Rationale: PQ Grass 27600 SU ist ein modifiziertes Breitspektrum-Grasallergen-SCIT-Produkt, das ein MCT-MPL-Adjuvans-System verwendet. Die optimale kumulative Dosis von PQ Grass 27600 SU wurde in der Phase-II-Dosisfindung auf der Grundlage einer statistisch hochsignifikanten Dosis-Wirkungs-Beziehung mit Plateaubildung ermittelt. Wir berichten hier über die Ergebnisse der pivotalen RESONATE-Studie, die zur Unterstützung des Zulassungsantrags durchgeführt wurde.

ABSTRACT Background PQ Grass 27600 SU (PQ Grass) cumulative dose is a pre‐seasonal, six‐injection, aluminium‐free, modified subcutaneous immunotherapy product under development for the treatment of allergic rhinitis (AR). A pivotal Phase III randomised double‐blind, placebo‐controlled clinical trial was performed to evaluate the efficacy and safety of PQ Grass in subjects with seasonal AR. Methods An adaptive group sequential trial PQGrass306 (G306) with one pre‐defined interim analysis was designed, using 2 parallel groups applying a 1:1 active versus placebo randomisation of patients aged 18–65. The primary efficacy endpoint was the EAACI (European Academy of Allergy and Clinical Immunology) Combined Symptom and Medication Score (EAACI‐CSMS 0–6 ) averaged over the peak grass pollen season (GPS). Results 858 subjects were screened and 555 subjects were randomised. Based on the results of the pre‐defined interim analysis, the trial was stopped for success showing superiority in favour of PQ Grass. The primary endpoint EAACI‐CSMS 0–6 (peak GPS) demonstrated a highly significant and clinically meaningful point difference of PQ Grass over placebo of −0.27 points (95% CI: −0.42 to −0.12), corresponding to a relative difference of −20.3% ( p = 0.0005). Highly consistent and beneficial results were obtained for PQ Grass for all key secondary endpoints. Significant induction of blocking IgG4 and IgA antibody subclasses occurred. PQ Grass was well tolerated, and no unexpected safety signals occurred. Conclusions This pivotal Phase III trial demonstrated a significant and clinically meaningful effect on the primary endpoint as well as highly consistent secondary endpoint results and a supportive safety profile.

Hintergrund: Graspollenallergie ist global gesehen die häufigste Pollenallergie. Die Familie der Gräser (Poaceae) besteht aus vielen Gattungen und Arten von allergologischer Bedeutung, aber sie alle vereint eine einheitliche Pollenkornmorphologie. Phänologie ist der Schlüssel zur Unterscheidung der verschiedenen Taxa. Methoden: PubMed wurde als Suchmaschine benutzt. Die angezeigten Publikationen wurden aufgrund ihrer Relevanz selektiert und zusammengefasst. Ergebnisse: Studien mit phänologischem Fokus sind immer noch selten. Die Zusammensetzung von Grasgattungen und -arten variiert beträchtlich von Region zu Region. Manche Taxa spielen eine wichtigere Rolle in Bezug auf Pollenfreisetzung und Allergenität als andere. Diskussion: Phänologische Routinen erfordern ein profundes botanisches Wissen und sind zeitintensiv. Nichtsdestotrotz sollten sie in Studien über die Graspollensaison genutzt werden, da sie ein besseres Verständnis über die Blütezeit ermöglichen. Zitierweise: Bastl K, Bastl M, Berger M, Dirr L, Berger UE. Phenology as a tool to gain more insights into the grass pollen season. Allergo J Int 2024;33:20-3 https://doi.org/10.1007/s40629-023-00264-7

Background: Pollen allergy can significantly limit people's quality of life. Recently, dietary supplements have become more important for pollen allergy sufferers. However, there is little research data on the effectiveness of these substances in terms of perceived relief of allergy symptoms. Especially when a study design other than the randomized controlled trial is chosen. Methods: A dietary supplement containing a root extract from Astragalus membranaceus was administered to 328 volunteers during the birch, grass and ragweed pollen season in Austria in 2018. Participants documented their symptoms and medication intake online in the pollen diary. All participants were asked to answer a questionnaire on quality of life at the end of the study. In addition to the participants' adherence, the "Symptom Load Index" and the participants' nasal symptoms were recorded and compared with a filtered group of pollen diary users. Results: Adherence reached 32.8% to 77.3%. Additional data from the quality of life questionnaire as well as the symptom load index and nasal symptoms showed differences between study participants and the other users of the pollen diary. Statistical significance was achieved for the ragweed pollen season and nasal symptoms, respectively. Discussion: The study design was based solely on the evaluation of crowdsourced symptom data by comparing study participants with a baseline. Participants' adherence was lower than expected, but a trend towards a reduction in symptoms was observed, which is also confirmed by the results of the quality of life questionnaire.

Summary Purpose Pollen allergy can have a significant impact on a person’s quality of life. Recently, food supplements have gained in importance for persons suffering from pollen allergy. Still, there is not much research data on the efficacy of food supplements and the experienced relief, especially when choosing study designs that require less effort than randomized controlled trials (RCT). Methods A food supplement containing an Astragalus membranaceus root extract was administered to 328 voluntary participants during the 2018 birch, grass and ragweed pollen season in Austria. Participants documented their symptoms and medication intake in the online Patients Hay-fever Diary (PHD). All participants were asked to answer a quality-of-life questionnaire at the end of the study. Alongside with the adherence rate the overall symptom load index (SLI) and the nasal symptoms of the participants were monitored and compared to a filtered group of users from the PHD. Results The adherence rates range from 32.8% to 77.3%. Additional data like a quality-of-life questionnaire and the mean overall/nasal SLI showed differences between participants and the baseline. However, they were only statistically significant for the ragweed pollen season and the nasal symptoms. Conclusion The study design relied on the evaluation of crowd-source symptom data alone by comparing the participants with a baseline. The participant adherence turned out lower than expected; however a trend for reduced symptoms was found and is also supported by the quality-of-life questionnaire.

In rhinitis and asthma, several mHealth apps have been developed but only a few have been validated. However, these apps have a high potential for improving person-centred care (PCC), especially in allergen immunotherapy (AIT). They can provide support in AIT initiation by selecting the appropriate patient and allergen shared decision-making. They can also help in (i) the evaluation of (early) efficacy, (ii) early and late stopping rules and (iii) the evaluation of (carried-over) efficacy after cessation of the treatment course. Future perspectives have been formulated in the first report of a joint task force (TF)-Allergic Rhinitis and Its Impact on Asthma (ARIA) and the European Academy of Allergy and Clinical Immunology (EAACI)-on digital biomarkers. The TF on AIT now aims to (i) outline the potential of the clinical applications of mHealth solutions, (ii) express their current limitations, (iii) make proposals regarding further developments for both clinical practice and scientific purpose and (iv) suggest which of the tools might best comply with the purpose of digitally-enabled PCC in AIT.

Hintergrund: Eine Pollenallergie kann die Lebensqualität von Menschen erheblich einschränken. In letzter Zeit haben Nahrungsergänzungsmittel bei Pollenallergikern an Bedeutung gewonnen. Doch es gibt nur wenige Forschungsdaten über die Wirksamkeit dieser Substanzen mit Bezug auf die empfundene Linderung von Allergiesymptomen. Insbesondere, wenn ein anderes Studiendesign als die randomisierte kontrollierte Studie gewählt wird. Methoden: Ein Nahrungsergänzungsmittel, das ein Wurzelextrakt aus Astragalus membranaceus enthält, wurde 328 freiwilligen Teilnehmern während der Birken-, Gräser- und Ambrosia-Pollensaison 2018 in Österreich verabreicht. Die Teilnehmer dokumentierten ihre Symptome und die Medikamenteneinnahme online, im Pollentagebuch. Alle Teilnehmer wurden gebeten, am Ende der Studie einen Fragebogen zur Lebensqualität zu beantworten. Neben der Adhärenz der Teilnehmer wurden der „Symptom Load Index“ sowie die nasalen Symptome der Teilnehmer erhoben und mit einer gefilterten Gruppe von Benutzern des Pollentagebuchs verglichen. Ergebnisse: Die Adhärenz erreichte 32,8 https://doi.org/10.1007/s40629-024-00283-y

Background: Grass pollen allergy is the most common pollen allergy globally. The grass family (Poaceae) consists of many genera and species of allergological importance, but they all share a uniform pollen grain morphology. Phenology is the key to distinguishing the different taxa. Methods: PubMed was used as a search engine. The displayed publications were selected and summarized based on their relevance. Results: Studies with a phenological focus are still rare. The composition of grass genera and species varies considerably from region to region. Some taxa play a more important role in pollen release and allergenicity than others. Discussion: Phenological routines require profound botanical knowledge and are time-consuming. Nevertheless, they should be used in studies on the grass pollen season, as they allow a better understanding of the flowering period.

The dataset presents a 43 year-long reanalysis of pollen seasons for three major allergenic genera of trees in Europe: alder (Alnus), birch (Betula), and olive (Olea). Driven by the meteorological reanalysis ERA5, the atmospheric composition model SILAM predicted the flowering period and calculated the Europe-wide dispersion pattern of pollen for the years 1980-2022. The model applied an extended 4-dimensional variational data assimilation of in-situ observations of aerobiological networks in 34 European countries to reproduce the inter-annual variability and trends of pollen production and distribution. The control variable of the assimilation procedure was the total pollen release during each flowering season, implemented as an annual correction factor to the mean pollen production. The dataset was designed as an input to studies on climate-induced and anthropogenically driven changes in the European vegetation, biodiversity monitoring, bioaerosol modelling and assessment, as well as, in combination with intra-seasonal observations, for health-related applications.

Ongoing and future climate change driven expansion of aeroallergen-producing plant species comprise a major human health problem across Europe and elsewhere. There is an urgent need to produce accurate, temporally dynamic maps at the continental level, especially in the context of climate uncertainty. This study aimed to restore missing daily ragweed pollen data sets for Europe, to produce phenological maps of ragweed pollen, resulting in the most complete and detailed high-resolution ragweed pollen concentration maps to date. To achieve this, we developed two statistical procedures, a Gaussian method (GM) and deep learning (DL) for restoring missing daily ragweed pollen data sets, based on the plant’s reproductive and growth (phenological, pollen production and frost-related) characteristics. DL model performances were consistently better for estimating annual total pollen concentrations than those of the GM approach. These are the first published modeled maps using altitude correction and phenology to recover missing pollen information. We created a web page (http://euragweedpollen.gmf.u-szeged.hu/), including daily ragweed pollen concentration data sets of the stations examined and their restored daily data, allowing one to upload newly measured or recovered daily data. Generation of these maps provides a means to track pollen impacts in the context of climatic shifts, identify geographical regions with high pollen exposure, determine areas of future vulnerability, apply spatially-explicit mitigation measures and prioritize management interventions.

Hintergrund: Die Erfassung des Pollenfluges wurde innerhalb der letzten Jahrzehnte mit unterschiedlichen Messmethoden bewerkstelligt. Von Beginn an waren folgende Fragestellungen von Bedeutung: die Positionierung des Messgerätes (insbesondere ob auf Dach- oder Nasenhöhe), die Zuverlässigkeit und die Vergleichbarkeit der Messungen. Methoden: Die derzeit gängigen Methoden für Pollenmessungen und die bisherigen Studien zur Messhöhe werden vorgestellt und verglichen. Ergebnisse: Das am weitesten verbreitete Messgerät ist die Pollen- und Sporenfalle nach dem Hirst-Design, deren Daten für Polleninformation, Pollenvorhersagemodelle und klinische Studien geeignet sind. Die Position des Messgerätes auf Dachhöhe ist weiterhin der Standard und korreliert am besten mit dem "realen" Pollenflug und regionalen Symptomdaten. Diskussion: Die Richtlinie zur Erfassung von Pollen und Sporen für Allergienetzwerke in Europa (EN 16868: 2019-09) war ein wichtiger Schritt zur Standardisierung. Neue automatische Messmethoden stecken hinsichtlich Validierung und Vergleichbarkeit noch im Versuchsstadium. Die Harmonisierung von Daten aus unterschiedlichen Messmethoden stellt die Herausforderung der Zukunft dar. Zitierweise: Bastl M, Bastl K, Dirr L, Berger M, Berger U. Methods and standards of pollen monitoring - significance of pollen measurements at different altitudes. Allergo J Int 2023; 32:162-6 https://doi.org/10.1007/s40629-023-00268-3

Ongoing and future climate change driven expansion of aeroallergen-producing plant species comprise a major human health problem across Europe and elsewhere. There is an urgent need to produce accurate, temporally dynamic maps at the continental level, especially in the context of climate uncertainty. This study aimed to restore missing daily ragweed pollen data sets for Europe, to produce phenological maps of ragweed pollen, resulting in the most complete and detailed high-resolution ragweed pollen concentration maps to date. To achieve this, we have developed two statistical procedures, a Gaussian method (GM) and deep learning (DL) for restoring missing daily ragweed pollen data sets, based on the plant's reproductive and growth (phenological, pollen production and frost-related) characteristics. DL model performances were consistently better for estimating seasonal pollen integrals than those of the GM approach. These are the first published modelled maps using altitude correction and flowering phenology to recover missing pollen information. We created a web page (http://euragweedpollen.gmf.u-szeged.hu/), including daily ragweed pollen concentration data sets of the stations examined and their restored daily data, allowing one to upload newly measured or recovered daily data. Generation of these maps provides a means to track pollen impacts in the context of climatic shifts, identify geographical regions with high pollen exposure, determine areas of future vulnerability, apply spatially-explicit mitigation measures and prioritize management interventions.

Abstract Background Allergic rhinitis (AR) is a major non‐communicable disease that affects the health‐related quality of life (HRQoL) of patients. However, data on HRQoL and symptom control in AR patients with comorbid asthma (AR + asthma) are lacking. Methods In this multicentre, cross‐sectional study, patients with AR were screened and administered questionnaires of demographic characteristics and health conditions (symptoms/diagnosis of AR and asthma, disease severity level, and allergic conditions). HRQoL was assessed using a modified version of the RHINASTHMA questionnaire (30, ‘not at all bothered’ ‐ 150 ‘very much bothered’) and symptom control was evaluated by a modified version of the Control of Allergic Rhinitis/Asthma Test (CARAT) (0, ‘no control’ ‐ 30, ‘very high control’). Results Out of 643 patients with AR, 500 (78%) had asthma as a comorbidity, and 54% had moderate‐severe intermittent AR, followed by moderate‐severe persistent AR (34%). Compared to the patients with AR alone, patients with AR + asthma had significantly higher RHINASTHMA (e.g., median RHINASTHMA‐total score 48.5 vs. 84, respectively) and a significantly lower CARAT score (median CARAT‐total score 23 vs. 16.5, respectively). Upon stratifying asthma based on severity, AR patients with severe persistent asthma had worse HRQoL and control than those with mild persistent asthma. The association was significantly higher among non‐obese participants compared to obese ones, with RHINASTHMA‐upper symptoms score but not with CARAT. Conclusions Our observation of poorer HRQoL and symptoms control in AR patients with comorbid asthma supports the importance of a comprehensive approach for the management of AR in case of a comorbid allergic condition.

The study is aimed at determining the potential spatiotemporal risk of the co-occurrence of airborne pollen and fungal spores high concentrations in different bio-climatic zones in Europe. Birch, grass, mugwort, ragweed, olive pollen and Alternaria and Cladosporium fungal spores were investigated at 16 sites in Europe, in 2005-2019. In Central and northern Europe, pollen and fungal spore seasons mainly overlap in June and July, while in South Europe, the highest pollen concentrations occur frequently outside of the spore seasons. In the coldest climate, no allergy thresholds were exceeded simultaneously by two spore or pollen taxa, while in the warmest climate most of the days with at least two pollen taxa exceeding threshold values were observed. The annual air temperature amplitude seems to be the main bioclimatic factor influencing the accumulation of days in which Alternaria and Cladosporium spores simultaneously exceed allergy thresholds. The phenomenon of co-occurrence of airborne allergen concentrations gets increasingly common in Europe and is proposed to be present on other continents, especially in temperate climate.

Hintergrund: Die Gräserpollensaison zeichnet sich durch eine besonders lange Dauer aus, umfasst in Europa die Monate Mai bis Juli, kann aber je nach Seehöhe beziehungsweise geografischer Lage variieren. Es werden im Speziellen drei Gräser vorgestellt, die durch eine spätere Blüte auffallen: Phragmites australis (Schilfrohr), Miscanthus spp.(Chinaschilf) und Zea mays (Mais). Ergebnisse: Phragmites australis (Schilfrohr) blüht zwischen August und September und sorgt an Standorten mit großen Schilfbeständen für relevanten Pollenflug. Miscanthus spp. (Chinaschilf) blüht von August bis Oktober und findet sich einerseits als Zierpflanze in urbanen Räumen und andererseits als Nutzpflanze im ländlichen Gebiet. Zea mays (Mais) blüht von Juli bis Oktober und kann vor allem im Umfeld von Maisfeldern für Beschwerden sorgen. Diskussion: Phänologische Routinen sind wichtiger Bestandteil der Aerobiologie, um lokalen und regionalen Besonderheiten wie spät blühenden Gräsern die Bedeutung beizumessen, die sie haben, nämlich eine nicht zu unterschätzende Rolle in der Verlängerung der Gräserpollensaison. Zitierweise: Dirr L, Bastl K, Bastl M, Berger M, Berger U. Prolonging the period of allergenic burden: late-flowering grasses and local peculiarities. Allergo J Int 2023;32:157-61 https://doi.org/10.1007/s40629-023-00267-4

Ragweed (Ambrosia artemisiifolia), originally native to North America, was introduced to Europe in the 19th century through contaminated seed consignments. Since then, this invasive neophyte has rapidly spread, particularly in Eastern and Central Europe. In Austria, ragweed has been established since the 1970ies and has gained significant attention due to its high allergenicity and negative impacts on crop yields. Therefore, the Ragweed Finder platform was established in 2017 to inform allergy sufferers and policymakers about ragweed distribution. This platform, available as a website and app, allows citizen-scientists to document ragweed populations. The reporting process involves completing a checklist, after which experts review the reports. Verified findings are collected and forwarded to the local authorities, who decide on further actions. Between 2017 and 2021, over 5000 reports were registered with a positivity rate of 91% resulting in the first legal regulation that deals with the control of ragweed in the federal state of Burgenland. The Ragweed Finder has since become the official reporting platform to enforce this law.