{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T10:04:12Z","timestamp":1784714652979,"version":"3.55.0"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2023,4,10]],"date-time":"2023-04-10T00:00:00Z","timestamp":1681084800000},"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":[[2023,7,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Early prediction of therapeutic response can optimize treatment strategies in atopic dermatitis (AD). Baricitinib is approved for moderate-to-severe AD in Europe, Japan and other countries.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To identify early clinical improvements that can reliably predict a later clinical response to baricitinib in adults with moderate-to-severe AD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Using data from one topical corticosteroid combination study [BREEZE-AD7 (NCT03733301)] and data pooled from two monotherapy studies [(BREEZE-AD1 (NCT03334396) and BREEZE-AD2 (NCT03334422)], we calculated the sensitivity and specificity, along with the positive predictive value (PPV) and negative predictive value (NPV), of predefined changes in single and combined clinical scores at weeks 2, 4 and 8, to predict clinical response at week 16. Clinical response was defined as \u2265 75% improvement in Eczema Area and Severity Index (EASI 75), \u2265 4-point improvement in Itch Numeric Rating Scale (Itch NRS \u2265 4), or a combination of both.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Composite predictors had higher predictive accuracy for week 16 response outcomes than did single parameters. This was evident as early as week 4 for the combination of EASI 50 or Itch NRS \u2265 3 and of validated Investigator Global Assessment for AD (vIGA-AD) score \u2264 2 or Itch NRS \u2265 3 (sensitivity 87\u2013100%; NPV 68\u2013100%). The predictive accuracy of these composite clinical predictors for week 16 response outcomes was highest at week 8 (sensitivity 92\u2013100%; NPV 80\u2013100%). At both weeks 4 and 8, EASI 50 or Itch NRS \u2265 3 had higher sensitivity and NPV than did vIGA-AD score \u2264 2 or Itch NRS \u2265 3.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Improvement in signs and symptoms early during treatment with baricitinib 4\u2005mg once daily predicts clinical response at week 16, providing a tool for dermatologists when choosing treatment strategies for patients with moderate-to-severe AD.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ced\/llad129","type":"journal-article","created":{"date-parts":[[2023,4,10]],"date-time":"2023-04-10T03:47:51Z","timestamp":1681098471000},"page":"881-888","source":"Crossref","is-referenced-by-count":8,"title":["Early improvements in signs and symptoms predict clinical response to baricitinib in patients with moderate-to-severe atopic dermatitis"],"prefix":"10.1093","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8800-3817","authenticated-orcid":false,"given":"Thomas","family":"Bieber","sequence":"first","affiliation":[{"name":"Department of Dermatology and Allergy, University of Bonn , Bonn , Germany"},{"name":"University Hospital , Bonn , Germany"},{"name":"Christine K\u00fchne \u2013 Center for Allergy Research and Education , Davos , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3770-1743","authenticated-orcid":false,"given":"Jacob P","family":"Thyssen","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Bispebjerg Hospital , Copenhagen , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9048-2044","authenticated-orcid":false,"given":"Alan D","family":"Irvine","sequence":"additional","affiliation":[{"name":"Clinical Medicine, Trinity College Dublin , Dublin , Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3590-6489","authenticated-orcid":false,"given":"Yuichiro","family":"Tsunemi","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Saitama Medical University , Saitama , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun-Fei","family":"Chen","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luna","family":"Sun","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Schloebe","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Riedl","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4428-2428","authenticated-orcid":false,"given":"Michael J","family":"Cork","sequence":"additional","affiliation":[{"name":"Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The Medical School, University of Sheffield , Sheffield , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,4,10]]},"reference":[{"key":"2023101015422028600_llad129-B1","author":"European Medicines Agency"},{"key":"2023101015422028600_llad129-B2","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":"2023101015422028600_llad129-B3","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":"2023101015422028600_llad129-B4","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1590\/abd1806-4841.20187682","article-title":"New and developing therapies for atopic dermatitis","volume":"93","author":"Hajar","year":"2018","journal-title":"An Bras Dermatol"},{"key":"2023101015422028600_llad129-B5","doi-asserted-by":"crossref","first-page":"850","DOI":"10.1111\/jdv.14888","article-title":"Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II","volume":"32","author":"Wollenberg","year":"2018","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2023101015422028600_llad129-B6","doi-asserted-by":"crossref","first-page":"413","DOI":"10.1016\/j.acvd.2017.01.011","article-title":"From evidence-based medicine to personalized medicine, with particular emphasis on drug-safety monitoring","volume":"110","author":"Ennezat","year":"2017","journal-title":"Arch Cardiovasc Dis"},{"key":"2023101015422028600_llad129-B7","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team"},{"key":"2023101015422028600_llad129-B8","doi-asserted-by":"crossref","first-page":"285","DOI":"10.1177\/1715163517710958","article-title":"Guidelines for the management of atopic dermatitis (eczema) for pharmacists","volume":"150","author":"Wong","year":"2017","journal-title":"Can Pharm J (Ott"},{"key":"2023101015422028600_llad129-B9","doi-asserted-by":"crossref","first-page":"445","DOI":"10.1007\/s40271-019-00373-y","article-title":"Patient-reported outcome measures in atopic dermatitis and chronic hand eczema in adults","volume":"12","author":"Barrett","year":"2019","journal-title":"Patient"},{"key":"2023101015422028600_llad129-B10","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1016\/j.jaad.2020.04.104","article-title":"The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD): the development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis","volume":"83","author":"Simpson","year":"2020","journal-title":"J\u00a0Am Acad Dermatol"},{"key":"2023101015422028600_llad129-B11","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":"2023101015422028600_llad129-B12","doi-asserted-by":"crossref","first-page":"606","DOI":"10.20344\/amp.11963","article-title":"Update on atopic dermatitis","volume":"32","author":"Torres","year":"2019","journal-title":"Acta Med Port"},{"key":"2023101015422028600_llad129-B13","author":"Weinblatt"},{"key":"2023101015422028600_llad129-B14","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1007\/s13555-021-00640-7","article-title":"Clinical tailoring of baricitinib 2\u2005mg in atopic dermatitis: baseline body surface area and rapid onset of action identifies response at week 16","volume":"12","author":"Silverberg","year":"2022","journal-title":"Dermatol Ther (Heidelb"},{"issue":"Suppl. 1","key":"2023101015422028600_llad129-B15","doi-asserted-by":"crossref","first-page":"S67","DOI":"10.1016\/j.jhep.2016.07.023","article-title":"Diagnostics in hepatitis C: the end of response-guided therapy?","volume":"65","author":"Maasoumy","year":"2016","journal-title":"J Hepatol"}],"container-title":["Clinical and Experimental Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ced\/advance-article-pdf\/doi\/10.1093\/ced\/llad129\/50474365\/llad129.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ced\/article-pdf\/48\/8\/881\/51990385\/llad129.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ced\/article-pdf\/48\/8\/881\/51990385\/llad129.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T15:43:53Z","timestamp":1696952633000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ced\/article\/48\/8\/881\/7111414"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,10]]},"references-count":15,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2023,4,10]]},"published-print":{"date-parts":[[2023,7,21]]}},"URL":"https:\/\/doi.org\/10.1093\/ced\/llad129","relation":{},"ISSN":["0307-6938","1365-2230"],"issn-type":[{"value":"0307-6938","type":"print"},{"value":"1365-2230","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,8]]},"published":{"date-parts":[[2023,4,10]]}}}