Die Erstlinientherapie bei einer schweren systemischen allergischen Reaktion (Anaphylaxie) ist die Gabe von Adrenalin, die im Notfall durch Selbstanwendung mit einem Adrenalin-Autoinjektor (AAI) intramuskulär (i. m.) erfolgen kann. AAIs werden trotz bekannten Anaphylaxie-Risikos häufig nicht verordnet, nicht mitgeführt oder im Notfall gar nicht oder mit Verzögerung eingesetzt. Mögliche Motive, den AAI nicht mitzuführen oder einzusetzen, sind logistische Gründe (wie u. a. Größe und Handhabbarkeit des AAI), Schwierigkeiten, die Symptome zu erkennen, die den Einsatz erfordern, mangelnde Vertrautheit mit der Anwendung des AAI und generell die Angst vor Nadeln. Kürzlich wurde in Deutschland ein Nasenspray zur intranasalen Anwendung von Adrenalin zugelassen und in Verkehr gebracht. Die pharmakokinetischen Studien zur Entwicklung dieses Adrenalin-Nasensprays (ANS) im Vergleich zu der i. m. Injektion mit einem AAI oder manuell (Spritze mit Injektionskanüle) ergaben vergleichbare Profile. Die einfache Anwendung, geringe Größe des Nasensprays, die Nadelfreiheit und verbesserte Lagerungsbedingungen des ANS können dazu beitragen, die Barrieren der Adrenalinanwendung, wie sie sowohl für Patientinnen und Patienten und andere Anwendende bis heute bestehen, abzubauen und eine Anaphylaxie rechtzeitig adäquat zu behandeln. Zitierweise: Treudler R, Beyer K, Blümchen K, Gernert S, Gerstlauer M, Hamelmann E, Jakob T, Klimek L, Pfaar O, Ruëff F, Schnadt S, Schönherr M, Seurig S, Vogelberg C, Wieczorek D, Worm M, Wüstenberg E. Treatment of severe allergic reactions and anaphylaxis with an adrenaline nasal spray. Allergo J Int. 2026;35:38-44

Background Preschool children with asthma are more susceptible to develop acute life-threatening respiratory distress leading to hospital admissions compared to school children and treatment options are limited for this age group. We evaluated the safety and efficacy of tiotropium as add-on therapy to inhaled corticosteroids (ICS) in preschool children with high-risk, partly controlled or uncontrolled asthma. Methods TIPP was a phase III, prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-group (investigator-initiated) trial conducted at 13 German centres (12 hospitals, one specialised medical practice). Children aged 1–5 years with physician-diagnosed asthma, partly controlled or uncontrolled symptoms despite ICS, and a history of severe exacerbations were randomly assigned to receive once-daily tiotropium (two puffs of 1.25 μg) via Respimat® inhaler or placebo as add-on to ICS therapy over 52 weeks. The primary outcome was time to first severe asthma exacerbation requiring hospitalisation and/or systemic corticosteroid treatment. All randomised participants were included in the intention-to-treat analysis and analysed by treatment received for safety. No primary or safety data were missing; therefore, no imputation was required. The study was registered in the “EU Clinical Trials Registry” (EudraCT 2021-000190-81). Findings Between February 2022 and March 2025, 100 of the planned 204 children were enrolled, of whom 86 were randomised to tiotropium + ICS (n = 44) or placebo + ICS (n = 42). Mean age was 3.3 years (Standard deviation (SD) 1.3). The primary outcome time to first severe asthma exacerbation did not differ between groups (Hazard ratio (HR): 0.99, 95% confidence interval (CI): 0.51–1.92; p = 0.98). At least one adverse event was reported in 41 (93%) of 44 children in the tiotropium + ICS group and 42 (100%) of 42 children in the placebo + ICS group. 397 adverse events were reported with tiotropium + ICS group and 450 with placebo + ICS group. Tiotropium was well tolerated, and no new safety signal was identified. Interpretation Tiotropium did not reduce the risk of a severe asthma exacerbation, but was well tolerated as add-on therapy to ICS in preschool children with high-risk asthma. Funding German Federal Ministry of Education and Research (01KG2030); study medication provided by Boehringer Ingelheim Pharma GmbH & Co. KG (0205-0546).

BACKGROUND:Allergen immunotherapy is the only disease-modifying treatment for IgE-mediated diseases for patients 5 years and over. The question is often asked why children receive the same doses as adults. There is not a single dose-finding study including children and/or adolescents. Moreover, randomized controlled trials that include all age groups but report effects separately are rare. METHOD:This randomized trial investigated the safety and tolerability of an accelerated dose escalation schedule (One-Strength group) compared to the standard regimen (Standard group) when using a birch pollen SCIT allergoid in patients aged 5-65 years. RESULTS:Overall, 201 patients were randomized to the two regimens: 87 adults, 52 adolescents, 62 children. Three hundred eighty-two treatment-related adverse drug reactions (ADRs) occurred in 81 patients (40.5%). A higher proportion of patients in the One-Strength group (48.5%) experienced at least one ADR compared to those in the Standard group (32.0%). The majority of ADRs were local (93.3%), and the majority were of mild intensity (95.8%). 3 patients in the One-Strength and 1 patient in the Standard group developed a total of 9 systemic ADRs, which all were classified as WAO grade 1 or 2 and most of mild intensity. No event of WAO grade 3 or higher was reported. No serious ADR occurred. Overall, tolerability was assessed as "very good" or "good" by more than 96% of investigators and patients. Safety and tolerability were comparable in the three age groups. CONCLUSION:Birch pollen SCIT was safe and well-tolerated when administered using a One-Strength dose-escalation regimen in patients aged 5-65 years.

Asthma is the most common chronic respiratory disease in children and adolescents. While most patients achieve good control with guideline-based treatment, a significant proportion experience persistent symptoms, frequent exacerbations, and impaired quality of life.This guideline aims to define severe and difficult-to-treat asthma in children and adolescents, support diagnostic precision, and provide practical, evidence-based recommendations for assessment and management, including biological therapies.The S1 guideline was developed under the coordination of the German Society for Pediatric Pulmonology following AWMF procedures. A structured consensus process involving experts from pediatric pulmonology, allergology, and general pediatrics was conducted. Existing national and international guidelines and new evidence were systematically reviewed and adapted.Key elements include a stepwise diagnostic algorithm to distinguish difficult-to-treat from truly severe asthma, guidance on assessing adherence, comorbidities, and inflammation biomarkers, and recommendations for targeted biological treatment. This guideline addresses monitoring tools, transition to adult care, and the role of rehabilitation.Children and adolescents with severe asthma require early referral to specialized centers and a structured, interdisciplinary approach. Personalized treatment strategies-including biologics-should be guided by phenotyping and biomarkers. Registry data are essential to improve care quality and generate real-world evidence.

First-line therapy for a severe allergic reaction (anaphylaxis) is the administration of adrenaline, which, in an emergency, can be self-administered intramuscularly (i.m.) via an adrenaline autoinjector (AAI). Despite the known risk of anaphylaxis, AAIs are often not prescribed, not carried, not used, or used with delay in an emergency. Possible reasons for this include logistical issues (e.g., size and portability of the AAI), difficulties in recognizing symptoms that require the use of an AAI, lack of familiarity with the AAI application, and general fear of injections. Recently, an adrenaline nasal spray (ANS) for intranasal application of adrenaline has been authorized and introduced in Germany. Pharmacokinetic studies for ANS development in comparison with the i.m. injection using an AAI or manual injection (syringe and needle) resulted in comparable profiles. The simple use and small size of the ANS, the needle-free design, and the improved storage conditions can help reduce barriers to adrenaline administration for patients and other users. This may lead to an earlier administration of adrenaline in anaphylaxis treatment.

Die Allergen-Immuntherapie (AIT) ist eine bewährte Behandlungsform zur Therapie allergischer Erkrankungen wie allergischer Rhinokonjunktivitis (ARC), allergischem Asthma (AA) und Insektengiftallergien. Besonders bei Kindern und Jugendlichen, die eine hohe Prävalenz dieser Erkrankungen aufweisen, spielt die AIT eine entscheidende Rolle, um nicht nur Symptome zu lindern, sondern auch die natürliche Krankheitsprogression zu beeinflussen. Dieser Artikel beleuchtet den Einsatz und die Bedeutung der AIT bei Kindern und Jugendlichen in Deutschland in der finalen Phase der Therapieallergene-Verordnung (TAV). Der Schwerpunkt liegt auf Effektivität und Sicherheit der Therapie sowie auf der Zulassung der jeweiligen Therapieallergene für die jeweilige Altersgruppe. Zitierweise: Gerstlauer M. Allergen immunotherapy in children and adolescents: current aspects 2024. Allergo J Int 2025;34:89-94

The diagnostic procedure to detect sensitization to bee or wasp venom should only be carried out if this results in a therapeutic consequence, i.e., allergen immunotherapy (AIT) against Hymenoptera venom (HG). The risk of a more severe reaction to another insect sting after a systemic allergic reaction is very low in children. Therefore, children who have only reacted with an intensified local reaction or generalized urticaria do not usually require AIT or an emergency kit. For children who show anaphylaxis that goes beyond urticaria, AIT and an emergency kit are indicated. The AIT for at least 3 years can significantly reduce the risk of another severe anaphylactic reaction. The chances of success of AIT are so good that in many cases the emergency kit can be dispensed with during the course of the reaction. Sting provocations for diagnostic purposes or to check the success of treatment are generally not indicated in children and adolescents.

BACKGROUND:Patients with allergic rhinitis (AR) and/or mild or moderate asthma derived from birch-family pollen allergy can be treated with liquid sublingual immunotherapy (SLIT-liquid). This study evaluated the impact of two SLIT extracts on AR and asthma progression or onset in these patients. METHODS:This was a sub-analysis of a retrospective, longitudinal comparative cohort study that used a German prescription database. Patients treated with 3-tree (birch/alder/hazel) or birch-only SLIT-liquid and followed up for up to 6 years after treatment were compared with controls dispensed symptomatic medications. Multiple regression analysis compared dispensation data as a proxy for disease status and progression. RESULTS:A total of 493 patients treated with 3-tree SLIT-liquid and 311 treated with birch SLIT-liquid were analysed vs. 44,835 patients included as controls. Overall, 70.5 % of patients presented solely AR, 24.2 % solely asthma, and 5.3 % both diseases. Compared with controls, patients treated with 3-tree SLIT-liquid had reduced risk of AR [odds ratio (OR) = 3.21, 95 % CI 2.54-4.06, p < 0.001], asthma progression (OR = 2.03, 95 % CI 1.43-2.89, p < 0.0001), or asthma onset (OR = 0.592, 95 % CI, 0.408-0.860, p = 0.006). Birch-only SLIT-liquid showed similar effectiveness in reducing AR and asthma medication dispensation but no significant effect in reducing new-onset asthma. CONCLUSIONS:This real-world study demonstrated the effectiveness of treatment with 3-tree SLIT-liquid or birch SLIT-liquid in slowing the progression of birch-family pollen allergy. 3-tree SLIT-liquid covering a broader repertoire of epitopes mimicking natural exposure throughout the year may be valuable for patients sensitised to birch and/or alder and/or hazel pollen suffering from overlapping tree-pollen seasons.

Background/Objectives: The guideline on allergen-specific immunotherapy of the European Academy of Allergy and Clinical Immunology recommends subcutaneous allergen-specific immunotherapy for the treatment of allergic rhinitis in children and adults with moderate to severe symptoms. The five years cohort study described below was designed in 2020 to demonstrate non-inferiority in terms of safety, tolerability and efficacy in a paediatric population compared with adult patients treated with microcrystalline tyrosine-adsorbed allergoids for their tree and grass pollen allergy in a perennial setting. Here, we present the preliminary findings from the first year. Methods: The Combined Symptom and Medication Score was chosen as the primary endpoint of this therapy. Secondary endpoints include the Rhinoconjunctivitis Quality of Life Questionnaire, the retrospective Rhinoconjunctivitis score, the Asthma Control Test and the Rhinitis Control Test, as well as an analysis of adverse drug reactions. Results: A total number of 320 patients were enrolled into this study, with 129 of these patients in the age group between 5 and 17 years and 191 patients in the adult age group. Mean Combined Symptom and Medication Score values did not differ significantly between minors and adults in the first pollen season after treatment induction. The retrospective score showed a strong and significant reduction in rhinoconjunctivitis and asthma symptoms. Treatment was well tolerated, with more than 80% of patients reporting no adverse drug reactions. Conclusions: The validity of this study approach of a cohort study has been confirmed by this first interim analysis for the initial course of therapy in the first year.

Asthma bronchiale ist die häufigste chronische Atemwegserkrankung im Kindes- und Jugendalter. Während der Großteil der Patient:innen unter leitliniengerechter Therapie gut behandelt werden kann, leidet eine relevante Subgruppe an schwerem oder schwer behandelbarem Asthma mit eingeschränkter Lebensqualität und hoher Krankheitslast. Diese Leitlinie zielt darauf ab, schweres Asthma im Kindes- und Jugendalter klar zu definieren, eine strukturierte diagnostische und therapeutische Herangehensweise zu fördern und konkrete Empfehlungen für das Management, einschließlich des Einsatzes von Biologika, zu geben. Die Leitlinie wurde unter Federführung der Gesellschaft für Pädiatrische Pneumologie (GPP) gemäß dem AWMF-Regelwerk erstellt. Grundlage war ein systematischer Literaturreview relevanter nationaler und internationaler Empfehlungen. Ein multidisziplinäres Expertengremium stimmte alle Empfehlungen konsensbasiert ab. Im Mittelpunkt steht ein mehrstufiges diagnostisches Vorgehen zur Differenzierung zwischen schwer behandelbarem und genuin schwerem Asthma. Es werden Kriterien zu Therapieadhärenz, Komorbiditätserfassung und phänotypspezifischer Auswahl von Biologika dargestellt. Weitere Themen sind Monitoring, Rehabilitation, Transition und zukünftige Therapien. Empfehlungen zur Anwendung bestehender und neuer monoklonaler Antikörper basieren auf aktueller Evidenz. Kinder mit schwerem Asthma benötigen eine strukturierte, interdisziplinäre Versorgung. Eine frühe phänotypbasierte Therapie mit Biologika sowie flächendeckende Registerdaten und patientenorientierte Versorgungspfade sind erforderlich, um die Prognose dieser Patientengruppe zu verbessern.

Hintergrund: Aktuell existiert in Deutschland kein einheitliches Bewertungssystem zur Definition und Einteilung des Schweregrades von Nahrungsmittelallergien (NMA). Nach Entwicklung der internationalen Einteilung „DEFASE“ („Definition of Food Allergy Severity“) wird dieses Bewertungssystem nun auch in Deutschland vorgestellt und seine Anwendbarkeit im deutschen Gesundheitssystem geprüft. Methodik: DEFASE wurde in einem zweistufigen Verfahren (Literaturrecherche und eDelphi-Verfahren) als Punktesystem zur Definition der Schwere von NMA erarbeitet. Es wurde ein internationaler Konsens für dieses Scoring-System erreicht. Das Scoring-System bietet ein Bewertungsraster, das den Schweregrad einer NMA unterstützend beurteilen kann. Zitierweise: Arasi S, Lange L, Blümchen K, Knappe N, Nemat K, Brehler R, Röseler S, Gerstlauer M, Hagemann J, Bärhold F, Casper I, Eigenmann P, Fiocchi A, Klimek L, Vogelberg C. Severity assessment of food allergies according to DEFASE criteria in the German healthcare system (d-DEFASE). A position paper of the Association of German Allergists (AeDA) and the Society for Pediatric Allergology and Environmental Medicine (GPA). Allergo J Int 2025;34:113-20 https://doi.org/10.1007/s40629-025-00334-y Schlussfolgerungen: Der DEFASE-Score ist die erste umfassende Einstufung des Schweregrades einer NMA, die nicht nur die Schwere einer einzelnen Reaktion, sondern das gesamte Krankheitsbild berücksichtigt. Wesentlich ist, dass hierfür ein internationaler Konsens über ein Scoring-System für NMA erreicht wurde, der als d-DEFASE nun auch in Deutschland eingesetzt werden kann. In Phase 3 soll das Bewertungssystem im Rahmen von Forschungsprojekten erprobt und in die klinische Praxis eingeführt werden.

In the original publication [...].

There is currently no standardized evaluation system in Germany for defining and classifying the severity of IgE-mediated food allergies (FA). Following the development of the international classification system named DEFASE (Definition of Food Allergy Severity), this evaluation system is now also being introduced in Germany and its applicability in the German healthcare system is being tested. An international consensus was reached on DEFASE through a two-stage process (systematic literature review followed by an e‑Delphi). The DEFASE score is the first comprehensive classification of the severity of a FA that takes into account not only the severity of an individual reaction, but the entire scenario of the disease, including the clinical features alongside patient’s reported outcomes and economic burden. It is important that an international consensus has been reached on a scoring system for FA, which can now also be used in Germany as d‑DEFASE. The scoring system is currently tested in research projects to be introduced soon into clinical practice, targeting these models to various food allergenic sources, populations, and settings.

Die Erweiterung der Zulassung von Dupilumab für die Behandlung der schweren atopischen Dermatitis bei Kindern ab sechs Monaten in Deutschland führt zu einem potenziellen Konflikt mit der Verabreichung von Lebendimpfstoffen. Laut Produktinformation ist die Verabreichung von Lebendimpfstoffen während einer laufenden Dupilumab-Therapie kontraindiziert. Dieses Positionspapier, das von Fachärzten für pädiatrische Immunologie und Allergologie aus Deutschland und der Schweiz verfasst wurde, soll Kinderärzte dabei unterstützen, ihren Patienten die bestmögliche Behandlung mit Dupilumab und geeigneten Impfungen auf der Grundlage der derzeit verfügbaren Evidenz zukommen zu lassen, einschließlich Aussagen und Ratschlägen für klinische Situationen. Die praktische Umsetzung dieser Aussagen erfordert ein differenziertes Vorgehen. Das Positionspapier behandelt die Situation in Deutschland unter besonderer Berücksichtigung der Empfehlungen der STIKO (Ständige Impfkommission) und des Robert-Koch-Instituts für den deutschsprachigen Raum sowie der hiesigen Rechtslage. Zitierweise: Schmidt SM, Ankermann T, Bauer CP, Fischer P, Gappa M, Gerstlauer M, Kopp M, Lau S, Lex C, Mischo B, Schaub B, Spindler T, Vogelberg C. Position Paper Dupilumab and Vaccination. Allergo J Int 2025;34:1-9 https://doi.org/10.1007/s40629-024-00319-3

Eine Diagnostik zum Nachweis einer Sensibilisierung gegen Biene- oder Wespengift soll nur durchgeführt werden, wenn sich daraus eine therapeutische Konsequenz, die Allergen-Immuntherapie (AIT) gegen Hymenopterengift (HG), ergibt. Bei Kindern ist das Risiko, nach einer systemisch allergischen Reaktion auf einen erneuten Insektenstich schwer zu reagieren, sehr gering. Deshalb benötigen Kinder, die nur mit verstärkter Lokalreaktion oder generalisierter Urtikaria reagiert haben, in der Regel keine AIT und kein Notfallset. Für Kinder, die eine über eine Urtikaria hinausgehende Anaphylaxie zeigen, sind AIT und Notfallset angezeigt. Durch die mindestens 3‑jährige AIT kann das Risiko einer erneuten schweren anaphylaktischen Reaktion signifikant gesenkt werden. Die Erfolgsaussichten der AIT sind so gut, dass in vielen Fällen bereits im Verlauf auf das Notfallset verzichtet werden kann. Stichprovokationen zur Diagnostik oder zur Überprüfung des Therapieerfolgs sind bei Kindern und Jugendlichen nicht indiziert.

The extension of the approval of dupilumab for the treatment of severe atopic dermatitis in children 6 months of age and older in Germany creates a potential conflict with the administration of live attenuated vaccines. According to the product information, the administration of live attenuated vaccines is contraindicated during ongoing dupilumab therapy. This position paper, written by specialists in pediatric immunology and allergology from Germany and Switzerland, aims to support pediatricians to provide their patients with the best possible treatment with dupilumab and appropriate vaccinations based on the currently available evidence, including statements and advice for clinical situations. The practical implementation of these statements requires a differentiated approach. The position paper covers the situation in Germany, with special attention to the recommendations of the STIKO (Standing Committee on Vaccination) and the Robert Koch Institute for German-speaking countries and the legal situation here.