Caroline Nilsson, Andrea Vereda, Magnus P. Borres, Mats Andersson, Eva Södergren, Magnus Rudengren, Alex Smith, Reyna J. Simon, Robert Ryan, Montserrat Fernández-Rivas, Daniel Adelman, Brian P. Vickery
{"title":"花生口服免疫疗法的探索性免疫原性结果：PALISADE 试验结果","authors":"Caroline Nilsson, Andrea Vereda, Magnus P. Borres, Mats Andersson, Eva Södergren, Magnus Rudengren, Alex Smith, Reyna J. Simon, Robert Ryan, Montserrat Fernández-Rivas, Daniel Adelman, Brian P. Vickery","doi":"10.1002/clt2.12326","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen-specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Exploratory analyses of serological data from participants receiving peanut (<i>Arachis hypogaea</i>) allergen powder-dnfp (PTAH) and placebo in the double-blind, randomized, phase 3 PALISADE trial were conducted to evaluate potential relationships between peanut-specific and peanut component–specific (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9) IgE and IgG4 levels and clinical outcomes.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A total of 269 participants (PTAH, <i>n</i> = 202; placebo, <i>n</i> = 67) were analyzed. No relationship was observed between specific IgE and IgG4 levels at screening and maximum tolerated peanut protein dose during screening or response status during exit double-blind placebo-controlled food challenge (DBPCFC). In PTAH-treated participants, no relationship was observed between IgE and IgG4 levels at screening and maximum symptom severity during exit DBPCFC. Postscreening ratios (ie, postscreening/screening) in the PTAH group were significant at the end of updosing and exit visit for most components. Postscreening changes in specific IgE levels were more pronounced with PTAH versus placebo for most components.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Specific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (<i>Arachis hypogaea</i>) allergen powder-dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment.</p>\n </section>\n \n <section>\n \n <h3> Clinical Trial Registration</h3>\n \n <p>ClinicalTrials.gov identifier: NCT02635776.</p>\n </section>\n </div>","PeriodicalId":10334,"journal":{"name":"Clinical and Translational Allergy","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/clt2.12326","citationCount":"0","resultStr":"{\"title\":\"Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial\",\"authors\":\"Caroline Nilsson, Andrea Vereda, Magnus P. Borres, Mats Andersson, Eva Södergren, Magnus Rudengren, Alex Smith, Reyna J. Simon, Robert Ryan, Montserrat Fernández-Rivas, Daniel Adelman, Brian P. Vickery\",\"doi\":\"10.1002/clt2.12326\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen-specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>Exploratory analyses of serological data from participants receiving peanut (<i>Arachis hypogaea</i>) allergen powder-dnfp (PTAH) and placebo in the double-blind, randomized, phase 3 PALISADE trial were conducted to evaluate potential relationships between peanut-specific and peanut component–specific (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9) IgE and IgG4 levels and clinical outcomes.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>A total of 269 participants (PTAH, <i>n</i> = 202; placebo, <i>n</i> = 67) were analyzed. No relationship was observed between specific IgE and IgG4 levels at screening and maximum tolerated peanut protein dose during screening or response status during exit double-blind placebo-controlled food challenge (DBPCFC). In PTAH-treated participants, no relationship was observed between IgE and IgG4 levels at screening and maximum symptom severity during exit DBPCFC. Postscreening ratios (ie, postscreening/screening) in the PTAH group were significant at the end of updosing and exit visit for most components. Postscreening changes in specific IgE levels were more pronounced with PTAH versus placebo for most components.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Specific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (<i>Arachis hypogaea</i>) allergen powder-dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Clinical Trial Registration</h3>\\n \\n <p>ClinicalTrials.gov identifier: NCT02635776.</p>\\n </section>\\n </div>\",\"PeriodicalId\":10334,\"journal\":{\"name\":\"Clinical and Translational Allergy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2024-01-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/clt2.12326\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Translational Allergy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/clt2.12326\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Allergy","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/clt2.12326","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 0
摘要
背景 花生及其成分的免疫球蛋白 E (IgE) 和免疫球蛋白 G4 (IgG4) 可能会影响对花生的临床反应性。已知过敏原特异性免疫疗法可改变 IgE 和 IgG4。花生口服免疫疗法可能会影响这些血清学参数。 方法 对双盲、随机、3 期 PALISADE 试验中接受花生（Arachis hypogaea）过敏原粉末-dnfp（PTAH）和安慰剂的参与者的血清学数据进行探索性分析，以评估花生特异性和花生成分特异性（Ara h 1、Ara h 2、Ara h 3、Ara h 6、Ara h 8 和 Ara h 9）IgE 和 IgG4 水平与临床结果之间的潜在关系。 结果 共分析了 269 名参与者（PTAH，n = 202；安慰剂，n = 67）。筛查时的特异性 IgE 和 IgG4 水平与筛查时的最大耐受花生蛋白剂量或退出双盲安慰剂对照食物挑战（DBPCFC）时的反应状态之间未发现任何关系。在接受过 PTAH 治疗的参与者中，筛查时的 IgE 和 IgG4 水平与退出 DBPCFC 时的最大症状严重程度之间未发现任何关系。PTAH 组的筛查后比率（即筛查后/筛查）在更新治疗结束时和退出访问时对大多数成分都有显著影响。就大多数成分而言，PTAH 组比安慰剂组特异性 IgE 水平的筛查后变化更明显。 结论 筛查时的特异性 IgE 和 IgG4 水平与筛查或出院时的 DBPCFC 结果无关，也不能预测对 PTAH 的临床反应。花生（Arachis hypogaea）过敏原粉末-dnfp含有相关的免疫优势过敏原，可通过治疗诱导免疫学变化。 临床试验注册 ClinicalTrials.gov identifier：NCT02635776。
Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial
Background
Immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen-specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.
Methods
Exploratory analyses of serological data from participants receiving peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) and placebo in the double-blind, randomized, phase 3 PALISADE trial were conducted to evaluate potential relationships between peanut-specific and peanut component–specific (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9) IgE and IgG4 levels and clinical outcomes.
Results
A total of 269 participants (PTAH, n = 202; placebo, n = 67) were analyzed. No relationship was observed between specific IgE and IgG4 levels at screening and maximum tolerated peanut protein dose during screening or response status during exit double-blind placebo-controlled food challenge (DBPCFC). In PTAH-treated participants, no relationship was observed between IgE and IgG4 levels at screening and maximum symptom severity during exit DBPCFC. Postscreening ratios (ie, postscreening/screening) in the PTAH group were significant at the end of updosing and exit visit for most components. Postscreening changes in specific IgE levels were more pronounced with PTAH versus placebo for most components.
Conclusions
Specific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (Arachis hypogaea) allergen powder-dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment.
期刊介绍：
Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience.
Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
