Hintergrund: Biologika sind Mittel der ersten Wahl bei Patienten mit schwerem, unzureichend kontrolliertem Asthma. Sie können zu einer starken Senkung (oder sogar vollständigen Vermeidung) von Exazerbationen, des Bedarfs an nebenwirkungsreichen systemischen Glukokortikoiden und zu einer deutlichen Besserung der Asthmakontrolle und der Lungenfunktion bei schwerem Asthma führen. Aufgrund der hohen Jahrestherapiekosten einer Biologika-Therapie besteht einerseits ein berechtigtes Interesse seitens der Kostenträger an einem leitlinien- und zulassungskonformen sowie wirtschaftlichen Einsatz von Biologika bei schwerem Asthma, andererseits besteht ein berechtigtes Interesse seitens der behandelnden Ärztinnen und Ärzte an einer regresssicheren Verordnung dieser Biologika. Methodik: In einer Analyse der Literatur und der Zulassungen wurde in Zusammenschau mit den Erfahrungen der beteiligten Autoren die Evidenz zur Therapie mit den für schweres Asthma zugelassenen Biologika Omalizumab, Mepolizumab, Reslizumab, Benralizumab, Dupilumab, Tezepelumab und Depemokimab zusammengetragen. Ergebnisse: Basierend auf den Leitlinien-Empfehlung und Zulassungen werden Empfehlungen für die Anwendung der genannten Biologika im deutschen Gesundheitssystem gegeben. In einer gemeinsamen Anstrengung verschiedener Fachgesellschaften (AeDA, DGP, BdP, GAN, DGAKI, GPP, GPA) wurden Dokumentationsbögen für alle für schweres Asthma zugelassenen Biologika erstellt, die als Grundlage der Dokumentation dienen können. Es wurden hierbei sowohl Bögen für die Einleitung einer Biologika-Therapie als auch Bögen zur Verlaufsfdokumentation einer Biologika-Therapie bei schwerem Asthma entwickelt. Schlussfolgerung: Die neuen Dokumentationsbögen fassen praxistauglich alle wichtigen Eckpunkte der Biologika-Verordnung und der Beurteilung des Biologika-Ansprechens bei schwerem Asthma auf einer Seite zusammen und dienen sowohl der Sicherstellung einer leitliniengerechten und zulassungskonformen Verordnung als auch der Vermeidung von Arzneimittel-Regressen. Zitierweise: Klimek L, Buhl R, Brehler R, Hamelmann E, Joest M, aufm Kampe K, Korn S, Lampert S, Mülleneisen N, Taube C, Trischler J, Vogelberg C, Schmitz F, Lommatzsch M. Position paper on the documentation of biologic therapies for severe asthma. Recommendations of the Association of German Allergologists (AeDA), the German Society for Pneumology and Respiratory Medicine (DGP), the Federal Association of Pneumology, Sleep and Respiratory Medicine (BdP), the German Asthma Net (GAN), the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Pneumology (GPP), and the Society for Pediatric Allergology and Environmental Medicine (GPA). Allergo J Int. 2026;35:65-76

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

Zusammenfassung Biologika sind Mittel der 1. Wahl bei Patienten mit schwerem, unzureichend kontrolliertem Asthma und können zu einer starken Senkung (oder sogar vollständigen Vermeidung) von Exazerbationen und des Bedarfs an nebenwirkungsreichen systemischen Kortikosteroiden und zu einer deutlichen Besserung der Asthma-Kontrolle und der Lungenfunktion bei schwerem Asthma führen. Aufgrund der hohen Jahrestherapiekosten einer Biologikatherapie besteht ein berechtigtes Interesse seitens der Kostenträger an einem leitlinien- und zulassungskonformen und wirtschaftlichen Einsatz von Biologika bei schwerem Asthma, andererseits besteht ein berechtigtes Interesse seitens der behandelnden Ärztinnen und Ärzte an einer regresssicheren Verordnung dieser Biologika. In einer Analyse der Literatur und der Zulassungen wurde in Zusammenschau mit den Erfahrungen der beteiligten Autoren die Evidenz zur Therapie mit den für schweres Asthma zugelassenen Biologika Omalizumab, Mepolizumab, Reslizumab, Benralizumab, Dupilumab, Tezepelumab und Depemokimab zusammengetragen. Basierend auf den Leitlinienempfehlung und Zulassungen werden Empfehlungen für die Anwendung der genannten Biologika im deutschen Gesundheitssystem gegeben. In einer gemeinsamen Anstrengung verschiedener Fachgesellschaften (AeDA, DGP, BdP, GAN, DGAKI, GPP, GPA) wurden Dokumentationsbögen für alle für schweres Asthma zugelassenen Biologika erstellt, die als Grundlage der Dokumentation dienen können. Es wurden hierbei sowohl Bögen für die Einleitung einer Biologikatherapie als auch Bögen zur Verlaufsdokumentation einer Biologikatherapie bei schwerem Asthma entwickelt. Die neuen Dokumentationsbögen fassen praxistauglich alle wichtigen Eckpunkte der Biologikaverordnung und der Beurteilung des Biologikaansprechens bei schwerem Asthma auf einer Seite zusammen und dienen sowohl der Sicherstellung einer leitliniengerechten und zulassungskonformen Verordnung als auch der Vermeidung von Arzneimittelregressen.

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).

Diese Arbeit gibt eine Übersicht über die verschiedenen Therapieoptionen bei Nahrungsmittelallergien, angefangen vom Verzehr stark erhitzter Lebensmittel, über Immuntherapien, Lebensmittel-Leitern bis zur medikamentösen Behandlung. Zitierweise: Knappe N, Nemat K, Vogelberg C. Therapeutic approaches to food allergies. Allergo J Int 2025;34:134-8 https://doi.org/10.1007/s15007-025-6519-y

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.

Biologics are the first-line treatment for patients with severe, inadequately controlled asthma. They can lead to a significant reduction in (or even complete avoidance of) exacerbations, a reduction in the need for systemic glucocorticoids with their many side effects, and a marked improvement in asthma control and lung function in severe asthma. Due to the high annual costs of biologic therapy, there is legitimate interest among health insurances in guideline- and approval-compliant as well as cost-effective use of biologics in severe asthma. On the other hand, there is also legitimate interest among treating physicians in prescribing these biologics without risk of insurer repayment demands. Using an analysis of the literature and regulatory approvals, the evidence for treatment with currently approved biologics for severe asthma—omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and depemokimab— was documented, and supplemented by the clinical experiences of the authors. Based on the guideline recommendations and approvals, recommendations are made for the use of the aforementioned biologics in the German healthcare system. In a joint effort by various professional associations (AeDA, DGP, BdP, GAN, DGAKI, GPP, GPA), documentation forms were created for all biologics approved for severe asthma, which can serve as a basis for documentation. Forms were developed both for the initiation of biologic therapy and for the documentation of biologic treatment responses in severe asthma. The new documentation forms concisely summarize all key points related to biologic prescription in severe asthma on a single page, serving both to ensure guideline-compliant and approval-compliant prescription and to avoid drug repayment demands.

Background:Biologics are the first-line treatment for patients with severe, poorly controlled asthma and can lead to a significant reduction (or even complete avoidance) of exacerbations and the need for systemic corticosteroids - which are associated with numerous side effects - as well as to a marked improvement in asthma control and lung function in severe asthma. Due to the high annual costs of biologic therapy, there is a legitimate interest on the part of payers in the cost-effective use of biologics for severe asthma in accordance with guidelines and regulatory approvals; conversely, there is a legitimate interest on the part of treating physicians in prescribing these biologics in a manner that protects them from liability claims. Methodology:In an analysis of the literature and regulatory approvals, combined with the experience of the participating authors, evidence was compiled regarding therapy with the biologics approved for severe asthma: omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and depemokimab. Results:Based on guideline recommendations and approvals, recommendations are provided for the use of the aforementioned biologics within the German healthcare system. In a joint effort by various professional societies (AeDA, DGP, BdP, GAN, DGAKI, GPP, GPA), documentation forms were created for all biologics approved for severe asthma, which can serve as a basis for documentation. Forms were developed both for initiating biologic therapy and for documenting the course of biologic therapy in severe asthma. Conclusion:The new documentation forms provide a practical, one-page summary of all key points regarding the prescription of biologics and the assessment of response to biologics in severe asthma, serving both to ensure prescribing in accordance with guidelines and regulatory requirements and to prevent drug-related claims.

BACKGROUND:Prevention and management of allergic reactions at school are recognized public health concerns. We analyzed food-induced anaphylaxis (FIA) cases which occurred in education facilities to better understand their management. METHODS:FIA cases recorded by the European Anaphylaxis Registry which occurred in (pre-)school settings were descriptively analyzed in a comparative manner to pediatric FIA cases that occurred outside education facilities. RESULTS:Of the 3450 pediatric FIA cases, 332 (9.6%) occurred in education facilities (median age: 4 years [IQR: 2-9]). 151 (45.5%) children had a known allergy to the culprit food. The main culprit foods were peanut (27.4%), hazelnut (12.7%), and cow's milk (9.4%). According to Ring classification, 209 (63.0%) reactions were grade 2, 120 (36.1%) grade 3, and 3 (0.9%; 1 death) grade 4. Adrenaline injection was reported in 50/305 (16.4%) children. Adrenaline use increased from 8.1% to 21.1% of cases during the study period (not statistically significant, p = .68). Compared to children with a FIA outside education facilities, children who experienced FIA in preschool-school settings were more likely to have a known allergy to the culprit food (p <.001) and to have experienced a peanut-induced anaphylaxis (p = .04), and were less likely to receive adrenaline (p <.001). CONCLUSION:Anaphylaxis occurring in educational settings can be severe, with frequent known allergy to the culprit food, peanut as the most frequent elicitor, and adrenaline underuse. Action at the national policy level and cross-country collaborations are required to implement a common approach to protect children in educational settings.

INTRODUCTION:We investigated whether having more birch trees or more allergenic trees around home in early adolescence was related to worse lung function up to early adulthood in the German cities of Munich and Dresden. METHODS:The analytic sample included 1539 participants from the population-based ISAAC II/SOLAR II study who were aged 9-11 at baseline and 19-24 at follow-up. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC were measured by spirometry at both time points. The number of birch trees, allergenic trees, and total trees, along with tree cover density and the normalized difference vegetation index (NDVI) were calculated in 300 m buffers around home at baseline. The associations were assessed by generalized least squares regressions with a variance-covariance structure accounting for heteroscedasticity and within-subject correlations. RESULTS:Participants living close to birch trees around age 10 tended to have slightly lower FEV1 and FVC up to early adulthood. These associations were not restricted to participants with asthma or hay fever. Similar, though much attenuated, associations were found for allergenic trees. No associations were found for the other exposures of interest. We saw some effect modification by ozone, nitrogen dioxide (NO2), and study town, but only for associations of NDVI with FEV1. DISCUSSION:Birch trees around the childhood home, as proxy of long-term exposure to allergenic birch pollen, were associated with slightly lower lung function up to early adulthood. Future studies on health effects of greenspace exposure should include species of plants.

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.

Asthma bronchiale ist mit einer Prävalenz von etwa 4

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.

BACKGROUND AND OBJECTIVES:The relationship between atopic dermatitis (AD), weight, height, and body mass index (BMI) in children and adolescents and the impact of systemic treatments is controversial. We report the distribution of weight, height, and BMI in the German TREATkids cohort compared to a standardized German cohort (Kromeyer-Hauschild) and the impact of systemic glucocorticoids. PATIENTS AND METHODS:This multicenter, prospective study analyzed weight and height data from pediatric patients (2-17 years) with moderate-to-severe AD enrolled in TREATkids. RESULTS:According to Kromeyer-Hauschild metrics, the median height, weight, and BMI of the TREATkids cohort were 42nd, 52nd, and 59th percentiles, respectively. A height deficit was observed compared to the reference population. Despite shorter stature, the children exhibited weight percentiles comparable to the general population. This combination of reduced height and normal weight led to high BMI-for-age percentiles. A sensitivity analysis excluding patients who had received systemic corticosteroids showed similar results for height-for-age, weight-for-age, and BMI-for-age percentiles. CONCLUSIONS:Children and adolescents with moderate-to-severe AD in TREATkids exhibit distinct anthropometric patterns, characterized by height deficits but normal weight distribution, independent of systemic glucocorticoid treatment.

Real-world evidence on clinical and molecular outcomes of systemic therapy for pediatric atopic dermatitis remains limited. Within the prospective TREATkids registry, we conducted an observational analysis of children and adolescents treated with dupilumab in routine care. Baseline data from 200 and follow-up data from 124 patients were evaluated for clinician- and patient-/caregiver-reported outcomes, alongside epidermal proteomic profiling using tape strips and the Olink Explore Inflammation 384 (n = 20) panel and 16S ribosomal RNA gene sequencing for skin microbiome assessment in subsets (n = 48). At treatment initiation, disease burden was high (mean Eczema Area and Severity Index = 16.5, objective SCORing Atopic Dermatitis = 44.9, peak pruritus numerical rating scale = 6.6). By month 3, Eczema Area and Severity Index 50, 75, and 90 response rates were 87, 60, and 30%. Response rates at months 6 and 12 were generally consistent with those observed at month 3, with no discontinuations and conjunctivitis occurring in 4.0%. Proteomic analyses demonstrated marked baseline upregulation of alarmins, T helper 2 chemokines, and tissue-remodeling markers in lesional skin, followed by downregulation of 144/161 dysregulated proteins at month 3, including CCL17/TARC, CXCL8, IL-6, IL-18, and matrix metalloproteinases. Microbiome profiling showed baseline dysbiosis with Staphylococcus aureus overabundance and reduced α-diversity, normalizing toward a nonlesional-like state after therapy at month 3. Overall, dupilumab was associated with rapid, sustained clinical and molecular improvement.

Abstract BackgroundAtopic dermatitis (AD) is one of the most common chronic inflammatory skin diseases, associated with itching, sleep disturbance, and impaired quality of life. Structured patient education can improve disease outcomes, but in-person programs are often unavailable in rural or underserved areas. Digital interventions may help overcome these barriers; however, their efficacy compared with routine care has not been evaluated. ObjectiveThis study aims to assess whether a digitally delivered, interdisciplinary care concept (ADCompanion) is noninferior to routine, real-world care, as available in well-served areas, in reducing disease severity among patients with AD. Secondary objectives include effects on quality of life, pruritus, psychosocial burden, family well-being, and health care costs. MethodsThis is a prospective, multicenter, 2-arm, 1:1 randomized noninferiority trial. Participants are stratified by age and disease severity. The intervention group receives standard therapy plus access to a digital platform with training modules and optional video consultations on skin care, nutrition, and psychosocial support. The control group receives routine care, optionally including face-to-face group training where available, and a basic app version for symptom tracking. The primary endpoint is physician-assessed disease severity (Scoring Atopic Dermatitis Index [SCORAD]) at 6 months; secondary endpoints include patient-reported outcomes, itch, quality of life, and disease-related costs. ResultsRecruitment of 603 participants across 7 centers in Germany was completed. Data collection was finalized in June 2025. At the time of protocol submission (February 2026), data cleaning had been completed, and the statistical analysis plan was finalized; final results are expected to be published in 2026. ConclusionsThis protocol describes a randomized trial designed to evaluate whether digitally delivered interdisciplinary care is noninferior to routine care for patients with AD. The findings of this study will inform the role of digital patient education as a complementary component within established care structures.

Bronchial asthma is one of the most common diseases in childhood and adolescence with a prevalence of about 4%. The diagnosis is initially based on typical symptoms such as recurrent shortness of breath and coughing, followed by lung function tests and, if necessary, sensitization testing. The treatment follows current guidelines and includes both nonpharmacological and pharmacological measures, which are considered equally important. The goal is the optimal asthma control, which means broadly unrestricted organ function, daily activity, and social participation.