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Introduction: Allergic diseases represent a broad spectrum of high-prevalence, chronic conditions that remain underdiagnosed and undertreated. The aims of this interdisciplinary, questionnaire-based, non-interventional study were to identify and analyze potential barriers to clinical allergological care in Germany. Methods: All hospitals listed in the German hospital register involved in the treatment of allergological patients (n = 899) were invited to participate. The study yielded a response rate of 52.1% (n = 468). Results: Overall, 88.5% of clinics agreed that allergological care in Germany needs improvement, especially in terms of reimbursement for diagnostics and therapy. More than 80% of participating clinics reported that the decreased availability of test substances and the time-intensity of allergological testing represent relevant barriers. For dermatology and pulmonology, the former is the strongest barrier, while for pediatric and ENT clinics, time-intensity is regarded as the strongest barrier. The availability of good therapy and appropriate guidelines present no barriers to allergological care. Regarding the use of digital healthcare concepts, a very large majority of clinics (n = 352; 91.4%) do not offer video consultations or the use of health applications in patient care. Conclusion: In conclusion, we have identified several structural barriers to allergological care in Germany. Reimbursement and the use of digital healthcare concepts in German clinics providing allergological care need improvement. Based on the results of this study, there is an urgent need for researchers and policymakers to further investigate and support allergology departments in their clinical work and in their implementation of digital healthcare concepts.

This publication is the second part of the German-language S3 guideline on urticaria. It covers the management of urticaria and should be used together with Part 1 of the guideline on classification and diagnosis. This publication was prepared according to the criteria of the AWMF on the basis of the international English-language S3 guideline with special consideration of health system conditions in German-speaking countries. Chronic urticaria has a high impact on the quality of life and daily activities of patients. Therefore, if causal factors cannot be eliminated, effective symptomatic treatment is necessary. The recommended first-line treatment is to administer new generation, non-sedating H1 antihistamines. If the standard dose is not sufficiently effective, the dose should be increased up to fourfold. For patients who do not respond to this treatment, the second-line treatment in addition to antihistamines in the treatment algorithm is omalizumab and, if this treatment fails, ciclosporin. Other low-evidence therapeutic agents should only be used if all treatments in the treatment algorithm agreed upon by the guideline group fail. Both the benefit-risk profile and cost should be considered. Corticosteroids are not recommended for long-term treatment due to their inevitable severe side effects.

Die vorliegende Publikation ist der zweite Abschnitt der deutschsprachigen S3-Leitlinie Urtikaria. Sie umfasst das Management der Urtikaria und sollte gemeinsam mit Teil 1 der Leitlinie zur Klassifikation und Diagnostik genutzt werden. Diese Publikation wurde auf der Basis der internationalen englischsprachigen S3-Leitlinie unter besonderer Berücksichtigung der medizinischen Gegebenheiten im deutschsprachigen Raum entsprechend den Kriterien der AWMF erstellt. Eine chronische Urtikaria hat einen hohen Einfluss auf Lebensqualität und Leistungsfähigkeit der Patienten. Sofern kausale Faktoren nicht beseitigt werden können, ist daher eine effektive symptomatische Behandlung notwendig. Die empfohlene Therapie der ersten Wahl ist die Gabe von nicht sedierenden H1-Antihistaminika der neuen Generation. Wenn die Standarddosierung nicht ausreichend wirksam ist, sollte die Dosis bis auf das Vierfache erhöht werden. Bei Patienten, die auch auf eine solche Behandlung nicht ansprechen, sind Therapeutika der zweiten Wahl zusätzlich zu Antihistaminika im Rahmen des Therapiealgorithmus zunächst Omalizumab und, bei Versagen dieser Therapie, Ciclosporin. Weitere Therapeutika mit geringer Evidenz sollten nur bei Versagen aller Therapien des konsentierten Algorithmus verwendet werden. Dabei sollten sowohl das Nutzen-Risiko-Profil als auch die Kosten berücksichtigt werden. Kortikosteroide werden für die Langzeitbehandlung aufgrund ihrer unvermeidbaren schweren Nebenwirkungen nicht empfohlen.

Die Lebenszeitprävalenz für Urtikaria, die zu den schweren allergischen Erkrankungen zählt, liegt bei nahezu 20%. Sie schränkt nicht nur die Lebensqualität der Betroffenen ein, sondern die generelle Leistungsfähigkeit in Beruf und Alltag. Die vorliegende Publikation ist der erste Abschnitt der Leitlinie Urtikaria. Dieser Teil der Leitlinie umfasst deren Klassifikation und Diagnostik unter Einbeziehung der wesentlichen Fortschritte in der Erforschung ihrer Ursachen, auslösenden Faktoren und Pathomechanismen. Zudem befasst sie sich mit Strategien zur ökonomischen Diagnostik der verschiedenen Unterformen der Urtikaria. Dies ist entscheidend für eine individuelle, patientenorientierte Therapie, die im zweiten Teil behandelt wird. Diese deutschsprachige Leitlinie wurde auf der Basis der internationalen englischsprachigen S3-Leitlinie unter besonderer Berücksichtigung der medizinischen Gegebenheiten im deutschsprachigen Raum entsprechend den Kriterien der AWMF erstellt. Die Leitlinie beschreibt in diesem Abschnitt die Klassifikation der Urtikaria, wobei spontan auftretende Quaddeln und Schwellungen von Urtikariaformen mit induzierbaren Symptomen abgegrenzt werden. Urtikaria wird als plötzlich auftretende Quaddeln, Schwellungen oder beides definiert, ist dabei aber abzugrenzen von Zuständen bei denen Quaddeln als kurzfristiges Symptom auftreten, wie zum Beispiel bei der Anaphylaxie. Die Diagnostik stützt sich auf (eingeschränkte) Laboruntersuchungen, aber insbesondere auch die Anamnese. Darüber hinaus stehen validierte Instrumente zur Verfügung, die den Schweregrad, die Aktivität und den Verlauf erfassen.

BackgroundEffectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.MethodsCOMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult and paediatric clinicians, pharmaceutical representatives, and health regulators from across Europe. Evidence included a systematic review of development, validity and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients’ and carers’ views about outcome measures. It was discussed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.ResultsBoth adult and paediatric COM sets include forced expiratory volume in 1 s (FEV1) as z-scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire and Asthma Control Test or Childhood Asthma Control Test, while the adult COM set includes the Severe Asthma Questionnaire and Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately).ConclusionsThis patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.

Background: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany. Methods: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, ‘DAK-Gesundheit’, were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed. Results: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population. Conclusions: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits. in press

The lifetime prevalence of urticaria, a severe allergic disease, is almost 20%. It not only limits the quality of life of those affected, but also their general performance at work and in their daily activities. This publication is the first section of the Urticaria Guideline. It covers the classification and diagnosis of urticaria, taking into account the major advances in research into its causes, triggering factors and pathomechanisms. It also addresses strategies for the efficient diagnosis of the different subtypes of urticaria. This is crucial for individual, patient-oriented treatment, which is covered in the second part of the guideline, published separately. This German-language guideline was developed according to the criteria of the AWMF on the basis of the international English-language S3 guideline with special consideration of health system characteristics in the German-speaking countries. This first part of the guideline describes the classification of urticaria, distinguishing spontaneously occurring wheals (hives) and angioedema from forms of urticaria with inducible symptoms. Urticaria is defined as sudden onset of wheals, angioedema, or both, but is to be distinguished from conditions in which wheals occur as a short-term symptom, such as anaphylaxis. The diagnosis is based on (a limited number of) laboratory tests, but especially on medical history. In addition, validated instruments are available to measure the severity, activity and course of the disease.

Hintergrund: Zur vorbeugenden Behandlung von COVID-19 (Coronaviruserkrankung 2019) wurden in einer beispiellosen weltweiten Forschungsanstrengung Sicherheit und Wirksamkeit neuer Impfstoffplattformen studiert, die noch nie zuvor am Menschen eingesetzt wurden. Weniger als ein Jahr nach der Entdeckung der SARS-CoV-2-Virussequenz (SARS-CoV-2, "severe acute respiratory syndrome coronavirus type 2") wurden diese in zahlreichen Landern fur den Einsatz zugelassen und es wurde mit Massenimpfungen begonnen. Die bislang in der Europaischen Union (EU) zugelassenen mRNA-Impfstoffe (mRNA, "messenger"-RNA) gegen SARS-CoV-2 BNT162b2 und mRNA-1273 basieren auf einer ahnlichen lipidbasierten Nanopartikeltragertechnologie; die Lipidkomponenten unterscheiden sich jedoch. Schwere allergische Reaktionen und Anaphylaxien nach COVID-19-Impfungen sind sehr seltene unerwunschte Nebenwirkungen, die aber aufgrund potenziell letaler Ausgange viel Aufmerksamkeit erhalten und ein hohes Mas an Verunsicherung ausgelost haben. Methoden: Das aktuelle Wissen zu anaphylaktischen Reaktionen auf Impfstoffe und speziell zu den derzeit neuen mRNA-COVID-19-Impfstoffen wurde zusammengestellt mittels einer Literaturanalyse durch Recherchen in Medline, Pubmed sowie den nationalen und internationalen Studien- und Leitlinienregistern, der Cochrane Library und dem Internet unter besonderer Berucksichtigung offizieller Webseiten der World Health Oranization (WHO), der Centers for Disease Control and Prevention (CDC), der European Medicines Agency (EMA), des Robert-Koch-Instituts (RKI) und des Paul-Ehrlich-Instituts (PEI). Ergebnisse: Basierend auf der internationalen Literatur und bisheriger Erfahrungen zu schweren allergischen Reaktionen im Kontext der COVID-19-Impfungen werden von einem Expertengremium Empfehlungen fur Prophylaxe, Diagnostik und Therapie dieser allergischen Reaktionen gegeben. Schlussfolgerung: Vor einer COVID-19-Impfung mit den derzeit zugelassenen Impfstoffen sind Allergietests fur die allermeisten Allergiker nicht notwendig. Bei allergischer/anaphylaktischer Reaktion auf den verabreichten COVID-19-Impfstoff wird eine allergologische Abklarung empfohlen, wie auch fur eine kleine potenzielle Risikopopulation vor der ersten Impfung. Die Evaluierung und Zulassung von Testverfahren sollten hierfur erfolgen. Zitierweise: Klimek L, Bergmann K-C, Brehler R, Pfutzner W, Zuberbier T, Hartmann K, Jakob T, Novak N, Ring J, Merk H; Hamelmann E, Ankermann T, Schmidt S, Untersmayr E, Hotzenecker W, Jensen-Jarolim E, Brockow K, Mahler V, Worm M. Practical Handling of Allergic Reactions to COVID-19 vaccines. A Position Paper from German and Austrian Allergy Societies AeDA, DGAKI, GPA and OGAI. Allergo J Int 2021;30:79-95 https: //doi.org/10.1007/s40629-021-00165-7

An expert workshop in collaboration of the German Society of Allergy and Clinical Immunology (DGAKI) and the Japanese Society of Allergy (JSA) provided a platform for key opinion leaders of both countries aimed to join expertise and to highlight current developments and achievements in allergy research. Key domains of the meeting included the following seven main sections and related subchapters: 1) basic immunology, 2) bronchial asthma, 3) prevention of allergic diseases, 4) food allergy and anaphylaxis, 5) atopic dermatitis, 6) venom allergy, and 7) upper airway diseases. This report provides a summary of panel discussions of all seven domains and highlights unmet needs and project possibilities of enhanced collaborations of scientific projects. © Dustri-Verlag Dr. K. Feistle.

ZusammenfassungDas vorliegende Addendum zur Leitlinie zur Diagnostik und Therapie von Patienten mit Asthma (2017) ergänzt wichtige neue Erkenntnisse zur Diagnostik und Therapie von Asthma sowie zu neu für die Therapie des Asthmas zugelassenen Medikamenten. Es werden sowohl für Kinder und Jugendliche als auch für Erwachsene mit Asthma die aktuellen, Evidenz-basierten diagnostischen und therapeutischen Empfehlungen dargelegt.

Zwei Mitarbeiter des National Health Service (NHS) in England entwickelten nach der Verabreichung des BNT162b2-Impfstoffs von BionNTech gegen COVID-19 schwere allergische Reaktionen. Die britische Fachinformation fur den BNT162b2-Impfstoff enthalt bereits Hinweise auf eine Kontraindikation zur Anwendung bei Personen, die allergisch auf den Impfstoff oder einen seiner Bestandteile reagiert haben. Als Vorsichtsmasnahme hat die englische Regulationsbehorde fur Arzneimittel und Gesundheitsprodukte (MHRA) eine vorlaufige Anleitung herausgegeben, "Patienten mit schweren Allergien" grundsatzlich nicht zu impfen. Allergische Reaktionen auf Impfstoffe sind sehr selten, aber Impfstoffkomponenten verursachen bekanntermasen allergische Reaktionen. BNT162b2 ist ein Impfstoff, der auf einer in Lipidnanopartikel eingebetteten mRNA basiert und mit weiteren Substanzen angereichert wird, um den Transport in die Zellen zu ermoglichen. In der zentralen klinischen Phase-III-Studie wurde der BNT162b2-Impfstoff im Allgemeinen gut vertragen. Impfstoffe gelten als eine der wirksamsten Masnahmen im Bereich der offentlichen Gesundheit. Schwere allergische Reaktionen auf Impfstoffe sind selten, konnen jedoch lebensbedrohlich sein. Es ist ratsam, die Impfteams auf diese Gefahr aufmerksam zu machen und angemessene Vorsichtsmasnahmen zu treffen, wahrend mehr Erfahrungen mit dem neuen Impfstoff gesammelt werden.

Hintergrund: Allergische Atemwegserkrankungen haben Einfluss auf die Leistungsfahigkeit und Lebensqualitat der Erkrankten. Die Allergen-Immuntherapie (AIT) stellt den einzigen kausalen Behandlungsansatz mit der Moglichkeit dar, den Krankheitsverlauf positiv zu beeinflussen. Allerdings fehlen fur Deutschland bislang differenzierte Zahlen zur Behandlung geeigneter Patienten. Methoden: Die Versorgungssituation in Deutschland wird mittels einer retrospektiven, querschnittlichen, kohortenbasierten Versorgungsanalyse auf der Basis von Patientenangaben und Routinedaten der gesetzlichen Krankenversicherung (GKV) untersucht. Es werden Merkmale ermittelt, die eine leitliniengerechte Versorgung begunstigen oder verhindern. Daruber hinaus werden Angaben zur Lebensqualitat und zu den Krankheitskosten bei allergischer Rhinitis und allergischem Asthma erhoben und ausgewertet. Ergebnisse: Die Routinedaten liefern umfassende und sektorubergreifende Informationen zu Diagnosen und Inanspruchnahme von Gesundheitsleistungen. Die Patientenangaben bieten Informationen zu Erkrankungsschwere, Therapiehistorie, Lebensqualitat, Inanspruchnahme alternativer Behandlungsmethoden und soziodemografischen Merkmalen. Diskussion: Mit VerSITA wird eine fundierte Grundlage fur zukunftige Forschung und zur Information von Entscheidungstragern geschaffen, um Masnahmen zur Optimierung der Versorgung zu entwickeln. Zitierweise: Valbert F, Neusser S, Riederer C, Wobbe-Ribinski S, Klimek L, Sperl A, Pfaar O, Werfel T, Hamelmann E, Neumann A, Wasem J, Biermann-Stallwitz J. Health care situation in patients with allergic respiratory diseases with special focus on specific immunotherapy. Allergo J Int 2021;30:39-45 https://doi.org/10.1007/s40629-020-00149-z

Background After the beginning and during the worldwide pandemic caused by the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), patients with allergic and atopic diseases have felt and still feel insecure. Currently, four vaccines against SARS-CoV-2 have been approved by the Paul Ehrlich Institute in Germany, and vaccination campaigns have been started nationwide. In this respect, it is of utmost importance to give recommendations on possible immunological interactions and potential risks of immunomodulatory substances (monoclonal antibodies, biologicals) during concurrent vaccination with the approved vaccines. Materials and methods This position paper provides specific recommendations on the use of immunomodulatory drugs in the context of concurrent SARS-CoV-2 vaccinations based on current literature. Results The recommendations are covering the following conditions in which biologicals are indicated and approved: 1) chronic inflammatory skin diseases (atopic dermatitis, chronic spontaneous urticaria), 2) bronchial asthma, and 3) chronic rhinosinusitis with nasal polyps (CRSwNP). Patients with atopic dermatitis or chronic spontaneous urticaria are not at increased risk for allergic reactions after COVID-19 vaccination. Nevertheless, vaccination may result in transient eczema exacerbation due to general immune stimulation. Vaccination in patients receiving systemic therapy with biologicals can be performed. Patients with severe asthma and concomitant treatment with biologicals also do not have an increased risk of allergic reaction following COVID-19 vaccination which is recommended in these patients. Patients with CRSwNP are also not known to be at increased risk for allergic vaccine reactions, and continuation or initiation of a treatment with biologicals is also recommended with concurrent COVID-19 vaccination. In general, COVID-19 vaccination should be given within the interval between two applications of the respective biological, that is, with a time-lag of at least 1 week after the previous or at least 1 week before the next biological treatment planned. Conclusion Biologicals for the treatment of atopic dermatitis, chronic spontaneous urticaria, bronchial asthma, and CRSwNP should be continued during the current COVID-19 vaccination campaigns. However, the intervals of biological treatment may need to be slightly adjusted (DGAKI/AeDA recommendations as of March 22, 2021).

Not available.

Introduction: Environmental exposure to mites and fungi has been proposed to critically contribute to the development of IgE-mediated asthma. A common denominator of such organisms is chitin. Human chitinases have been reported to be upregulated by interleukin-13 secreted in the context of Th2-type immune responses and to induce asthma. We assessed whether chitin-containing components induced chitinases in an innate immune-dependent way and whether this results in bronchial hyperresponsiveness. Materials and Methods: Monocyte/macrophage cell lines were stimulated with chitin-containing or bacterial components in vitro. Chitinase activity in the supernatant and the expression of the chitotriosidase gene were measured by enzyme assay and quantitative PCR, respectively. Non-sensitized mice were stimulated with chitin-containing components intranasally, and a chitinase inhibitor was administered intraperitoneally. As markers for inflammation leukocytes were counted in the bronchoalveolar lavage (BAL) fluid, and airway hyperresponsiveness was assessed via methacholine challenge. Results: We found both whole chitin-containing dust mites as well as the fungal cell wall component zymosan A but not endotoxin-induced chitinase activity and chitotriosidase gene expression in vitro. The intranasal application of zymosan A into mice led to the induction of chitinase activity in the BAL fluid and to bronchial hyperresponsiveness, which could be reduced by applying the chitinase inhibitor allosamidin. Discussion: We propose that environmental exposure to mites and fungi leads to the induction of chitinase, which in turn favors the development of bronchial hyperreactivity in an IgE-independent manner.

Summary Background Allergic respiratory diseases have an impact on the performance and quality of life of the patients. The allergen immunotherapy (AIT) is the only causal treatment approach with the chance to positively influence the course of the disease. However, differentiated figures for the treatment of suitable patients in Germany are still missing. Methods The health care situation in Germany is examined with a retrospective, cross-sectional, cohort-based health care analysis based on patient data and routine data from statutory health insurance (SHI). Characteristics are identified that encourage or prevent guideline-based care. In addition, data on quality of life and costs of illness of allergic rhinitis and allergic asthma are collected and evaluated. Results Routine data provide comprehensive and cross-sectoral information about diagnoses and utilization of health care services. In addition, primary data give information on disease severity, treatment history, quality of life, use of alternative treatment methods, and sociodemographic characteristics of the patients. Conclusion Analysis of the care situation with regard to the specific immunotherapy in cases of allergic respiratory diseases (VerSITA) provides a solid basis for future research and for informing decision-makers in order to develop measures to optimize care.

The Global Initiative for Asthma recommends a stepwise approach to adjust asthma treatment to the needs of individual patients; inhaled corticosteroids (ICS) remain the core pharmacological treatment. However, many patients remain poorly controlled, and evidence-based algorithms to decide on the best order and rationale for add-on therapies are lacking. We explore the challenges of asthma management in primary care and review outcomes from randomised controlled trials and meta-analyses comparing the long-acting muscarinic antagonist (LAMA) tiotropium with long-acting β2-agonists (LABAs) or leukotriene receptor antagonists (LTRAs) as add-on to ICS in patients with asthma. In adults, LAMAs and LABAs provide a greater improvement in lung function than LTRAs as add-on to ICS. In children, results were positive and comparable between therapies, but data are scarce. This information could aid decision-making in primary care, supporting the use of add-on therapy to ICS to help improve lung function, control asthma symptoms and prevent exacerbations.

Introduction In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV1) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF25–75%) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF25–75% with FEV1 as an endpoint to assess bronchodilator responsiveness in children with asthma. Methods Change from baseline in trough FEF25–75% and trough FEV1 following treatment with either tiotropium (5 µg or 2.5 µg) or placebo Respimat® was analyzed in four phase III trials in children (aged 6–11 years) and adolescents (aged 12–17 years) with symptomatic moderate (VivaTinA-asthma® and PensieTinA-asthma®) and mild (CanoTinA-asthma® and RubaTinA-asthma®) asthma. Data from all treatment arms were pooled and correlations between FEF25–75% and FEV1 were calculated and analyzed. Results A total of 1590 patients were included in the analysis. Tiotropium Respimat® consistently improved FEF25–75% and FEV1 versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF25–75% response with tiotropium versus placebo were largely more pronounced than improvements in FEV1. Statistical assessment of the correlation of FEV1 and FEF25–75% showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80). Conclusions In pediatric patients, FEF25–75% may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV1 and should be evaluated as an additional lung function measurement.

BACKGROUND & AIMS: Establishment of the gastrointestinal microbiota during infancy affects immune system development and oral tolerance induction. Perturbations in the microbiome during this period can contribute to development of immune-mediated diseases. We monitored microbiota maturation and associations with subsequent development of allergies in infants and children. METHODS: We collected 1453 stool samples, at 5, 13, 21, and 31weeks postpartum (infants), and once at school age (6-11 years), from 440 children (49.3% girls, 24.8% born by cesarean delivery; all children except for 6 were breastfed for varying durations; median 40 weeks; interquartile range, 30-53 weeks). Microbiota were analyzed by amplicon sequencing. Children were followed through 3 years of age for development of atopic dermatitis; data on allergic sensitization and asthma were collected when children were school age. RESULTS: Diversity of fecal microbiota, assessed by Shannon index, did not differ significantly among children from 5 through 13 weeks after birth, but thereafter gradually increased to 21 and 31 weeks. Most bacteria within the Bacteroidetes and Proteobacteria phyla were already present at 5 weeks after birth, whereas many bacteria of the Firmicutes phylum were acquired at later times in infancy. At school age, many new Actinobacteria, Firmicutes, and Bacteroidetes bacterial taxa emerged. The largest increase in microbial diversity occurred after 31 weeks. Vaginal, compared with cesarean delivery, was most strongly associated with an enrichment of Bacteroides species at 5 weeks through 31 weeks. From 13 weeks onward, diet became the most important determinant of microbiota composition; cessation of breast-feeding, rather than solid food introduction, was associated with changes. For example, Bifidobacteria, staphylococci, and streptococci significantly decreased on cessation of breastfeeding, whereas bacteria within the Lachnospiraceae family (Pseudobutyrivibrio, Lachnobacterium, Roseburia, and Blautia) increased. When we adjusted for confounding factors, we found fecal microbiota composition to be associated with development of atopic dermatitis, allergic sensitization, and asthma. Members of the Lachnospiraceae family, as well as the genera Faecalibacterium and Dialister, were associated with a reduced risk of atopy. CONCLUSIONS: In a longitudinal study of fecal microbiota of children from 5 weeks through 6 to 11 years, we tracked changes in diversity and composition associated with the development of allergies and asthma.

Introduction Airway obstruction is usually assessed by measuring forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF). This post hoc study investigated comparative responses of lung function measurements in adults and adolescents (full analysis set, N = 3873) following treatment with tiotropium Respimat®. Methods Lung function outcomes were analysed from five phase III trials in adults (≥ 18 years) with symptomatic severe, moderate and mild asthma (PrimoTinA-asthma®, MezzoTinA-asthma® and GraziaTinA-asthma®, respectively), and one phase III trial in adolescents (12–17 years) with symptomatic moderate asthma (RubaTinA-asthma®). Changes from baseline versus placebo in FEV1, FVC, PEF and FEV1/FVC ratio with tiotropium 5 µg or 2.5 µg added to at least stable inhaled corticosteroids at week 24 (week 12 in GraziaTinA-asthma) were analysed. Results All lung function measures improved in all studies with tiotropium 5 µg (mean change from baseline versus placebo), including peak FEV1 (110–185 mL), peak FVC (57–95 mL) and morning PEF (15.8–25.6 L/min). Changes in adolescents were smaller than those in adults, and were statistically significant primarily for FEV1 and PEF, but not for FVC. Conclusion Consistent improvements were seen across all lung function measures with the addition of tiotropium to other asthma treatments in adults across all severities, whereas the improvements with tiotropium in adolescents primarily impacted measures of flow rather than lung volume. This may reflect less pronounced airway remodelling and air trapping in adolescents with asthma versus adults., Plain Language Summary Asthma is characterised by problems with the way that the lungs work, particularly narrowing of the airways. Doctors can measure the effect of asthma on someone’s breathing in different ways. We looked to see whether these different methods work for different people with asthma, and whether treatment affects all measurements in a similar way. Lung function was measured after treatment with a drug that opens the airways (tiotropium), and comparisons were made between adults and adolescents with asthma. We also looked at people with severe asthma and those whose asthma was less severe. Tiotropium improved all the measures of lung function in both age groups and across severities. One measure improved more in adults than in adolescents. This may be because adolescents had better lung function at the start and thus less room for improvement, or because the adolescents had not had asthma for as long, and so may have had less long-term damage to their airways than adults. Trial Registration Numbers: NCT00772538, NCT00776984, NCT01172808, NCT01172821, NCT01316380, NCT01257230.

Five biologicals have been approved for severe eosinophilic asthma, a well-recognized phenotype. Systematic reviews (SR) evaluated the efficacy and safety of benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab (alphabetical order) compared to standard of care for severe eosinophilic asthma. PubMed, Embase and Cochrane Library were searched to identify RCTs and health economic evaluations, published in English. Critical and important asthma-related outcomes were evaluated for each of the biologicals. The risk of bias and the certainty of the evidence were assessed using GRADE. 19 RCTs (three RCTs for benralizumab, three RCTs for dupilumab, three RCTs for mepolizumab, five RCTs for omalizumab and five RCTs for reslizumab), including subjects 12 to 75 years old (except for omalizumab including also subjects 6-11 years old), ranging from 12 to 56 weeks were evaluated. All biologicals reduce exacerbation rates with high certainty of evidence: benralizumab incidence rate ratio (IRR) 0.53 (95% CI 0.39 to 0.72), dupilumab (IRR) 0.43 (95% CI 0.32 to 0.59), mepolizumab IRR 0.49 (95% CI 0.38 to 0.66), omalizumab (IRR) 0.56 (95% CI 0.40 to 0.77) and reslizumab (IRR) 0.46 (95% CI 0.37 to 0.58). Benralizumab, dupilumab and mepolizumab reduce the daily dose of oral corticosteroids (OCS) with high certainty of evidence. All evaluated biologicals probably improve asthma control, QoL and FEV1 , without reaching the minimal important difference (moderate certainty). Benralizumab, mepolizumab and reslizumab slightly increase drug-related adverse events (AE) and drug-related serious AE (low to very low certainty of evidence). The incremental cost-effectiveness ratio per quality-adjusted life year value is above the willingness to pay threshold for all biologicals (moderate certainty). Potential savings are driven by decrease in hospitalizations, emergency and primary care visits. There is high certainty that all approved biologicals reduce the rate of severe asthma exacerbations and for benralizumab, dupilumab and mepolizumab for reducing OCS. There is moderate certainty for improving asthma control, QoL, FEV1 . More data on long-term safety are needed together with more efficacy data in the paediatric population.

Die Anzahl der von Allergien betroffenen Patienten nimmt weltweit zu. Hiermit gehen erhebliche Kosten fur die Gesundheits- und Sozialsysteme durch allergische Erkrankungen einher. Integrierte Versorgungskonzepte sind erforderlich, die innerhalb der nationalen Gesundheitssysteme eine umfassende Versorgung ermoglichen. Die ARIA-Initiative entwickelt international gultige Leitlinien fur allergische Atemwegserkrankungen. ARIA dient der verbesserten Versorgung von Patienten mit Allergien und chronischen Atemwegserkrankungen. In Zusammenarbeit mit anderen internationalen Initiativen, nationalen Fachgesellschaften und Patientenorganisationen im Bereich Allergien und Atemwegserkrankungen wurde eine realitatsnahe, integrative Versorgungsleitlinie („integrated care pathways“, ICPs) fur eine digital unterstutzte, integrative, individualisierte Behandlung von allergischer Rhinitis (AR) mit komorbidem Asthma entwickelt, die in der vorliegenden Arbeit auf das deutsche Gesundheitssystem ubertragen wird. Die vorliegende ICP-Versorgungsleitlinie umfasst wesentliche Bereiche der Versorgung von Patienten mit AR mit und ohne Asthma einschlieslich der Sicht von Patienten und weiterer versorgungsnaher Gesundheitsdienstleister. Eine umfassende ICP-Leitlinie kann die Versorgungsrealitat wesentlich besser abbilden als herkommliche Leitlinienmodelle.

Background: Since the beginning of the COVID-19 pandemic, the treatment of patients with allergic and atopy-associated diseases has faced major challenges. Recommendations for “social distancing” and the fear of patients becoming infected during a visit to a medical facility have led to a drastic decrease in personal doctor-patient contacts. This affects both acute care and treatment of the chronically ill. The immune response after SARS-CoV-2 infection is so far only insufficiently understood and could be altered in a favorable or unfavorable way by therapy with monoclonal antibodies. There is currently no evidence for an increased risk of a severe COVID-19 course in allergic patients. Many patients are under ongoing therapy with biologicals that inhibit type 2 immune responses via various mechanisms. There is uncertainty about possible immunological interactions and potential risks of these biologicals in the case of an infection with SARS-CoV-2. Materials and methods: A selective literature search was carried out in PubMed, Livivo, and the internet to cover the past 10 years (May 2010 – April 2020). Additionally, the current German-language publications were analyzed. Based on these data, the present position paper provides recommendations for the biological treatment of patients with allergic and atopy-associated diseases during the COVID-19 pandemic. Results: In order to maintain in-office consultation services, a safe treatment environment must be created that is adapted to the pandemic situation. To date, there is a lack of reliable study data on the care for patients with complex respiratory, atopic, and allergic diseases in times of an imminent infection risk from SARS-CoV-2. Type-2-dominant immune reactions, as they are frequently seen in allergic patients, could influence various phases of COVID-19, e.g., by slowing down the immune reactions. Theoretically, this could have an unfavorable effect in the early phase of a SARS-Cov-2 infection, but also a positive effect during a cytokine storm in the later phase of severe courses. However, since there is currently no evidence for this, all data from patients treated with a biological directed against type 2 immune reactions who develop COVID-19 should be collected in registries, and their disease courses documented in order to be able to provide experience-based instructions in the future. Conclusion: The use of biologicals for the treatment of bronchial asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, and spontaneous urticaria should be continued as usual in patients without suspected infection or proven SARS-CoV-2 infection. If available, it is recommended to prefer a formulation for self-application and to offer telemedical monitoring. Treatment should aim at the best possible control of difficult-to-control allergic and atopic diseases using adequate rescue and add-on therapy and should avoid the need for systemic glucocorticosteroids. If SARS-CoV-2 infection is proven or reasonably suspected, the therapy should be determined by weighing the benefits and risks individually for the patient in question, and the patient should be involved in the decision-making. It should be kept in mind that the potential effects of biologicals on the immune response in COVID-19 are currently not known. Telemedical offers are particularly desirable for the acute consultation needs of suitable patients.

No abstract available.

In order to summarize recent research on the prevention of allergies—particularly asthma—and stimulate new activities for future initiatives, a virtual workshop sponsored by the EAACI Clemens von Pirquet foundation and EUFOREA was held in October 2021. The determinants of the “allergic march” as well as the key messages from intervention studies were reviewed by an international faculty of experts. Several unmet needs were identified, and a number of priorities for future studies were proposed.