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      DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy

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          Abstract

          A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory framework under the transitional provision of the Therapy Allergen Ordinance (TAO), and the consequences for the planned guideline work of the DGAKI, regulatory challenges in the approval of AIT products for children and adolescents as well as allergy diagnostics. The content and discussion points of this dialogue are summarized and are set in context with the current literature.

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          Allergen immunotherapy for allergic rhinoconjunctivitis: a systematic review and meta-analysis.

          Sangeeta Dhami, Ulugbek Nurmatov, Stefania Arasi … (2017)
          The European Academy of Allergy and Clinical Immunology (EAACI) is in the process of developing Guidelines on Allergen Immunotherapy (AIT) for Allergic Rhinoconjunctivitis. In order to inform the development of clinical recommendations, we undertook a systematic review to assess the effectiveness, cost-effectiveness and safety of AIT in the management of allergic rhinoconjunctivitis METHODS: We searched 15 international biomedical databases for published, in progress and unpublished evidence. Studies were independently screened by two reviewers against pre-defined eligibility criteria and critically appraised using established instruments. Our primary outcomes of interest were symptom, medication and combined symptom and medication scores. Secondary outcomes of interest included cost-effectiveness and safety. Data were descriptively summarized and then quantitatively synthesized using random-effects meta-analyses.
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            Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper.

            O Pfaar, P Demoly, R. Gerth van Wijk … (2014)
            Allergen immunotherapy (AIT) has been thoroughly documented in randomized controlled trials (RCTs). It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy (SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints.
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              Guideline on allergen immunotherapy in IgE-mediated allergic diseases

              Oliver Pfaar, Tobias Ankermann, Matthias Augustin … (2022)
              Not available
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                Author and article information

                Journal
                Journal ID (nlm-ta): Allergol Select
                Journal ID (publisher-id): Dustri
                Title: Allergologie Select
                Publisher: Dustri-Verlag Dr. Karl Feistle
                ISSN (Electronic): 2512-8957
                Publication date Collection: 2023
                Publication date (Electronic): 12 December 2023
                Volume: 7
                Pages: 229-235
                Affiliations
                [1 ]Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg,
                [2 ]Children’s Center Bethel, University Hospital OWL, Bielefeld University, Bielefeld,
                [3 ]Department of Pulmonary Medicine, University Hospital Essen – Ruhrlandklinik, Essen,
                [4 ]Department of Otorhinolaryngology, Düsseldorf University Hospital, Heinrich Heine University, Düsseldorf,
                [5 ]Comprehensive Allergy Center, Department of Dermatology and Allergy, Hannover Medical School, Hannover,
                [6 ]Department of Dermatology and Allergy, Hannover Medical School, Hannover,
                [7 ]Paul-Ehrlich-Institut, Langen,
                [8 ]Allergology and Immunology, Department of Dermatology, Venereology and Allergology, Charité –Universitätsmedizin Berlin, Berlin, Germany
                Author notes
                Correspondence to: Prof. Dr. med. Oliver Pfaar, Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität, Marburg, Baldinger Strasse, 35043 Marburg, Germany, oliver@ 123456pfaar.org
                Article
                DOI: 10.5414/ALX02450E
                PMC ID: 10740146
                PubMed ID: 38143938
                SO-VID: 4f1f3b12-47dc-4816-9ef1-a6de0f87115f
                Copyright © © Dustri-Verlag Dr. K. Feistle
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 25 October 2023
                Date accepted : 30 October 2023
                Categories
                Subject: Discussion
                Subject: Allergy

                Keywords: therapy allergen ordinance (tao),guidelines,ait products for children and adolescents,allergen diagnostics
                Data availability:
                Keywords: therapy allergen ordinance (tao), guidelines, ait products for children and adolescents, allergen diagnostics

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