{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T17:59:56Z","timestamp":1788026396087,"version":"build-2784847793"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Keymed Biosciences (Chengdu) Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Stapokibart is a novel anti-interleukin-4 receptor \u03b1 (IL-4R\u03b1) monoclonal antibody approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the safety, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of stapokibart in children with moderate-to-severe AD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a multicentre open-label single-arm phase Ib\/IIa trial (NCT06162507) involving 8 weeks of treatment and 8 weeks of follow-up. Children aged 6\u201311\u2005years received subcutaneous stapokibart based on a bodyweight-tiered regimen (30\u201360\u2005kg: 300\u2005mg every 3 weeks for a total of three doses, including a 600-mg loading dose; 15\u201330\u2005kg: 150\u2005mg every 2 weeks for a total of four doses, including a 300-mg loading dose).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty-five patients (13 weighing 30\u201360\u2005kg; 12 weighing 15\u201330\u2005kg) received stapokibart; 68% reported mild or moderate adverse events. At week 8, 54% (n = 7\/13) of those weighing 30\u201360\u2005kg and 75% (n = 9\/12) of those weighing 15\u201330\u2005kg achieved a \u2265 75% improvement from baseline in Eczema Area and Severity Index. Stapokibart concentrations increased rapidly following the first dose, climbed further with repeated dosing and gradually declined after treatment discontinuation. Stapokibart reduced inflammatory biomarkers in both groups. No treatment-related antidrug antibodies were detected. No new safety signals emerged.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Stapokibart shows potential in improving disease outcomes and appears to be well tolerated in children aged 6\u201311\u2005years with moderate-to-severe AD. Larger controlled studies are needed to confirm long-term benefits.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljaf455","type":"journal-article","created":{"date-parts":[[2025,11,23]],"date-time":"2025-11-23T12:48:08Z","timestamp":1763902088000},"page":"621-628","source":"Crossref","is-referenced-by-count":7,"title":["Safety and efficacy of stapokibart, an anti-interleukin-4 receptor \u03b1 monoclonal antibody, in children aged 6\u201311\u2005years with moderate-to-severe atopic dermatitis: an open-label single-arm phase Ib\/IIa trial"],"prefix":"10.1093","volume":"194","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1885-4579","authenticated-orcid":false,"given":"Mutong","family":"Zhao","sequence":"first","affiliation":[{"name":"Department of Dermatology, Beijing Children\u2019s Hospital, Capital Medical University, National Key Discipline of Pediatrics, Key Laboratory of Major Diseases in Children, Ministry of Education, National Center for Children\u2019s Health , Beijing ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zigang","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Beijing Children\u2019s Hospital, Capital Medical University, National Key Discipline of Pediatrics, Key Laboratory of Major Diseases in Children, Ministry of Education, National Center for Children\u2019s Health , Beijing ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liming","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Affiliated Hangzhou First People\u2019s Hospital, School of Medicine, Westlake University , Hangzhou ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4533-7067","authenticated-orcid":false,"given":"Zhu","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Hunan Children\u2019s Hospital , Changsha, Hunan ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dermatology Hospital of Southern Medical University , Guangzhou ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9323-2035","authenticated-orcid":false,"given":"Zhimiao","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Dermatology Hospital of Southern Medical University , Guangzhou ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangfeng","family":"Ding","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine , Shanghai 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