{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T20:40:12Z","timestamp":1791924012954,"version":"4.3.4"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,2,22]],"date-time":"2023-02-22T00:00:00Z","timestamp":1677024000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Janssen-Cilag B.V."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The effectiveness of available biologics for the treatment of hidradenitis suppurativa (HS) is limited. Additional therapeutic options are needed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To investigate the efficacy and mode of action of guselkumab [an anti-interleukin (IL)-23p19 monoclonal antibody] 200\u2005mg subcutaneously every 4 weeks for 16 weeks in patients with HS.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>An open-label, multicentre, phase IIa trial in patients with moderate-to-severe HS was carried out (NCT04061395). The pharmacodynamic response in skin and blood was measured after 16 weeks of treatment. Clinical efficacy was assessed using the Hidradenitis Suppurativa Clinical Response (HiSCR), the International Hidradenitis Suppurativa Severity Score System (IHS4), and the abscess and inflammatory nodule (AN) count. The protocol was reviewed and approved by the local institutional review board (METC 2018\/694), and the study was conducted in accordance with good clinical practice guidelines and applicable regulatory requirements.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Thirteen of 20 patients (65%) achieved HiSCR with a statistically significant decrease in median IHS4 score (from 8.5 to 5.0; P = 0.002) and median AN count (from 6.5 to 4.0; P = 0.002). The overall patient-reported outcomes did not show a similar trend. One serious adverse event, likely to be unrelated to guselkumab treatment, was observed. In lesional skin, transcriptomic analysis revealed the upregulation of various genes associated with inflammation, including immunoglobulins, S100, matrix metalloproteinases, keratin, B-cell and complement genes, which decreased in clinical responders after treatment. Immunohistochemistry revealed a marked decrease in inflammatory markers in clinical responders at week 16.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Sixty-five per cent of patients with moderate-to-severe HS achieved HiSCR after 16 weeks of treatment with guselkumab. We could not demonstrate a consistent correlation between gene and protein expression and clinical responses. The main limitations of this study were the small sample size and absence of a placebo arm. The large placebo-controlled phase IIb NOVA trial for guselkumab in patients with HS reported a lower HiSCR response of 45.0\u201350.8% in the treatment group and 38.7% in the placebo group. Guselkumab seems only to be of benefit in a subgroup of patients with HS, indicating that the IL-23\/T helper 17 axis is not central to the pathophysiology of HS.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljad010","type":"journal-article","created":{"date-parts":[[2023,2,22]],"date-time":"2023-02-22T16:46:20Z","timestamp":1677084380000},"page":"601-609","source":"Crossref","is-referenced-by-count":38,"title":["Guselkumab for hidradenitis suppurativa: a phase II, open-label, mode-of-action study"],"prefix":"10.1093","volume":"188","author":[{"given":"Koen","family":"Dudink","sequence":"first","affiliation":[{"name":"Laboratory for Experimental Immunodermatology"},{"name":"Department of Dermatology and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klasiena","family":"Bouwman","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Groningen, University Medical Center Groningen , Groningen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanqing","family":"Chen","sequence":"additional","affiliation":[{"name":"Translational Sciences and Medicine, Janssen Research & Development , San Diego, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel E","family":"DePrimo","sequence":"additional","affiliation":[{"name":"Formerly employed by Janssen Research & Development , San Diego, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto J","family":"Munoz-Elias","sequence":"additional","affiliation":[{"name":"Formerly employed by Janssen Research & Development , San Diego, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pim","family":"Aarts","sequence":"additional","affiliation":[{"name":"Department of Dermatology and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renske","family":"Schappin","sequence":"additional","affiliation":[{"name":"Department of Dermatology and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edwin F","family":"Florencia","sequence":"additional","affiliation":[{"name":"Laboratory for Experimental Immunodermatology"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bennie","family":"van Heeswijk","sequence":"additional","affiliation":[{"name":"Department of Rheumatology , Erasmus MC, University Medical Center Rotterdam , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisette M","family":"Prens","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Groningen, University Medical Center Groningen , Groningen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hessel H","family":"van der Zee","sequence":"additional","affiliation":[{"name":"Department of Dermatology and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Errol 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