Amy M Scurlock, David M Fleischer, George Du Toit, Nicolette J T Arends, Jacqueline A Pongracic, Juan Trujillo, Paul Turner, Christian Vogelberg, Katharine J Bee, Todd D Green, Jonas Meney, Timothée Bois, Dianne E Campbell, Hugh A Sampson, A Wesley Burks
{"title":"Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities.","authors":"Amy M Scurlock, David M Fleischer, George Du Toit, Nicolette J T Arends, Jacqueline A Pongracic, Juan Trujillo, Paul Turner, Christian Vogelberg, Katharine J Bee, Todd D Green, Jonas Meney, Timothée Bois, Dianne E Campbell, Hugh A Sampson, A Wesley Burks","doi":"10.1016/j.anai.2025.04.002","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There is a high prevalence rate of atopic comorbidities, including atopic dermatitis (AD), asthma, and concomitant food allergy (CFA), in children with peanut allergy.</p><p><strong>Objective: </strong>To evaluate whether concomitant atopic comorbidities affect the safety and efficacy of VIASKIN peanut patch (patch containing 250 µg peanut protein [VP250]).</p><p><strong>Methods: </strong>EPITOPE was a phase 3, double-blind, placebo-controlled trial designed to assess treatment response to VP250, as measured by eliciting dose at 12 months, in children with peanut allergy aged 1 to 3 years. This subgroup analysis assessed response rates for prespecified subgroups, including children with asthma, AD/eczema, and CFA. The safety profile of VP250 was evaluated by atopic condition in all randomized participants who received at least 1 dose.</p><p><strong>Results: </strong>Responder rates were significantly greater with VP250 vs placebo, irrespective of the presence of atopic conditions. There was no significant interaction effect between participants with an atopic comorbidity and those without. The safety profile was generally similar across subgroups without any additional safety signals. There was no clinically meaningful change in severity of AD in those receiving VP250, regardless of baseline AD status. Rates of anaphylaxis were higher in those with AD or CFA receiving VP250 vs those without; however, these imbalances were also observed in the placebo group.</p><p><strong>Conclusion: </strong>The results suggest that 12 months of treatment with VP250 was effective in desensitizing children with peanut allergy aged 1 to 3 years, with no difference in efficacy and a favorable safety profile, regardless of the presence of atopic comorbidities.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03211247.</p>","PeriodicalId":50773,"journal":{"name":"Annals of Allergy Asthma & Immunology","volume":" ","pages":""},"PeriodicalIF":5.8000,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Allergy Asthma & Immunology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.anai.2025.04.002","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: There is a high prevalence rate of atopic comorbidities, including atopic dermatitis (AD), asthma, and concomitant food allergy (CFA), in children with peanut allergy.
Objective: To evaluate whether concomitant atopic comorbidities affect the safety and efficacy of VIASKIN peanut patch (patch containing 250 µg peanut protein [VP250]).
Methods: EPITOPE was a phase 3, double-blind, placebo-controlled trial designed to assess treatment response to VP250, as measured by eliciting dose at 12 months, in children with peanut allergy aged 1 to 3 years. This subgroup analysis assessed response rates for prespecified subgroups, including children with asthma, AD/eczema, and CFA. The safety profile of VP250 was evaluated by atopic condition in all randomized participants who received at least 1 dose.
Results: Responder rates were significantly greater with VP250 vs placebo, irrespective of the presence of atopic conditions. There was no significant interaction effect between participants with an atopic comorbidity and those without. The safety profile was generally similar across subgroups without any additional safety signals. There was no clinically meaningful change in severity of AD in those receiving VP250, regardless of baseline AD status. Rates of anaphylaxis were higher in those with AD or CFA receiving VP250 vs those without; however, these imbalances were also observed in the placebo group.
Conclusion: The results suggest that 12 months of treatment with VP250 was effective in desensitizing children with peanut allergy aged 1 to 3 years, with no difference in efficacy and a favorable safety profile, regardless of the presence of atopic comorbidities.
期刊介绍：
Annals of Allergy, Asthma & Immunology is a scholarly medical journal published monthly by the American College of Allergy, Asthma & Immunology. The purpose of Annals is to serve as an objective evidence-based forum for the allergy/immunology specialist to keep up to date on current clinical science (both research and practice-based) in the fields of allergy, asthma, and immunology. The emphasis of the journal will be to provide clinical and research information that is readily applicable to both the clinician and the researcher. Each issue of the Annals shall also provide opportunities to participate in accredited continuing medical education activities to enhance overall clinical proficiency.
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