{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T16:46:22Z","timestamp":1793119582910,"version":"4.5.0"},"reference-count":24,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2023,6,1]]},"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>Safe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of interleukin-13\u2013targeted treatment with tralokinumab monotherapy in adolescents with AD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>The 52-week, randomized, double-blinded, placebo-controlled, phase 3 ECZTRA 6 trial was conducted from July 17, 2018, through March 16, 2021, at 72 centers across 10 countries in North America, Europe, Asia, and Australia. Enrolled patients were 12 to 17 years old with moderate to severe AD (Investigator\u2019s Global Assessment [IGA] score \u22653; Eczema Area and Severity Index [EASI] \u226516).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Patients were randomized (1:1:1) to tralokinumab (150 or 300 mg) or placebo every 2 weeks for 16 weeks. Patients with an IGA score of 0 (clear) or 1 (almost clear) and\/or 75% or higher improvement in EASI (EASI 75) at week 16 without rescue medication received maintenance treatment; other patients switched to open-label tralokinumab, 300 mg, every 2 weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>Primary end points at week 16 were an IGA score of 0 or 1 and\/or achieving EASI 75. Key secondary end points were a reduction of Adolescent Worst Pruritus Numeric Rating Scale of 4 or more, change in SCORing AD, and change in Children\u2019s Dermatology Life Quality Index from baseline to week 16. Safety end points were the number of adverse events and serious adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 301 patients randomized, 289 comprised the full analysis set (median [IQR] age, 15.0 [13.0-16.0] years; 149 [51.6%] male). More patients receiving tralokinumab, 150 mg, (n\u2009=\u200998), and tralokinumab, 300 mg (n\u2009=\u200997), achieved an IGA score of 0 or 1 without rescue medication at week 16 (21 [21.4%] and 17 [17.5%], respectively) vs placebo (n\u2009=\u200994; 4 [4.3%]) (adjusted difference, 17.5% [95% CI, 8.4%-26.6%]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001 and 13.8% [95% CI, 5.3%-22.3%]; <jats:italic>P<\/jats:italic>\u2009=\u2009.002, respectively). More patients receiving tralokinumab, 150 mg (28 [28.6%]), and tralokinumab, 300 mg, (27 [27.8%]) vs placebo (6 [6.4%]) achieved EASI 75 without rescue at week 16 (adjusted difference, 22.5% [95% CI, 12.4%-32.6%]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001 and 22.0% [95% CI, 12.0%-32.0%]; <jats:italic>P<\/jats:italic>\u2009&amp;amp;lt;\u2009.001, respectively). Proportions of patients with Adolescent Worst Pruritus Numeric Rating Scale reduction of 4 or more from baseline were greater with tralokinumab, 150 mg (23.2%), and tralokinumab, 300 (25.0%), vs placebo (3.3%), and adjusted mean changes were greater in SCORing AD with tralokinumab, 150 mg (\u201327.5), and tralokinumab, 300 mg (\u201329.1), vs placebo (\u20139.5) and in Children\u2019s Dermatology Life Quality Index with tralokinumab, 150 mg (\u20136.1), and tralokinumab, 300 mg (\u20136.7), vs placebo (\u20134.1) at week 16. At week 52, tralokinumab efficacy was maintained without rescue in more than 50% of patients meeting primary end point(s) at week 16. In the open-label phase, IGA score of 0 or 1 and EASI 75 were achieved in 33.3% and 57.8%, respectively, at week 52. Tralokinumab was well tolerated, without frequency of conjunctivitis increasing through week 52.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Relevance<\/jats:title><jats:p>In this randomized clinical trial, tralokinumab was efficacious and well tolerated, supporting its value for treating adolescents with moderate to severe AD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03526861?term=NCT03526861&amp;amp;amp;draw=2&amp;amp;amp;rank=1\">NCT03526861<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamadermatol.2023.0627","type":"journal-article","created":{"date-parts":[[2023,4,19]],"date-time":"2023-04-19T15:02:20Z","timestamp":1681916540000},"page":"596","source":"Crossref","is-referenced-by-count":146,"title":["Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis"],"prefix":"10.1001","volume":"159","author":[{"given":"Amy S.","family":"Paller","sequence":"first","affiliation":[{"name":"Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten","family":"Flohr","sequence":"additional","affiliation":[{"name":"Department of Paediatric Dermatology, St John\u2019s Institute of Dermatology, Guy\u2019s and St Thomas\u2019 NHS Foundation Trust, King\u2019s College London, London, England, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Cork","sequence":"additional","affiliation":[{"name":"Sheffield Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Children\u2019s Hospitals, Clinical Research Facility, Sheffield, England, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Bewley","sequence":"additional","affiliation":[{"name":"Barts Health NHS Trust, London, England, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Blauvelt","sequence":"additional","affiliation":[{"name":"Oregon Medical Research Center, Portland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. Chih-ho","family":"Hong","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Imafuku","sequence":"additional","affiliation":[{"name":"Fukuoka University, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie L. A.","family":"Schuttelaar","sequence":"additional","affiliation":[{"name":"University Medical Center Groningen, University of Groningen, Groningen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric L.","family":"Simpson","sequence":"additional","affiliation":[{"name":"Oregon Health & Science University, Portland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weily","family":"Soong","sequence":"additional","affiliation":[{"name":"AllerVie Health\/Alabama Allergy & Asthma Center, Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Arlert","sequence":"additional","affiliation":[{"name":"LEO Pharma A\/S, Ballerup, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja Wendicke","family":"Lophaven","sequence":"additional","affiliation":[{"name":"LEO Pharma A\/S, Ballerup, 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