Current practice of allergy diagnosis and the potential impact of regulation in Europe

Cardona, Victòria; Demoly, Pascal; Dreborg, Sten; Kalpaklıoğlu, Ayşe Füsun; Klimek, Ludger; Muraro, Antonella; Pfaar, Oliver; Popov, Todor A.; Hoffmann, Hans‐Jürgen

doi:10.1111/all.13306

Cited by 25 publications

(28 citation statements)

References 9 publications

(11 reference statements)

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“…In a recent survey of EAACI, the National Allergy Societies of Europe declared the lack of DAs a serious threat to current clinical practice. 9 Skin tests were shown to be the mainstay diagnostic procedure for the majority of allergic diseases and are used as first approach in 90% of patients with suspected inhalant allergies (asthma and rhinitis): organ-specific allergen challenges are regarded to be an important part of the diagnostic work-up. 9 The below listed recommendations given by this EAACI task force would facilitate better diagnosis and management of allergic diseases in European citizens.…”

Section: Discussion Of the E A Aci Ta S K Force Memb Er Smentioning

confidence: 99%

In‐vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper

Klimek

Hoffmann

Kalpaklıoğlu

et al. 2020

Allergy

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Diagnostic allergens are defined as medicinal products in the EU. Marketing authorization by national authorities is necessary; however, diagnostic allergens are not homogeneously regulated in different EU member states. Allergen manufacturers argue with increasing costs forcing them to continuously reduce the diagnostic allergen portfolios offered to allergists. In contrast, EAACI and national European Allergy Societies see the need for the availability of a wide range of high‐quality diagnostic allergens for in vivo diagnosis of IgE‐mediated allergies not only covering predominant but also less frequent allergen sources. In a recent EAACI task force survey, the current practice of allergy diagnosis was shown to rely on skin tests as first option in almost 2/3 of all types of allergic diseases and in 90% regarding respiratory allergies. With the need to ensure the availability of high‐quality diagnostic allergens in the EU, an action plan has been set up by EAACI to analyse the current regulatory demands in EU member states and to define possible solutions stated in this document: (a) simplification of authorization for diagnostic allergens; (b) specific regulation of special types of diagnostic allergens; (c) new models beyond the current model of homologous groups; (d) simplification of pharmacovigilance reporting; (e) reduction of regulation fees for diagnostic allergens; (f) reimbursement for diagnostic allergens. Joining forces of allergists, manufacturers and authorities are of high importance to ensure remaining relevant allergens in the EU markets to facilitate a sustainable and comprehensive service for the diagnosis and treatment of allergic diseases.

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Section: Discussion Of the E A Aci Ta S K Force Memb Er Smentioning

confidence: 99%

In‐vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper

Klimek

Hoffmann

Kalpaklıoğlu

et al. 2020

Allergy

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“…In patients with upper airway allergies, skin tests such as SPT and intracutaneous tests (ICT) are the most commonly used in vivo methods to diagnose IgE-mediated allergic reactions (72)(73)(74)(75)(76) . A recent EAACI task force survey investigating the current practice of allergy diagnosis in Europe found that in almost twothirds of all types of allergic diseases and in 90% of respiratory allergies the diagnosis relies on skin tests as the first option (77) .…”

Section: Skin Testsmentioning

confidence: 99%

European position paper on diagnostic tools in rhinology

Rimmer

Hellings

Lund

et al. 2019

Rhin

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114

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is the official Journal of the European and International Rhinologic Societies and appears quarterly in March, June, September and December. Cited in Pubmed, Current Contents, Index Medicus, Exerpta Medica and Embase Founded in 1963 by H.A.E. van Dishoeck, Rhinology is a worldwide non-profit making journal. The journal publishes original papers on basic research as well as clinical studies in the major field of rhinology, including physiology, diagnostics, pathology, immunology, medical therapy and surgery of both the nose and paranasal sinuses. Review articles and short communications are also pulished. All papers are peer-reviewed. Letters-to-the-editor provide a forum for comments on published papers, and are not subject to editorial revision except for correction of English language. In-depth studies that are too long to be included into a regular issue can be published as a supplement. Supple ments are not subject to peer-review.

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“…This was made possible by surveying all affiliated national societies inside and outside the EU. In total, 31 countries responded . The national societies were questioned about the types of tests used by their members and their awareness of national legislation pertaining to in vivo diagnostic tests and changes that might occur as a result of the transposition of Directive 2001/83 EC .…”

Section: The Future Of Diagnostic Allergens For In Vivo Testingmentioning

confidence: 99%

Perspectives in allergen immunotherapy: 2017 and beyond

Pfaar

Бонини

Cardona

et al. 2018

Allergy

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The Future of the Allergists and Specific Immunotherapy (FASIT) workshop provides a regular platform for global experts from academia, allergy clinics, regulatory authorities and industry to review developments in the field of allergen immunotherapy (AIT). The most recent meeting, held in February 2017, had two main themes: advances in AIT and hot topics in AIT from the regulatory point of view. The first theme covered opportunities for personalized AIT, advances in adjuvants and delivery systems, and the development of new molecules and future vaccines for AIT. Key topics in the second part of the meeting were the effects of the enactment of European Directive 2001/83 on the availability of allergens for therapy and diagnosis across the EU, the challenges of conducting Phase 3 studies in the field, the future role of allergen exposure chambers in AIT studies and specific considerations in performing AIT studies in the paediatric population. Finally, the group highlighted the forthcoming EAACI guidelines and their particular importance for the standardization of practice in the treatment of allergies. This review presents a comprehensive insight into those panel discussions and highlights unmet needs and also possible solutions to them for the future.

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Current practice of allergy diagnosis and the potential impact of regulation in Europe

Cited by 25 publications

References 9 publications

In‐vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper

In‐vivo diagnostic test allergens in Europe: A call to action and proposal for recovery plan—An EAACI position paper

European position paper on diagnostic tools in rhinology

Perspectives in allergen immunotherapy: 2017 and beyond

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