{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,12]],"date-time":"2026-11-12T11:24:55Z","timestamp":1794482695150,"version":"4.9.1"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T00:00:00Z","timestamp":1680220800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,7,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Baricitinib, an oral selective Janus kinase (JAK)1\/JAK2 inhibitor, is approved in many countries for moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of three doses of baricitinib in combination with low-to-moderate potency topical corticosteroids in paediatric patients with moderate-to-severe AD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients (aged 2 to &amp;lt; 18\u2005years) were randomized (1 : 1 : 1 : 1) to once-daily baricitinib low dose (1\u2005mg equivalent), medium dose (2\u2005mg equivalent), high dose (4\u2005mg equivalent) or placebo for 16 weeks. The primary endpoint was the proportion of patients achieving a validated Investigator Global Assessment\u00ae (vIGA-AD) of 0\/1 with a \u2265 2-point improvement at week 16. Key secondary endpoints included the proportions of patients achieving \u2265 75% and \u2265 90% improvement in the Eczema Area and Severity Index (EASI-75 and EASI-90, respectively), \u2265 75% improvement in the SCORing Atopic Dermatitis (SCORAD 75), mean change from baseline in EASI score and proportion of patients achieving a 4-point improvement in the Itch Numeric Rating scale (NRS) for patients aged \u2265 10\u2005years. Primary and key secondary efficacy analyses were conducted on the intent-to-treat population and adjusted for multiplicity. Safety analyses included all randomized patients who received \u2265 1 dose of study treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 483 patients were randomized (mean age 12\u2005years). The baricitinib 4\u2005mg equivalent achieved a statistically significant (P &amp;lt; 0.05) improvement vs. placebo on all 16-week endpoints (vIGA 0\/1 with \u2265 2-point improvement, EASI-75, EASI-90, SCORAD 75, mean change in EASI score and Itch NRS 4-point improvement for patients aged \u2265 10\u2005years). Improvement (P &amp;lt; 0.05, non-multiplicity adjusted) was also observed for baricitinib 4\u2005mg equivalent vs. placebo in the ability to fall asleep and in reduction of topical corticosteroid use. Few patients discontinued due to adverse events (1.6% for placebo and 0.6% for those treated with baricitinib). There were no deaths, venous thromboembolic events, arterial thrombotic events, major adverse cardiovascular events, malignancies, gastrointestinal perforations or opportunistic infections seen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The results indicate that baricitinib offers a potential therapeutic option with a favourable benefit\u2013risk profile for paediatric patients with moderate-to-severe AD who are candidates for systemic therapies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljad096","type":"journal-article","created":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T06:00:45Z","timestamp":1680242445000},"page":"23-32","source":"Crossref","is-referenced-by-count":91,"title":["Efficacy and safety of baricitinib in combination with topical corticosteroids in paediatric patients with moderate-to-severe atopic dermatitis with an inadequate response to topical corticosteroids: results from a phase III, randomized, double-blind, placebo-controlled study (BREEZE-AD PEDS)"],"prefix":"10.1093","volume":"189","author":[{"given":"Antonio","family":"Torrelo","sequence":"first","affiliation":[{"name":"Department of Dermatology, Hospital Infantil Universitario Ni\u00f1o Jes\u00fas , Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Rewerska","sequence":"additional","affiliation":[{"name":"Diamond Clinic , Krak\u00f3w , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Galimberti","sequence":"additional","affiliation":[{"name":"Dermatology Service, Hospital Italiano de Buenos Aires , Buenos Aires , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Paller","sequence":"additional","affiliation":[{"name":"Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine , Chicago, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chin-Yi","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, New Taipei Municipal TuCheng Hospital , New Taipei City , Taiwan"},{"name":"Department of Dermatology, Linkou Chang Gung Memorial Hospital , Taoyuan , Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Apurva","family":"Prakash","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danting","family":"Zhu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco Antonio G","family":"Pontes Filho","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Shuo","family":"Wu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence F","family":"Eichenfield","sequence":"additional","affiliation":[{"name":"University of California San Diego and Rady Children\u2019s Hospital , San Diego, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,3,31]]},"reference":[{"key":"2023112114075718400_ljad096-B1","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1038\/jid.2010.251","article-title":"Eczema prevalence in the United States: data from the 2003 National Survey of Children\u2019s Health","volume":"131","author":"Shaw","year":"2011","journal-title":"J Invest Dermatol"},{"key":"2023112114075718400_ljad096-B2","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1001\/jamadermatol.2019.3336","article-title":"Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial","volume":"156","author":"Simpson","year":"2020","journal-title":"JAMA Dermatol"},{"key":"2023112114075718400_ljad096-B3","doi-asserted-by":"crossref","first-page":"1282","DOI":"10.1016\/j.jaad.2020.06.054","article-title":"Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11\u2005years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial","volume":"83","author":"Paller","year":"2020","journal-title":"J Am Acad Dermatol"},{"key":"2023112114075718400_ljad096-B4","author":"DUPIXENT\u00ae (dupilumab)"},{"key":"2023112114075718400_ljad096-B5","doi-asserted-by":"crossref","first-page":"s29","DOI":"10.25251\/skin.6.supp.s29","article-title":"Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial","volume":"6","author":"Paller","year":"2022","journal-title":"Skin"},{"key":"2023112114075718400_ljad096-B6","author":"Adtralza\u00ae (tralokinumab)"},{"key":"2023112114075718400_ljad096-B7","doi-asserted-by":"crossref","first-page":"2169","DOI":"10.1016\/S0140-6736(21)00589-4","article-title":"Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial","volume":"397","author":"Reich","year":"2021","journal-title":"Lancet"},{"key":"2023112114075718400_ljad096-B8","author":"RINVOQ\u2122 (upadacitinib)"},{"key":"2023112114075718400_ljad096-B9","doi-asserted-by":"crossref","first-page":"1165","DOI":"10.1001\/jamadermatol.2021.2830","article-title":"Efficacy and safety of abrocitinib in combination with topical therapy in adolescents with moderate-to-severe atopic dermatitis: the JADE TEEN randomized clinical trial","volume":"157","author":"Eichenfield","year":"2021","journal-title":"JAMA Dermatol"},{"key":"2023112114075718400_ljad096-B10","author":"CIBINQOTM (abrocitinib)"},{"key":"2023112114075718400_ljad096-B11","doi-asserted-by":"crossref","first-page":"5298","DOI":"10.4049\/jimmunol.0902819","article-title":"Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050","volume":"184","author":"Fridman","year":"2010","journal-title":"J Immunol"},{"key":"2023112114075718400_ljad096-B12","doi-asserted-by":"crossref","first-page":"913","DOI":"10.1016\/j.jaad.2018.01.018","article-title":"Baricitinib in adult patients with moderate-to-severe atopic dermatitis: a phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study","volume":"80","author":"Guttman-Yassky","year":"2018","journal-title":"J Am Acad Dermatol"},{"key":"2023112114075718400_ljad096-B13","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1111\/bjd.18898","article-title":"Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials","volume":"183","author":"Simpson","year":"2020","journal-title":"Br J Dermatol"},{"key":"2023112114075718400_ljad096-B14","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.1001\/jamadermatol.2020.3260","article-title":"Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis: a randomized clinical trial","volume":"156","author":"Reich","year":"2020","journal-title":"JAMA Dermatol"},{"key":"2023112114075718400_ljad096-B15","doi-asserted-by":"crossref","first-page":"62","DOI":"10.1016\/j.jaad.2021.02.028","article-title":"Baricitinib in patients with moderate-to-severe atopic dermatitis: results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5)","volume":"85","author":"Simpson","year":"2021","journal-title":"J Am Acad Dermatol"},{"key":"2023112114075718400_ljad096-B16","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1111\/bjd.21630","article-title":"Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance or contraindication to ciclosporin: results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4)","volume":"187","author":"Bieber","year":"2022","journal-title":"Br J Dermatol"},{"key":"2023112114075718400_ljad096-B17","doi-asserted-by":"crossref","DOI":"10.1016\/j.jaad.2021.06.450","article-title":"Baricitinib for the treatment of pediatric patients with moderate-to-severe atopic dermatitis","volume":"85","author":"Paller","year":"2021","journal-title":"J Am Acad Dermatol"},{"key":"2023112114075718400_ljad096-B18","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1016\/j.jaad.2013.10.010","article-title":"Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis","volume":"70","author":"Eichenfield","year":"2014","journal-title":"J Am Acad Dermatol"},{"key":"2023112114075718400_ljad096-B19","author":"International Conference on Harmonisation"},{"key":"2023112114075718400_ljad096-B20","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.aay4447","article-title":"JAK inhibition increases bone mass in steady-state conditions and ameliorates pathological bone loss by stimulating osteoblast function","volume":"12","author":"Adam","year":"2020","journal-title":"Sci Transl Med"}],"container-title":["British Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/bjd\/advance-article-pdf\/doi\/10.1093\/bjd\/ljad096\/50416411\/ljad096.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/189\/1\/23\/53664815\/ljad096.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/189\/1\/23\/53664815\/ljad096.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,21]],"date-time":"2023-11-21T15:59:02Z","timestamp":1700582342000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjd\/article\/189\/1\/23\/7097622"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,31]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,3,31]]},"published-print":{"date-parts":[[2023,7,7]]}},"URL":"https:\/\/doi.org\/10.1093\/bjd\/ljad096","relation":{},"ISSN":["0007-0963","1365-2133"],"issn-type":[{"value":"0007-0963","type":"print"},{"value":"1365-2133","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,7]]},"published":{"date-parts":[[2023,3,31]]}}}