{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T03:09:05Z","timestamp":1785553745915,"version":"3.56.0"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,12,22]],"date-time":"2023-12-22T00:00:00Z","timestamp":1703203200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Janssen-Cilag GmbH"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,6,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The anti-interleukin-23 antibody guselkumab (GUS) demonstrated favourable week 24 efficacy and safety over fumaric acid esters (FAE) in systemic treatment-na\u00efve patients with moderate-to-severe plaque psoriasis (study part I).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To compare, in study part II, the sustainability of treatment responses (weeks 24\u201332) in GUS- and FAE-treated patients and treatment responses (weeks 32\u201356) in patients treated with GUS and FAE and in FAE nonresponders switching to GUS; and, in part III, to investigate the maintenance of response through week 100 in patients withdrawn from GUS at week 56.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>At week 0, systemic treatment-na\u00efve patients were randomized 1 : 1 to GUS or FAE as per label. At week 32, patients with a Psoriasis Area and Severity Index (PASI) 75 (\u2265 75% improvement in PASI score) response (r) continued assigned treatment (GUSr-GUS; FAEr-FAE), whereas nonresponders (nr) received GUS (FAEnr-GUS; GUSnr-GUS). GUS-treated patients with a week 56 PASI 90 response (\u2265 90% improvement in PASI score) were withdrawn (w) and followed until loss of response or week 100.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>At week 32, 98% (n = 54\/55) of GUS- and 41% (n = 14\/34) of FAE-treated patients were PASI 75 responders. At week 56, 91%, 50% and 80% of GUSr-GUS, FAEr-FAE and FAEnr-GUS patients, respectively, achieved a PASI 90 response; 72%, 29% and 45%, respectively, achieved a Dermatology Life Quality Index score of 0\/1. At week 100, 44 weeks postwithdrawal, 47% (n = 17\/36) and 25% (n = 3\/12) of GUS-GUSw and FAE\u00adGUSw patients, respectively, maintained a PASI score \u2264 5. Overall, the adverse event and discontinuation rates were lower for GUS than FAE.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In these exploratory analyses, GUS, as a first-line systemic treatment or second-line systemic treatment in FAE nonresponders, was associated with long-term clinical efficacy up to week 100, including a withdrawal period.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljad523","type":"journal-article","created":{"date-parts":[[2023,12,22]],"date-time":"2023-12-22T15:47:07Z","timestamp":1703260027000},"page":"36-48","source":"Crossref","is-referenced-by-count":5,"title":["Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-na\u00efve patients and nonresponders to fumaric acid esters: results from parts II and III of a randomized active-comparator-controlled phase IIIb trial\u00a0(POLARIS)"],"prefix":"10.1093","volume":"191","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8513-550X","authenticated-orcid":false,"given":"Diamant","family":"Tha\u00e7i","sequence":"first","affiliation":[{"name":"Institute and Comprehensive Centre for Inflammation Medicine, University of L\u00fcbeck , L\u00fcbeck , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Pinter","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venereology and Allergology, University Hospital of Frankfurt am Main , Frankfurt am Main , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Sebastian","sequence":"additional","affiliation":[{"name":"Dermatological Practice Dr. med. Michael Sebastian , Mahlow , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Termeer","sequence":"additional","affiliation":[{"name":"Dermatological Practice Prof. Dr. med. Christian Termeer , Stuttgart , Germany"},{"name":"University of Freiburg, Department of Dermatology , Freiburg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Sticherling","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Hospital of Erlangen, Psoriasis-Center, Deutsches Zentrum Immuntherapie , Erlangen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sascha","family":"Gerdes","sequence":"additional","affiliation":[{"name":"Psoriasis Center, Department of Dermatology, Venerology and Allergology, University Hospital Schleswig-Holstein , Campus Kiel, Kiel , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Knut","family":"Sch\u00e4kel","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University Hospital Heidelberg , Heidelberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven","family":"Wegner","sequence":"additional","affiliation":[{"name":"Janssen-Cilag GmbH , Neuss , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefanie","family":"Krampe","sequence":"additional","affiliation":[{"name":"Janssen-Cilag GmbH , Neuss , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger","family":"Bartz","sequence":"additional","affiliation":[{"name":"Janssen-Cilag GmbH , Neuss , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Rausch","sequence":"additional","affiliation":[{"name":"Janssen-Cilag GmbH , Neuss , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friedemann","family":"Taut","sequence":"additional","affiliation":[{"name":"Taut Science and Service GmbH , Konstanz , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kilian","family":"Eyerich","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venerology, Medical Center, University of Freiburg , Freiburg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,12,22]]},"reference":[{"key":"2024090210051385600_ljad523-B1","doi-asserted-by":"crossref","first-page":"1475","DOI":"10.3390\/ijms20061475","article-title":"Psoriasis pathogenesis and treatment","volume":"20","author":"Rendon","year":"2019","journal-title":"Int J Mol Sci"},{"key":"2024090210051385600_ljad523-B2","doi-asserted-by":"crossref","first-page":"1073","DOI":"10.1016\/j.jaad.2018.11.058","article-title":"Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities","volume":"80","author":"Elmets","year":"2019","journal-title":"J Am Acad 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