Hyeon Jin Kim,Yesol Yim,Christa J Nehs,Jaeyu Park,Sunyoung Kim,Nikolaos G Papadopoulos,Jiseung Kang,Dong Keon Yon
{"title":"Maternal Opioid Use and Subsequent Risk of Allergic Diseases in Children: Emulation of Target Trials Using the Korean Nationwide Birth Cohort.","authors":"Hyeon Jin Kim,Yesol Yim,Christa J Nehs,Jaeyu Park,Sunyoung Kim,Nikolaos G Papadopoulos,Jiseung Kang,Dong Keon Yon","doi":"10.1111/all.70231","DOIUrl":"https://doi.org/10.1111/all.70231","url":null,"abstract":"","PeriodicalId":122,"journal":{"name":"Allergy","volume":"95 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146014692","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}
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.
{"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}
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.
{"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}
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.
{"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}
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}
{"title":"Circulating Type 2 Memory B Cell Frequency Is a Biomarker for Allergen Immunotherapy Efficacy in Patients With Allergic Rhinitis.","authors":"Yue Ma,Shuying Li,Lei Ye,Lin Qiu,Jiayu Wu,Jiaying Li,Xian Feng,Wei Qian,Xiangping Yang,Huabin Li,Hongfei Lou","doi":"10.1111/all.70221","DOIUrl":"https://doi.org/10.1111/all.70221","url":null,"abstract":"","PeriodicalId":122,"journal":{"name":"Allergy","volume":"42 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2026-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145994797","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}
Qingqing Xu, Yang Sun, Carmen Messerlian, Chenyin Dong, Yu Zhang, Vicente Mustieles, Chong Liu, Keyi Si, Jun Liu, Yunjiang Yu, Yi‐Xin Wang
{"title":"Association Between Fluoride Exposure and Asthma Among US Children and Adolescents","authors":"Qingqing Xu, Yang Sun, Carmen Messerlian, Chenyin Dong, Yu Zhang, Vicente Mustieles, Chong Liu, Keyi Si, Jun Liu, Yunjiang Yu, Yi‐Xin Wang","doi":"10.1111/all.70214","DOIUrl":"https://doi.org/10.1111/all.70214","url":null,"abstract":"","PeriodicalId":122,"journal":{"name":"Allergy","volume":"5 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145986252","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}