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Allergic Sensitization to Inhalant Allergens in the Upper Respiratory Tract-the B Cell Side. 上呼吸道吸入性过敏原的过敏致敏- B细胞侧。
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-23 DOI: 10.1111/all.70229
Ola Grimsholm,Mohammed Zghaebi,Bita Hambrecht,Tanja Kalic,Christopher C Udoye,Rudolf Manz,Barbara Bohle,Katarzyna M Sitnik,Julia Eckl-Dorna,Heimo Breiteneder
Allergic diseases are on the rise worldwide, driven by respiratory epithelial barrier dysfunction that promotes sensitization to inhalant allergens such as pollen, dust mites, pet dander, and fungal spores. These antigens trigger IgE-mediated immune responses that lead to diseases such as allergic rhinitis (AR) and asthma. B cells play a central role by producing allergen-specific IgE, presenting antigens, releasing cytokines, and forming memory B cells (MBCs). Their differentiation into IgE-secreting plasma cells (PCs) mainly relies on T cell help, germinal center (GC) reactions, and/or extrafollicular responses and class switch recombination (CSR), which makes them important therapeutic targets. The nasal mucosa, as the first point of contact for allergens, acts both as a barrier and as an immunological site. In AR, IL-13-driven goblet cell hyperplasia and overproduction of mucus compromise the integrity of the barrier. Although the nasal microbiome can influence the immune response, its role in atopy remains unclear. Local B cell activity, including extrafollicular IgE production and ectopic GCs, enhances mucosal immunity. Epithelial cells detect allergens via pattern recognition receptors (PRRs) and release alarmins (IL-25, IL-33, TSLP), which can trigger type 2 inflammation. Proteases from allergens such as house dust mites (HDM) disrupt epithelial junctions, while pollutants, smoke, microplastics, and allergen-derived metabolites further modulate immune activation. Allergens are transported to the lymph nodes by the passive flow to follicular dendritic cells (FDCs) or by active uptake by interferon regulatory factor (IRF) 4-dependent conventional type 2 DCs, which activate T follicular helper (TFH) cells to drive IgE responses. Advanced lymphoid organoids that mimic the microenvironment of GCs offer promising models for the study of allergic sensitization but require improved standardization.
过敏性疾病在世界范围内呈上升趋势,这是由呼吸道上皮屏障功能障碍引起的,它促进了对吸入性过敏原(如花粉、尘螨、宠物皮屑和真菌孢子)的致敏。这些抗原触发ige介导的免疫反应,导致过敏性鼻炎(AR)和哮喘等疾病。B细胞通过产生过敏原特异性IgE、呈递抗原、释放细胞因子和形成记忆B细胞(MBCs)发挥核心作用。它们向ige分泌浆细胞(PCs)的分化主要依赖于T细胞帮助、生发中心(GC)反应和/或滤泡外反应和类开关重组(CSR),这使它们成为重要的治疗靶点。鼻黏膜作为过敏原的第一个接触点,既是屏障又是免疫部位。在AR中,il -13驱动的杯状细胞增生和粘液的过量产生损害了屏障的完整性。虽然鼻腔微生物组可以影响免疫反应,但其在特应性反应中的作用尚不清楚。局部B细胞活性,包括滤泡外IgE产生和异位GCs,增强粘膜免疫。上皮细胞通过模式识别受体(PRRs)检测过敏原并释放警报器(IL-25、IL-33、TSLP),从而引发2型炎症。来自屋尘螨(HDM)等过敏原的蛋白酶破坏上皮连接,而污染物、烟雾、微塑料和过敏原衍生的代谢物进一步调节免疫激活。过敏原通过被动流向滤泡树突状细胞(fdc)或通过干扰素调节因子(IRF) 4依赖的传统2型树突状细胞的主动摄取被转运到淋巴结,后者激活T滤泡辅助细胞(TFH)来驱动IgE反应。模拟GCs微环境的高级淋巴样器官为研究过敏性致敏提供了有希望的模型,但需要改进标准化。
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引用次数: 0
Targeting Immunologic Pathways in Eosinophilic Granulomatosis With Polyangiitis: Translating Emerging Evidence Into Clinical Practice. 嗜酸性肉芽肿伴多血管炎的靶向免疫途径:将新出现的证据转化为临床实践。
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-23 DOI: 10.1111/all.70215
Harold Wilson-Morkeh,Lior Seluk,Philipp Bosch,Carolina Aguiar,Jens Thiel,Bernhard Hellmich,Michael E Wechsler,Salman Siddiqui
Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare and potentially life-threatening systemic, inflammatory disease with multi-organ manifestations, variable presentation and complex pathology. Multiple interconnected immunological pathways are implicated in EGPA pathology, including a type-2 immune response driving predominantly eosinophilic inflammation, B-cell mediated autoimmunity, neutrophil activation, and the generation of pathogenic anti-neutrophil cytoplasmic antibodies, all of which can contribute to tissue/organ damage. High-dose glucocorticoids are the mainstay treatment for EGPA, but over the past two decades the development of biologic treatments targeting interleukin (IL)-5, eosinophils and B-cells has revitalized the treatment landscape. Mepolizumab, a humanized monoclonal antibody that specifically targets IL-5, and benralizumab, which targets the IL-5 receptor (IL-5Rα), are both approved for the treatment of patients with non-severe relapsing or refractory EGPA. In Phase III trials, these biologics have demonstrated favorable safety profiles and efficacy, with treatment leading to remission induction, remission maintenance, and oral glucocorticoid sparing benefits. However, as understanding of the full complexity of EGPA pathogenesis improves, new treatment targets are emerging. Consequently, understanding key pathogenic mechanisms at the patient level, enabling a more tailored treatment approach, is an important goal for future research.
嗜酸性肉芽肿病合并多血管炎(EGPA)是一种罕见且可能危及生命的全身性炎症性疾病,具有多器官表现、多变的表现和复杂的病理。多种相互关联的免疫途径与EGPA病理有关,包括2型免疫反应,主要驱动嗜酸性粒细胞炎症,b细胞介导的自身免疫,中性粒细胞活化和致病性抗中性粒细胞细胞质抗体的产生,所有这些都可能导致组织/器官损伤。高剂量糖皮质激素是EGPA的主要治疗方法,但在过去二十年中,针对白细胞介素(IL)-5、嗜酸性粒细胞和b细胞的生物治疗的发展使治疗领域重新焕发活力。Mepolizumab是一种特异性靶向IL-5的人源化单克隆抗体,而benralizumab是靶向IL-5受体(IL-5Rα)的,两者都被批准用于治疗非严重复发或难治性EGPA患者。在III期试验中,这些生物制剂已显示出良好的安全性和有效性,治疗可诱导缓解,维持缓解,并可节省口服糖皮质激素。然而,随着对EGPA发病机制的全面复杂性的了解的提高,新的治疗靶点正在出现。因此,了解患者水平的关键致病机制,使更有针对性的治疗方法,是未来研究的重要目标。
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引用次数: 0
An Old Story Back: Human Milk Antibodies' Protective Roles Against Allergy Development. 一个古老的故事:人乳抗体对过敏发展的保护作用。
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-22 DOI: 10.1111/all.70218
Courtney M Jackson,Maria Carmen Collado,David C Dallas,Richard A Insel,Andrew J Macpherson,Debra J Palmer,Antti E Seppo,Valerie Verhasselt,Kirsi M Järvinen
Human milk is a rich source of immunomodulatory factors that influence the development of the infant immune system, including susceptibility to allergic diseases. Among these components, milk antibodies have been extensively studied for their role in protecting against infections; however, their potential contribution to allergy prevention may be equally important. The mechanisms of protection include allergen exclusion, enhanced and targeted antigen presentation, immune modulation via shaping of the infant gut microbiome, and direct regulation of gut immune responses. This review summarizes current evidence on the secretion of human milk antibodies, highlights what is known and what remains unclear about their role in allergy prevention and outlines the need for further research to develop antibody-based strategies for early allergy prevention.
母乳是影响婴儿免疫系统发育的免疫调节因子的丰富来源,包括对过敏性疾病的易感性。在这些成分中,牛奶抗体因其在预防感染方面的作用而被广泛研究;然而,它们对预防过敏的潜在贡献可能同样重要。保护机制包括过敏原排斥,增强和靶向抗原呈递,通过塑造婴儿肠道微生物组进行免疫调节,以及直接调节肠道免疫反应。这篇综述总结了目前关于人乳抗体分泌的证据,强调了它们在过敏预防中的已知和不清楚的作用,并概述了进一步研究开发基于抗体的早期过敏预防策略的必要性。
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引用次数: 0
Maternal Opioid Use and Subsequent Risk of Allergic Diseases in Children: Emulation of Target Trials Using the Korean Nationwide Birth Cohort. 儿童中母亲阿片类药物的使用和随后的过敏性疾病风险:韩国全国出生队列目标试验的模拟
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-22 DOI: 10.1111/all.70231
Hyeon Jin Kim,Yesol Yim,Christa J Nehs,Jaeyu Park,Sunyoung Kim,Nikolaos G Papadopoulos,Jiseung Kang,Dong Keon Yon
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引用次数: 0
Comparative Transcriptomic Analysis of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Using Nasal Tissue and Brushing Samples. 使用鼻腔组织和刷牙样本对嗜酸性慢性鼻窦炎合并鼻息肉(CRSwNP)进行比较转录组学分析。
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-21 DOI: 10.1111/all.70227
Daiki Nakashima,Tomomitsu Hirota,Natsuki Inoue,Mamoru Yoshikawa,Eri Mori,Nobuyoshi Otori,Hiromi Kojima,Yohei Sato,Hideaki Morita,Tsuguhisa Nakayama,Mayumi Tamari
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引用次数: 0
Medical Algorithm: Personalized Immunoglobulin Replacement Therapy for Inborn Errors of Immunity. 医学算法:针对先天免疫缺陷的个性化免疫球蛋白替代疗法。
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-21 DOI: 10.1111/all.70223
Melek Yorgun Altunbas,Cevdet Özdemir,Elif Karakoc-Aydiner
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引用次数: 0
Efficacy and Safety of Ligelizumab in Individuals With Confirmed Peanut Allergy. 利利珠单抗在花生过敏患者中的疗效和安全性。
IF 12 1区 医学 Q1 ALLERGY Pub Date : 2026-01-20 DOI: 10.1111/all.70206
Philippe Bégin, Motohiro Ebisawa, Antonella Muraro, Gideon Lack, Matthew Greenhawt, Rima Rachid, Brian P Vickery, Aikaterini Anagnostou, Jeffrey Leflein, Kirsten P Perrett, Ivan Bottoli, Benjamin Ortiz, Motoi Hosoe, Eva Schlosser, Wei Wang, Munir Winkel, Aurelie Gautier, Kari C Nadeau

Background: The growing burden of food allergy globally has been accompanied by increasing demand for effective treatments. Ligelizumab is a humanised anti-IgE monoclonal antibody that can strongly inhibit allergic pathways. This phase 3 study evaluated the efficacy and safety of ligelizumab in participants with confirmed IgE-mediated peanut allergy.

Methods: This was a 52-week, multicentre, randomised, double-blind, placebo-controlled study in adults and adolescents with confirmed peanut allergy. Participants received either ligelizumab 120 mg or 240 mg or placebo subcutaneously every 4 weeks. The primary endpoint was the proportion of participants tolerating ≥ 600 mg of peanut protein without dose-limiting symptoms during a double-blind, placebo-controlled, food challenge at week 12. Secondary endpoints included tolerance to higher doses of peanut protein. However, the study was terminated early due to evidence from blinded data reviews that the target efficacy would not be met. All participants enrolled at the time of termination could complete week 12 assessments.

Results: The primary endpoint was met in the ligelizumab 240 mg treatment arm, with 44.7% (21/47) of participants tolerating ≥ 600 mg of peanut protein versus 4.3% (1/23) for placebo. Numerically higher efficacy was observed in the ligelizumab 120 mg treatment arm (15.7% [8/51]) versus placebo. Positive dose-dependent trends were observed across the key secondary endpoints, but statistical significance, per the pre-planned testing strategy, was not achieved. Safety profiles were consistent with known data, with no new safety signals observed.

Conclusions: Ligelizumab 240 mg demonstrated clinical superiority over placebo, with favourable tolerability, in treating IgE-mediated peanut allergy, despite early termination of the study.

背景:全球食物过敏负担的增加伴随着对有效治疗的需求的增加。利格单抗是一种人源化抗ige单克隆抗体,能强烈抑制过敏途径。这项3期研究评估了利格利单抗在确诊ige介导的花生过敏患者中的疗效和安全性。方法:这是一项为期52周、多中心、随机、双盲、安慰剂对照的研究,研究对象是确诊花生过敏的成人和青少年。参与者每4周皮下注射120mg或240mg利利单抗或安慰剂。主要终点是在第12周的双盲、安慰剂对照、食物挑战期间耐受≥600mg花生蛋白且无剂量限制性症状的参与者比例。次要终点包括对高剂量花生蛋白的耐受性。然而,由于来自盲法数据审查的证据表明无法达到目标疗效,该研究被提前终止。所有在终止时登记的参与者都可以完成第12周的评估。结果:利利珠单抗240mg治疗组达到了主要终点,44.7%(21/47)的参与者耐受≥600mg花生蛋白,而安慰剂组为4.3%(1/23)。在数值上,利利珠单抗120mg治疗组与安慰剂组相比疗效更高(15.7%[8/51])。在关键次要终点均观察到正剂量依赖趋势,但根据预先计划的测试策略,未达到统计学显著性。安全概况与已知数据一致,未观察到新的安全信号。结论:尽管研究提前终止,但240mg利利珠单抗在治疗ige介导的花生过敏方面表现出优于安慰剂的临床优势,具有良好的耐受性。
{"title":"Efficacy and Safety of Ligelizumab in Individuals With Confirmed Peanut Allergy.","authors":"Philippe Bégin, Motohiro Ebisawa, Antonella Muraro, Gideon Lack, Matthew Greenhawt, Rima Rachid, Brian P Vickery, Aikaterini Anagnostou, Jeffrey Leflein, Kirsten P Perrett, Ivan Bottoli, Benjamin Ortiz, Motoi Hosoe, Eva Schlosser, Wei Wang, Munir Winkel, Aurelie Gautier, Kari C Nadeau","doi":"10.1111/all.70206","DOIUrl":"https://doi.org/10.1111/all.70206","url":null,"abstract":"<p><strong>Background: </strong>The growing burden of food allergy globally has been accompanied by increasing demand for effective treatments. Ligelizumab is a humanised anti-IgE monoclonal antibody that can strongly inhibit allergic pathways. This phase 3 study evaluated the efficacy and safety of ligelizumab in participants with confirmed IgE-mediated peanut allergy.</p><p><strong>Methods: </strong>This was a 52-week, multicentre, randomised, double-blind, placebo-controlled study in adults and adolescents with confirmed peanut allergy. Participants received either ligelizumab 120 mg or 240 mg or placebo subcutaneously every 4 weeks. The primary endpoint was the proportion of participants tolerating ≥ 600 mg of peanut protein without dose-limiting symptoms during a double-blind, placebo-controlled, food challenge at week 12. Secondary endpoints included tolerance to higher doses of peanut protein. However, the study was terminated early due to evidence from blinded data reviews that the target efficacy would not be met. All participants enrolled at the time of termination could complete week 12 assessments.</p><p><strong>Results: </strong>The primary endpoint was met in the ligelizumab 240 mg treatment arm, with 44.7% (21/47) of participants tolerating ≥ 600 mg of peanut protein versus 4.3% (1/23) for placebo. Numerically higher efficacy was observed in the ligelizumab 120 mg treatment arm (15.7% [8/51]) versus placebo. Positive dose-dependent trends were observed across the key secondary endpoints, but statistical significance, per the pre-planned testing strategy, was not achieved. Safety profiles were consistent with known data, with no new safety signals observed.</p><p><strong>Conclusions: </strong>Ligelizumab 240 mg demonstrated clinical superiority over placebo, with favourable tolerability, in treating IgE-mediated peanut allergy, despite early termination of the study.</p>","PeriodicalId":122,"journal":{"name":"Allergy","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146002751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of Betalactam-Predictor: A Clinical Decision Tool for Delabeling Low-Risk Betalactam Allergy Patients. Initial Validation in Penicillin Allergy. 贝他坦预测器的开发:对低风险贝他坦过敏患者去标签的临床决策工具。青霉素过敏的初步验证。
IF 12.4 1区 医学 Q1 ALLERGY Pub Date : 2026-01-19 DOI: 10.1111/all.70222
Marina Labella,Rafael Nuñez,Inmaculada Doña,Julia Rodríguez de Guzmán,Esther Moreno,Lene Heise Garvey,Jose Julio Laguna,Annick Barbaud,Patrizia Bonnadona,Jonas Bredtoft Boel,Holger Mosbech,Giovanna Sfriso,Mariana Castells,Elizabeth Phillips,María José Torres
BACKGROUNDA label of betalactam (BL) allergy is estimated in around 10% of the population in their medical records. Second-line choices carry significant negative consequences, including reduced efficacy, effectiveness, and safety. This study aimed to develop a new highly specific score constructed by selecting variables assisted by artificial intelligence to identify low-risk BL-allergic patients.METHODSIn this study, derivation and validation of the BL-predictor score were performed on a retrospective cohort of 2207 patients who underwent penicillin allergy testing at Málaga University Hospital (Spain). The development of the BL-predictor encompassed expert drafting and a two-step variable selection process consisting of univariate analysis and variable filtering, followed by stepwise logistic regression with resampling. To assess the efficiency, a multicentric retrospective external validation was performed in 4261 patients from six populations: Salamanca and Madrid, Spain; Nashville, United States of America; Verona, Italy; Paris, France; and Copenhagen, Denmark.RESULTSThe definitive questionnaire consisted of eight items and risk points were computed from the logistic regression model as follows: +1 for reactions after first dose or in less than 1 h (ITEM-1), +2 for anaphylaxis (ITEM-2); +1 for previous reaction with the culprit (ITEM-3); -1 for resolution in > 24 h (ITEM-4); +2 for spontaneous resolution (ITEM-5); -2 for unknown symptoms (ITEM-6); -2 for reaction occurred > 5 years (ITEM-7), and -1 for another reported drug allergy (ITEM-8). After establishing a threshold of ≤ 0 points to classify individuals with low risk, internal validation showed a specificity of 86% and a negative predictive value (NPV) of 83%. Overall multicenter external validation showed a specificity of 93%, which implies a 25% increase in specificity compared to the previously published BL decision tool.CONCLUSIONThis score would simplify diagnostic procedures in low-risk patients, enabling rapid delabeling, potentially in non-specialty settings, and reducing diagnostic costs and the negative consequences associated with incorrect antibiotic allergy labels.
背景:在医疗记录中,估计约有10%的人患有倍他坦(BL)过敏。二线选择会带来显著的负面影响,包括降低疗效、有效性和安全性。本研究旨在通过人工智能辅助变量的选择,建立一个新的高度特异性评分,以识别低风险的bl过敏患者。方法在本研究中,对在Málaga大学医院(西班牙)接受青霉素过敏试验的2207例患者进行回顾性队列研究,推导并验证了bl预测评分。bl预测器的开发包括专家起草和由单变量分析和变量过滤组成的两步变量选择过程,然后是带重采样的逐步逻辑回归。为了评估有效性,对来自6个人群的4261名患者进行了多中心回顾性外部验证:西班牙的萨拉曼卡和马德里;美利坚合众国纳什维尔;意大利维罗纳;法国巴黎;以及丹麦的哥本哈根。结果最终问卷由8个项目组成,根据logistic回归模型计算风险点如下:首次给药后或小于1 h的反应+1 (ITEM-1),过敏反应+2 (ITEM-2);与肇事者之前的反应+1(项目3);-1表示> 24 h的分辨率(ITEM-4);自发分解+2 (ITEM-5);-2为未知症状(项目6);-2表示在50年以内发生反应(ITEM-7), -1表示另一种药物过敏(ITEM-8)。在建立≤0分的阈值对低风险个体进行分类后,内部验证显示特异性为86%,阴性预测值(NPV)为83%。整体多中心外部验证显示特异性为93%,这意味着与先前发表的BL决策工具相比,特异性提高了25%。结论该评分将简化低风险患者的诊断程序,实现快速去除标签,可能在非专业设置,并降低诊断成本和与不正确的抗生素过敏标签相关的负面后果。
{"title":"Development of Betalactam-Predictor: A Clinical Decision Tool for Delabeling Low-Risk Betalactam Allergy Patients. Initial Validation in Penicillin Allergy.","authors":"Marina Labella,Rafael Nuñez,Inmaculada Doña,Julia Rodríguez de Guzmán,Esther Moreno,Lene Heise Garvey,Jose Julio Laguna,Annick Barbaud,Patrizia Bonnadona,Jonas Bredtoft Boel,Holger Mosbech,Giovanna Sfriso,Mariana Castells,Elizabeth Phillips,María José Torres","doi":"10.1111/all.70222","DOIUrl":"https://doi.org/10.1111/all.70222","url":null,"abstract":"BACKGROUNDA label of betalactam (BL) allergy is estimated in around 10% of the population in their medical records. Second-line choices carry significant negative consequences, including reduced efficacy, effectiveness, and safety. This study aimed to develop a new highly specific score constructed by selecting variables assisted by artificial intelligence to identify low-risk BL-allergic patients.METHODSIn this study, derivation and validation of the BL-predictor score were performed on a retrospective cohort of 2207 patients who underwent penicillin allergy testing at Málaga University Hospital (Spain). The development of the BL-predictor encompassed expert drafting and a two-step variable selection process consisting of univariate analysis and variable filtering, followed by stepwise logistic regression with resampling. To assess the efficiency, a multicentric retrospective external validation was performed in 4261 patients from six populations: Salamanca and Madrid, Spain; Nashville, United States of America; Verona, Italy; Paris, France; and Copenhagen, Denmark.RESULTSThe definitive questionnaire consisted of eight items and risk points were computed from the logistic regression model as follows: +1 for reactions after first dose or in less than 1 h (ITEM-1), +2 for anaphylaxis (ITEM-2); +1 for previous reaction with the culprit (ITEM-3); -1 for resolution in > 24 h (ITEM-4); +2 for spontaneous resolution (ITEM-5); -2 for unknown symptoms (ITEM-6); -2 for reaction occurred > 5 years (ITEM-7), and -1 for another reported drug allergy (ITEM-8). After establishing a threshold of ≤ 0 points to classify individuals with low risk, internal validation showed a specificity of 86% and a negative predictive value (NPV) of 83%. Overall multicenter external validation showed a specificity of 93%, which implies a 25% increase in specificity compared to the previously published BL decision tool.CONCLUSIONThis score would simplify diagnostic procedures in low-risk patients, enabling rapid delabeling, potentially in non-specialty settings, and reducing diagnostic costs and the negative consequences associated with incorrect antibiotic allergy labels.","PeriodicalId":122,"journal":{"name":"Allergy","volume":"1 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145994796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Omalizumab Dose-Related Efficacy in a Cohort of Children With Severe Food Allergy: OSAFA Observational Study. Omalizumab在严重食物过敏儿童队列中的剂量相关疗效:OSAFA观察性研究
IF 12 1区 医学 Q1 ALLERGY Pub Date : 2026-01-19 DOI: 10.1111/all.70228
Stefania Arasi, Carol Bitetti, Lucia Lo Scalzo, Alessandra Spagnoli, Elena Fabrizi, Alessandro Fiocchi, Arianna Cafarotti

Background: We recently published on the clinical efficacy of a 1-year-long evaluation of 65 asthmatics with severe IgE-mediated food allergy (FA) under Omalizumab: Omalizumab is safe and able to increase reactivity threshold, allows safe food introduction, and improves quality of life (OSAFA-study, ClinicalTrials.gov, NCT06316414). Herein, we assess Omalizumab dose-related efficacy during the first year Omalizumab treatment in achieving food desensitization in patients with severe FA.

Methods: Children (6-18 years) with severe asthma and severe allergy to ≥ 1 food allergen were screened. Oral food challenges (OFCs), skin prick test (SPT), complete blood count, chemistry, total and specific IgE were measured at baseline and at 12 months of Omalizumab.

Results: Seventy-six patients (previously published cohort plus 11 newly-enrolled patients) were included (OSAFA [Omalizumab in Severe Asthmatics with Food Allergy] study). 69.7% were male; mean age (SD) 12.2 [4.19] years. 77.6% were allergic to 2+ foods. Total IgE median was 644 kU/L. After adjusting for confounders, such as age, sex, and co-existing allergies, a significant association was observed between the achievement of desensitization and the dosage (mg/month) of Omalizumab (OR: 1.151, 95% CI: 1.066-1.258), while no significant effect was observed for total IgE levels at the baseline (OR: 0.999, 95% CI: 0.998-1.001).

Conclusions: The findings of this study indicate that the efficacy of Omalizumab is independent, all else being equal, from total IgE levels, suggesting that body weight is the most appropriate parameter for calculating its dosage in the treatment of patients with severe FA.

背景:我们最近发表了一项为期1年的评估,对65名患有严重ige介导的食物过敏(FA)的哮喘患者使用Omalizumab的临床疗效:Omalizumab是安全的,能够提高反应性阈值,允许安全的食物引入,并改善生活质量(OSAFA-study, ClinicalTrials.gov, NCT06316414)。在此,我们评估了Omalizumab治疗第一年实现严重FA患者食物脱敏的剂量相关疗效。方法:筛选对≥1种食物过敏原有严重哮喘和严重过敏的6 ~ 18岁儿童。口服食物挑战(OFCs)、皮肤点刺试验(SPT)、全血细胞计数、化学、总IgE和特异性IgE在基线和奥玛单抗12个月时进行测量。结果:76例患者(先前发表的队列加上11例新入组患者)被纳入(OSAFA [Omalizumab治疗伴有食物过敏的严重哮喘患者]研究)。69.7%为男性;平均年龄(SD) 12.2[4.19]岁。77.6%对2种以上食物过敏。总IgE中位数为644 kU/L。在调整混杂因素(如年龄、性别和共存的过敏)后,观察到脱敏效果与Omalizumab剂量(mg/月)之间存在显著关联(OR: 1.151, 95% CI: 1.066-1.258),而基线时的总IgE水平未观察到显著影响(OR: 0.999, 95% CI: 0.998-1.001)。结论:本研究结果表明,在其他条件相同的情况下,Omalizumab的疗效与总IgE水平是独立的,这表明体重是计算其治疗严重FA患者剂量的最合适参数。
{"title":"Omalizumab Dose-Related Efficacy in a Cohort of Children With Severe Food Allergy: OSAFA Observational Study.","authors":"Stefania Arasi, Carol Bitetti, Lucia Lo Scalzo, Alessandra Spagnoli, Elena Fabrizi, Alessandro Fiocchi, Arianna Cafarotti","doi":"10.1111/all.70228","DOIUrl":"10.1111/all.70228","url":null,"abstract":"<p><strong>Background: </strong>We recently published on the clinical efficacy of a 1-year-long evaluation of 65 asthmatics with severe IgE-mediated food allergy (FA) under Omalizumab: Omalizumab is safe and able to increase reactivity threshold, allows safe food introduction, and improves quality of life (OSAFA-study, ClinicalTrials.gov, NCT06316414). Herein, we assess Omalizumab dose-related efficacy during the first year Omalizumab treatment in achieving food desensitization in patients with severe FA.</p><p><strong>Methods: </strong>Children (6-18 years) with severe asthma and severe allergy to ≥ 1 food allergen were screened. Oral food challenges (OFCs), skin prick test (SPT), complete blood count, chemistry, total and specific IgE were measured at baseline and at 12 months of Omalizumab.</p><p><strong>Results: </strong>Seventy-six patients (previously published cohort plus 11 newly-enrolled patients) were included (OSAFA [Omalizumab in Severe Asthmatics with Food Allergy] study). 69.7% were male; mean age (SD) 12.2 [4.19] years. 77.6% were allergic to 2+ foods. Total IgE median was 644 kU/L. After adjusting for confounders, such as age, sex, and co-existing allergies, a significant association was observed between the achievement of desensitization and the dosage (mg/month) of Omalizumab (OR: 1.151, 95% CI: 1.066-1.258), while no significant effect was observed for total IgE levels at the baseline (OR: 0.999, 95% CI: 0.998-1.001).</p><p><strong>Conclusions: </strong>The findings of this study indicate that the efficacy of Omalizumab is independent, all else being equal, from total IgE levels, suggesting that body weight is the most appropriate parameter for calculating its dosage in the treatment of patients with severe FA.</p>","PeriodicalId":122,"journal":{"name":"Allergy","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146002780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multi-Omics-Based Biological Mechanisms for Childhood Allergen Sensitization Trajectories: COCOA Study. 儿童过敏原致敏轨迹的多组学生物学机制:COCOA研究。
IF 12 1区 医学 Q1 ALLERGY Pub Date : 2026-01-19 DOI: 10.1111/all.70230
Hea Young Oh, Eun Lee, Jeonghun Yeom, Hyun Ju Yoo, Seung Hwa Lee, So-Yeon Lee, Hyo-Bin Kim, Song-I Yang, Da Kyeong Lee, Jisun Yoon, Eom Ji Choi, Youn Ho Shin, Kangmo Ahn, Jihyun Kim, Dong In Suh, Ji Soo Park, Kyung Won Kim, Soo-Jong Hong
{"title":"Multi-Omics-Based Biological Mechanisms for Childhood Allergen Sensitization Trajectories: COCOA Study.","authors":"Hea Young Oh, Eun Lee, Jeonghun Yeom, Hyun Ju Yoo, Seung Hwa Lee, So-Yeon Lee, Hyo-Bin Kim, Song-I Yang, Da Kyeong Lee, Jisun Yoon, Eom Ji Choi, Youn Ho Shin, Kangmo Ahn, Jihyun Kim, Dong In Suh, Ji Soo Park, Kyung Won Kim, Soo-Jong Hong","doi":"10.1111/all.70230","DOIUrl":"https://doi.org/10.1111/all.70230","url":null,"abstract":"","PeriodicalId":122,"journal":{"name":"Allergy","volume":" ","pages":""},"PeriodicalIF":12.0,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146002746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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