Volume 7 (2023)
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Original
Prospective, monocentric, observational study of the long-term effectiveness of omalizumab in chronic urticaria
Stephan Traidl and Bettina Wedi
Page No. 1
Abstract
Allergologie select, Vol. 7/2023 (1-7)
Prospective, monocentric, observational study of the long-term effectiveness of omalizumab in chronic urticaria
Stephan Traidl and Bettina Wedi
Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany
Omalizumab, a monoclonal antibody targeting IgE, has been approved in 2014 for the treatment of H1 antihistaminerefractory chronic urticaria. Data on longterm effectiveness and predictive factors for treatment response are currently limited. In this monocentric, prospective, observational study, 112 patients with chronic spontaneous urticaria (CSU) and 32 patients with chronic inducible urticaria (CIndU) were included. In addition to a rapid response, omalizumab also showed good effectiveness on both forms of chronic urticaria over 2 years. Low total IgE and elevated Yersinia IgA were identified as potential predictive markers for slower treatment responses in CSU. In conclusion, the present study highlights the efficacy of omalizumab for the treatment of chronic urticaria. With emerging new therapeutic options for chronic urticaria, further genetic as well as molecular markers are needed to establish patientspecific therapy selection.Correspondence to:
Dr. med. Stephan Traidl, Klinik für Dermatologie, Allergologie und Venerologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
Email: [email protected]
Review
Chronic recurrent wheals – If not chronic spontaneous urticaria, what else?
Hanna Bonnekoh, Karoline Krause, and Pavel Kolkhir
Page No. 8
Abstract
Allergologie select, Vol. 7/2023 (8-16)
Chronic recurrent wheals – If not chronic spontaneous urticaria, what else?
Hanna Bonnekoh1,2, Karoline Krause1,2, and Pavel Kolkhir1,2
1Institute of Allergology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, and 2Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany
Chronic urticarial rash, mostly due to chronic spontaneous urticaria (CSU), is seen in up to 1 – 4% of the general population. Urticarial vasculitis (UV) and autoinflammatory syndromes, i.e., cryopyrinassociated periodic syndromes (CAPS) and Schnitzler syndrome (SchS), can mimic CSUlike rash but represent rare disorders with systemic symptoms including fever, headache, conjunctivitis, and arthralgia. Clinical and laboratory features can point to the presence of any of these diseases in patients initially presenting with chronic urticarial rash. These include long-lasting wheals (> 24 hours), lesional burning, systemic symptoms, and/or increase in inflammatory markers (e.g., C-reactive protein, serum amyloid A, and/or S100A8/9). Lesional skin biopsy usually demonstrates leukocytoclastic vasculitis (UV) or neutrophil-rich infiltrate (CAPS and SchS). In contrast to CSU, where second-generation H1 antihistamines and omalizumab allow to control symptoms in most patients, systemic immunosuppression and anti-interleukin (IL)-1 therapies are needed in case of UV and autoinflammatory diseases, respectively. The rarity and low awareness of CSU differential diagnoses may be related to the longer delays in diagnosis and therapy in those affected with UV, CAPS, and SchS. Knowledge of the differential diagnoses of CSU is important because only correct diagnosis allows adequate therapy. Complications such as the development of lymphoproliferative disease in SchS and amyloidosis in CAPS, and the presence of comorbid diseases, such as systemic lupus erythematosus in UV, must be considered and monitored.Correspondence to:
Dr. med. Hanna Bonnekoh, Charite – Universitätsmedizin Berlin, Institut für Allergieforschung, Hindenburgdamm 30, 12203 Berlin, Germany
Email: [email protected]
Case Report
Case report: Severe chronic spontaneous urticaria successfully treated with omalizumab and dupilumab
Viktoria Puxkandl, Wolfram Hoetzenecker, and Sabine Altrichter
Page No. 17
Abstract
Allergologie select, Vol. 7/2023 (17-19)
Case report: Severe chronic spontaneous urticaria successfully treated with omalizumab and dupilumab
Viktoria Puxkandl1, Wolfram Hoetzenecker1, and Sabine Altrichter1,2
1Department of Dermatology, Comprehensive Allergy Center, Kepler University Hospital Linz & Johannes Kepler University, Linz, Austria, and 2Departement of Dermatology and Allergology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Urticaria is a disease triggered by mast cells and characterized by recurrent symptoms such as wheals and/or angioedema. Most patients benefit from treatment with antihistamines (AH) or, if not effective enough, from additional therapy with omalizumab, which leads to significant symptom relief. Here we present a patient with therapy-resistant chronic spontaneous urticaria treated with AH, omalizumab, and glucocorticosteroids. The subsequent recommended therapy according to the current guideline, cyclosporine A, was contraindicated in this patient. Therefore, therapy with dupilumab was initiated, resulting in a complete control of symptoms. In this case report, we present a case of successful dual therapy with omalizumab and dupilumab.Correspondence to:
Wolfram Hoetzenecker, MD, PhD, Department of Dermatology, Kepler University Hospital Linz & Johannes Kepler University, Comprehensive Allergy Center, Krankenhausstrasse 9, 4020 Linz, Austria
Email: wolfram.hoetzenecker@kepleruniversitätsklinikum.at
Case Report
Treatment of severe cow’s milk allergy with omalizumab in an adult
Benjamin Klein, Jan Christoph Simon, and Regina Treudler
Page No. 20
Abstract
Allergologie select, Vol. 7/2023 (20-24)
Treatment of severe cow’s milk allergy with omalizumab in an adult
Benjamin Klein, Jan Christoph Simon, and Regina Treudler
Department of Dermatology, Venereology, and Allergology, and LICA-CAC, University Hospital Leipzig, Leipzig, Leipzig, Germany
Background: The therapy of severe food allergy so far consists mainly of allergen abstinence and emergency treatment. The use of anti-IgE antibodies represents a promising therapy. Case report: We report on a 22-year-old male with severe cow’s milk allergy with multiple anaphylactic reactions, known since infancy and persisting into adulthood with sometimes severe immediate-type reactions on accidental ingestion. The prick test for native whole milk was positive, the CAP-FEIA was also positive for milk protein, mare’s milk, whey, sheep’s milk whey as well as Bos d4, Bos d5, and Bos d8 and blue cheese; total IgE was 1,265 kU/L. The patient’s history included well-controlled bronchial asthma. An off-label therapy with omalizumab (3 × 150 mg/month SC) and cetirizine 10 mg once daily was initiated. Under this therapy, we performed a double-blind oral exposure test to cow’s milk in the patient after long term. Thereby 14 mL could be tolerated. After consumption of 30 mL of cow’s milk, urticaria, dyspnea, and angioedema occurred. Conclusion: Under therapy with omalizumab, an increase of the tolerance to cow’s milk was shown in our patient. As a consequence, reactions during accidental consumption could be prevented.Correspondence to:
Dr. med. Benjamin Klein, Department of Dermatology, Venerology, and Allergology, University Hospital Leipzig, Philipp Rosenthal Strasse 23, 04103 Leipzig, Germany
Email: [email protected]
Review
Allergen challenge tests in allergen immunotherapy: State of the art
Petra Zieglmayer, René Zieglmayer, and Patrick Lemell
Page No. 25
Abstract
Allergologie select, Vol. 7/2023 (25-32)
Allergen challenge tests in allergen immunotherapy: State of the art
Petra Zieglmayer1,2, René Zieglmayer2, and Patrick Lemell2
1Karl Landsteiner University, Krems, and 2Vienna Challenge Chamber, Vienna, Austria
Introduction: Treatment effects in allergen immunotherapy (AIT) studies are based on symptomatic improvement, and evaluations of naturally exposed patients do often show weak efficacy. Allergen challenge tests, such as conjunctival (CAC), nasal (NAC), or bronchial (BAC) challenge tests, or challenges in allergen exposure chambers (AEC) are accepted by regulators for AIT phase II studies only. Materials and methods: This review aims to describe different allergen challenge test methods, summarizes safety and limitations for each, and discusses their potential for use in AIT trials. Results: Organ-specific allergen challenges provide information about individual reactivity, reaction threshold, and organspecific efficacy of AIT. AECs, targeting all affected organs simultaneously, were developed to investigate disease mechanisms and treatment effects under controlled and reproducible conditions. Conclusion: A high level of standardization is existing for NAC only; in CAC and BAC, the toolbox is limited to subjective symptom scoring with no validated objective parameters identified yet. AECs are complex and heterogenous; correlation of systems and comparability of study data is claimed. All challenge methods are safe when conducted by experienced staff.Correspondence to:
PD Dr. Petra Zieglmayer, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften, Department für Allgemeine Gesundheitsberufe, Kompetenzzentrum für Allergologie und Immunologie, Dr.-Karl-Dorrek-Straße 30, 3500 Krems, Austria
Email: [email protected]
Review
Allergic asthma: An indication for allergen immunotherapy
Tobias Ankermann and Randolf Brehler
Page No. 33
Abstract
Allergologie select, Vol. 7/2023 (33-38)
Allergic asthma: An indication for allergen immunotherapy
Tobias Ankermann1 and Randolf Brehler2
1Childrens Hospital, Städtisches Krankenhaus Kiel gGmbH, Kiel, and 2Department of Dermatology, University Hospital Münster, Germany
Allergen immunotherapy (AIT) as a validated, disease-modifying treatment is nowadays a widely recommended therapy option for allergic rhinitis and allergic asthma. The registration of allergen extracts used for AIT is based on allergen standardization, dose finding trials, and phase 3 trials proving their efficacy in high-quality, statistically significant randomized clinical trials. Real-world evidence (RWE) studies confirm the clinical relevance of these findings. The most data are available for the treatment of patients suffering from allergic rhinitis. Due to the similar inflammatory mechanisms, allergic rhinitis is often associated with allergic asthma. AIT, which induces tolerance against individual allergens, is the approach to treat the underlying mechanisms of these two interrelated respiratory diseases. Some trials have been published focusing primarily on the effect of AIT on parameters of allergic asthma. Here we give a summary of the evidence for the efficacy of AIT in the indication of allergic asthma.Correspondence to:
Prof. Dr. med. Randolf Brehler, Universitätsklinikum Münster, Klinik für Hautkrankheiten, Allergologie, Berufsdermatologie und Umweltmedizin, Von-Esmarch-Straße 58, 48149 Münster
Email: [email protected]
Review
Clinical endpoints in allergen immunotherapy: State of the art 2022
Roy Gerth van Wijk, Ludger Klimek, and Oliver Pfaar
Page No. 39
Abstract
Allergologie select, Vol. 7/2023 (39-46)
Clinical endpoints in allergen immunotherapy: State of the art 2022
Roy Gerth van Wijk1, Ludger Klimek2, and Oliver Pfaar3
1Section of Allergology and Clinical Immunology, Department of Internal Medicine, Erasmus MC, Rotterdam, the Netherlands, 2Center for Rhinology and Allergology, Wiesbaden, and 3Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
110 years after the classical study by Noon, numerous studies have confirmed the efficacy of allergen immunotherapy. A variety of clinical endpoints have been used in these trials. This review gives an overview of clinical endpoints for randomized clinical trials on allergen immunotherapy (AIT) in rhinitis and asthma. In addition, real-life studies have been carried out with the same kind of endpoints. In general, AIT studies are characterized by a lack of standardized and validated outcome measures. For allergic rhinoconjunctivitis, digital tools have been developed to monitor patients. Such tools are particularly useful to obtain real-world evidence for AIT. Finally, well-accepted outcome measures are available for cost-effectiveness studies.Correspondence to:
Roy Gerth van Wijk, MD, PhD, Professor of Allergy, Section of Allergology and Clinical Immunology, Department of Internal Medicine, Erasmus MC, Rotterdam the Netherlands
Email: [email protected]
Review
Real-life evidence in allergen immunotherapy: Moving forward with mHealth apps
Bernardo Sousa-Pinto, Oliver Pfaar, and Jean Bousquet
Page No. 47
Abstract
Allergologie select, Vol. 7/2023 (47-56)
Real-life evidence in allergen immunotherapy: Moving forward with mHealth apps
Bernardo Sousa-Pinto1,2,3, Oliver Pfaar4, and Jean Bousquet5,6,7
1MEDCIDS, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, 2CINTESIS, Center for Health Technology and Services Research, 3RISE, Health Research Network, University of Porto, Porto, Portugal, 4Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, 5Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, 6Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany, and 7University Hospital Montpellier, Montpellier, France
Aim: The efficacy and safety of allergen immunotherapy (AIT) in allergic rhinitis has been classically assessed using randomized controlled trials (RCTs). However, RCTs may have limitations in their external validity, and their evidence may be complemented with that from real-world studies. We aimed to review the mHealth apps that can be used for retrieving real-world data on AIT in allergic rhinitis. Materials and methods: We applied an automatic tool to identify the mHealth apps (available in the Google Play and Apple App stores) that can be used to assess patients under AIT for allergic rhinitis. Apps meeting the inclusion criteria were reviewed, and the corresponding scientific evidence was assessed. Results: We identified five apps with scientific publications in the context of allergic rhinitis: AirRater, AllergyMonitor, MASK-air, Husteblume, and Pollen App. Of those, only MASK-air and AllergyMonitor assessed AIT in patients with allergic rhinitis. MASK-air has enabled the comparison of reported symptoms among patients treated vs. not-treated with AIT. MASK-air has also allowed for the development of combined symptom-medication scores that can be used as endpoints for AIT trials. AllergyMonitor has identified that mobile technology can improve adherence to AIT and is set to support the prescription of AIT for patients with allergic rhinitis by a more precise identification of the pollen season. Conclusion: Mobile health tools allow for the collection of large volumes of real-world data and can be useful for generating hypotheses on AIT. However, such hypotheses require confirmation by epidemiological studies and RCTs.Correspondence to:
Jean Bousquet, Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Hindenburgdamm 30 (Geländeadresse, Haus II), 12200 Berlin, Germany
Email: [email protected]
Position Paper
Vegan diets from an allergy point of view – Position paper of the DGAKI working group on food allergy
Imke Reese, Christiane Schäfer, Barbara Ballmer-Weber, Kirsten Beyer, Sabine Dölle-Bierke, Suzanne van Dullemen, Uta Jappe, Sabine Müller, Sabine Schnadt, Regina Treudler, and Margitta Worm
Page No. 57
Abstract
Allergologie select, Vol. 7/2023 (57-83)
Vegan diets from an allergy point of view – Position paper of the DGAKI working group on food allergy
Imke Reese1, Christiane Schäfer2, Barbara Ballmer-Weber3,4, Kirsten Beyer5, Sabine Dölle-Bierke6, Suzanne van Dullemen7, Uta Jappe8,9, Sabine Müller10, Sabine Schnadt11, Regina Treudler12, and Margitta Worm6
1Nutrition Therapy, Munich, 2NutritionTherapy, Schwarzenbek, Germany, 3Clinic for Dermatology and Allergology, Cantonal Hospital St. Gallen, St. Gallen, 4Department of Dermatology, University Hospital Zürich, Switzerland, 5Clinic for Pediatrics with focus on Pneumology and Immunology, Charité-Universitätsmedizin – Campus Virchow-Klinikum, 6Allergology and Immunology, Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, 7University Clinic Frankfurt, Clinic for Pediatrics, Frankfurt, 8Division of Clinical and Molecular Allergology, Research Center Borstel, German Center for Lung Research (DZL) Airway Research Center North (ARCN), Borstel, 9Interdisciplinary Allergy Outpatient Clinic, Department of Pneumology, University of Lübeck, Lübeck, 10Department of Dermatology and Venereology, University Clinic Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, 11German Allergy and Asthma Association (DAAB), Mönchengladbach, and 12Department of Dermatology, Venereology and Allergology, Leipzig University Medical Center, Leipzig, Germany
Vegan diets are currently attracting a great deal of attention. However, avoiding animal-based foods restricts the diet and is associated with risks, the extent and medical implications of which are at present not sufficiently understood. Elimination diets represent the usual therapeutic long-term management in the presence of food allergy. In order to understand the risks of vegan diets and to discuss these critically from the perspective of food allergies, the expertise of a nutritionist/dietitian with expertise in this area is indispensable. This position paper deals with the incentives behind and the benefits of a plant-based diet. The knowledge required to cover macro- and micronutrient dietary requirements is presented. Using the avoidance of cow’s milk as an example, the challenges of adequately meeting nutritional needs are identified and (so-called) milk alternatives are evaluated from an allergy and nutritional point of view. Finally, other plant-based (substitute) products are evaluated from the same perspective, as significant protein sources in vegan diets (e.g., legumes, nuts, and seeds) are at the same time potential and potent triggers of allergic reactions. However, the allergic potential of many substitute products cannot be fully assessed at present due to gaps in research. Wheat as the most important trigger for anaphylaxis in adults is also evaluated. Finally, the increase in ultra-processed products in the (vegan) food sector and their potential consequences for the immune system are discussed.
Please notice: There is an erratum to this article, which can be found at: https://www.dustri.com/nc/de/article-response-page.html?artId=191243&doi=10.5414%2FALX02400ECorr.Correspondence to:
Dr. Imke Reese, Ernährungsberatung und -therapie, Schwerpunkt Allergologie, Ansprengerstr. 19, 80803 Munich, Germany
Email: [email protected]
Review
Vaccination against infectious agents and allergen-specific immunotherapy: A critical analysis
Margitta Worm and Oliver Pfaar
Page No. 84
Abstract
Allergologie select, Vol. 7/2023 (84-89)
Vaccination against infectious agents and allergen-specific immunotherapy: A critical analysis
Margitta Worm1 and Oliver Pfaar2
1Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergology, Campus Charité Mitte, Universitätsmedizin Berlin, and 2Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany
Allergen immunotherapy (AIT) and vaccination against infectious agents (VIA) are treatments actively interfering with the immune system. This raises the question of whether these therapies influence each other positively and/or negatively if applied simultaneously. For AIT, it should be taken into account that the mechanisms of subcutaneous and sublingual allergen application are in principle similar, but must be assessed in respect to vaccination differently due to their different routes of allergen administration. Here, the immunological mechanisms of both AIT application forms in respect to VIA are discussed in more detail followed by a critical discussion based on the literature and considering current practice.Correspondence to:
Prof. Dr. med. Margitta Worm, Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergology, Campus Charité Mitte, Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
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
Page No. 90
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
SARS-CoV-2 and allergy – what have we learned after two and a half years?
Knut Brockow, Rosi Wang, Sonja Mathes, Rebekka Bent, Valentina Faihs, Bernadette Eberlein, Ulf Darsow, and Tilo Biedermann
Page No. 101
Abstract
Allergologie select, Vol. 7/2023 (101-112)
SARS-CoV-2 and allergy – what have we learned after two and a half years?
Knut Brockow, Rosi Wang, Sonja Mathes, Rebekka Bent, Valentina Faihs, Bernadette Eberlein, Ulf Darsow, and Tilo Biedermann
Department of Dermatology and Allergy Biederstein, Technical University of Munich, Faculty of Medicine, Munich, Germany
Background: Coronavirus disease-2019 (COVID-19) has significantly hampered the regular workflow for allergists and allergy departments. Materials and methods: The purpose of this review is to highlight our own experiences on SARS-CoV-2 and allergy as well as to discuss findings from the literature. Results: Vaccination against SARS-CoV-2 is needed for protection against severe infection. Skin reactions may arise with SARS-CoV-2 infections. Short-term general immune reactions and skin reactions are also possible upon SARS-CoV-2 vaccination; however, they recur in only a proportion of patients during follow-up vaccinations. Initial reports of anaphylaxis after vaccination fueled public fear. On the other hand, more recent epidemiologic data do not show a substantially increased anaphylaxis risk compared with other vaccines. Fear-related reactions may be essential for many “anaphylaxis” reports. In Germany, the flow chart developed by Paul-Ehrlich-Institut (PEI) and Robert-Koch-Institut (RKI) together with the allergological societies helps to care for patients with suspected “allergy history” safely and effectively. Through this, patients with increased risk of anaphylaxis to SARS-CoV-2 vaccines and their ingredients (e.g., polyethylene glycol (PEG), polysorbate 80) are identified. However, since only small amounts of these excipients are contained in mRNA vaccines, even some PEG-allergic patients can tolerate the vaccination. In Germany, an allergy test-guided procedure is recommended for high-risk patients, including an allergy history, prick tests, intradermal and basophil activation tests, and, if necessary, provocation tests. This also appears effective for anxiety reduction in patients with vaccination skepticism. To date, all of our patients have been able to be vaccinated with SARS-CoV-2 vaccines without the occurrence of significant reactions. Conclusion: Many initial concerns about unexpected side effects of SARS-CoV-2 vaccination have not been confirmed. The flowchart and, in the case of suspicion of hypersensitivity, an allergy test-guided risk assessment helps to reduce patients’ fear of vaccination and enables safe vaccination.Correspondence to:
Knut Brockow, Department of Dermatology and Allergy Biederstein, Technical University of Munich, Faculty of Medicine, Biedersteiner Straße 29, 80802 Munich, Germany
Email: [email protected]
Case Report
Oral mite anaphylaxis (pancake syndrome) caused by storage mite Acarus siro and its treatment with allergen immunotherapy
Tanjana Preiser-Funke and Karl-Christian Bergmann
Page No. 113
Abstract
Allergologie select, Vol. 7/2023 (113-115)
Oral mite anaphylaxis (pancake syndrome) caused by storage mite Acarus siro and its treatment with allergen immunotherapy
Tanjana Preiser-Funke1 and Karl-Christian Bergmann2
1Nuss-Anaphylaxie Netzwerk e.V., Wiesbaden, and 2Institute of Allergology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany
A 10-year-old atopic patient with asthma, peanut, and house dust mite allergy developed frequent episodes with symptoms including abdominal pain, nausea, vomiting, dizziness, drop of blood pressure, and occasionally shortness of breath and wheezing. After detailed diagnostics including an ISAC test and several other specific IgE blood tests, which could not explain the symptoms, the patient tested positive for specific IgE to Acarus siro (flour mites) (9.2 kU/L). As no oral food challenge with Acarus siro was available, the patient’s family implemented avoidance measures by storing food containing flour in the refrigerator, and the patient started subcutaneous immunotherapy (SCIT) with Depigoid Acarus siro. The implementation of avoidance measures led to an immediate improvement of symptoms, and after 3 years of treatment, products containing flour, stored at room temperature, are tolerated again.Correspondence to:
Prof. Karl-Christian Bergmann, Charité – Universitätsmedizin Berlin, Ambulanz: Campus
Benjamin Franklin, Haus 2, Hindenburgdamm 30, 12200 Berlin, Germany, and Tanjana Preiser-Funke, Nuss-Anaphylaxie Netzwerk e.V., Philipp-Holl Str. 4, 65195 Wiesbaden
Email: [email protected]; [email protected]
Review
Milk ladder as a therapeutic option for cow’s milk allergy: Proposal for a step-by-step plan for cow’s milk introduction in cow’s milk allergy
Amely Brückner, Petra Funk-Wentzel, Julia Kahle, and Stephanie Hompes
Page No. 116
Abstract
Allergologie select, Vol. 7/2023 (116-121)
Milk ladder as a therapeutic option for cow’s milk allergy: Proposal for a step-by-step plan for cow’s milk introduction in cow’s milk allergy
Amely Brückner1, Petra Funk-Wentzel2, Julia Kahle3, and Stephanie Hompes4
1Elbe Klinikum Buxtehude, Clinic for Dermatology, Competence Center for Chronic Skin Diseases, Buxtehude,2Practice for Nutrition Therapy, Stuttgart, 3Practice for Allergological Nutrition Therapy, Viersen, and 4Altona Children’s Hospital, Hamburg, Germany
In regard to cow’s milk allergy, the current option of avoiding can be expanded by (re-)introducing milk using a milk ladder. So-called “food ladders” are internationally well known and utilized for both non-IgE-mediated and IgE-mediated cow’s milk allergy. Stepping up the stairs from highly processed baked goods with milk via cooked milk products to pasteurized fresh milk reflects the status of acquired tolerance of each level. The allergenicity of milk depends on processing and amount. By implementing the milk ladder, it can enhance the clinical process of tolerance development, lead to meeting nutrient requirements quickly, and involve parents actively in the therapeutical process. The milk ladder, for the first time being published and adapted for Germany, describes a structured framework that might be adapted individually regarding the time period on a certain level or other variations such as preparation/amount of milk products. From a safety perspective, healthcare professionals should pay great attention to patient selection and education prior to implementing the milk ladder. Detailed advice as well as recipes and a graphical presentation can be found in the supplemental material.Correspondence to:
Dipl. oec. troph. Amely Brückner, Elbe Kliniken Stade Buxtehude – Dermatologisches Zentrum Buxtehude, Kompetenzzentrum für chronische Hauterkrankungen, Am Krankenhaus 1, 21614 Buxtehude, Germany
Email: [email protected]
Guideline
Guideline for allergological diagnosis of drug hypersensitivity reactions
Knut Brockow, Gerda Wurpts, Axel Trautmann, Wolfgang Pfützner, Regina Treudler, Andreas J. Bircher, Randolf Brehler, Timo Buhl, Heinrich Dickel, Thomas Fuchs, Thilo Jakob, Julia Kurz, Burkhard Kreft, Lars Lange, Hans F. Merk, Maja Mockenhaupt, Norbert Mülleneisen, Hagen Ott, Johannes Ring, Franziska Ruëff, Bernhardt Sachs, Helmut Sitter, Bettina Wedi, Stefan Wöhrl, Margitta Worm, and Torsten Zuberbier
Page No. 122
Abstract
Allergologie select, Vol. 7/2023 (122-139)
Guideline for allergological diagnosis of drug hypersensitivity reactions
Knut Brockow1, Gerda Wurpts2, Axel Trautmann3, Wolfgang Pfützner4, Regina Treudler5, Andreas J. Bircher6, Randolf Brehler7, Timo Buhl8, Heinrich Dickel9, Thomas Fuchs8, Thilo Jakob10, Julia Kurz4, Burkhard Kreft11, Lars Lange12, Hans F. Merk2, Maja Mockenhaupt13, Norbert Mülleneisen14, Hagen Ott15, Johannes Ring1, Franziska Ruëff16, Bernhardt Sachs2, Helmut Sitter17, Bettina Wedi18, Stefan Wöhrl19, Margitta Worm20, and Torsten Zuberbier20
1Department of Dermatology and Allergology Biederstein, Faculty of Medicine, Technical University of Munich, Munich, 2Department of Dermatology and Allergology, Germany, Aachen Comprehensive Allergy Center (ACAC), University Hospital of RWTH Aachen University, Aachen, 3Department of Dermatology and Allergology, Allergy Center Mainfranken, University Hospital Würzburg, Würzburg, 4Department of Dermatology and Allergology, University Hospital Giessen and Marburg, Marburg, 5Department of Dermatology, Venerology and Allergology, University of Leipzig, Leipzig, Germany, 6Facoltà di Scienze biomediche, Università della Svizzera italiana, Lugano, and Department of Dermatology and Allergology, University Hospital Basel, Switzerland, 7Department of Dermatology, Münster University Hospital, Münster, 8Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, 9Department of Dermatology, Venerology and Allergology, St. Josef Hospital, University Hospital of the Ruhr University Bochum, Bochum, 10Department of Dermatology and Allergology, University Hospital, Justus-Liebig University, Gießen, 11Department of Dermatology and Venereology, University Hospital Halle, Halle (Saale), 12Pediatric Clinic, Marienhospital Bonn, Bonn, 13Documentation Center for Severe Skin Reactions, Department of Dermatology and Venereology, University Medical Center Freiburg, Freiburg, 14Asthma Allergy Center Leverkusen, Leverkusen, 15Children’s and Youth Hospital Auf der Bult, Hanover, 16Department of Dermatology and Allergology, Allergy Center, Ludwig Maximilian University of Munich, 17Institute for Theoretical Surgery, Philipps University of Marburg, Marburg, 18Hanover Medical School, Department of Dermatology, Allergology and Venereology, Hanover, Germany, 19Floridsdorf Allergy Center (FAZ), Vienna, Austria, and 20Allergology and Immunology, Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany
Correspondence to:
Prof. Dr. med. Knut Brockow, Department of Dermatology and Allergology at Biederstein, Faculty of Medicine, Technical University of Munich, Biedersteiner Straße 29, 80802 Munich, Germany
Email: [email protected]
Original
High-risk groups for alpha-gal sensitization
Marie Benders-Guedj, Martin Köberle, Heidelore Hofmann, Tilo Biedermann, and Ulf Darsow
Page No. 140
Abstract
Allergologie select, Vol. 7/2023 (140-148)
High-risk groups for alpha-gal sensitization
Marie Benders-Guedj, Martin Köberle, Heidelore Hofmann, Tilo Biedermann, and Ulf Darsow
Department of Dermatology and Allergy Biederstein, Faculty of Medicine, Technical University of Munich, Munich, Germany
Background: Tick bite-induced IgE-mediated reactions to the oligosaccharide galactose α-1,3-galactose (alpha-gal) are increasingly recognized. This study investigated alpha-gal sensitization in three groups with different tick bite exposure. Materials and methods: Specific IgE antibodies to alpha-gal and total IgE were investigated in 485 patients with Lyme borreliosis with different disease manifestations and compared to a control group of 200 randomly selected patients without increased exposure to tick bites. A group of 232 hunters and forest workers served as a model for multiple tick bites. Results: Specific IgE (sIgE) antibodies to alpha-gal (> 0.1 kU/L) were found in 12.6% of all borreliosis samples compared to the control group with 9% (relative risk 1.4; 95% CI 0.85 – 2.3; not significant (n.s.). The highest prevalence of sIgE to alpha-gal was observed in hunters and forest service employees (22.8%, relative risk 2.5; 95% CI 1.5 – 4.2; p < 0.001). Higher age and elevated total IgE were also associated with alpha-gal sensitization. Conclusion: IgE sensitization to alpha-gal tends to be more frequent in tick-exposed patients with borreliosis than in controls (n.s.). Moreover, hunters and forest workers show an even higher rate of elevated IgE to alpha-gal. Thus, frequent tick contact may result in alpha-gal sensitization. In the area of Munich, the prevalence of alpha-gal sensitization appears lower than in the state of Baden-Württemberg and lower than in the USA, which may be due to the difference in tick species or the frequency of tick exposure. This study could show that alpha-gal sensitization and presumably alpha-gal syndrome does not seem to be a modern problem but existed already more than 30 years ago.Correspondence to:
Prof. Dr. U. Darsow, Department of Dermatology and Allergy Biederstein, School of Medicine, Technical University of Munich, Biedersteiner Str. 29, 80802 Munich, Germany
Email: [email protected]
Original
Animal bite anaphylaxis, rarely diagnosed but underappreciated
Gregg M. Stave
Page No. 149
Abstract
Allergologie select, Vol. 7/2023 (149-153)
Animal bite anaphylaxis, rarely diagnosed but underappreciated
Gregg M. Stave
Division of Occupational and Environmental Medicine, Duke University, Durham, NC, USA
Background: Animal allergies are common, with reactions ranging from rhinoconjunctivitis from respiratory exposure to anaphylaxis, usually from animal bites. Since animal bites are also common, this raises the question of how often anaphylaxis occurs following a bite. Materials and methods: A PubMed, Google, and Google Scholar literature review was performed using keywords such as animal bite anaphylaxis. An inquiry was made to the Anaphylaxis Registry ANAPHYLAXIE.net to see if additional cases were contained in the registry. Results: Approximately 40 cases of animal bite anaphylaxis are described in the literature, mostly from rodent bites (mice, rats, hamsters, and guinea pigs). A survey of laboratory animal bite anaphylaxis in the U.S. identified previously unreported cases, suggesting that most cases are not reported. Conclusion: Anaphylaxis from animal bites is rarely reported, but occurs more frequently than suggested by case reports and should be considered in a symptomatic patient following a bite.Correspondence to:
Gregg M. Stave, MD, JD, MPH, Duke Occupational & Environmental Medicine, DUMC 3834, Durham, NC 27710, USA
Email: [email protected]
Guideline
Diagnosis and treatment of Hymenoptera venom allergy
Franziska Ruëff, Andrea Bauer, Sven Becker, Randolf Brehler, Knut Brockow, Adam M. Chaker, Ulf Darsow, Jörg Fischer, Thomas Fuchs, Michael Gerstlauer, Sunhild Gernert, Eckard Hamelmann, Wolfram Hötzenecker, Ludger Klimek, Lars Lange, Hans Merk, Norbert K. Mülleneisen, Irena Neustädter, Wolfgang Pfützner, Wolfgang Sieber, Helmut Sitter, Christoph Skudlik, Regina Treudler, Bettina Wedi, Stefan Wöhrl, Margitta Worm and Thilo Jakob
Page No. 154
Abstract
Allergologie select, Vol. 7/2023 (154-190)
Diagnosis and treatment of Hymenoptera venom allergy
Franziska Ruëff1, Andrea Bauer2, Sven Becker3, Randolf Brehler4, Knut Brockow5, Adam M. Chaker6, Ulf Darsow5, Jörg Fischer7, Thomas Fuchs8, Michael Gerstlauer9, Sunhild Gernert10, Eckard Hamelmann11, Wolfram Hötzenecker12, Ludger Klimek13, Lars Lange10, Hans Merk14, Norbert K. Mülleneisen15, Irena Neustädter16, Wolfgang Pfützner17, Wolfgang Sieber18, Helmut Sitter19, Christoph Skudlik20, Regina Treudler21, Bettina Wedi22, Stefan Wöhrl23, Margitta Worm24 and Thilo Jakob25
1Department of Dermatology and Allergy, LMU University Hospital, Munich, 2Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, 3Department of Otorhinolaryngology, Head and Neck Surgery, University of Tuebingen, Tübingen, 4Department of Dermatology, Münster University Hospital, Münster, 5Department of Dermatology and Allergology Biederstein, Faculty of Medicine, Technical University of Munich, Munich, 6Department of Otorhinolaryngology Klinikum rechts der Isar, Faculty of Medicine, Technical University of Munich, Munich, 7University Hospital for Dermatology and Allergology, Clinic Oldenburg, Oldenburg, 8Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, 9Clinic for Children and Adolescents, University Hospital Augsburg, Augsburg, 10Pediatric Clinic, Marienhospital Bonn, GFO Kliniken, Bonn, 11Children’s Center Bethel, University Hospital OWL, Bielefeld University, Bielefeld, Germany, 12Department of Dermatology, Kepler University Hospital, Medical Faculty of University Linz, Linz, Austria, 13Center for Rhinology and Allergology, Wiesbaden, 14Department of Dermatology and Allergology, University Hospital of RWTH Aachen University, Aachen, 15Center for Asthma and Allergy, Leverkusen, 16Cnopfsche Paediatric Clinic, Nuremberg, 17Department of Dermatology and Allergology, University Hospital Marburg, Philipps-Universität Marburg, Marburg, 18Hospital Wörth an der Donau, Wörth an der Donau, 19Institute for Theoretical Surgery, Philipps-University Marburg, Marburg, 20Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm) at the University of Osnabrueck, Osnabrueck, and BG Clinic Hamburg, Hamburg, 21University Leipzig Medical Faculty, Leipzig, 22Comprehensive Allergy, Department of Dermatology and Allergy, Hannover Medical School, Hanover, Germany, 23Floridsdorf Allergy Center (FAZ), Vienna, Austria, 24Department of Dermatology, Venereology and Allergology, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, and 25Department of Dermatology and Allergology, University Hospital Giessen, Justus Liebig University Gießen, Gießen, Germany
Hymenoptera venom (HV) is injected into the skin during a sting by Hymenoptera such as bees or wasps. Some components of HV are potential allergens and can cause large local and/or systemic allergic reactions (SAR) in sensitized individuals. During their lifetime, ~ 3% of the general population will develop SAR following a Hymenoptera sting. This guideline presents the diagnostic and therapeutic approach to SAR following Hymenoptera stings. Symptomatic therapy is usually required after a severe local reaction, but specific diagnosis or allergen immunotherapy (AIT) with HV (VIT) is not necessary. When taking a patient’s medical history after SAR, clinicians should discuss possible risk factors for more frequent stings and more severe anaphylactic reactions. The most important risk factors for more severe SAR are mast cell disease and, especially in children, uncontrolled asthma. Therefore, if the SAR extends beyond the skin (according to the Ring and Messmer classification: grade > I), the baseline serum tryptase concentration shall be measured and the skin shall be examined for possible mastocytosis. The medical history should also include questions specific to asthma symptoms. To demonstrate sensitization to HV, allergists shall determine concentrations of specific IgE antibodies (sIgE) to bee and/or vespid venoms, their constituents and other venoms as appropriate. If the results are negative less than 2 weeks after the sting, the tests shall be repeated (at least 4 – 6 weeks after the sting). If only sIgE to the total venom extracts have been determined, if there is double sensitization, or if the results are implausible, allergists shall determine sIgE to the different venom components. Skin testing may be omitted if in-vitro methods have provided a definitive diagnosis. If neither laboratory diagnosis nor skin testing has led to conclusive results, additional cellular testing can be performed. Therapy for HV allergy includes prophylaxis of reexposure, patient self treatment measures (including use of rescue medication) in the event of re-stings, and VIT. Following a grade I SAR and in the absence of other risk factors for repeated sting exposure or more severe anaphylaxis, it is not necessary to prescribe an adrenaline auto-injector (AAI) or to administer VIT. Under certain conditions, VIT can be administered even in the presence of previous grade I anaphylaxis, e.g., if there are additional risk factors or if quality of life would be reduced without VIT. Physicians should be aware of the contraindications to VIT, although they can be overridden in justified individual cases after weighing benefits and risks. The use of β-blockers and ACE inhibitors is not a contraindication to VIT. Patients should be informed about possible interactions. For VIT, the venom extract shall be used that, according to the patient’s history and the results of the allergy diagnostics, was the trigger of the disease. If, in the case of double sensitization and an unclear history regarding the trigger, it is not possible to determine the culprit venom even with additional diagnostic procedures, VIT shall be performed with both venom extracts. The standard maintenance dose of VIT is 100 µg HV. In adult patients with bee venom allergy and an increased risk of sting exposure or particularly severe anaphylaxis, a maintenance dose of 200 µg can be considered from the start of VIT. Administration of a non-sedating H1-blocking antihistamine can be considered to reduce side effects. The maintenance dose should be given at 4-weekly intervals during the first year and, following the manufacturer’s instructions, every 5 – 6 weeks from the second year, depending on the preparation used; if a depot preparation is used, the interval can be extended to 8 weeks from the third year onwards. If significant recurrent systemic reactions occur during VIT, clinicians shall identify and as possible eliminate co-factors that promote these reactions. If this is not possible or if there are no such co-factors, if prophylactic administration of an H1-blocking antihistamine is not effective, and if a higher dose of VIT has not led to tolerability of VIT, physicians should should consider additional treatment with an anti IgE antibody such as omalizumab as off lable use. For practical reasons, only a small number of patients are able to undergo sting challenge tests to check the success of the therapy, which requires in-hospital monitoring and emergency standby. To perform such a provocation test, patients must have tolerated VIT at the planned maintenance dose. In the event of treatment failure while on treatment with an ACE inhibitor, physicians should consider discontinuing the ACE inhibitor. In the absence of tolerance induction, physicians shall increase the maintenance dose (200 µg to a maximum of 400 µg in adults, maximum of 200 µg HV in children). If increasing the maintenance dose does not provide adequate protection and there are risk factors for a severe anaphylactic reaction, physicians should consider a co-medication based on an anti-IgE antibody (omalizumab; off-label use) during the insect flight season. In patients without specific risk factors, VIT can be discontinued after 3 – 5 years if maintenance therapy has been tolerated without recurrent anaphylactic events. Prolonged or permanent VIT can be considered in patients with mastocytosis, a history of cardiovascular or respiratory arrest due to Hymenoptera sting (severity grade IV), or other specific constellations associated with an increased individual risk of recurrent and/or severe SAR (e.g., hereditary α-tryptasemia). In cases of strongly increased, unavoidable insect exposure, adults may receive VIT until the end of intense contact. The prescription of an AAI can be omitted in patients with a history of SAR grade I and II when the maintenance dose of VIT has been reached and tolerated, provided that there are no additional risk factors. The same holds true once the VIT has been terminated after the regular treatment period. Patients with a history of SAR grade ≥ III reaction, or grade II reaction combined with additional factors that increase the risk of non response or repeated severe sting reactions, should carry an emergency kit, including an AAI, during VIT and after regular termination of the VIT.Correspondence to:
Prof. Dr. med. Franziska Ruëff, Klinik und Poliklinik für Dermatologie, und Allergologie, Klinikum der Universität München, Frauenlobstraße 9-11, 80337 Munich, Germany,
Email: [email protected]
Original
Management of allergic rhinitis improves clinical outcomes of difficult-to-treat tic disorders or attention-deficit/hyperactivity disorders
Rui-Li Yu, Jing Wang, Xue-Song Wang, Hong-Tian Wang, and Xue-Yan Wang
Page No. 191
Abstract
Allergologie select, Vol. 7/2023 (191-197)
Management of allergic rhinitis improves clinical outcomes of difficult-to-treat tic disorders or attention-deficit/hyperactivity disorders
Rui-Li Yu1, Jing Wang2, Xue-Song Wang3, Hong-Tian Wang1, and Xue-Yan Wang1
1Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, 2Department of Pediatrics, First Medical Center, PLA General Hospital, Beijing, and 3Department of Otolaryngology, Binzhou Central Hospital Affiliated to Binzhou Medical College, Binzhou, Shandong, China
Aims: This case series aimed to evaluate the effects of treatment for allergic rhinitis (AR) in AR-diagnosed children with previous diagnosis of tic disorders/attention-deficit/hyperactivity disorders (TD/ADHD) but unresponsive to behavioral or medical treatment. Materials and methods: Between July 2016 and June 2021, children diagnosed with AR in our hospital were enrolled. All were diagnosed with TD/ADHD refractory to behavioral or medical treatment. The demography and clinical information were collected from medical records. The outcomes were visual analogue scale (VAS) for AR severity, Yale Comprehensive Tic Severity Scale (YGTSS) for TD symptoms, and Attention-Deficit Hyperactivity Screening Scale (SNAP-IV) for ADHD symptoms. Results: A total of 27 children (18 boys, 9 girls) were included, with a mean age 7.4 ± 2.9 years (3 – 17 years). They had undergone behavioral or medical treatment of TD/ADHD for 3.6 ± 1.9 years but without significant improvement in TD/ADHD symptoms. After 2-6 months of systematic treatment for AR, VAS was decreased to 0.4 ± 0.1 from 0.8 ± 0.2, YGTSS to 3.5 ± 0.7 from 6.8 ± 1.4, and SNAP-IV to 0.4 ± 0.1 from 0.6 ± 0.2 (all p < 0.001). No recurrence of TD/ADHD symptoms was reported during a mean follow-up of 2.4 ± 1.1 years (0.5 – 5 years). Conclusion: AR treatment improves TD/ADHD outcomes in children with difficult-to-treat TD/ADHD. In TD/ADHD children who are unresponsive to behavioral or drug treatment and have AR-related symptoms, AR examination and treatment are recommended for better prognosis.Correspondence to:
Hong-Tian Wang, PhD, Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, China, 100038
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
Page No. 198
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]
Review
Allergen immunotherapy of insect venom allergy: Almost 100 years old, but steadily updated
Wolfgang Pfützner
Page No. 211
Abstract
Allergologie select, Vol. 7/2023 (211-218)
Allergen immunotherapy of insect venom allergy: Almost 100 years old, but steadily updated
Wolfgang Pfützner
Allergy Section, Department of Dermatology and Allergology, University Hospital Marburg, Philipps-Universität Marburg, Germany
Allergen immunotherapy (AIT) with Hymenoptera venom (HV) shows high efficiency treating insect venom allergy, covering an almost 100-year-long history. Untreated patients with HV allergy can develop serious, potentially lethal sting reactions. Before starting AIT with HV, indication and contraindications, the presence of comorbidities and the intake of concomitant medications as well as individual risk factors have to be carefully evaluated. Application of HV-AIT entails an individually adapted procedure in case of undesired adverse events or initial failure to induce tolerance, as the final goal has to be the development of immunologic protection against anaphylactic sting reactions.Correspondence to:
Prof. Dr. med. Wolfgang Pfützner, Allergy Section, Department of Dermatology and Allergology, University Hospital Marburg, Biegenstraße 10, 35037 Marburg, Germany
Email: [email protected]
Review
AIT 2023: Current innovation and future outlook
Magdalena Zemelka-Wiacek and Marek Jutel
Page No. 219
Abstract
Allergologie select, Vol. 7/2023 (219-228)
AIT 2023: Current innovation and future outlook
Magdalena Zemelka-Wiacek1 and Marek Jutel1,2
1Department of Clinical Immunology, Wroclaw Medical University, Wroclaw, and 2ALL-MED Medical Research Institute, Wroclaw, Poland
Although used for over 100 years, allergen immunotherapy (AIT) is still an indispensable tool in modern allergy managemen20t due to its potential to cure allergic diseases. Its current rapid development through the application of personalized and precision medicine approaches is strongly supported by advances in mHealth, component-resolved diagnosis (CRD)-based diagnostics, validation of novel biomarkers, advanced data management, and development of novel preparations. This review summarizes the key advances in the field and shows the perspectives for further development of next-generation AIT treatments.Correspondence to:
Marek Jutel and Magdalena Zemelka-Wiacek, Department of Clinical Immunology, Wroclaw Medical University, Parkowa 34, 51-616 Wroclaw, Poland
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
Page No. 229
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
AIT in pediatric allergology: Opportunities and difficulties on the home stretch of the Therapy Allergen Ordinance
Christian Vogelberg and Michael Gerstlauer
Page No. 236
Abstract
Allergologie select, Vol. 7/2023 (236-241)
AIT in pediatric allergology: Opportunities and difficulties on the home stretch of the Therapy Allergen Ordinance
Christian Vogelberg1 and Michael Gerstlauer2
1Department of Pediatrics, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, and 2Pediatric and Adolescent Medicine, University Hospital Augsburg, Augsburg, Germany
Allergen immunotherapy (AIT) is the only causal therapy for allergic diseases and therefore particularly important. Allergen preparations have been classified as medicinal products since 1989 (Directive 89/342/EEC) and were taken over into Directive 2001/83/EC in 2001. In addition, in 2008 the Therapy Allergen Ordinance (TAO) came into force to stricter regulate the exception for named patient products (NPP) by exclusion of common therapy allergens from the exception to be marketed as NPP. The TAO regulates the requirements for testing safety and efficacy for these common therapy allergens. Due to the long transitional provisions, the last deadlines for solving clinical shortcomings will end in 2026. The advantage of this regulation is that the market for common allergens has been cleared of products without proof of efficacy, and new preparations with an optimal dose range are developed through dose-finding studies. The demand for long-term pediatric studies has been outlined by the standard Pediatric Investigation Plan (PIP) on allergen products from the Pediatric Committee of the EMA (PDCO). This is particularly problematic, as it is foreseeable that recruitment of patients will be limited and ethical problems arise from the prolonged use of placebo. Furthermore, many newly approved preparations will not be used in pediatrics for the foreseeable future, as no marketing authorization has yet been granted for this age group. This will result in a serious supply gap for children.Correspondence to:
Prof. Dr. med. Christian Vogelberg, University Hospital Carl Gustav Carus, Department of Pediatric Pneumology and Allergology, Fetscherstr. 74, 01307 Dresden, Germany
Email: [email protected]
