{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T21:26:43Z","timestamp":1792099603027,"version":"4.4.0"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,4,17]],"date-time":"2024-04-17T00:00:00Z","timestamp":1713312000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Maruho Co. Ltd","award":["2011200017"],"award-info":[{"award-number":["2011200017"]}]},{"name":"Chugai Pharmaceutical Co. 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Current treatment options for PN in Japan are limited.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate the optimal dose, efficacy and safety of long-term treatment with nemolizumab in patients with PN in Japan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In a 16-week double-blind phase II\/III study, patients aged \u2265 13\u2005years with PN were randomly assigned (1 : 1 : 1) to nemolizumab 30-mg, 60-mg or placebo groups, with concomitant topical corticosteroids, every 4 weeks. The primary efficacy endpoint was the percentage change in the weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS) score (range 0\u201310, with higher scores indicating worse itching) from baseline to week 16. Secondary efficacy endpoints assessed the impact of treatment on pruritus, PN severity, sleep and quality of life.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>At week 16, the least-squares mean percentage change from baseline in the PP-NRS score was \u221261.1% in the nemolizumab 30-mg group (n = 77), \u221256.0% in the 60-mg group (n = 76), and \u221218.6% in the placebo group (n = 76). Differences between both nemolizumab groups and placebo were significant; the difference between the 30-mg and placebo groups was \u221242.5% [95% confidence interval (CI) \u221251.9 to \u221233.1; P &amp;lt; 0.0001], and between the 60-mg and placebo groups was \u221237.4% (95% CI \u221246.7 to \u221228.1; P &amp;lt; 0.0001). Patients treated with nemolizumab also had greater improvements in the number and severity of prurigo nodules, and in sleep and quality of life compared with the placebo group. Both nemolizumab doses were well tolerated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Improvements in PN were greater following nemolizumab treatment, despite continuation of topical corticosteroids in both groups.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljae131","type":"journal-article","created":{"date-parts":[[2024,4,17]],"date-time":"2024-04-17T19:01:41Z","timestamp":1713380501000},"page":"200-208","source":"Crossref","is-referenced-by-count":19,"title":["Efficacy and safety of nemolizumab and topical corticosteroids for prurigo nodularis: results from a\u00a0randomized double-blind placebo-controlled phase II\/III clinical study in patients aged \u2265 13\u2005years"],"prefix":"10.1093","volume":"191","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5773-9485","authenticated-orcid":false,"given":"Hiroo","family":"Yokozeki","sequence":"first","affiliation":[{"name":"Department of Dermatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0450-1377","authenticated-orcid":false,"given":"Hiroyuki","family":"Murota","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Nagasaki University Graduate School of Biomedical Sciences , Nagasaki , 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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