{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T01:03:04Z","timestamp":1792544584456,"version":"4.5.0"},"reference-count":12,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,10,19]],"date-time":"2022-10-19T00:00:00Z","timestamp":1666137600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Validated, inclusive and easy\u2010to\u2010use outcomes for hidradenitis suppurativa are essential both in the clinical trial setting and clinical practice. The continuous IHS4 is a validated tool that dynamically assesses nodules\/abscesses\/draining tunnels and classifies disease severity as mild\/moderate\/severe. However, dichotomous outcomes are often required for clinical trials reporting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To develop and validate a dichotomous outcome based on IHS4 that can be used in clinical trial settings and day\u2010to\u2010day clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>De\u2010identified data from the PIONEER\u2010I and \u2010II studies were accessed through Vivli. Potential IHS4 thresholds were analysed using baseline to Week 12 data from adalimumab\u2010 and placebo\u2010treated hidradenitis suppurativa patients in the PIONEER\u2010I trial. The final threshold was chosen based on its ability to discriminate between patients treated with adalimumab or placebo and its association with reduction in inflammatory lesions. The final threshold was validated using data from baseline to Week 12 from adalimumab\u2010 and placebo\u2010treated hidradenitis suppurativa patients in both the PIONEER\u2010II and the combined PIONEER\u2010I and \u2010II studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The best performing cut\u2010off for the IHS4 was a 55% reduction of the IHS4 score (IHS4\u201055). Patients who achieved the IHS4\u201055 had an odd's ratio of 2.00 [95%\u2010CI 1.26\u20133.18,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u20090.003], 2.79 (95%\u2010CI 1.76\u20134.43,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u20090.001) and 2.16 (95%\u2010CI 1.43\u20133.29,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u20090.001) for being treated with adalimumab rather than placebo in PIONEER\u2010I, PIONEER\u2010II and the combined dataset, respectively. Additionally, the achievement of the IHS4\u201055 was associated with a significant reduction in inflammatory nodules, abscesses and draining tunnels in all analysed datasets.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>IHS4\u201055,\u00a0a\u00a0novel dichotomous IHS4 version, based on a 55% reduction of the total score was developed. The IHS4\u201055 performs similarly to the HiSCR in discriminating between adalimumab\u2010 and placebo\u2010treated hidradenitis suppurativa patients and shows significant associations with reductions in lesion counts. Moreover, the IHS4\u201055 addresses some of the HiSCR drawbacks by dynamically including draining tunnels in a validated manner. By allowing the analysis of hidradenitis suppurativa patients with an abscess and nodule count below 3 but many draining tunnels, this outcome measure will improve inclusivity in clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdv.18632","type":"journal-article","created":{"date-parts":[[2022,10,3]],"date-time":"2022-10-03T02:18:25Z","timestamp":1664763505000},"page":"395-401","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":68,"title":["Development and validation of\n                    <scp>IHS4<\/scp>\n                    \u201055, an\n                    <scp>IHS4<\/scp>\n                    dichotomous outcome to assess treatment effect for hidradenitis suppurativa"],"prefix":"10.1111","volume":"37","author":[{"given":"Thrasivoulos","family":"Tzellos","sequence":"first","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Department of Dermatology Nordland Hospital Trust  Bod\u00f8 Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsey R.","family":"van Straalen","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Department of Dermatology University of Michigan  Ann Arbor Michigan USA"}],"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 e.V.  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 e.V.  Dessau Germany"},{"name":"Department of Dermatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah","family":"Goldfarb","sequence":"additional","affiliation":[{"name":"Departments of Medicine and Dermatology Minneapolis VA Health Care System  Minneapolis Minnesota USA"},{"name":"Departments of Medicine and Dermatology University of Minnesota  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wayne","family":"Gulliver","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Faculty of Medicine Memorial University of Newfoundland  St. John's Newfoundland Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor B. E.","family":"Jemec","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Department of Dermatology, Zealand University Hospital, Roskilde and Health Sciences Faculty University of Copenhagen  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle A.","family":"Lowes","sequence":"additional","affiliation":[{"name":"The Rockefeller University  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8160-4169","authenticated-orcid":false,"given":"Angelo Valerio","family":"Marzano","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  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":"Errol P.","family":"Prens","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Department of Dermatology Erasmus University Medical Center Rotterdam  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3201-4637","authenticated-orcid":false,"given":"Christopher J.","family":"Sayed","sequence":"additional","affiliation":[{"name":"Department of Dermatology University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hessel H.","family":"van der Zee","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Department of Dermatology Erasmus University Medical Center Rotterdam  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1646-2608","authenticated-orcid":false,"given":"Christos C.","family":"Zouboulis","sequence":"additional","affiliation":[{"name":"European Hidradenitis Suppurativa Foundation e.V.  Dessau Germany"},{"name":"Departments of Dermatology, Venereology, Allergology and Immunology, Dessau Medical Center Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg  Dessau Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,10,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2021.1677"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2022.02.003"},{"key":"e_1_2_9_4_1","article-title":"Interventions for hidradenitis suppurativa","volume":"2015","author":"Ingram JR","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2017.0432"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504370"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2018.05.040"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13270"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.14609"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.15748"},{"key":"e_1_2_9_11_1","unstructured":"InflaRx.InflaRx Announces Top\u2010Line SHINE Phase IIb Results for IFX\u20101 in Hidradenitis Suppurativa. Available at: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 June 05 2022)."},{"key":"e_1_2_9_12_1","unstructured":"InflaRx.InflaRx Reports Additional Analysis of the SHINE Phase IIb Results for IFX\u20101 in Hidradenitis Suppurativa. Available at: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 June 05 2022)."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdin.2020.09.005"}],"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.18632","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jdv.18632","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdv.18632","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T09:42:28Z","timestamp":1692697348000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdv.18632"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,19]]},"references-count":12,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1111\/jdv.18632"],"URL":"https:\/\/doi.org\/10.1111\/jdv.18632","archive":["Portico"],"relation":{},"ISSN":["0926-9959","1468-3083"],"issn-type":[{"value":"0926-9959","type":"print"},{"value":"1468-3083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,19]]},"assertion":[{"value":"2022-06-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-10-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}