{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T12:55:58Z","timestamp":1791896158615,"version":"4.3.4"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,7,31]],"date-time":"2023-07-31T00:00:00Z","timestamp":1690761600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Maruho Co. Ltd"},{"name":"Chugai Pharmaceutical Co. Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Atopic dermatitis (AD) is a chronic, inflammatory skin condition affecting up to one-quarter of children. Uncontrolled pruritus associated with childhood AD, and the accompanying scratching, negatively impacts quality of life (QoL), sleep and development. The humanized monoclonal antibody nemolizumab, used concomitantly with topical agents, was shown to reduce pruritus and improve QoL in patients with AD aged \u2265 13\u2005years. However, data relating to its efficacy and safety in younger children (aged &amp;lt; 13\u2005years) have been lacking.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate the efficacy and safety of nemolizumab, administered concomitantly with topical agents, in Japanese paediatric patients (aged 6\u201312\u2005years) with AD and inadequately controlled moderate-to-severe pruritus.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was a randomized, placebo-controlled, double-blind, parallel-group, multicentre, 16-week, phase III study. Patients aged \u2265 6 and &amp;lt; 13\u2005years, with confirmed AD, and an inadequate pruritic response despite treatment with topical agents and oral antihistamines were randomly assigned (1 : 1) to receive nemolizumab 30\u2005mg or placebo every 4 weeks (Q4W). The primary efficacy endpoint was the change in the weekly mean 5-level itch score from baseline to week 16; secondary efficacy endpoints were related to pruritus, indicators for AD and QoL. Safety was assessed via adverse events (AEs) and laboratory test results.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In total, 89 patients were enrolled, received either nemolizumab 30\u2005mg (n = 45) or placebo (n = 44) Q4W, and completed the study. The mean patient age was 9.1 (SD 1.9) years, and mean duration of AD was 8.5 (2.7) years. The change in 5-level itch score from baseline to week 16 showed a statistically significant difference in the nemolizumab treatment group (\u22121.3) compared with placebo (\u22120.5; least-squares mean difference \u22120.8, 95% confidence interval \u22121.1 to \u22120.5; P &amp;lt; 0.0001). Improvements with nemolizumab were observed from the second day of administration. Secondary endpoints were in favour of nemolizumab. No AEs resulted in discontinuation, and the overall safety profile in patients aged 6\u201312\u2005years was comparable with that in older patients (aged \u2265 13\u2005years) with AD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Nemolizumab is a potential new treatment option for paediatric patients with AD whose pruritus has not been sufficiently improved with topical treatments and antihistamines.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljad268","type":"journal-article","created":{"date-parts":[[2023,7,28]],"date-time":"2023-07-28T04:26:21Z","timestamp":1690518381000},"page":"20-28","source":"Crossref","is-referenced-by-count":52,"title":["Efficacy and safety of nemolizumab in paediatric patients aged 6\u201312\u2005years with atopic dermatitis with moderate-to-severe pruritus: results from a phase III, randomized, double-blind, placebo-controlled, multicentre study"],"prefix":"10.1093","volume":"190","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5903-3187","authenticated-orcid":false,"given":"Atsuyuki","family":"Igarashi","sequence":"first","affiliation":[{"name":"Department of Dermatology, NTT Medical Center Tokyo , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2646-3006","authenticated-orcid":false,"given":"Toshio","family":"Katsunuma","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0986-8469","authenticated-orcid":false,"given":"Takayo","family":"Matsumura","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Maruho Co. 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