{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T05:43:09Z","timestamp":1784698989578,"version":"3.55.0"},"reference-count":23,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T00:00:00Z","timestamp":1716508800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Prurigo nodularis (PN) is an intensely pruritic disease characterized by itchy nodules on the trunk\/extremities; it is often accompanied by skin pain and sleep disruption with negative impacts on the quality of life (QoL). The patient\u2010reported outcome (PRO) instruments, Worst Itch\u2010Numeric Rating Scale (WI\u2010NRS), Skin Pain\u2010NRS, Sleep\u2010NRS and Dermatology Life Quality Index (DLQI) have been psychometrically validated and the clinically meaningful within\u2010patient improvement thresholds (responder definition) have been established through data pooled from the two Phase\u20103 trials (PRIME, NCT04183335 and PRIME2, NCT04202679) of dupilumab in adults with PN uncontrolled on topical therapies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To estimate the proportion of dupilumab\u2010treated patients (vs. placebo) achieving clinically meaningful improvement in itch, skin pain, sleep and QoL, either alone or in combination, from the data pooled from PRIME and PRIME2 trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The patient\u2010level data pooled from the two Phase\u20103 trials (<jats:italic>N<\/jats:italic>\u2009=\u2009311) were used for this post hoc analysis. Thresholds of clinically meaningful within\u2010patient improvement in PRO instrument scores from baseline at Week 24 used for defining responders were 4 (WI\u2010NRS and Skin Pain\u2010NRS), 2 (Sleep\u2010NRS) and 9 points (DLQI). The proportion of dupilumab\u2010treated patients, versus placebo, achieving the thresholds, and the time taken to achieve the thresholds were evaluated for the individual and combination of PROs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Responder rates were significantly higher with dupilumab, versus placebo at Week 24 for WI\u2010NRS (58.8% vs. 19.0%, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001), Skin Pain\u2010NRS (49.7% vs. 20.9%, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001), Sleep\u2010NRS (42.5% vs. 23.4%, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) and DLQI (64.7% vs. 22.8%, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). Proportion of patients achieving simultaneous improvement in symptoms and QoL (24.8% vs. 6.3%, <jats:italic>p\u2009&lt;<\/jats:italic>\u20090.0001) were significantly higher in dupilumab\u2010treated patients versus placebo. The time needed for achieving clinically meaningful improvement in symptoms were significantly lower in dupilumab\u2010treated patients, versus placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Significantly greater proportion of dupilumab\u2010treated patients with PN, versus placebo, demonstrated clinically meaningful improvements in PRO measures of symptoms and QoL.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.20099","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T12:33:37Z","timestamp":1716554017000},"page":"1965-1972","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Responder analysis using clinically meaningful thresholds: Post hoc analyses from randomized dupilumab clinical trials in patients with prurigo nodularis"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3736-1515","authenticated-orcid":false,"given":"Shawn G.","family":"Kwatra","sequence":"first","affiliation":[{"name":"Johns Hopkins Medical Institutions  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gil","family":"Yosipovitch","sequence":"additional","affiliation":[{"name":"University of Miami  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3612-7786","authenticated-orcid":false,"given":"Sonja","family":"St\u00e4nder","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Center for Chronic Pruritus University Hospital M\u00fcnster  M\u00fcnster Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Guillemin","sequence":"additional","affiliation":[{"name":"IQVIA  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00e9r\u00f4me","family":"Msihid","sequence":"additional","affiliation":[{"name":"Sanofi  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7371-6486","authenticated-orcid":false,"given":"Ashish","family":"Bansal","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc.  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Makhija","sequence":"additional","affiliation":[{"name":"Sanofi  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simmi","family":"Wiggins","sequence":"additional","affiliation":[{"name":"Sanofi  Reading UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Zahn","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc.  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan B.","family":"Thomas","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc.  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9887-8159","authenticated-orcid":false,"given":"Donia","family":"Bahloul","sequence":"additional","affiliation":[{"name":"Sanofi  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,24]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2020.04.183"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2021.5307"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.05.035"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2020.07.025"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2021.02.756"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.04.044"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2021.05.036"},{"key":"e_1_2_11_9_1","unstructured":"FDA approves first treatment for prurigo nodularis [press release]. 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