{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T02:35:30Z","timestamp":1792204530723,"version":"4.4.0"},"reference-count":16,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,10,19]],"date-time":"2024-10-19T00:00:00Z","timestamp":1729296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","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":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated tool that measures inflammatory lesions, including draining tunnels, in hidradenitis suppurativa (HS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate secukinumab efficacy using IHS4 in patients with moderate to severe HS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data from the SUNSHINE and SUNRISE trials, which assessed subcutaneous secukinumab 300\u2009mg every 2 (SECQ2W) and 4 (SECQ4W) weeks in adults with moderate to severe HS, were analyzed. Assessments included changes from baseline in IHS4 and severity classification up to Week 52; IHS4\u201055, IHS4\u201075, IHS4\u201090 responses (55%, 75% and 90% reduction in IHS4) and concordance between IHS4\u201055 and HS clinical response (HiSCR), at Weeks 16 and 52.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 1084 patients (SECQ2W\u2009=\u2009361; SECQ4W\u2009=\u2009360; placebo\u2009=\u2009363) were analyzed. At Week 16, SECQ2W and SECQ4W demonstrated a numerically higher reduction in IHS4 from baseline versus placebo (adjusted mean [95% CI]: \u221210.80 [\u221212.30 to \u22129.30] and \u22129.46 [\u221210.96 to \u22127.96] vs. \u22124.92 [\u22126.43 to \u22123.41]); the reduction was maintained until Week 52 in both dose regimens. A greater proportion of patients achieved IHS4\u201055 with SECQ2W (43.4%) and SECQ4W (39.5%) versus placebo (31.5%) at Week 16, with further improvement at Week 52. Similar trends were observed for IHS4\u201075 and IHS4\u201090 responses. While no patients had mild disease based on IHS4 (80.7% had severe and 19.3% had moderate HS) at baseline, a greater proportion of patients were categorized as having mild disease at Week 16 in the SECQ2W (25.9%) and SECQ4W (24.0%) groups versus placebo (16.4%); this trend continued up to Week 52 in both dose regimens. Strong concordance (&gt;85%) was observed between IHS4\u201055 and HiSCR.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Both SECQ2W and SECQ4W demonstrated efficacy in improving treatment response as measured by IHS4 and reducing disease severity versus placebo at Week 16 and these improvements were sustained through Week 52. These findings support that the dynamic and dichotomous IHS4 can efficiently detect treatment response changes in clinical trial settings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trials Registration<\/jats:title><jats:p>SUNSHINE (NCT03713619); SUNRISE (NCT03713632).<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.20369","type":"journal-article","created":{"date-parts":[[2024,10,19]],"date-time":"2024-10-19T03:49:07Z","timestamp":1729309747000},"page":"1421-1430","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (<scp>IHS4<\/scp>): A post hoc analysis of the <scp>SUNSHINE<\/scp> and <scp>SUNRISE<\/scp> trials"],"prefix":"10.1111","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1646-2608","authenticated-orcid":false,"given":"Christos C.","family":"Zouboulis","sequence":"first","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg  Dessau Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3896-0309","authenticated-orcid":false,"given":"Athanassios","family":"Kyrgidis","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Department of Maxillofacial Surgery, Papanikolaou General Hospital of Thessaloniki Aristotle University of Thessaloniki  Thessaloniki Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1171-4917","authenticated-orcid":false,"given":"Afsaneh","family":"Alavi","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Department of Dermatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor B. E.","family":"Jemec","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Department of Dermatology Zeeland University Hospital  Roskilde Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences University of Copenhagen  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Martorell","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Department of Dermatology Hospital de Manises  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8160-4169","authenticated-orcid":false,"given":"Angelo V.","family":"Marzano","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Dermatology Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico  Milan Italy"},{"name":"Department of Pathophysiology and Transplantation Universit\u00e0 Degli Studi di Milano  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hessel H.","family":"van der Zee","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Department of Dermatology Erasmus Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena B.","family":"Wozniak","sequence":"additional","affiliation":[{"name":"Novartis Ireland Limited  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela Llobet","family":"Martinez","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torben","family":"Kasparek","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Bachhuber","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine\u2010Elke","family":"Ortmann","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iryna","family":"Lobach","sequence":"additional","affiliation":[{"name":"Novartis Ireland Limited  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Thomas","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoba","family":"Ravichandran","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thrasyvoulos","family":"Tzellos","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation (EHSF)  Dessau Germany"},{"name":"Department of Dermatology Nordland Hospital Trust  Bod\u00f8 Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,19]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1159\/000431175"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.14123"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13216"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.14609"},{"key":"e_1_2_13_6_1","first-page":"623","volume-title":"Dermatologic Surgery. 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Available from:https:\/\/www.inflarx.de\/Home\/Investors\/Press\u2010Releases\/07\u20102019\u2010InflaRx\u2010Reports\u2010Additional\u2010Analysis\u2010of\u2010the\u2010SHINE\u2010Phase\u2010IIb\u2010Results\u2010for\u2010IFX\u20101\u2010in\u2010Hidradenitis\u2010Suppurativa\u2010.html(Accessed March 05 2024)."},{"key":"e_1_2_13_16_1","unstructured":"InflaRx.InflaRx announces top\u2010line SHINE Phase IIb results for IFX\u20101 in hidradenitis suppurativa. Available from:https:\/\/www.inflarx.de\/Home\/Investors\/Press\u2010Releases\/06\u20102019\u2010InflaRx\u2010Announces\u2010\u2010Top\u2010Line\u2010SHINE\u2010Phase\u2010IIb\u2010Results\u2010for\u2010IFX\u20101\u2010in\u2010Hidradenitis\u2010Suppurativa\u2010.html(Accessed March 05 2024)."},{"key":"e_1_2_13_17_1","first-page":"e496","article-title":"International hidradenitis suppurativa severity scoring system (IHS4) as a holistic measure of hidradenitis suppurativa disease severity compared with Hurley staging: a post hoc analysis of the SUNRISE and SUNSHINE phase 3 trials of secukinumab","volume":"38","author":"Zouboulis CC","year":"2023","journal-title":"J Eur Acad Dermatol Venereol"}],"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.20369","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,4]],"date-time":"2025-08-04T07:20:52Z","timestamp":1754292052000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.20369"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,19]]},"references-count":16,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1111\/jdv.20369"],"URL":"https:\/\/doi.org\/10.1111\/jdv.20369","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,19]]},"assertion":[{"value":"2024-04-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-09-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}