{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T17:58:47Z","timestamp":1788026327291,"version":"build-2784847793"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T00:00:00Z","timestamp":1771200000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Keymed Biosciences"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Moderate-to-severe atopic dermatitis (AD) imposes a significant burden on adolescents and their families, leading to a substantial reduction in quality of life. Treatment options remain limited. Stapokibart, a novel humanized monoclonal antibody that targets interleukin-4R\u03b1, has been approved in China for the treatment of adults with moderate-to-severe AD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of stapokibart in adolescents with moderate-to-severe AD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this randomized double-blind placebo-controlled phase III trial (NCT06277765), eligible patients were randomized (2 : 1) to stapokibart 300\u2005mg (loading dose 600\u2005mg) or placebo for 18 weeks. Patients with a baseline weight \u2265 60\u2005kg received subcutaneous stapokibart or placebo every 2 weeks (Q2W), while those weighing 30 to &amp;lt; 60\u2005kg received treatment every 3 weeks (Q3W). All patients were given moisturizers during the entire study period. Co-primary endpoints were the proportions of patients achieving a \u2265 75% improvement from baseline in Eczema Area and Severity Index (EASI 75) and an Investigator\u2019s Global Assessment (IGA) score of clear or almost clear (IGA 0 or 1) with \u2265 2-point reduction from baseline (IGA response) at week 18. Safety was also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 180 enrolled patients, 120 received stapokibart (Q2W, n = 54; Q3W, n = 66) and 60 received placebo (Q2W, n = 26; Q3W, n = 34). In total, 178 (98.9%) patients completed the double-blind treatment. At week 18, higher proportions of patients treated with stapokibart than those treated with placebo achieved EASI 75 [73.9% (n = 88\/119) vs. 43% (n = 26\/60); difference: 30.5% (95% confidence interval 15.3\u201344.3; P &amp;lt; 0.001)] and an IGA response [57.1% (n = 68\/119) vs. 25% (n = 15\/60); difference: 31.8% (95% confidence interval 16.6\u201344.4; P &amp;lt; 0.001)]. The proportion of patients achieving \u2265 4-point reductions in weekly average of daily Peak Pruritus Numerical Rating Scale score was also significantly higher in the stapokibart group than in the placebo group [36.1% (n = 43\/119) vs. 15% (n = 9\/60); difference: 21.1% (95% confidence interval 7.4\u201332.4; P = 0.004)]. The incidence of adverse events was similar between the stapokibart (62.5%; n = 75\/120) and placebo (62%; n = 37\/60) groups. No conjunctivitis was seen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Stapokibart has a high efficacy and favourable safety in adolescents with moderate-to-severe AD.<\/jats:p>\n                    <jats:p>An author video to accompany this article is available online.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljag052","type":"journal-article","created":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T12:48:10Z","timestamp":1770986890000},"page":"1067-1076","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial"],"prefix":"10.1093","volume":"194","author":[{"given":"Cheng","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Dermatology, Peking University 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