{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:12:07Z","timestamp":1789603927706,"version":"build-2803163510"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T00:00:00Z","timestamp":1706054400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T00:00:00Z","timestamp":1706054400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Drugs"],"published-print":{"date-parts":[[2024,3]]},"DOI":"10.1007\/s40272-023-00611-9","type":"journal-article","created":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T12:02:32Z","timestamp":1706097752000},"page":"163-173","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Infections in Children Aged 6 Months to 5 Years Treated with Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis"],"prefix":"10.1007","volume":"26","clinical-trial-number":[{"clinical-trial-number":"nct03346434","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Amy S.","family":"Paller","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine C.","family":"Siegfried","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Cork","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter D.","family":"Arkwright","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence F.","family":"Eichenfield","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Ramien","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faisal A.","family":"Khokhar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annie","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonya L.","family":"Cyr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,1,24]]},"reference":[{"issue":"4","key":"611_CR1","doi-asserted-by":"publisher","first-page":"417","DOI":"10.1016\/j.anai.2020.12.020","volume":"126","author":"JI Silverberg","year":"2021","unstructured":"Silverberg JI, Barbarot S, Gadkari A, et al. Atopic dermatitis in the pediatric population. A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol. 2021;126(4):417\u201328. https:\/\/doi.org\/10.1016\/j.anai.2020.12.020.","journal-title":"Ann Allergy Asthma Immunol"},{"issue":"3 Suppl","key":"611_CR2","doi-asserted-by":"publisher","first-page":"S18","DOI":"10.1016\/j.sder.2012.07.006","volume":"31","author":"CN Ellis","year":"2012","unstructured":"Ellis CN, Mancini AJ, Paller AS, Simpson EL, Eichenfield LF. Understanding and managing atopic dermatitis in adult patients. Semin Cutan Med Surg. 2012;31(3 Suppl):S18-22. https:\/\/doi.org\/10.1016\/j.sder.2012.07.006.","journal-title":"Semin Cutan Med Surg"},{"issue":"3","key":"611_CR3","doi-asserted-by":"publisher","first-page":"329","DOI":"10.1007\/s12016-016-8548-5","volume":"51","author":"PY Ong","year":"2016","unstructured":"Ong PY, Leung DYM. Bacterial and viral infections in atopic dermatitis: a comprehensive review. Clinic Rev Allerg Immunol. 2016;51(3):329\u201337. https:\/\/doi.org\/10.1007\/s12016-016-8548-5.","journal-title":"Clinic Rev Allerg Immunol."},{"issue":"6","key":"611_CR4","doi-asserted-by":"publisher","first-page":"S118","DOI":"10.1016\/j.jaci.2003.09.033","volume":"112","author":"JM Spergel","year":"2003","unstructured":"Spergel JM, Paller AS. Atopic dermatitis and the atopic march. J Allergy Clin Immunol. 2003;112(6):S118\u201327. https:\/\/doi.org\/10.1016\/j.jaci.2003.09.033.","journal-title":"J Allergy Clin Immunol"},{"issue":"3 Suppl","key":"611_CR5","doi-asserted-by":"publisher","first-page":"S10","DOI":"10.1016\/j.sder.2012.07.004","volume":"31","author":"AS Paller","year":"2012","unstructured":"Paller AS, Simpson EL, Eichenfield LF, Ellis CN, Mancini AJ. Treatment strategies for atopic dermatitis: optimizing the available therapeutic options. Semin Cutan Med Surg. 2012;31(3 Suppl):S10-17. https:\/\/doi.org\/10.1016\/j.sder.2012.07.004.","journal-title":"Semin Cutan Med Surg"},{"issue":"6","key":"611_CR6","doi-asserted-by":"publisher","first-page":"850","DOI":"10.1111\/jdv.14888","volume":"32","author":"A Wollenberg","year":"2018","unstructured":"Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. J Eur Acad Dermatol Venereol. 2018;32(6):850\u201378. https:\/\/doi.org\/10.1111\/jdv.14888.","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"5","key":"611_CR7","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1080\/1744666X.2017.1298443","volume":"13","author":"NA Gandhi","year":"2017","unstructured":"Gandhi NA, Pirozzi G, Graham NMH. Commonality of the IL-4\/IL-13 pathway in atopic diseases. Expert Rev Clin Immunol. 2017;13(5):425\u201337. https:\/\/doi.org\/10.1080\/1744666X.2017.1298443.","journal-title":"Expert Rev Clin Immunol"},{"issue":"5","key":"611_CR8","doi-asserted-by":"publisher","first-page":"1188","DOI":"10.1111\/all.14151","volume":"75","author":"A Le Floc\u2019h","year":"2020","unstructured":"Le Floc\u2019h A, Allinne J, Nagashima K, et al. Dual blockade of IL-4 and IL-13 with dupilumab, an IL-4R\u03b1 antibody, is required to broadly inhibit type 2 inflammation. Allergy. 2020;75(5):1188\u2013204. https:\/\/doi.org\/10.1111\/all.14151.","journal-title":"Allergy"},{"issue":"3","key":"611_CR9","doi-asserted-by":"publisher","first-page":"626","DOI":"10.1016\/j.jaci.2014.11.001","volume":"135","author":"F Annunziato","year":"2015","unstructured":"Annunziato F, Romagnani C, Romagnani S. The 3 major types of innate and adaptive cell-mediated effector immunity. J Allergy Clin Immunol. 2015;135(3):626\u201335. https:\/\/doi.org\/10.1016\/j.jaci.2014.11.001.","journal-title":"J Allergy Clin Immunol"},{"issue":"10356","key":"611_CR10","doi-asserted-by":"publisher","first-page":"908","DOI":"10.1016\/S0140-6736(22)01539-2","volume":"400","author":"AS Paller","year":"2022","unstructured":"Paller AS, Simpson EL, Siegfried EC, et al. Dupilumab in children 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2022;400(10356):908\u201319. https:\/\/doi.org\/10.1016\/S0140-6736(22)01539-2.","journal-title":"Lancet"},{"issue":"5","key":"611_CR11","doi-asserted-by":"publisher","first-page":"1282","DOI":"10.1016\/j.jaad.2020.06.054","volume":"83","author":"AS Paller","year":"2020","unstructured":"Paller AS, Siegfried EC, Tha\u00e7i D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2020;83(5):1282\u201393. https:\/\/doi.org\/10.1016\/j.jaad.2020.06.054.","journal-title":"J Am Acad Dermatol"},{"issue":"1","key":"611_CR12","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1001\/jamadermatol.2019.3336","volume":"156","author":"EL Simpson","year":"2020","unstructured":"Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis. A phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44\u201356. https:\/\/doi.org\/10.1001\/jamadermatol.2019.3336.","journal-title":"JAMA Dermatol"},{"issue":"24","key":"611_CR13","doi-asserted-by":"publisher","first-page":"2335","DOI":"10.1056\/NEJMoa1610020","volume":"375","author":"EL Simpson","year":"2016","unstructured":"Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335\u201348. https:\/\/doi.org\/10.1056\/NEJMoa1610020.","journal-title":"N Engl J Med"},{"issue":"2","key":"611_CR14","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1111\/pde.14909","volume":"39","author":"AS Paller","year":"2022","unstructured":"Paller AS, Beck LA, Blauvelt A, et al. Infections in children and adolescents treated with dupilumab in pediatric clinical trials for atopic dermatitis\u2014a pooled analysis of trial data. Pediatr Dermatol. 2022;39(2):187\u201396. https:\/\/doi.org\/10.1111\/pde.14909.","journal-title":"Pediatr Dermatol"},{"issue":"3","key":"611_CR15","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1007\/s40257-019-00445-7","volume":"20","author":"LF Eichenfield","year":"2019","unstructured":"Eichenfield LF, Bieber T, Beck LA, et al. Infections in dupilumab clinical trials in atopic dermatitis: a comprehensive pooled analysis. Am J Clin Dermatol. 2019;20(3):443\u201356. https:\/\/doi.org\/10.1007\/s40257-019-00445-7.","journal-title":"Am J Clin Dermatol"},{"issue":"3","key":"611_CR16","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1111\/bjd.17869","volume":"181","author":"B Akinlade","year":"2019","unstructured":"Akinlade B, Guttman-Yassky E, de Bruin-Weller M, et al. Conjunctivitis in dupilumab clinical trials. Br J Dermatol. 2019;181(3):459\u201373. https:\/\/doi.org\/10.1111\/bjd.17869.","journal-title":"Br J Dermatol"},{"issue":"1","key":"611_CR17","doi-asserted-by":"publisher","first-page":"101","DOI":"10.1007\/s40257-020-00577-1","volume":"22","author":"A Bansal","year":"2021","unstructured":"Bansal A, Simpson EL, Paller AS, et al. Conjunctivitis in dupilumab clinical trials for adolescents with atopic dermatitis or asthma. Am J Clin Dermatol. 2021;22(1):101\u201315. https:\/\/doi.org\/10.1007\/s40257-020-00577-1.","journal-title":"Am J Clin Dermatol"},{"issue":"10086","key":"611_CR18","doi-asserted-by":"publisher","first-page":"2287","DOI":"10.1016\/S0140-6736(17)31191-1","volume":"389","author":"A Blauvelt","year":"2017","unstructured":"Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287\u2013303. https:\/\/doi.org\/10.1016\/S0140-6736(17)31191-1.","journal-title":"Lancet"},{"issue":"1","key":"611_CR19","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1016\/j.jaci.2018.08.022","volume":"143","author":"E Guttman-Yassky","year":"2019","unstructured":"Guttman-Yassky E, Bissonnette R, Ungar B, et al. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol. 2019;143(1):155\u201372. https:\/\/doi.org\/10.1016\/j.jaci.2018.08.022.","journal-title":"J Allergy Clin Immunol"},{"issue":"1","key":"611_CR20","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1016\/j.jid.2019.05.024","volume":"140","author":"C Callewaert","year":"2020","unstructured":"Callewaert C, Nakatsuji T, Knight R, et al. IL-4R\u03b1 blockade by dupilumab decreases Staphylococcus aureus colonization and increases microbial diversity in atopic dermatitis. J Invest Dermatol. 2020;140(1):191\u2013202. https:\/\/doi.org\/10.1016\/j.jid.2019.05.024.","journal-title":"J Invest Dermatol"},{"issue":"7","key":"611_CR21","doi-asserted-by":"publisher","first-page":"1501","DOI":"10.1007\/s13555-022-00737-7","volume":"12","author":"EB Haddad","year":"2022","unstructured":"Haddad EB, Cyr SL, Arima K, et al. Current and emerging strategies to inhibit type 2 inflammation in atopic dermatitis. Dermatol Ther (Heidelb). 2022;12(7):1501\u201333. https:\/\/doi.org\/10.1007\/s13555-022-00737-7.","journal-title":"Dermatol Ther (Heidelb)."},{"issue":"5","key":"611_CR22","doi-asserted-by":"publisher","first-page":"1421","DOI":"10.1016\/j.jaip.2023.03.020","volume":"11","author":"DYM Leung","year":"2023","unstructured":"Leung DYM, Bissonnette R, Kreimer S, et al. Dupilumab inhibits vascular leakage of blood proteins into atopic dermatitis skin. J Allergy Clin Immunol Pract. 2023;11(5):1421\u20138. https:\/\/doi.org\/10.1016\/j.jaip.2023.03.020.","journal-title":"J Allergy Clin Immunol Pract"}],"container-title":["Pediatric Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40272-023-00611-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40272-023-00611-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40272-023-00611-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T10:19:18Z","timestamp":1708683558000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40272-023-00611-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,24]]},"references-count":22,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["611"],"URL":"https:\/\/doi.org\/10.1007\/s40272-023-00611-9","relation":{},"ISSN":["1174-5878","1179-2019"],"issn-type":[{"value":"1174-5878","type":"print"},{"value":"1179-2019","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,24]]},"assertion":[{"value":"3 December 2023","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 January 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifier: NCT03346434. The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication. Medical writing and editorial assistance was provided by Alessandra Iannino, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice Guidelines.\n                      \n                      .","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Dr Paller reported serving as an investigator, consultant, and\/or data and safety monitoring board member for AbbVie, Abeona Therapeutics, Amryt Pharma, Azitra, BioCryst, BMS, Boehringer Ingelheim, Castle Creek Biosciences, Catawba Research, Dermavant, Eli Lilly, Galderma, Incyte, InMed Pharmaceuticals, Janssen, Krystal Biotech, LEO Pharma, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWi Biotechnology, and UCB. Dr Siegfried reported serving as a consultant, data safety monitoring board member, and\/or principal investigator in clinical trials for Dermavant, Eli Lilly, GSK, Janssen, LEO Pharma, Novan, Pfizer, Regeneron Pharmaceuticals Inc., Stiefel, and Verrica Pharmaceuticals. Dr Cork reported serving as an investigator and\/or consultant for AbbVie, Astellas Pharma, Boots, Dermavant, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, LEO Pharma, L\u2019Or\u00e9al, Menlo Therapeutics, Novartis, Oxagen, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals Inc., and Sanofi. Dr Arkwright reported acting as an investigator for Regeneron Pharmaceuticals Inc. and receiving grants from and acting as an advisor for Sanofi. Dr Eichenfield reported receiving honoraria for consulting services and\/or research support from AbbVie, Amgen, Arcutis, Aslan, Bausch, BMS, Castle Biosciences, Dermavant, Eli Lilly, Fort\u00e9 Pharma, Galderma, Incyte, Novartis, Otsuka, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and UCB. Dr Ramien reported serving as a consultant, speaker, and\/or investigator for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. Drs Khokhar, Chen, and Cyr are employees and shareholders of Regeneron Pharmaceuticals Inc. Dr Zhang is an employee of and may hold stock and\/or stock options in Sanofi.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}},{"value":"Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication have been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to\n                      \n                      .","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. An independent data and safety monitoring committee conducted blinded monitoring of patient safety data. The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. All patients, or their parents\/guardians, provided written informed consent before participating in the trial. Pediatric patients provided assent according to the Ethics Committee (Institutional Review Board\/Independent Ethics Committee)-approved standard practice for pediatric patients at each participating center.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"For each patient, written informed consent was obtained from a parent or legal guardian.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"A.S. Paller, E.C. Siegfried, M.J. Cork, and P.D. Arkwright acquired data. Z. Chen conducted the statistical analyses on the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}