{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T04:02:04Z","timestamp":1792728124793,"version":"4.5.0"},"reference-count":22,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T00:00:00Z","timestamp":1687824000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","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":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that causes substantial physical, emotional and psychological burdens. Guselkumab, a monoclonal antibody that binds to the p19 subunit of interleukin\u201023, has demonstrated high levels of efficacy in the treatment of inflammatory diseases, including psoriasis and psoriatic arthritis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the effect of guselkumab on the treatment of HS, a phase 2, multicentre, randomized, placebo\u2010controlled, double\u2010blind, proof\u2010of\u2010concept study was conducted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients \u226518\u2009years of age with moderate\u2010to\u2010severe HS for \u22651\u2009year were randomized to (1) guselkumab 200\u2009mg by subcutaneous (SC) injection every 4\u2009weeks (q4w) through Week 36 (guselkumab SC); (2) guselkumab 1200\u2009mg intravenously (IV) q4w for 12\u2009weeks, then switched to guselkumab 200\u2009mg SC q4w from Weeks 12 through 36 (guselkumab IV); or (3) placebo for 12\u2009weeks, with re\u2010randomization to guselkumab 200\u2009mg SC q4w at Weeks 16 through 36 (placebo\u2009\u2192\u2009guselkumab 200\u2009mg) or guselkumab 100\u2009mg SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32 (placebo\u2009\u2192\u2009guselkumab 100\u2009mg). End points included HS clinical response (HiSCR) and patient\u2010reported outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Although guselkumab SC or guselkumab IV resulted in numerically higher HiSCR versus placebo at Week 16 (50.8%, 45.0%, 38.7%, respectively), statistical significance was not achieved. Numerically greater improvements in patient\u2010reported outcomes were also observed for guselkumab SC and guselkumab IV versus placebo at Week 16. Through Week 40, no clear differences to suggest a dose response were observed for HiSCR and patient\u2010reported outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Despite modest improvements, the primary end point was not met and the overall findings do not support the efficacy of guselkumab in the treatment of HS. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link>: NCT 03628924.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.19252","type":"journal-article","created":{"date-parts":[[2023,6,15]],"date-time":"2023-06-15T04:12:08Z","timestamp":1686802328000},"page":"2098-2108","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Guselkumab for the treatment of patients with moderate\u2010to\u2010severe hidradenitis suppurativa: A phase 2 randomized study"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9405-0479","authenticated-orcid":false,"given":"Alexa B.","family":"Kimball","sequence":"first","affiliation":[{"name":"Department of Dermatology Beth Israel Deaconess Medical Center and Harvard Medical School  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Podda","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Medical Center Klinikum Darmstadt Teaching Hospital Goethe\u2010University Frankfurt  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1171-4917","authenticated-orcid":false,"given":"Afsaneh","family":"Alavi","sequence":"additional","affiliation":[{"name":"Department of Dermatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Miller","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaung\u2010Kaung","family":"Shen","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu","family":"Li","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Xu","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenglong","family":"Han","sequence":"additional","affiliation":[{"name":"Patient\u2010Reported Outcomes Janssen Global Services, LLC  Malvern Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Fakharzadeh","sequence":"additional","affiliation":[{"name":"Immunology Global Medical Affairs Janssen Pharmaceutical Companies of Johnson &amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya\u2010Wen","family":"Yang","sequence":"additional","affiliation":[{"name":"Immunology Global Medical Affairs Janssen Pharmaceutical Companies of Johnson &amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"DePrimo","sequence":"additional","affiliation":[{"name":"Zentalis Pharmaceuticals  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto","family":"Munoz","sequence":"additional","affiliation":[{"name":"Prometheus Biosciences  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9534-6199","authenticated-orcid":false,"given":"Yanqing","family":"Chen","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0797-6570","authenticated-orcid":false,"given":"Thierry","family":"Passeron","sequence":"additional","affiliation":[{"name":"Department of Dermatology CHU Nice, Cote d'Azur University  Nice France"},{"name":"C3M, INSERM U1065 Cote d'Azur University  Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9557-3642","authenticated-orcid":false,"given":"Kim","family":"Papp","sequence":"additional","affiliation":[{"name":"Alliance Clinical Trials and Probity Medical Research, Inc  Waterloo Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,6,27]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp1014163"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpobgyn.2014.07.012"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.5070\/D3237035729"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2018.02965"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-017-0647-3"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-021-01566-2"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coph.2019.04.006"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2010.07.010"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.15368"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.041"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41553"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.42010"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2016.11.042"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504370"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-016-0502-4"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdin.2020.09.005"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2020.07.040"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.17716"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2019.05.016"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2021-001679"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2014.01.025"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.7326\/M22-1460"}],"container-title":["Journal of the European Academy of Dermatology and Venereology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.19252","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T13:14:32Z","timestamp":1711026872000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.19252"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,27]]},"references-count":22,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["10.1111\/jdv.19252"],"URL":"https:\/\/doi.org\/10.1111\/jdv.19252","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,27]]},"assertion":[{"value":"2023-01-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-05-10","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-06-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}