extracting fluid (wt/vol)
- e.
will determine
- a.
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This educational activity is supported by an educational grant from GlaxoSmithKline
Previous Presentation: This paper was presented at the European Academy of Allergy Asthma and Immunology Annual Meeting on June 7, 2009 in Warsaw, Poland at Immunotherapy Interest Section Business Meeting invited by Giovanni Passalacqua, MD (chair) and Moises Calderon, MD, PhD (secretary).