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Requirements for regulatory acceptance of biomarkers 监管机构接受生物标记物的要求
Q3 Medicine Pub Date : 2024-10-17 DOI: 10.1007/s40629-024-00312-w
Hilke Zander, Jörg Engelbergs

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.

一般来说,生物标志物可以提高医药产品开发的成功率,从而加快新疗法的推出,改善获益与风险之间的关系。因此,基于预测性生物标记物的患者识别在所有治疗领域都变得越来越重要[1]。随着预测性生物标记物引导的个性化(精准)医疗的应用日益广泛,需要发现新型生物标记物作为生理病理状况的可测量指标[2]。生物标志物可用于诊断和预后、监测疾病进展,也可用于选择最有效的疗法和预测治疗结果[3, 4]。本文简要介绍了生物标记物的监管定义以及欧洲药品管理局(EMA)的生物标记物鉴定程序。随着形势的不断发展,关于体外医疗器械(IVDR)的新法规(欧盟)2017/746[5]对欧盟 IVD 法律框架引入了重要变化,特别是首次从法律上定义了 "辅助诊断 "设备(CDx)。本文强调了 CDx 和医药产品的代码开发所面临的挑战,为这一复杂的监管领域提供了科学监管方面的考虑因素。
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引用次数: 0
Impact of obesity on allergic respiratory diseases and on mental and cognitive performance 肥胖对过敏性呼吸道疾病以及智力和认知能力的影响
Q3 Medicine Pub Date : 2024-10-14 DOI: 10.1007/s40629-024-00308-6
Nora Geissler, Erika Garner-Spitzer, Aleksandra Inic-Kanada, Daniela D. Pollak,  Ursula Wiedermann

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.

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.

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.

肥胖症和过敏症是人类文明中最常见的疾病之一。鉴于近年来这两种疾病的发病率同时上升,有人提出这两者之间可能存在因果关系。特别是,肥胖患者患支气管哮喘的风险增加,这可能是由于机械性限制,也可能是由于新陈代谢的变化对免疫功能产生了不利影响。神经科学研究也表明,肥胖会导致大脑功能和心理健康受损。在下面的综述中,我们将仔细研究肥胖对过敏性疾病和认知能力的影响。人类研究和动物模型(小鼠)都表明,肥胖会导致气道过敏反应增加。我们在肥胖小鼠模型中的研究证实,肥胖表型与过敏敏感性和过敏表现的增加有关。这些变化与肠道微生物菌群组成的显著变化有关。微生物群的变化还与过敏性气道炎症和 T 辅助细胞 1(Th1)型肺巨噬细胞发病率增加有关。有趣的是,尽管微生物群发生了变化,但通过诱导口服耐受性仍可有效预防过敏的发生。此外,研究还发现,肥胖小鼠的焦虑和抑郁症状增加,认知能力下降。肥胖是一种复杂的代谢性疾病,会严重影响人体的肠道微生物组和免疫系统,导致过敏性哮喘发病率增加和神经/心理变化。应关注减轻肥胖影响的预防和治疗措施,包括管理现有过敏性疾病的口服耐受性。
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引用次数: 0
One health: the impact of environment, detergents and hygiene on barrier, microbiome and allergy 同一健康:环境、清洁剂和卫生对屏障、微生物群和过敏的影响
Q3 Medicine Pub Date : 2024-10-09 DOI: 10.1007/s40629-024-00307-7
Hanna Mayerhofer,  Isabella Pali-Schöll PhD

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].

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].

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.

从鼻咽部到肺部、子宫、阴道和消化道等各种体表,如皮肤和粘膜,都包含着复杂的微生物生态系统,这些生态系统是根据各自生态位的具体情况量身定制的[1]。所谓的菌群失调--微生物组成的不利变化--与多种疾病的发病机制有关[2]。胃肠道疾病、心血管疾病、新陈代谢疾病、神经退行性疾病、心理疾病、肿瘤疾病以及过敏性疾病都与微生物菌群失调有关。过敏症的易感性可能是遗传所致;此外,当今生活方式中的外在因素也越来越多地导致微生物群发生变化,同时也破坏了皮肤和粘膜屏障,从而导致过敏症的发生[3]。她是工业化国家所有性别的成人和儿童的代表。在她的日常生活中,皮肤和粘膜微生物群受到各种外源因素的影响。这些因素包括日常个人卫生用品、洗衣和洗碗用的洗涤剂、食物、药物、动物接触以及暴露于各种户外环境。吉塞拉的日常生活将说明人体微生物群和皮肤屏障是如何以积极或消极的方式发生改变的,以及这可能如何影响过敏症的发生。此外,还将通过替代产品和行为举例,讨论预防和管理菌群失调的潜在措施。
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引用次数: 0
Discharge management after anaphylaxis 过敏性休克后的出院管理
Q3 Medicine Pub Date : 2024-10-02 DOI: 10.1007/s40629-024-00306-8
Valentina Faihs,  Johannes Ring, Knut Brockow, Kirsten Beyer, Ernst Rietschel, Sabine Schnadt, Britta Stöcker, Regina Treudler, Margitta Worm, Ludger Klimek

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.”

过敏性休克患者通常会在日常生活中遭受深远的影响。遗憾的是,急性期治疗成功后的出院管理往往仍然不足。为了防止今后再次发生过敏反应并改善患者的生活质量,急性期治疗后出院时应注意或遵循以下几点。这些要点包括:详细询问病史以确定潜在的诱发因素;记录急性治疗过程;建议进一步进行过敏评估;开具包括肾上腺素自动注射器在内的自救应急包,并就如何使用该应急包进行教育和练习,包括书面应急计划。此外,避免潜在诱因的建议和患者组织信息也很有帮助。本文旨在提供过敏性休克急性期治疗成功后出院管理的最新概述。请记住:"过敏性休克发生后也意味着有可能在下一次过敏性休克发生之前"。
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引用次数: 0
The role of IgG1 and IgG4 as dominant IgE-blocking antibodies during allergen immunotherapy IgG1 和 IgG4 在过敏原免疫疗法中作为主要 IgE 阻断抗体的作用
Q3 Medicine Pub Date : 2024-09-30 DOI: 10.1007/s40629-024-00309-5
Barbara Bohle PhD

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.

过敏原免疫疗法(AIT)是唯一能改变对过敏原过敏反应的治疗方法。与临床症状减轻相关的一种免疫机制是诱导免疫球蛋白 E(IgE)阻断抗体。其中,AIT 诱导的过敏原特异性 IgG4 抗体被认为是临床疗效的候选生物标志物。由于知道并非所有 AIT 诱导的过敏原特异性 IgG 抗体都具有阻断生物活性,因此流行采用不同的体外检测方法来评估 AIT 期间和之后收集的血清的阻断能力。它们的测量原理各不相同,都是检测是否阻止了 IgE 与过敏原的结合或过敏原与效应细胞表面高亲和力 Fc epsilon 受体结合的 IgE 的相互作用。最近,在 AIT 过程中出现的其他异型(如 IgG1 和 IgA)对 IgE 阻断作用的贡献也得到了证实。结果表明,过敏原特异性抗体的不同异型是 AIT 过程中的主要 IgE 阻断因子。
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引用次数: 0
Abstracts of the 19th German Allergy Congress, Dresden, September 26–28, 2024 第 19 届德国过敏大会摘要,德累斯顿,2024 年 9 月 26-28 日
Q3 Medicine Pub Date : 2024-08-29 DOI: 10.1007/s40629-024-00305-9
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引用次数: 0
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 正常妊娠和剖宫产时的母体微生物群与新生儿微生物群的早期发育阶段--一项纵向试点研究的结果
Q3 Medicine Pub Date : 2024-08-22 DOI: 10.1007/s40629-024-00303-x
Sonja Granser,  Philipp Foessleitner BSc

Aim

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.

Methods

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.

Results

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]; p > 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; p < 0.01).

Conclusion

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.

目的 在 Foessleitner 等人的这项研究中,对妊娠三个月的母体微生物组和影响剖宫产后婴儿微生物组发育的因素进行了调查。方法 在妊娠最后三个月和剖宫产当天采集母体阴道拭子和直肠拭子。此外,还在婴儿出生后立即进行剖宫产时以及出生后第二/第三天采集了胎盘拭子、宫内拭子以及婴儿皮肤拭子、口腔拭子和蜕膜拭子。所有样本均采用 16s rRNA 扩增子测序法分析微生物组成。结果 共有 30 位母亲及其新生儿参与了这项研究,所有母体、宫腔内和胎盘样本以及 30 位新生儿中的 18 位都获得了微生物组样本。阴道和直肠微生物组在妊娠三个月期间保持稳定,没有发生显著变化(包络多变量方差分析 [PERMANOVA];p >;0.05)。术中样本(胎盘、宫内)和新生儿出生时的拭子均始终无菌。然而,婴儿的微生物定植随后迅速发生,新生儿口腔粘膜和粪便样本显示,早在出生后的第二/第三天,其微生物定植就与母亲有显著差异(PERMANOVA;p <;0.01)。结论因此,本研究的结论是:健康孕妇的阴道和直肠微生物群在最后三个月不会发生变化,婴儿和胎盘在出生时没有微生物定植,新生儿出生后微生物群的发展似乎主要受环境暴露的影响。
{"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,&nbsp; 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> &gt; 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> &lt; 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}
引用次数: 0
An update on the clinical implications of the microbiome in the development of allergy diseases 微生物组对过敏性疾病发生的临床影响的最新进展
Q3 Medicine Pub Date : 2024-08-09 DOI: 10.1007/s40629-024-00300-0
Larissa Koidl,  Eva Untersmayr

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.

这篇微型综述是对 2021 年发表的上一篇综述的更新,旨在总结微生物组对过敏性疾病影响的最新发现。我们涵盖了食物过敏、气道过敏和皮肤过敏等主题,并特别关注其临床意义。本刊物筛选了 2021 年 1 月至 2024 年 3 月间发表的文章。
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引用次数: 0
Prevalence of fungal sensitization and its association with clinical parameters of asthma—A longitudinal study in a tertiary care center in Tamil Nadu 泰米尔纳德邦一家三级医疗中心的真菌过敏流行率及其与哮喘临床参数的关系--纵向研究
Q3 Medicine Pub Date : 2024-08-08 DOI: 10.1007/s40629-024-00302-y
Zubair Khan, Jebin S Roger, P. Patil, Devasahayam J Christopher
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引用次数: 0
Mannan‑, VLP-, and flagellin-based adjuvants for allergen-specific immunotherapy: a review of the current literature 基于曼南、VLP 和鞭毛蛋白的过敏原特异性免疫疗法佐剂:现有文献综述
Q3 Medicine Pub Date : 2024-07-18 DOI: 10.1007/s40629-024-00298-5
Clara Pignard, Hannah Schiller, Alisa Seyffer, Stefan Schülke PhD

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.

目前,过敏原特异性免疫疗法(AIT)的有效成分来自致病过敏原,是过敏症患者唯一可改变病情的治疗方法。然而,与用于预防传染病的减毒活疫苗等相比,用于 AIT 的纯化过敏原在许多情况下仅显示出较低的免疫原性。这就降低了治疗效果,延长了治疗时间。在这种情况下,佐剂可能是一种很有前途的工具,它可以减少相应过敏原的剂量,同时提高共同应用的过敏原的免疫原性和/或调节过敏原特异性免疫反应,使其趋向于 T 辅助细胞 1 (Th1) 或调节表型,或产生阻断抗体异型。目前可用的佐剂可分为第一代佐剂(通过聚集和控制共同应用的过敏原从仓库中释放来促进免疫反应)和第二代佐剂(通过激活免疫细胞表达的模式识别受体来触发免疫反应)。本综述总结了目前或以前用于 AIT 的佐剂(氢氧化铝、磷酸钙、微晶酪氨酸和单磷脂 A [MPLA])的机制和效果,并重点介绍了利用甘露聚糖、病毒样颗粒 (VLP) 和鞭毛蛋白佐剂和疗法治疗过敏性疾病的新进展。
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引用次数: 0
期刊
Allergo Journal International
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