Journal of Allergy and Clinical Immunology最新文献

{"title":"Real-life observation of wildfire smoke–impaired COVID-19 vaccine immunity","authors":"Gursharan Kaur Sanghar BS,&nbsp;Melissa Teuber BS,&nbsp;Resmi Ravindran PhD,&nbsp;Emma Jean Keller PhD,&nbsp;Sean Raffuse A. MS,&nbsp;Pedro A. Hernandez BS,&nbsp;Angela Linderholm PhD,&nbsp;Gabrielle Echt BS,&nbsp;Lisa Franzi BS,&nbsp;Kaelyn Tuermer-Lee BS,&nbsp;Maya Juarez BS,&nbsp;Timothy E. Albertson MD, MPH, PhD,&nbsp;Imran H. Khan PhD, MBA,&nbsp;Angela Haczku MD, PhD","doi":"10.1016/j.jaci.2025.01.035","DOIUrl":"10.1016/j.jaci.2025.01.035","url":null,"abstract":"<div><h3>Background</h3><div>Wildfires are increasingly common, with wildfire smoke affecting millions globally; yet, its impact on immune responses is poorly understood.</div></div><div><h3>Objective</h3><div>This real-world study, conducted on participants in the Pfizer BNT162b2 coronavirus disease 2019 (COVID-19) vaccine trial, examined the effects of wildfire smoke exposure on long-term vaccine immunity.</div></div><div><h3>Methods</h3><div>We recruited 52 healthy, nonsmoking individuals (aged 26-83 years) who were either vaccinated (group 1 [n = 28]) or injected with placebo (group 2 [n = 24]) during conditions of heavy wildfire smoke. The group 2 subjects underwent vaccination several months later, outside wildfire season. Blood was taken before and 1 month after the vaccine or placebo injections, as well as 6 months after vaccination. We analyzed levels of intracellular cytokines, B-cell, and natural killer (NK) cell markers by flow cytometry, as well as serum immunoglobulin levels against common coronaviruses by using multiplex assays.</div></div><div><h3>Results</h3><div>A robust spike receptor-binding domain (S-RBD)-specific IgG response was observed 1 month after booster and declined variably 6 months later. Wildfire smoke acutely increased IL-13 expression by CD56^bright NK cells at the time of vaccination; this increase negatively correlated with level of anti–S-RBD IgG (<em>r</em> = –0.41; <em>P</em> &lt; .05). Total IgG levels positively correlated with the Air Quality Index measured during vaccination (<em>r</em> = 0.96; <em>P</em> &lt; .01). Similarly to age (but not to sex, body mass index, or race/ethnicity), the 2-week Air Quality Index averages during vaccination showed a significant negative correlation with anti–S-RBD IgG levels 6 months later (<em>r</em> = –0.41; <em>P</em> &lt; .05).</div></div><div><h3>Conclusion</h3><div>Wildfire smoke may lead to inappropriate immunoglobulin production and diminished vaccine immunity. We highlight a previously unrecognized pathway involving NK cell–derived IL-13 and nonspecific B-cell activation and underscore the significance of environmental exposures in shaping immunity.</div></div>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages 1371-1377.e6"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381255","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":"Features of hyperinflammation link the biology of Epstein-Barr virus infection and cytokine storm syndromes","authors":"Meng Liu MD ,&nbsp;Kailey E. Brodeur BS ,&nbsp;Jacob R. Bledsoe MD ,&nbsp;Claudia N. Harris BS ,&nbsp;Jill Joerger MS, MT ,&nbsp;Rachel Weng ,&nbsp;Evan E. Hsu BA ,&nbsp;Michael T. Lam MD, PhD ,&nbsp;Casey A. Rimland MD, PhD ,&nbsp;Courtney E. LeSon BS ,&nbsp;Jian Yue MD ,&nbsp;Lauren A. Henderson MD ,&nbsp;Fatma Dedeoglu MD ,&nbsp;Jane W. Newburger MD ,&nbsp;Peter A. Nigrovic MD ,&nbsp;Mary Beth F. Son MD ,&nbsp;Pui Y. Lee MD, PhD","doi":"10.1016/j.jaci.2024.11.029","DOIUrl":"10.1016/j.jaci.2024.11.029","url":null,"abstract":"<div><h3>Background</h3><div>Overt immune activation by viral infections can lead to cytokine storm syndromes, such as hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS).</div></div><div><h3>Objective</h3><div>We aimed to compare the immune response to different viral pathogens to understand the connection between infections and cytokine storm syndromes.</div></div><div><h3>Methods</h3><div>We recruited children who sought care at the emergency department with fever for ≥3 days. We performed immune profiling using Olink proximity extension assay and flow cytometry. We compared the findings with cases of HLH, MAS, Kawasaki disease (KD), and multisystem inflammatory syndrome in children (MIS-C).</div></div><div><h3>Results</h3><div>We enrolled 352 febrile patients and studied 110 cases of confirmed common viral infections. We found that Epstein-Barr virus (EBV) uniquely triggered high levels of multiple cytokines (IL-18, IL-27, TNF, FLT3 ligand, and lymphotoxin alpha) and IFN-γ–induced chemokines (CXCL9/10/11 and CCL19). These patterns are similar to the hyperinflammatory response associated with HLH/MAS but are less consistent with the findings in KD and MIS-C. Flow cytometry analysis revealed that CD38⁺HLA-DR⁺ T lymphocytes, which are pathogenic cells responsible for IFN-γ production in HLH/MAS, are vastly expanded in patients with acute EBV infection. Cell sorting identified CD38⁺HLA-DR⁺ T cells as atypical lymphocytes that are classically associated with acute EBV infection.</div></div><div><h3>Conclusion</h3><div>This work broadens our understanding of common viral infections in children and provides an immunologic basis for the link between EBV infection and HLH/MAS.</div></div>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages 1346-1356.e9"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769122","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":"Inborn errors of immunity reveal molecular requirements for generation and maintenance of human CD4+ IL-9–expressing cells","authors":"Geetha Rao MSc ,&nbsp;Corinne D. Mack PhD ,&nbsp;Tina Nguyen PhD ,&nbsp;Natalie Wong BSc Hons ,&nbsp;Kathryn Payne BSc Hons ,&nbsp;Lisa Worley PhD ,&nbsp;Paul E. Gray MD, FRACP ,&nbsp;Melanie Wong MBBS, PhD, FRACP, FRCPA ,&nbsp;Peter Hsu FRACP, PhD ,&nbsp;Michael O. Stormon MBBS, FRACP ,&nbsp;Kahn Preece MD ,&nbsp;Daniel Suan MBBS, PhD ,&nbsp;Michael O’Sullivan MBBS ,&nbsp;Annaliesse K. Blincoe BHB, MBChB ,&nbsp;Jan Sinclair MD ,&nbsp;Satoshi Okada MD, PhD ,&nbsp;Sophie Hambleton PhD ,&nbsp;Peter D. Arkwright FRCPCH, DPhil ,&nbsp;Kaan Boztug MD ,&nbsp;Polina Stepensky MD ,&nbsp;Cindy S. Ma PhD","doi":"10.1016/j.jaci.2024.11.031","DOIUrl":"10.1016/j.jaci.2024.11.031","url":null,"abstract":"<div><h3>Background</h3><div>CD4⁺ T cells play essential roles in adaptive immunity. Distinct CD4⁺ T-cell subsets—T_H1, T_H2, T_H17, T_H22, T follicular helper, and regulatory T cells—have been identified, and their contributions to host defense and immune regulation are increasingly well defined. IL-9–producing T_H9 cells were first described in 2008 and appear to play both protective and pathogenic roles in human immunity. However, key requirements for generating human T_H9 cells remain incompletely defined.</div></div><div><h3>Objective</h3><div>We sought to define signaling pathways that regulate IL-9 production by human CD4⁺ T cells.</div></div><div><h3>Methods</h3><div>Human naive and memory CD4⁺ T cells were cultured under different conditions, and the molecular mechanisms regulating IL-9 induction were determined by assessing the ability of CD4⁺ T cells from a broad range of patients (n = 92) with pathogenic variants in key immune genes (n = 21) to differentiate into IL-9⁺ cells.</div></div><div><h3>Results</h3><div>We identified 2 culture conditions that yielded IL-9–expressing cells from naive CD4⁺ T cells and amplified IL-9 production by <em>in vivo</em>–generated memory CD4⁺ T cells: TGF-β plus IL-4 (ie, T_H9 polarizing condition), and the combination of IL-21, IL-23, IL-6, IL-1β, and TGF-β (ie, T_H17 polarizing condition). Combining these conditions had a synergistic effect in generating IL-9⁺CD4⁺ T cells. IL-9 induction required STAT3-activating cytokines as well as intact signaling via the T-cell receptor and STAT5. Importantly, IL-9 induction was restrained by IFN-γ/STAT1 and IL-10.</div></div><div><h3>Conclusions</h3><div>Our findings revealed critical molecules involved in inducing/restraining IL-9 production by human CD4⁺ T cells, thereby identifying pathways that could be targeted to modulate IL-9 in health and disease.</div></div>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages 1161-1178"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769124","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":"Thymic and T-cell intrinsic critical roles associated with severe combined immunodeficiency and Omenn syndrome due to a heterozygous variant (G201R) in PSMB10","authors":"Hye Sun Kuehn PhD ,&nbsp;Marita Bosticardo PhD ,&nbsp;Antonio C. Arrieta MD ,&nbsp;Jennifer L. Stoddard BS ,&nbsp;Francesca Pala PhD ,&nbsp;Julie E. Niemela MS ,&nbsp;Agustin A. Gil Silva BS ,&nbsp;Paighton L. King CPNP-PC ,&nbsp;Ana Esteve-Sole PhD ,&nbsp;Amreen Naveen MS ,&nbsp;Eduardo Anaya MS ,&nbsp;Pooi Meng Truong RN, BSN ,&nbsp;Ottavia M. Delmonte MD, PhD ,&nbsp;David K. Buchbinder MD ,&nbsp;Sergio D. Rosenzweig MD, PhD ,&nbsp;Luigi D. Notarangelo MD","doi":"10.1016/j.jaci.2024.12.1082","DOIUrl":"10.1016/j.jaci.2024.12.1082","url":null,"abstract":"<div><h3>Background</h3><div>Heterozygous immunoproteasome 20 S subunit beta 10 (PSMB10) mutations can cause severe combined immunodeficiency and Omenn syndrome. Hematopoietic stem cell transplantation in these patients is associated with severe complications and poor immune reconstitution, often resulting in death.</div></div><div><h3>Objective</h3><div>We sought to perform immunologic and molecular characterization of an infant with a <em>PSMB10</em> heterozygous variant.</div></div><div><h3>Methods</h3><div>A heterozygous variant in <em>PSMB10</em> (p.G201R) was identified in the index patient but not her parents. Detailed immunophenotyping and functional studies, including flow cytometry, immunoblotting, and T-cell development in artificial thymic organoids, were performed.</div></div><div><h3>Results</h3><div>The patient presented with severe B-, natural killer–, and T-cell lymphopenia, with a progressive increase in memory CD4⁺ T cells and loss of CD8⁺ T cells, diminished Vbeta family diversity, and abnormal IL-7 signaling. Immunoproteasome protein expression (PSMB9 and PSMB10) was markedly reduced in the patient’s cells, including PBMCs, EBV-transformed B cells, and fibroblasts, the mutation likely acting in a dominant-negative fashion. The patient’s CD34⁺ cells showed a normal early T-cell development but slightly impaired generation of CD3⁺TCR αβ⁺ cells in artificial thymic organoids, and human thymus single-cell RNA sequencing demonstrated that <em>PSMB10</em> is expressed in different subsets of cortical and medullary thymic epithelial cells. Collectively, these data indicate that <em>PSMB10</em> mutations affect positive selection of CD8 T cells, generation of a diverse T-cell repertoire, and negative selection of autoreactive T cells.</div></div><div><h3>Conclusions</h3><div>The PSMB10 G201R variant is associated with reduced immunoproteasome expression levels that appear to play vital roles in hematopoietic and extrahematopoietic immune system development and function. PSMB10-associated thymoproteasome dysfunction leads to impaired thymopoiesis and the development of severe combined immunodeficiency and Omenn syndrome, suggesting possible benefit from thymus implantation.</div></div>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages 1378-1385.e2"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142903211","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":"Transcriptomic profiling of chronic hand eczema skin reveals shared immune pathways and molecular drivers across subtypes","authors":"Anna Sophie Quaade PhD ,&nbsp;Thomas Litman PhD ,&nbsp;Xing Wang PhD ,&nbsp;Christine Becker PhD ,&nbsp;Benjamin D. McCauley BS ,&nbsp;Julie Breinholt Kjær Sølberg PhD ,&nbsp;Jacob P. Thyssen PhD, DMSc ,&nbsp;Jeanne Duus Johansen DMSc","doi":"10.1016/j.jaci.2024.12.1091","DOIUrl":"10.1016/j.jaci.2024.12.1091","url":null,"abstract":"<div><h3>Background</h3><div>Chronic hand eczema (CHE) is a common skin disease with different subtypes, but knowledge of the molecular patterns associated with each subtype is limited.</div></div><div><h3>Objective</h3><div>We sought to characterize the CHE transcriptome across subtypes.</div></div><div><h3>Methods</h3><div>Using RNA sequencing, we studied the transcriptome of 220 full-thickness skin biopsy samples collected from palms, dorsa, and arms from 96 patients with CHE and/or atopic dermatitis (AD) and 32 healthy controls. The primary analysis focused on 16 healthy and 54 lesional CHE palm samples that were further stratified by AD status and unique etiology. Differentially expressed genes (DEGs) were identified across the cohort, and Ingenuity Pathway Analysis (IPA) was used for pathway analysis and upstream regulator prediction.</div></div><div><h3>Results</h3><div>We identified anatomic site-specific transcriptomic variations, showing unique characteristics in both healthy and CHE-affected palm skin. In CHE palms, we identified 2333 DEGs versus healthy palms. Upregulated genes predominantly involved keratinocyte host inflammation and immune signaling, while downregulated genes were linked to lipid metabolism and epidermal barrier function. IPA revealed numerous activated proinflammatory pathways, dominated by T_H1 and T_H2. Key upstream regulators included type 1 (IFN-γ, TNF, STAT1, IL-2) and type 2 (IL-4) associated molecules, and IL-1β. Lesional palm signatures were broadly shared across CHE subtypes. No DEGs were found between allergic and irritant contact dermatitis CHE. Subtype-specific pathway and upstream regulator activity variations were noted.</div></div><div><h3>Conclusion</h3><div>The lesional CHE transcriptome is primarily shared among subtypes and is characterized by activation of several immune pathways, dominated by T_H1 and T_H2. Key shared upstream regulators were identified, highlighting potential universal therapeutic targets.</div></div>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages 1250-1263"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CME Calendar-AAAAI","authors":"","doi":"10.1016/S0091-6749(25)00230-1","DOIUrl":"10.1016/S0091-6749(25)00230-1","url":null,"abstract":"","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages A25-A26"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143760769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Information for Readers","authors":"","doi":"10.1016/S0091-6749(25)00228-3","DOIUrl":"10.1016/S0091-6749(25)00228-3","url":null,"abstract":"","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Page A21"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143760767","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":"Long COVID: Pathophysiology, current concepts, and future directions","authors":"Chrysanthi Skevaki MD ,&nbsp;Charalampos D. Moschopoulos MD ,&nbsp;Paraskevi C. Fragkou MD, PhD ,&nbsp;Karsten Grote PhD ,&nbsp;Elisabeth Schieffer MD ,&nbsp;Bernhard Schieffer MD","doi":"10.1016/j.jaci.2024.12.1074","DOIUrl":"10.1016/j.jaci.2024.12.1074","url":null,"abstract":"<div><div>Long COVID, an umbrella term referring to a variety of symptoms and clinical presentations that emerges in a subset of patients after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has a significant effect on quality of life and places a substantial burden on health care systems worldwide, straining financial and human resources. The pathophysiology of long COVID remains incompletely understood, though several hypotheses have been proposed to explain different aspects of this complex condition. SARS-CoV-2 persistence, direct organ damage, innate and adaptive immune system perturbation, autoimmunity, latent virus reactivation, endothelial dysfunction, and microbiome disturbances are among the most relevant avenues for elucidating the evolution, complexity, and mechanisms of long COVID. Active investigation regarding potential biomarkers for long COVID and its associated disease endotypes highlights the role of inflammatory mediators, immunophenotyping, and multiomics approaches. Further advances in understanding long COVID are needed to inform current and future therapeutics.</div></div>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":"155 4","pages":"Pages 1059-1070"},"PeriodicalIF":11.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142887521","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":"Nasal production of IL-26 involving T cells in smokers with and without COPD.","authors":"Julia Arebro, Nikolaos Pournaras, Patricia Ramos-Ramírez, Eduardo I Cardenas, Elga Bandeira, Karlhans Fru Che, Bettina Brundin, Apostolos Bossios, Reza Karimi, Sven Nyrén, Pär Stjärne, Magnus Sköld, Anders Lindén","doi":"10.1016/j.jaci.2025.03.017","DOIUrl":"https://doi.org/10.1016/j.jaci.2025.03.017","url":null,"abstract":"<p><strong>Background: </strong>Novel specific therapy in COPD will require accessible targets for endotyping to identify responsive patients. It is therefore of interest that interleukin (IL)-26 in the bronchoalveolar space is enhanced and associates with bronchoalveolar pathology among long-term smokers (LTS) with and without COPD.</p><p><strong>Objective: </strong>To determine whether IL-26 in the nasal cavity can be produced by T cells and associates with bronchoalveolar pathology and clinical symptoms in LTS with and without COPD.</p><p><strong>Methods: </strong>We characterized LTS with and without COPD plus healthy non-smokers (HNS) using radiology, spirometry, modified Medical Research Council (mMRC) scale, and St George's Respiratory Questionnaire (SGRQ). We determined extracellular IL-26 concentrations (ELISA) in nasal (NAL) and bronchoalveolar lavage (BAL) samples, BAL neutrophil counts, and NAL IL-26⁺ T cell expression (flow cytometry).</p><p><strong>Results: </strong>The NAL IL-26 concentrations were higher in LTS with COPD than in HNS. These enhanced IL-26 concentrations displayed a positive correlation with FEV₁/FVC. The IL-26 protein was expressed in CD4⁺ and CD8⁺ T cells, but only a small portion of these cells co-expressed IL-15, IL-17A, or IL-22 in LTS with COPD. In this group, IL-26⁺ CD3⁺ T cells displayed a negative correlation with FEV₁, as did with extracellular NAL IL-26 concentrations. The relative mean fluorescence intensity (rMFI) for CD8⁺ T cells displayed a negative correlation with mMRC and SGRQ score.</p><p><strong>Conclusion: </strong>In the nasal cavity, IL-26 can be produced by local T cells. This IL-26 reflects bronchoalveolar pathology and clinical symptoms, thereby constituting an accessible target with potential for clinically relevant endotyping in COPD.</p>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":" ","pages":""},"PeriodicalIF":11.4,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752318","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":"Biomarker-driven drug development for Allergic Diseases and Asthma-An FDA public workshop.","authors":"Ronald L Rabin, Matthew C Altman, S Hasan Arshad, Richard D Beger, Pamela A Frischmeyer-Guerrerio, Elena Goleva, Robert G Hamilton, Gurjit K Khurana Hershey, Mohamed H Shamji, Hugh A Sampson, Alexandra F Santos, Wayne G Shreffler, Alkis Togias, Stefan Vieths, Erik Wambre, Sally E Wenzel, Kathleen Hise, Joohee Lee, Anubha Tripathi, Jay E Slater","doi":"10.1016/j.jaci.2025.03.014","DOIUrl":"https://doi.org/10.1016/j.jaci.2025.03.014","url":null,"abstract":"<p><p>The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, NIH staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate endpoint for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into three sessions: 1) FDA and EU regulators discussing regulatory perspectives on use of biomarkers in drug development programs; 2) investigators discussing biomarkers for pediatric and adult asthma; and 3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.</p>","PeriodicalId":14936,"journal":{"name":"Journal of Allergy and Clinical Immunology","volume":" ","pages":""},"PeriodicalIF":11.4,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143743166","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}