{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T16:35:05Z","timestamp":1793723705174,"version":"4.6.1"},"reference-count":23,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Pediatr"],"published-print":{"date-parts":[[2024,4,1]]},"abstract":"Importance<\/jats:title>No approved allergen-specific treatment exists for immunoglobulin E (IgE)\u2013mediated cow\u2019s milk allergy (CMA), a common childhood food allergy.<\/jats:p><\/jats:sec>Objective<\/jats:title>To assess dose, efficacy, and safety of epicutaneous immunotherapy with Viaskin Milk in children with IgE-mediated CMA.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>A phase 1\/2, 2-part, randomized, double-blind, placebo-controlled dose-ranging clinical trial in children aged 2 to 17 years with IgE-mediated CMA was conducted between November 2014 through December 2017. It took place at 17 trial sites in the US and Canada. Current CMA was confirmed by double-blind, placebo-controlled food challenge at study entry. Part A assessed the short-term safety of 150 \u03bcg, 300 \u03bcg, or 500 \u03bcg of Viaskin Milk; part B evaluated the efficacy and safety of the 3 doses vs placebo over 12 months of treatment. Of the 308 screened participants with physician-diagnosed CMA, 198 met eligibility criteria (including an eliciting dose 300 mg or less) and were randomized.<\/jats:p><\/jats:sec>Intervention<\/jats:title>Safety of Viaskin Milk (150-\u03bcg, 300-\u03bcg, or 500-\u03bcg doses) was evaluated over a 3-week period (part A). In part B, 180 additional participants were randomized to receive Viaskin Milk at doses of 150 \u03bcg, 300 \u03bcg, or 500 \u03bcg or placebo (1:1:1:1) for 12 months.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome was the proportion of treatment responders, defined as a 10-fold or more increase in the cumulative reactive dose of cow\u2019s milk protein (reaching at least 144 mg) or a cumulative reactive dose of cow\u2019s milk protein at 1444 mg or more at the month 12 double-blind, placebo-controlled food challenge.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 95.5% of the randomized participants (mean [SD] age, 8 [4.17] years; 124 of 198 were male [62.6%]) completed treatment. The highest response rate was observed in participants who received Viaskin Milk at the 300-\u03bcg dose with 24 of 49 responders (49.0%) overall vs 16 of 53 responders (30.2%) in the placebo group (odds ratio, 2.19; 95% CI, 0.91-5.41; P<\/jats:italic>\u2009=\u2009.09), highest in the 2 to 11 years age group (22 of 38 [57.9%] vs 13 of 40 [32.5%]; P<\/jats:italic>\u2009=\u2009.04). Most treatment-emergent adverse events were mild or moderate application-site reactions. One participant in the 500-\u03bcg Viaskin Milk dose group experienced treatment-related anaphylaxis.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this randomized clinical trial, 12 months of daily epicutaneous immunotherapy with a dose of Viaskin Milk at 300 \u03bcg was associated with a statistically significant treatment response in 2- to 11-year-old children with IgE-mediated CMA. Treatment-related anaphylaxis and treatment-related discontinuation rates were low. Further research is needed to explore Viaskin Milk as a viable treatment option for children with IgE-mediated CMA.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT02223182<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamapediatrics.2023.6630","type":"journal-article","created":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T16:32:44Z","timestamp":1708965164000},"page":"345","source":"Crossref","is-referenced-by-count":18,"title":["Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk vs Placebo in Children With Cow\u2019s Milk Allergy"],"prefix":"10.1001","volume":"178","author":[{"given":"Daniel","family":"Petroni","sequence":"first","affiliation":[{"name":"Seattle Allergy and Asthma Research Institute, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"B\u00e9gin","sequence":"additional","affiliation":[{"name":"Section of Allergy, Immunology and Rheumatology, Department of Pediatrics, CHU Sainte-Justine, Montr\u00e9al, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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