Practical Recommendations for Mixing Allergy Immunotherapy Extracts

Daigle, Barbara J.; Rekkerth, Donna J.

doi:10.2500/ar.2015.6.0111

Cited by 11 publications

(6 citation statements)

References 28 publications

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“…In case of fungal extracts, there exists a tradeoff between maximum allergen recovery and the increased release of nonallergenic substances such as melanin, which is released by highly pigmented spores and phenols, which are known to cause protein precipitations [13,51,112]. Moreover, proteases that might cause the degradation of some allergens might also be extracted during longer extractions times [12,31,110,[112][113][114][115][116]. However, the effects of phenols and proteases can be prevented by the addition of phenol-binding components and protease inhibitors [13,110].…”

Section: Timementioning

confidence: 99%

Problems Encountered Using Fungal Extracts as Test Solutions for Fungal Allergy Diagnosis

Pfeiffer,

Swoboda

2023

JoF

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Fungal allergy is a worldwide public health burden, and problems associated with a reliable allergy diagnosis are far from being solved. Especially, the lack of high-quality standardized fungal extracts contributes to the underdiagnosis of fungal allergy. Compared to the manufacturing processes of extracts from other allergen sources, the processes used to manufacture extracts from fungi show the highest variability. The reasons for the high variability are manifold as the starting material, the growth conditions, the protein extraction methods, and the storage conditions all have an influence on the presence and quantity of individual allergens. Despite the vast variety of studies that have analyzed the impact of the different production steps on the allergenicity of fungal allergen extracts, much remains unknown. This review points to the need for further research in the field of fungal allergology, for standardization and for generally accepted guidelines on the preparation of fungal allergen extracts. In particular, the standardization of fungal extracts has been and will continue to be difficult, but it will be crucial for improving allergy diagnosis and therapy.

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Section: Timementioning

confidence: 99%

Problems Encountered Using Fungal Extracts as Test Solutions for Fungal Allergy Diagnosis

Pfeiffer,

Swoboda

2023

JoF

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“…In contrast, while NPPs are not marketed as such in the United States, it has been reported that products are frequently mixed at the physician's office. Although respective guidance has been developed for this approach, there is a lack of evidence to support the efficacy of the individual mixtures used. Moreover, the EU is an evolving structure with the decision of the UK to leave the EU and several countries having joined the EU in the last decades.…”

Section: Current Regulatory Challenges For Allergen Products and Unmementioning

confidence: 99%

Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

Bonertz

Roberts

Hoefnagel

et al. 2017

Allergy

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Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high-quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe, a depiction of the different types of relevant procedures, as well as the committees involved, is provided and the fundamental role of national agencies of the EU member states in this complex and unique network is highlighted. Furthermore, the regulatory agencies from Australia, Canada, Japan, Russia, and Switzerland provided information on the system implemented in their countries for the regulation of allergen products.While AIT products are commonly classified as biological medicinal products, they are made available by varying types of procedures, most commonly either by obtaining a marketing authorization or by being distributed as named patient products. Exemptions from marketing authorizations in exceptional cases, as well as import of allergen products from other countries, are additional tools applied by countries to ensure availability of needed AIT products. Several challenges for AIT products are apparent from this analysis and will require further consideration. K E Y W O R D Sallergen immunotherapy, allergic diseases, allergy, regulation | INTRODUCTIONThe availability of medicinal products to provide a reliable diagnosis of clinical allergy and effective treatment(s) is of critical importance for patients with suspected or proven allergy. Products for allergen immunotherapy (AIT) have been approved by national competent authorities in different regions of the world. However, the regulatory landscape governing the approval of these products is enormously heterogeneous-both within the European Union (EU) and even more so when looking globally-thereby rendering it extremely complicated and challenging to develop a harmonized, international approach to regulating these products.Pharmaceutical companies are increasingly focused on global strategies to develop and market their products. It is therefore very important to understand the current regulatory situation for allergen products from an international perspective, as this will have a direct impact on the availability of these medicinal products to patients throughout the world. Certain regulatory patterns can be observed on a global scale. For example, whereas AIT was previously mainly used and placed on the market on the basis of expert opinions with limited regulatory oversight, the requirements for high-quality clinical data for granting market access have greatly increased during the last 20 years. In the EU, legislation applicable for new and existing products 1,2 has been in force since 1989 demanding that allergen products are registered as medicinal products with corresponding requirements for clinical data. The development of the guid...

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“…Because of this, immunotherapy based on patients’ specific allergens has become a common treatment for AR 6 . When patients experience allergy symptoms to only a few allergens, the choice of what antigens to include in their treatment is straightforward.…”

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confidence: 99%

“…5 Because of this, immunotherapy based on patients' specific allergens has become a common treatment for AR. 6 When patients experience allergy symptoms to only a few allergens, the choice of what antigens to include in their treatment is straightforward. However, when symptoms are caused due to numerous allergens, as is the case with 60% to 80% of patients with AR, 7 choosing the combination of antigens to include in their treatment can become complicated.…”

mentioning

confidence: 99%

“…When patients experience allergy symptoms to only a few allergens, the choice of what antigens to include in their treatment is straightforward. However, when symptoms are caused due to numerous allergens, as is the case with 60% to 80% of patients with AR, 7 choosing the combination of antigens to include in their treatment can become complicated 6,8,9 . To simplify this, antigens have been extensively studied to determine the best way to maximize therapy while minimizing the number of antigens required to adequately treat patients.…”

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confidence: 99%

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Cross‐reactivity in Skin Prick Test Results of Members Within Pooideae Subfamily

Harding¹,

Kinealy²,

Franzese³

2021

OTO Open

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Objective Molecular similarities of grass pollen antigens have led to the view that cross-reactivity exists within members of the Pooideae subfamily of grasses. This has resulted in testing for only the most antigenically representative member of Pooideae, Timothy grass ( Phleum pratense), despite little literature to support the claim that Phleum is the most representative member or that in vitro cross-reactivity correlates with in vivo cross-reactivity. The aim of the study was to determine if patients with allergic rhinitis symptoms and positive skin prick test results to meadow fescue ( Festuca pratensis) also have positive results to Timothy grass. Study Design Retrospective cross-sectional study. Setting Tertiary care center in middle Missouri. Methods A retrospective chart review identified patients ≥12 years old with a diagnosis of allergic rhinitis who underwent skin prick testing between March 2016 and July 2018, by using a search with CPT code 95004 ( Current Procedural Terminology). Positive skin prick test results were based on wheal produced ≥3 mm than the negative control. Results After review of 2182 charts, 1587 patients met criteria to test for Phleum and Festuca. In total, 1239 patients had a positive result for Phleum or Festuca. Of these, 479 (38.6%) tested positive for Festuca alone, while 342 (27.6%) and 418 (33.7%) tested positive for Phleum alone and Phleum+ Festuca, respectively. Conclusion Clinical cross-reactivity among Pooideae members may not be as complete as traditionally thought. P pratense may not be the most antigenically representative subfamily member, and other grasses may need to be included in skin prick testing.

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Practical Recommendations for Mixing Allergy Immunotherapy Extracts

Cited by 11 publications

References 28 publications

Problems Encountered Using Fungal Extracts as Test Solutions for Fungal Allergy Diagnosis

Problems Encountered Using Fungal Extracts as Test Solutions for Fungal Allergy Diagnosis

Challenges in the implementation of EAACI guidelines on allergen immunotherapy: A global perspective on the regulation of allergen products

Cross‐reactivity in Skin Prick Test Results of Members Within Pooideae Subfamily

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