{"title":"Requirements for regulatory acceptance of biomarkers","authors":"Hilke Zander, Jörg Engelbergs","doi":"10.1007/s40629-024-00312-w","DOIUrl":"10.1007/s40629-024-00312-w","url":null,"abstract":"<p>Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit–risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVDR) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific–regulatory considerations in this complex regulatory field.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 8","pages":"309 - 312"},"PeriodicalIF":0.0,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00312-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142714360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nora Geissler, Erika Garner-Spitzer, Aleksandra Inic-Kanada, Daniela D. Pollak, Ursula Wiedermann
{"title":"Impact of obesity on allergic respiratory diseases and on mental and cognitive performance","authors":"Nora Geissler, Erika Garner-Spitzer, Aleksandra Inic-Kanada, Daniela D. Pollak, Ursula Wiedermann","doi":"10.1007/s40629-024-00308-6","DOIUrl":"10.1007/s40629-024-00308-6","url":null,"abstract":"<p>Obesity and allergies are among the most common diseases of our civilization. Given the simultaneous rise in the prevalence of these diseases in recent years, a potential causal link between the two has been proposed. In particular, obese patients are at an increased risk of developing bronchial asthma, likely due to mechanical restrictions but also to metabolic changes that adversely affect immune function. Neuroscience studies have also shown that obesity can lead to impaired brain function and mental health. In the following review, we will take a closer look at our studies that focus on the influence of obesity on allergic diseases and cognitive performance.</p><p>Both human studies and animal models (mice) have shown that obesity leads to increased allergic responses in the airways. Our studies in a mouse model of obesity confirm that an obese phenotype is associated with increased allergic sensitization and manifestation. These changes are associated with significant shifts in the composition of the gut microbial flora. The microbiome changes are further associated with allergic airway inflammation and an increased incidence of T helper 1 (Th1) type pulmonary macrophages. Interestingly, despite the changes in the microbiome, it is possible to effectively prevent allergy development by inducing oral tolerance. Furthermore, it was observed that obese mice show increased signs of anxiety and depression, as well as reduced cognitive performance.</p><p>Obesity is a complex metabolic disease that significantly impacts our body’s gut microbiome and immune system, resulting in an increased incidence of allergic asthma and neurological/psychological changes. Attention should be given to both the prophylactic and therapeutic measures to mitigate the impact of obesity, including oral tolerance for managing existing allergic diseases.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 7","pages":"247 - 251"},"PeriodicalIF":0.0,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00308-6.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142447335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"One health: the impact of environment, detergents and hygiene on barrier, microbiome and allergy","authors":"Hanna Mayerhofer, Isabella Pali-Schöll PhD","doi":"10.1007/s40629-024-00307-7","DOIUrl":"10.1007/s40629-024-00307-7","url":null,"abstract":"<p>A variety of body surfaces, such as skin and mucosal membranes—from the nasopharyngeal area to the lungs, uterus, vaginal area, and digestive tract—contain complex microbial ecosystems that are tailored to the specifics of the respective niche [1].</p><p>The so-called dysbiosis—a disadvantageous change in the composition of the microbiome—is associated with the pathogenesis of a variety of diseases [2]. Gastrointestinal as well as cardiovascular, metabolic, neurodegenerative, psychological, oncological, and also allergic diseases have been linked to microbial dysbiosis. Susceptibility to allergies can be due to genetic predisposition; in addition, extrinsic factors from today’s lifestyle increasingly contribute to microbiome changes, but also to the disruption of the skin and mucosal barrier and thus to the development of allergies [3].</p><p>Gisela, a fictional farmer, guides us through this review. She is representative of adults and children of all genders in industrialized countries. During her daily routine, the skin and mucosal microbiome is influenced by a variety of exogenous factors. These include everyday personal hygiene products, detergents for laundry and dishes, food, medication, animal contact, and exposure to various outdoor environments. Gisela’s daily routine will illustrate how the human microbiome and the skin barrier are modified in positive or negative ways, and how this could influence the development of allergies. Furthermore, potential measures for the prevention and management of dysbiosis will be discussed in terms of examples of alternative products and behaviors.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 7","pages":"252 - 262"},"PeriodicalIF":0.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00307-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142447408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Valentina Faihs, Johannes Ring, Knut Brockow, Kirsten Beyer, Ernst Rietschel, Sabine Schnadt, Britta Stöcker, Regina Treudler, Margitta Worm, Ludger Klimek
{"title":"Discharge management after anaphylaxis","authors":"Valentina Faihs, Johannes Ring, Knut Brockow, Kirsten Beyer, Ernst Rietschel, Sabine Schnadt, Britta Stöcker, Regina Treudler, Margitta Worm, Ludger Klimek","doi":"10.1007/s40629-024-00306-8","DOIUrl":"10.1007/s40629-024-00306-8","url":null,"abstract":"<div><p>People who have suffered from anaphylaxis often experience far-reaching consequences in everyday life. Unfortunately, discharge management after successful acute treatment is often still inadequate. In order to prevent further reactions in the future and improve the patient’s quality of life, there are several points that should be addressed or followed upon discharge from acute treatment. These include taking a detailed medical history to identify potential triggers, documenting the acute therapy, recommending further allergological assessment and prescribing an emergency kit for self-help including an adrenaline auto-injector—with education and practice on how to use it, including a written emergency plan. In addition, recommendations for avoiding potential triggers and information on patient organizations are helpful. This article aims to provide an up-to-date overview of discharge management after successful acute treatment of anaphylaxis. Remember: “After anaphylaxis also means potentially before the next anaphylaxis.”</p></div>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 8","pages":"275 - 281"},"PeriodicalIF":0.0,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00306-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142714438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The role of IgG1 and IgG4 as dominant IgE-blocking antibodies during allergen immunotherapy","authors":"Barbara Bohle PhD","doi":"10.1007/s40629-024-00309-5","DOIUrl":"10.1007/s40629-024-00309-5","url":null,"abstract":"<p>Allergen immunotherapy (AIT) is the only treatment that modifies the allergic response to allergens. One immune mechanism associated with a reduction in clinical symptoms is the induction of immunoglobulin E (IgE)-blocking antibodies. In particular, AIT-induced allergen-specific IgG4 antibodies were regarded a candidate biomarker for clinical efficacy. With the knowledge that not all AIT-induced allergen-specific IgG antibodies bear blocking bioactivity, different in vitro assays became popular to assess the blocking capacity of sera collected during and after AIT. Their measuring principles vary in the detection of the prevention of IgE-binding to allergen or of allergen interactions with IgE bound to high-affinity Fc epsilon receptors on the surface of effector cells. More recently, the contribution to IgE-blocking of other isotypes that arise in the course of AIT, e.g., IgG1 and IgA, was confirmed. The results indicated that different isotypes of allergen-specific antibodies serve as dominant IgE-blocking factors in the course of AIT.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 8","pages":"282 - 288"},"PeriodicalIF":0.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142714615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Abstracts of the 19th German Allergy Congress, Dresden, September 26–28, 2024","authors":"","doi":"10.1007/s40629-024-00305-9","DOIUrl":"10.1007/s40629-024-00305-9","url":null,"abstract":"","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 6","pages":"194 - 245"},"PeriodicalIF":0.0,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142414831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The maternal microbiome in normal pregnancy and at delivery by cesarean section and the early developmental phase of the neonatal microbiome—presentation of a longitudinal pilot study","authors":"Sonja Granser, Philipp Foessleitner BSc","doi":"10.1007/s40629-024-00303-x","DOIUrl":"10.1007/s40629-024-00303-x","url":null,"abstract":"<div><h3>Aim</h3><p>In this study by Foessleitner et al., both the maternal microbiome in the third trimester of pregnancy and the factors that influence the development of the child’s microbiome after cesarean delivery were investigated.</p><h3>Methods</h3><p>Maternal vaginal and rectal swabs were collected at inclusion in the last trimester of pregnancy and on the day of the cesarean section. In addition, placental and intrauterine swabs as well as infant dermal, buccal, and meconium swabs were taken during the cesarean section immediately after birth and subsequently on the second/third day of life. All samples were analyzed for microbial composition using 16s rRNA amplicon sequencing.</p><h3>Results</h3><p>A total of 30 mothers and their newborns were included in the study, with microbiome samples available for all maternal, intrauterine cavity, and placenta samples, as well as for 18 out of the 30 newborns. The vaginal and rectal microbiome was stable over the course of the third trimester and showed no significant changes (permutational multivariate analysis of variance [PERMANOVA]; <i>p</i> > 0.05). Both the intraoperative samples (placental, intrauterine) and the neonatal swabs at the time of birth were consistently sterile. However, rapid infant microbial colonization subsequently occurred, with neonatal buccal mucosa and stool samples showing significantly different microbial colonization from their mothers as early as the second/third day of life (PERMANOVA; <i>p</i> < 0.01).</p><h3>Conclusion</h3><p>The conclusion of the presented study was therefore that the vaginal and rectal microbiome of healthy pregnant women does not change in the last trimester, the infant and the placenta are not microbially colonized at the time of birth, and the development of the newborn’s microbiome after birth appears to be influenced mainly by environmental exposure.</p></div>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 7","pages":"269 - 273"},"PeriodicalIF":0.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00303-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142447347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An update on the clinical implications of the microbiome in the development of allergy diseases","authors":"Larissa Koidl, Eva Untersmayr","doi":"10.1007/s40629-024-00300-0","DOIUrl":"10.1007/s40629-024-00300-0","url":null,"abstract":"<p>This mini-review is an update on a previous review published in 2021 and aims to summarize recent findings on the influence of the microbiome on allergic diseases. We cover the topics of food allergy, airway allergies, and skin allergies with a particular focus on clinical implications. Articles published between January 2021 and March 2024 were screened to be included in this publication.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 7","pages":"263 - 268"},"PeriodicalIF":0.0,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00300-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141925178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zubair Khan, Jebin S Roger, P. Patil, Devasahayam J Christopher
{"title":"Prevalence of fungal sensitization and its association with clinical parameters of asthma—A longitudinal study in a tertiary care center in Tamil Nadu","authors":"Zubair Khan, Jebin S Roger, P. Patil, Devasahayam J Christopher","doi":"10.1007/s40629-024-00302-y","DOIUrl":"https://doi.org/10.1007/s40629-024-00302-y","url":null,"abstract":"","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"28 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141928039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clara Pignard, Hannah Schiller, Alisa Seyffer, Stefan Schülke PhD
{"title":"Mannan‑, VLP-, and flagellin-based adjuvants for allergen-specific immunotherapy: a review of the current literature","authors":"Clara Pignard, Hannah Schiller, Alisa Seyffer, Stefan Schülke PhD","doi":"10.1007/s40629-024-00298-5","DOIUrl":"10.1007/s40629-024-00298-5","url":null,"abstract":"<div><p>Currently, allergen-specific immunotherapy (AIT) with active ingredients derived from the causative allergen source is the only disease-modifying treatment for allergic patients. However, compared to, e.g., live-attenuated vaccines for the prevention of infectious diseases, purified allergens for AIT in many cases display only a low immunogenicity. This reduces treatment efficacy and prolongs treatment duration. Here, adjuvants may be a promising tool, allowing for dose reduction of the respective allergen while increasing immunogenicity of co-applied allergens and/or modulating allergen-specific immune responses toward T helper 1 (Th1) or regulatory phenotypes or the production of blocking antibody isotypes. Currently available adjuvants can be distinguished into first-generation adjuvants (promoting immune responses via aggregation and controlled release of co-applied allergens from a depot) and second-generation adjuvants (triggering immune responses via the activation of pattern recognition receptors expressed by immune cells). This review summarizes the mechanisms and effects of adjuvants currently or previously used for AIT (aluminum hydroxide, calcium phosphate, microcrystalline tyrosine, and monophosphoryl lipid A [MPLA]) and focuses on novel developments using mannan-, virus-like particle (VLP)-, and flagellin-based adjuvants and therapeutics for the treatment of allergic diseases.</p></div>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 8","pages":"289 - 303"},"PeriodicalIF":0.0,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00298-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141827171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}