Guideline
ARIA guideline 2019: treatment of allergic rhinitis in the German health system
L. Klimek, C. Bachert, O. Pfaar, S. Becker, T. Bieber, R. Brehler, R. Buhl, I. Casper, A. Chaker, W. Czech, J. Fischer, T. Fuchs, M. Gerstlauer, K. Hörmann, T. Jakob, K. Jung, M.V. Kopp, V. Mahler, H. Merk, N. Mülleneisen, K. Nemat, U. Rabe, J. Ring, J. Saloga, W. Schlenter, C. Schmidt-Weber, H. Seyfarth, A. Sperl, T. Spindler, P. Staubach, S. Strieth, R. Treudler, C. Vogelberg, A. Wallrafen, W. Wehrmann, H. Wrede, T. Zuberbier, A. Bedbrook, G.W. Canonica, V. Cardona, T.B. Casale, W. Czarlewski, W.J. Fokkens, E. Hamelmann, P.W. Hellings, M. Jutel, D. Larenas-Linnemann, J. Mullol, N.G. Papadopoulos, S. Toppila- Salmi, T. Werfel and J. Bousquet
Volume 3 (2019) p. 22 - 50
Abstract
Allergologie select, Volume 3/2019 (22-50)
ARIA guideline 2019: treatment of allergic rhinitis in the German health system
Ludger Klimek1, Claus Bachert2, Oliver Pfaar3, Sven Becker4, Thomas Bieber5, Randolf Brehler6, Roland Buhl7, Ingrid Casper1, Adam Chaker8, Wolfgang Czech9, Jörg Fischer10, Thomas Fuchs11, Michael Gerstlauer12, Karl Hörmann13, Thilo Jakob14, Kirsten Jung15, Matthias V. Kopp16, Vera Mahler17, Hans Merk18, Norbert Mülleneisen19, Katja Nemat20, Uta Rabe21, Johannes Ring22, Joachim Saloga23, Wolfgang Schlenter24, Carsten Schmidt-Weber25, Holger Seyfarth26, Annette Sperl1, Thomas Spindler27, Petra Staubach23, Sebastian Strieth28, Regina Treudler29, Christian Vogelberg30, Andrea Wallrafen31, Wolfgang Wehrmann32, Holger Wrede33, Torsten Zuberbier34, Anna Bedbrook35, Giorgio W. Canonica36, Victoria Cardona37, Thomas B. Casale38, Wienczylawa Czarlewski39, Wytske J. Fokkens40, Eckard Hamelmann41, Marek Jutel42, Désirée Larenas-Linnemann43, Joaquim Mullol44, Nikolaos G. Papadopoulos45, Sanna Toppila-Salmi46, Thomas Werfel47, and Jean Bousquet34#35#48#49
1Center of Rhinology and Allergology, Wiesbaden, Germany, 2Upper Airways Research Laboratory and Department of Oto-Rhino-Laryngology, Ghent University and Ghent, University Hospital, Ghent, Belgium, Division of ENT Diseases, CLINTEC, Karolinska Institute, University of Stockholm, Stockholm, Sweden, 3Department of Otorhinolaryngology, Head and Neck, Surgery, Section of Rhinology and Allergy, University, Hospital Marburg, Philipps-Universität Marburg,Marburg, Germany, 4Department of Otolaryngology, Head and Neck Surgery, University of Tübingen, Tübingen, Germany, 5Department of Dermatology and Allergy, University of Bonn, Bonn, Germany, Christine Kühne-Center for Allergy Research and Education (CK-CARE) Davos-Augsburg-Bonn-St Gallen-Zürich, St. Gallen, Switzerland, 6Department of Allergy, Occupational Dermatology and Environmental Medicine, Universitätsklinikum Münster, Münster, Germany, 7Pulmonary Department,Mainz University Hospital,Mainz, Germany, 8Department of Otolaryngology and Center for Allergy and Environment (ZAUM), Klinikum rechts der Isar, Technical University of Munich and Helmholtz Center Munich, Munich, Germany, 9Department of Dermatology, University of Freiburg, Freiburg, Germany, 10Department of Dermatology, Eberhard Karls University, Tübingen, Tübingen, Germany, 11Department of Dermatology, Venereology, and Allergology, University Medical Center, Georg August University, Göttingen, Germany, 12Pediatric Pneumology and Allergology Unit, Medical University of Augsburg, Augsburg, Germany, 13Department of Otorhinolaryngology, Mannheim University Hospital, Mannheim, Germany, 14Department of Dermatology and Allergology, University Medical Center Gießen and Marburg, Campus Gießen, Justus-Liebig-University, Gießen, Germany, 15Group Practice for Dermatology, Erfurt, Germany, 16Clinic of Pediatric and Adolescent Medicine, Airway Research Center North (ARCN), Member of the German Lung Center (DZL), Lübeck University, Lübeck, Germany, 17Medical Faculty, Friedrich- Alexander-University (FAU) Erlangen-Nürnberg, Germany, 18Department of Dermatology and Allergology, University Hospital, RWTH Aachen University, Aachen, Germany, 19Asthma and Allergy Centre, Leverkusen, Germany, 20Department of Pediatrics, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany, 21Department of Allergology, Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH, Treuenbrietzen, Germany, 22Department and Outpatient Clinic for Dermatology and Allergology am Biederstein, Technical University of Munich, Munich, Germany and Christine Kühne Center for Allergy Research and Education (CK-Care), Davos, Switzerland, 23Department of Dermatology, University Medical Center Mainz,Mainz, Germany, 24Former Head ENT - Department, Katharina- Kasper-Kliniken, Marienkrankenhaus, c/o University Hospital, Frankfurt, Germany, 25Center for Allergy and Environment (ZAUM), Member of the German Center of Lung Research (DZL) and the Inflammation and Immunology Helmholtz Initiative, Technical University of Munich and Helmholtz Center Munich, Munich, Germany, 26Pharmacy Association in Hesse, Offenbach, Germany, 27Allergy Campus Davos, Hochgebirgsklinik Davos dpt. Pediatrics, Davos, Switzerland, 28Department of Otolaryngology, University Medical Center Mainz, Mainz, Germany, 29Department of Dermatology, Venereology and Allergology, LICA – Leipzig Comprehensive Allergy Center, University of Leipzig, Leipzig, Germany, 30Department of Pediatric Pneumology and Allergology, University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany, 31German Allergy and Asthma Association, Mönchengladbach, Germany, 32Dermatology Group Practice,Münster, Germany, 33Herford, North Rhine-Westphalia, Germany, 34Department of Dermatology and Allergy, Allergie-Centrum – Charité, Charité – Universitätsmedizin, Berlin, Berlin, Germany, 35MACVIA-France, Montpellier, France, 36Allergy Section, Allergy and Respiratory Diseases, DIMI, University of Genoa, Genoa, Italy, 37Department of Internal Medicine, Hospital Universitari Vall d’Hebron, Barcelona, Spain, 38Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA, 39Medical Consulting Czarlewski, Levallois, France, 40Department Otorhinolaryngologie, Academic Medical Centers, Amsterdam, The Netherlands, 41Children’s Center, Protestant Hospital Bethel, University Bielefeld, Bielefeld Germany, 42Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, Poland and ALL-MED Medical Research Institute, Wroclaw, Poland, 43HospitalMédica Sur, México City, Mexico, 44Unitat de Rinologia i Clínica de l’Olfacte, Servei d’ORL, Hospital Clínic, Clinical and Experimental Respiratory Immunoallergy, IDIBAPS, University of Barcelona, Barcelona, Spain, 45Department of Allergy, 2nd Pediatric Clinic, University of Athens, Athens, Greece, 46Haartman Institute, University of Helsinki, Helsinki, Finland, 47Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany, 48University Hospital, Montpellier, 49 INSERM, Unit 1168, Paris, France
Background: The number of patients affected by allergies is increasing worldwide. The resulting allergic diseases are leading to significant costs for health care and social systems. Integrated care pathways are needed to enable comprehensive care within the national health systems. The ARIA (Allergic Rhinitis and its Impact on Asthma) initiative develops internationally applicable guidelines for allergic respiratory diseases.
Methods: ARIA serves to improve the care of patients with allergies and chronic respiratory diseases. In collaboration with other international initiatives, national associations and patient organizations in the field of allergies and respiratory diseases, real-life integrated care pathways have been developed for a digitally assisted, integrative, individualized treatment of allergic rhinitis (AR) with comorbid asthma. In the present work, these integrated care pathways have been adapted to the German situation and health system.
Results: The present ICP (integrated care pathway) guideline covers key areas of the care of AR patients with and without asthma. It includes the views of patients and other healthcare providers.
Discussion: A comprehensive ICP guideline can reflect real-life care better than traditional guideline models.Correspondence to:
Prof. Dr. Jean Bousquet
Centre Hospitalier
Régional Universitaire´de Montpellier (CHU)
371 Avenue du Doyen Gaston Giraud
34295 Montpellier Cedex 5, France
Email: [email protected]
Original
Guideline on diagnostic procedures for suspected hypersensitivity to beta-lactam antibiotics
Gerda Wurpts, Werner Aberer, Heinrich Dickel, Randolf Brehler, Thilo Jakob, Burkhard Kreft, Vera Mahler, Hans F. Merk, Norbert Mülleneisen, Hagen Ott, Wolfgang Pfützner, Stefani Röseler, Franziska Ruëff, Helmut Sitter, Cord Sunderkötter, Axel Trautmann, Regina Treudler, Bettina Wedi, Margitta Worm, und Knut Brockow
Volume 4 (2020) p. 11 - 43
Abstract
Allergologie select, Vol. 4/2020 (11-43)
Guideline on diagnostic procedures for suspected hypersensitivity to beta-lactam antibiotics
Gerda Wurpts1, Werner Aberer2, Heinrich Dickel3, Randolf Brehler4, Thilo Jakob5, Burkhard Kreft6, Vera Mahler7,8, Hans F. Merk1, Norbert Mülleneisen9, Hagen Ott10, Wolfgang Pfützner11, Stefani Röseler1, Franziska Ruëff12, Helmut Sitter13, Cord Sunderkötter6, Axel Trautmann14, Regina Treudler15, Bettina Wedi16, Margitta Worm17, und Knut Brockow18
1Clinic for Dermatology and Allergology, Aachen Comprehensive Allergy Center (ACAC), Uniklinik RWTH Aachen, Germany 2Department of Dermatology, Graz Medical University, Graz, Austria, 3Department of Dermatology, Venereology and Allergology, St. Josef Hospital, University Hospital of the Ruhr University Bochum, Bochum, 4Department of Dermatology, University Hospital Münster, Münster, 5Department of Dermatology and Allergology, University Hospital Gießen und Marburg, Gießen Site, Gießen, 6Department of Dermatology and Venereology, University, Hospital Halle (Saale), Halle (Saale), 7Paul-Ehrlich Institute, Langen, 8Department of Dermatology, University Hospital Erlangen, Erlangen, 9Asthma and Allergy Centre, Leverkusen, 10Division of Pediatric Dermatology and Allergology, Auf der Bult Children’s Hospital, Hannover, 11Department of Dermatology and Allergology, University Hospital Gießen und Marburg, Marburg Site, Marburg, 12Department of Dermatology and Allergy, University Hospital, LMU Munich, Munich, 13Institute of Surgical Research, Philipps University Marburg, Marburg, 14Department of Dermatology and Allergy, Allergy Center Mainfranken, University Hospital Würzburg, Würzburg, 15Department of Dermatology, Venereology, and Allergology and Leipzig Interdisciplinary Center for Allergology – LICA-CAC, University of Leipzig, Leipzig, 16Department of Dermatology and Allergy, Comprehensive Allergy Center, Hannover Medical School, Hannover, 17Department of Dermatology, Venereology, and Allergology, Charité University Hospital Berlin, Allergy Center Charité (ACC), Berlin, and 18Department of Dermatology and Allergology am Biederstein, School of Medicine, Technical University of Munich, Munich, Germany
This guideline on diagnostic procedures for suspected beta-lactam antibiotic (BLA) hypersensitivity was written by the German and Austrian professional associations for allergology, and the Paul-Ehrlich Society for Chemotherapy in a consensus procedure according to the criteria of the German Association of Scientific Medical Societies. BLA such as penicillins and cephalosporins represent the drug group that most frequently triggers drug allergies. However, the frequency of reports of suspected allergy in patient histories clearly exceeds the number of confirmed cases. The large number of suspected BLA allergies has a significant impact on, e.g., the quality of treatment received by the individual patient and the costs to society as a whole. Allergies to BLA are based on different immunological mechanisms and often manifest as maculopapular exanthema, as well as anaphylaxis; and there are also a number of less frequent special clinical manifestations of drug allergic reactions. All BLA have a beta-lactam ring. BLA are categorized into different classes: penicillins, cephalosporins, carbapenems, monobactams, and beta-lactamase inhibitors with different chemical structures. Knowledge of possible cross-reactivity is of considerable clinical significance. Whereas allergy to the common beta-lactam ring occurs in only a small percentage of all BLA allergic patients, cross-reactivity due to side chain similarities, such as aminopenicillins and aminocephalosporins, and even methoxyimino cephalosporins, are more common. However, the overall picture is complex and its elucidation may require further research. Diagnostic procedures used in BLA allergy are usually made up of four components: patient history, laboratory diagnostics, skin testing (which is particularly important), and drug provocation testing. The diagnostic approach – even in cases where the need to administer a BLA is acute – is guided by patient history and risk – benefit ratio in the individual case. Here again, further studies are required to extend the present state of knowledge. Performing allergy testing for suspected BLA hypersensitivity is urgently recommended not only in the interests of providing the patient with good medical care, but also due to the immense impact of putative BLA allergies on society as a whole.Correspondence to:
Dr. med. Gerda Wurpts, Clinic for Dermatology and Allergology, Aachen Comprehensive Allergy Center (ACAC), Uniklinik RWTH Aachen, Pauwelsstraße 30, 52074 Aachen, Germany
Email: [email protected]
Review
Assessment of the effects of a work-related allergy to seafood on the reduction of earning capacity in the context of BK No. 5101
Heinrich Dickel, Annette Kuehn, Beate Dickel, Andrea Bauer, Detlef Becker, Manigé Fartasch, Michael Haeberle, Swen Malte John, Vera Mahler, Christoph Skudlik, Elke Weisshaar, Thomas Werfel, Johannes Geier, and Thomas Ludwig Diepgen† for the working group “Evaluation of Allergens with regard to BK No. 5101” of the ABD and the DKG in the DDG
Volume 5 (2021) p. 33 - 44
Abstract
Allergologie select, Vol. 5/2021 (33-44)
Assessment of the effects of a work-related allergy to seafood on the reduction of earning capacity in the context of BK No. 5101
Heinrich Dickel1, Annette Kuehn2, Beate Dickel3, Andrea Bauer4, Detlef Becker5, Manigé Fartasch6, Michael Haeberle7, Swen Malte John8, Vera Mahler9, Christoph Skudlik8, Elke Weisshaar10, Thomas Werfel11, Johannes Geier12, and Thomas Ludwig Diepgen13† for the working group “Evaluation of Allergens with regard to BK No. 5101” of the ABD and the DKG in the DDG
1Department of Dermatology, Venerology and Allergology, St. Josef-Hospital, University Hospital of the Ruhr University Bochum (UK RUB), Bochum, Germany, 2Department of Infection and Immunity, Luxembourg Institute of Health, Esch-sur-Alzette, Luxembourg, 3Dermatological Practice Dr. med. Peter Wenzel, Hattingen, Germany, 4Department of Dermatology, University Allergy Center, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany, 5Department of Dermatology, University Medical Center, Mainz, Germany, 6Institute for Prevention and Occupational Medicine (IPA) of the German Social Accident Insurance, Department of Clinical and Experimental Occupational Dermatology, Ruhr University Bochum, Bochum, Germany, 7Dermatological Practice, Künzelsau, Germany, 8Department of Dermatology, Environmental Medicine and Health Theory, University of Osnabrück and Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm) at the University of Osnabrück, Osnabrück, Germany, 9Paul-Ehrlich-Institut (PEI), Langen, Germany, 10Division of Occupational Dermatology, Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany, 11Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany, 12Information Network of Departments of Dermatology (IVDK), Institute at the University Medical Center Göttingen, Göttingen, Germany, 13University of Heidelberg, Heidelberg, Germany
Fish, crustaceans, and mollusks are among the most potent allergenic foods of animal origin and are thus important triggers of work-related immediate-food allergies. In Germany, work-related seafood allergies are of great importance in the fishing and processing industries as well as in the areas of food preparation, food control, and food sales. There is no causal therapy of seafood allergy, only the strict and lifelong avoidance of allergens remains. The following recommendations serve to assess the impact of a seafood allergy with regard to the work opportunities ended by it for the assessment of the reduction of earning capacity (MdE (German for Minderung der Erwerbsfähigkeit)) in the context of the occupational disease number 5101 of the Annex to the German regulation for occupational diseases. As a special feature of work-related seafood allergy with regard to insurance law aspects, it must be taken into account that there is a potential risk of systemic reaction with subsequent multi-organ involvement. For the estimation of MdE in the general labor market, the impact of a seafood allergy can therefore be assessed, depending on its clinical severity, as generally “mild” to “severe” in justified individual cases.Correspondence to:
Priv.-Doz. Dr. med. Heinrich Dickel, Department of Dermatology, Venerology and Allergology, St. Josef-Hospital, University Hospital of the Ruhr University Bochum (UK RUB), Gudrunstraße 56, 44791 Bochum, Germany
Email: [email protected]
Statement
Induction of penicillin tolerance during pregnancy: Allergological opinion on the recommendation of the current AWMF Guidelines on Diagnosis and Treatment of Syphilis (AWMF Registry No. 059-002)
Bettina Wedi, Werner Aberer, Knut Brockow, Heinrich Dickel, Randolf Brehler, Thilo Jakob, Burkhard Kreft, Vera Mahler, Hans F. Merk, Norbert Mülleneisen, Hagen Ott, Wolfgang Pfützner, Stefani Röseler, Franziska Ruëff, Cord Sunderkötter, Axel Trautmann, Regina Treudler, Margitta Worm, and Gerda Wurpts
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Volume 5 (2021) p. 67 - 71
Abstract
Allergologie select, Vol. 5/2021 (67-71)
Induction of penicillin tolerance during pregnancy: Allergological opinion on the recommendation of the current AWMF Guidelines on Diagnosis and Treatment of Syphilis (AWMF Registry No. 059-002)
Bettina Wedi1, Werner Aberer2, Knut Brockow3, Heinrich Dickel4, Randolf Brehler5, Thilo Jakob6, Burkhard Kreft7, Vera Mahler8,9, Hans F. Merk10, Norbert Mülleneisen11, Hagen Ott12, Wolfgang Pfützner13, Stefani Röseler14, Franziska Ruëff15, Cord Sunderkötter16, Axel Trautmann17, Regina Treudler18, Margitta Worm19, and Gerda Wurpts20
1Department of Dermatology, Allergology, and Venereology, Comprehensive Allergy Center, Hannover Medical School, Germany, 2Department of Dermatology, Medical University Graz, Austria, 3Department and Outpatient Clinic for Dermatology and Allergology am Biederstein, Technical University of Munich, 4Department of Dermatology, Venereology, and Allergology, St. Josef-Hospital, University Hospital of the Ruhr University of Bochum, 5Department of Dermatology, University Hospital Muenster, 6Department of Dermatology and Allergology, University Medical Center Gießen and Marburg, Campus Gießen, 7Department of Dermatology and Venereology, University Hospital Halle (Saale), 8Paul-Ehrlich-Institut, Langen, 9Dermatologists at the Merckhaus Dr. Herbst and Kollegen, Darmstadt, 10Department of Dermatology and Allergology, Aachen Comprehensive Allergy Center (ACAC), University Hospital RWTH Aachen, 11Lung and Allergy Center, Leverkusen, 12Pediatric Dermatology and Allergology, Children’s and Youth Hospital “Auf der Bult”, Hannover, 13Department of Dermatology and Allergology, University Medical Center Gießen and Marburg, Campus Marburg, 14Augustinians Hospital, Academic Teaching Hospital of the University of Cologne, 15Department and Outpatient Clinic of Dermatology, and Allergology, Allergy Center, Hospital of the University of Munich, 16University Hospital and Outpatient Clinic of Dermatogy and Venereology, University Hospital Halle (Saale), 17Department and Outpatient Clinic of Dermatology, Venereology, and Allergology, Allergy Center Mainfranken, University Hospital Würzburg, 18Department and Outpatient Clinic of Dermatology, Venereology, and Allergology and Leipzig Interdisciplinary Allergy Center – LICACAC, University of Leipzig, 19Department for Dermatology, Venereology, and Allergology, Charité-University Medicine Berlin, Allergy Center-Charité (ACC), Berlin, 20Department of Dermatology and Allergology, Aachen Comprehensive Allergy Center (ACAC), University Hospital RWTH Aachen, Germany
Correspondence to:
Prof. Dr. Bettina Wedi, Klinik für Dermatologie, Allergologie und Venerologie, Comprehensive Allergy Center, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
Email: [email protected]
Guideline
Update of the S2k guideline on the management of IgE-mediated food allergies
Margitta Worm, Imke Reese, Barbara Ballmer-Weber, Kirsten Beyer, Stephan C. Bischoff, Barbara Bohle, Knut Brockow, Martin Claßen, Peter J. Fischer, Eckard Hamelmann, Uta Jappe, Jörg Kleine-Tebbe, Ludger Klimek, Berthold Koletzko, Lars Lange, Susanne Lau, Ute Lepp, Vera Mahler, Katja Nemat, Martin Raithel, Joachim Saloga, Christiane Schäfer, Sabine Schnadt, Jens Schreiber, Zsolt Szépfalusi, Regina Treudler, Martin Wagenmann, Thomas Werfel, and Torsten Zuberbier
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Volume 5 (2021) p. 195 - 243
Abstract
Allergologie select, Vol. 5/2021 (195-243)
Update of the S2k guideline on the management of IgE-mediated food allergies
Margitta Worm1, Imke Reese2, Barbara Ballmer-Weber3, Kirsten Beyer4, Stephan C. Bischoff5, Barbara Bohle6, Knut Brockow7, Martin Claßen8, Peter J. Fischer9, Eckard Hamelmann10, Uta Jappe11#12, Jörg Kleine-Tebbe13, Ludger Klimek14, Berthold Koletzko15, Lars Lange16, Susanne Lau4, Ute Lepp17, Vera Mahler18, Katja Nemat19, Martin Raithel20, Joachim Saloga21, Christiane Schäfer22, Sabine Schnadt23, Jens Schreiber24, Zsolt Szépfalusi25, Regina Treudler26, Martin Wagenmann27, Thomas Werfel28, and Torsten Zuberbier29
1Allergology and Immunology, Department of Dermatology, Venereology, and Allergology, Charité – Universitätsmedizin Berlin, Germany, 2Nutritional Counseling and Therapy, Focus on Allergology, Munich, Germany, 3University Hospital Zurich, Department of Dermatology, Zurich, Switzerland, and Cantonal Hospital St. Gallen, Department of Dermatology and Allergology, St. Gallen, Switzerland, 4Clinic of Pediatrics m. S. Pneumology, Immunology and Intensive Care Medicine, Charité – Universitätsmedizin Berlin, Germany, 5Institute of Nutritional Medicine and Prevention, University of Hohenheim, Stuttgart, Germany, 6Institute of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria, 7Department of Dermatology and Allergology, Biederstein, Klinikum rechts der Isar, Technical University of Munich, Germany, 8Klinik für Kinder und Jugendmedizin/Päd. Intensivmedizin, Eltern-Kind-Zentrum Prof. Hess Klinikum Bremen-Mitte, 9Practice for Pediatric and Adolescent Medicine m. S. Allergology and Pediatric Pneumology, Schwäbisch Gmünd, 10University Clinic for Pediatric and Adolescent Medicine, Evangelisches Klinikum Bethel gGmbH, Bielefeld, 11Research Group Clinical and Molecular Allergology, Research Center Borstel, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Borstel, 12Interdisciplinary Allergy Outpatient Clinic, Medical Clinic III, University Hospital Schleswig-Holstein, Lübeck, 13Allergy and Asthma Center Westend, Berlin, 14Center for Rhinology and Allergology, Wiesbaden, 15Pediatric Clinic and Pediatric Polyclinic, Dr. von Haunersches Kinderspital, Department of Metabolic and Nutritional Medicine, Ludwig-Maximilians-University, Munich, 16Pediatric and Adolescent Medicine, St.- Marien-Hospital, Bonn, 17Practice for Pulmonary Medicine and Allergology, Buxtehude, 18Paul-Ehrlich-Institut, Langen, 19Practice for Pediatric Pneumology/Allergology at the Children’s Center Dresden (Kid), Dresen, 20Medical Clinic II, Malteser Waldkrankenhaus, Erlangen, 21Department of Dermatology, University Medical Center, Johannes Gutenberg-University Mainz, 22Nutritional Therapy, Focus on Allergology and Gastroenterology, Schwarzenbek, Germany, 23German Allergy and Asthma Association, Mönchengladbach, Germany, 24Pneumology, University Hospital of Otto von Guericke University, Magdeburg, Germany, 25University Hospital for Pediatrics and Adolescent Medicine, Medical University of Vienna, Austria, 26Clinic of Dermatology, Venereology and Allergology, University Medical Center Leipzig, Germany, 27Nose and Throat Clinic, University Hospital Düsseldorf, Germany, 28Clinic of Dermatology, Allergology and Venerology, Hannover Medical School, Germany, and 29Department of Dermatology, Venerology and Allergology, Charité – Universitätsmedizin Berlin
Correspondence to:
Univ.-Prof. Dr. med. Margitta Worm, Allergologie und Immunologie, Klinik für Dermatologie, Venerologie, und Allergologie, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117 Berlin
Email: [email protected]
Original
Anaphylactic reactions after COVID-19 vaccination in Germany
Immanuel Barth, Karin Weißer, Dominique Gaston-Tischberger, Vera Mahler, and Brigitte Keller-Stanislawski
Volume 7 (2023) p. 90 - 100
Abstract
Allergologie select, Vol. 7/2023 (90-100)
Anaphylactic reactions after COVID-19 vaccination in Germany
Immanuel Barth1, Karin Weißer1, Dominique Gaston-Tischberger1, Vera Mahler2, and Brigitte Keller-Stanislawski1
1Division Safety of Medicinal Products and Medical Devices, and 2Division Allergology, Paul-Ehrlich-Institut, Langen, Germany
For the COVID-19 vaccines used in Germany, severe allergic (anaphylactic) reactions after vaccination have been reported in very rare cases. While Comirnaty and Spikevax are mRNA vaccines, Vaxzevria and Jcovden comprise vector vaccines, and Nuvaxovid a recombinant spike protein vaccine. The reporting rate of anaphylaxis after mRNA vaccination was higher in females receiving their first vaccination dose, with 0.97 and 1.12 reports per 100,000 vaccinations for Comirnaty and Spikevax, respectively, compared with vaccinated males and subsequent vaccinations. The Paul-Ehrlich-Institut (PEI) investigated 106 responses of 321 cases of confirmed anaphylactic reactions concerning subsequent allergy testing and revaccination with a COVID-19 vaccine. The collected data indicate that only a small proportion of cases (22%) were IgE-mediated reactions. A large proportion (73%) of patients could be revaccinated under precautionary measures without recurrence of anaphylaxis. The pathomechanism of the majority of anaphylactic reactions remains unclear and should be investigated in further studies.Correspondence to:
Dr. Immanuel Barth, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 7, 63325 Langen
Email: [email protected]
Review
Allergen-specific immunotherapy and evidence: A European regulatory perspective
Detlef Bartel, Andreas Bonertz, Diana Hartenstein, Stefan Kaul, Iris Lauer, Christina Reeb, Karen Rösner-Friese, Katja Sliva, Julia Zimmer, Stefan Vieths, and Vera Mahler
Volume 7 (2023) p. 198 - 210
Abstract
Allergologie select, Vol. 7/2023 (198-210)
Allergen-specific immunotherapy and evidence: A European regulatory perspective
Detlef Bartel, Andreas Bonertz, Diana Hartenstein, Stefan Kaul, Iris Lauer, Christina Reeb, Karen Rösner-Friese, Katja Sliva, Julia Zimmer, Stefan Vieths, and Vera Mahler
Paul-Ehrlich-Institut, Langen, Germany
Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.Correspondence to:
Prof. Dr. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51 – 59, 63325 Langen, Germany
Email: [email protected]
Discussion
DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy
Oliver Pfaar, Eckard Hamelmann, Christian Taube, Martin Wagenmann, Bettina Wedi, Thomas Werfel, Detlef Bartel, Andreas Bonertz, Diana Hartenstein, Susanne Kaul, Vera Mahler, and Margitta Worm
Volume 7 (2023) p. 229 - 235
Abstract
Allergologie select, Vol. 7/2023 (229-235)
DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy
Oliver Pfaar1, Eckard Hamelmann2, Christian Taube3, Martin Wagenmann4, Bettina Wedi5, Thomas Werfel6, Detlef Bartel7, Andreas Bonertz7, Diana Hartenstein7, Susanne Kaul7, Vera Mahler7, and Margitta Worm8
1Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, 2Children’s Center Bethel, University Hospital OWL, Bielefeld University, Bielefeld, 3Department of Pulmonary Medicine, University Hospital Essen – Ruhrlandklinik, Essen, 4Department of Otorhinolaryngology, Düsseldorf University Hospital, Heinrich Heine University, Düsseldorf, 5Comprehensive Allergy Center, Department of Dermatology and Allergy, Hannover Medical School, Hannover, 6Department of Dermatology and Allergy, Hannover Medical School, Hannover, 7Paul-Ehrlich-Institut, Langen, 8Allergology and Immunology, Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany
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.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
Email: [email protected]
Review
Regulatory framework for development and marketing authorization of allergen products for diagnosis of rare type I and type IV allergies: The current status
Julia Zimmer and Vera Mahler
Volume 8 (2024) p. 212 - 219
Abstract
Allergologie select, Vol. 8/2024 (212-219)
Regulatory framework for development and marketing authorization of allergen products for diagnosis of rare type I and type IV allergies: The current status
Julia Zimmer and Vera Mahler
Paul-Ehrlich-Institut, Division of Allergology, Langen, Germany
Development, production, and marketing authorization of allergen products is generally challenging due to several specific characteristics, including the natural source as well as the multitude of allergenic materials. Also, depending on the frequency of sensitization in the population, the number of patients available for inclusion in clinical trials can be a limiting factor for product development. In the development of allergen products for diagnosis of type I and type IV allergies these challenges are particularly demanding because, in contrast to certain products for allergen-specific immunotherapy, no exemptions from marketing authorization are foreseen for this product group in Directive 2001/83/EC. Thus, the regulatory framework is constantly adapted within the legal scope in order to balance necessary regulatory requirements ensuring quality, safety, and efficacy with the clinical need for a comprehensive range of diagnostic allergen products. In this article, we give an overview on the current regulatory framework for development and marketing authorization of allergen products for diagnosis of rare type I and type IV allergies.Correspondence to:
Prof. Dr. med. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51 – 59, 63325 Langen, Germany
Email: [email protected]
Autorenreferate
IPES 2023 – 16th International Paul-Ehrlich-Seminar; September 6 – 9, 2023, Langen, Germany
Chair: Stefan Vieths and Vera Mahler, Langen, Germany
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Jahrgang 47 (2024) p. 329 - 377
Abstract
Allergologie, Jahrgang 47, 6/2024, S. 329-377
IPES 2023 – 16th International Paul-Ehrlich-Seminar; September 6 – 9, 2023, Langen, Germany
Chair: Stefan Vieths and Vera Mahler, Langen, Germany
Original
Procedure for a standardized preparation of skin prick test solutions for the diagnosis of occupational type I allergies in the absence of commercial extracts
Sabine Kespohl, Robin Jost, Silke Maryska, Lena-Maria Altin, Ingrid Sander, Stefan Schülke, Kathrin E. Paulus-Tremel, Andreas Bonertz, Thomas Klose, Vera Mahler, and Monika Raulf
Volume 8 (2024) p. 238 - 250
Abstract
Allergologie select, Vol. 8/2024 (238-250)
Procedure for a standardized preparation of skin prick test solutions for the diagnosis of occupational type I allergies in the absence of commercial extracts
Sabine Kespohl1, Robin Jost2, Silke Maryska1, Lena-Maria Altin3, Ingrid Sander1, Stefan Schülke2, Kathrin E. Paulus-Tremel2, Andreas Bonertz2, Thomas Klose3, Vera Mahler2, and Monika Raulf1
1Institute for Prevention and Occupational Medicine of the DGUV, Ruhr-University Bochum (IPA), Bochum, 2Division Allergology, Paul-Ehrlich-Institut, Langen, and 3Sonnenschein Apotheke, Koblenz, Germany
In order to ensure valid diagnostics for occupational test allergen solutions despite the ongoing reduction in the availability of commercial test extracts, a plan B was initiated for the possible production of skin prick test (SPT) solutions in public pharmacies. For important occupational allergen sources (wheat and rye, storage mites, animal epithelia, mold material) laboratory extraction methods were analyzed in comparison to pharmacy compatible extraction methods regarding protein quantity and quality in SDS-PAGE combined with silver staining. Subsequently, using the example of bovine epithelia, adapted extraction procedures as well as in-process and final product controls were transferred to a public pharmacy. Allergen sources with a high protein content, such as wheat and rye grains as well as storage mites, showed good comparability of the extractable protein quantity and protein pattern, regardless of the applied extraction method. In contrast, allergen source materials with a low total protein content, such as animal epithelia and molds, can benefit from laboratory extraction conditions such as mechanical disruption and specific buffer additives. In the qualitative protein silver staining, characteristic protein patterns were identified for each allergen source. Depending on the extraction method, only minor differences in total protein patterns were observed in animal epithelia and molds. Using source materials from two suppliers, the resulting allergen extracts displayed clear differences in protein content in storage mites and quantitative and qualitative differences in molds. A practical preparation attempt of SPT solutions in a public pharmacy was successful. SPT solutions prepared with adapted pharmacy extraction methods showed a comparable protein and Bos d 2 allergen content and equivalent qualities in the protein pattern compared to a previously available commercial SPT solution. Accordingly, it can be assumed that standardized SPT solutions with sufficient allergen quality for occupational allergen sources can be prepared in public pharmacies if certified allergen sources with appropriate protein content are available.Correspondence to:
Dr. Sabine Kespohl, Institute for Prevention and Occupational Medicine of the German Social Accident Insurance, Institute of the Ruhr-Universität Bochum (IPA), Department Competence Center Allergology/Immunology, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany
Email: [email protected]
Review
Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects
Robin Jost, Sabine Kespohl, Kathrin E. Paulus-Tremel, Julia Zimmer, Andreas Bonertz, Ingrid Sander, Thomas Klose, Lena-Maria Altin, Simone Heller, Ralph Heimke-Brinck, Frank Dörje, Susanne Philippus, Matthias Meyer, Sabrina Segebrecht, Torsten Wessel, Dieter Starke, Stefan Schülke, Monika Raulf, and Vera Mahler
Volume 8 (2024) p. 251 - 264
Abstract
Allergologie select, Vol. 8/2024 (251-264)
Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects
Robin Jost1,2, Sabine Kespohl3, Kathrin E. Paulus-Tremel1, Julia Zimmer1, Andreas Bonertz1, Ingrid Sander3, Thomas Klose4, Lena-Maria Altin4, Simone Heller4, Ralph Heimke-Brinck5, Frank Dörje5, Susanne Philippus6, Matthias Meyer7, Sabrina Segebrecht8, Torsten Wessel9, Dieter Starke10, Stefan Schülke1, Monika Raulf3, and Vera Mahler1,2
1Allergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse), 2Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, 3Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum, 4Sonnenschein Apotheke, Koblenz, 5Pharmacy Department, Erlangen University Hospital, Erlangen, 6Thuringian State Authority for Consumer Protection, Department Pharmacy, Bad Langensalza, 7Bundeswehr Commissioner for the Surveillance of Medicinal Products, Supervisory Agency for Public Law Tasks of the Bundeswehr Medical Service South, Munich, 8Drug Supervision, State Social Services Agency of Land Schleswig-Holstein, Neumünster, 9Pharmacy Inspector, Local inspectorate for pharmacies, District of Wesel, Moers, and 10 State Agency for Social Affairs, Youth and Care, Rhineland-Palatinate, Koblenz, Germany
The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MAs) by pharmaceutical companies and the lack of new MAs for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung – ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.Correspondence to:
Prof. Dr. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany
Email: [email protected]
Original
Therapy Allergen Ordinance (TAO): The final stretch
Vera Mahler, Diana Hartenstein, Iris Lauer, Stefan Vieths, Claudia Ruoff, Julia Zimmer, and Susanne Kaul
Volume 9 (2025) p. 93 - 99
Abstract
Allergologie select, Vol. 9/2025 (93-99)
Therapy Allergen Ordinance (TAO): The final stretch
Vera Mahler1, Diana Hartenstein1, Iris Lauer1, Stefan Vieths2, Claudia Ruoff3, Julia Zimmer1, and Susanne Kaul1
1Allergology Division, 2President of the Paul-Ehrlich-Institut; Molecular Allergology Research Group, and 3Legal Affairs Section, Safety of Biomedicines and Diagnostics Division, Paul-Ehrlich-Institut, Langen, Germany
The Therapy Allergen Ordinance (TAO) aims to migrate allergen immunotherapy (AIT) products for the treatment of common allergies, which were previously marketed in Germany as named patient products (NPPs), into authorized products provided their quality, efficacy, and safety are adequately shown. The TAO applies to all NPPs containing active ingredients based on the following allergen sources: house dust mites, bee venom, wasp venom, pollen from sweet grasses (excluding maize), birch, alder, or hazel. The last product-specific deadlines granted under the TAO for the submission of clinical data relevant to the marketing authorization process will expire in 2026. The subsequent final assessment of the updated marketing authorization application (MAA) is carried out by the competent authority, the Paul-Ehrlich-Institut. During this period of processing by the competent authority, the products remain marketable until a decision regarding the MAA has been reached. Currently (as of August 08, 2025), 40 AIT products are still marketable under the transitional provisions of the TAO (10 preparations for the treatment of allergies to house dust mites, 10 against tree pollen allergies, 16 against grass pollen allergies, and 4 mixed preparations containing non-homologous allergen groups). For 8 of these products, pharmaceutical companies have initiated the withdrawal of MAA as of October 01, 2025 or January 31, 2026, respectively. Prior to the final assessment of the updated MAAs, the competent authority is unable to make any public statements as to whether the individual applications for the remaining 32 products under the transitional provision will be concluded positively with the granting of the marketing authorization or its rejection. With the rejection of a marketing authorization, the product-specific marketability ends immediately, i.e., there is no additional sell-off period for the TAO products concerned. If a marketing authorization is granted, the marketability of the specific product is perpetuated.Correspondence to:
Prof. Vera Mahler, MD, Abteilung Allergologie, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany
Email: [email protected]
