{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T13:12:23Z","timestamp":1770469943006,"version":"3.49.0"},"reference-count":50,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T00:00:00Z","timestamp":1753660800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Early clinical development of novel psoriasis therapies is hampered by a decreasing number of moderate\u2010to\u2010severe psoriasis patients eligible for participation in trials since efficacious treatments, such as biologics, have become widely available. The aim of this study was to establish mild psoriasis patients as a suitable alternative trial population since these patients are generally not eligible for these treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized double\u2010blind controlled trial was performed in 20 mild psoriasis patients (psoriasis area and severity index\u2009\u22645), randomized 3:1 to guselkumab 100\u2009mg or placebo, and 5 moderate\u2010to\u2010severe psoriasis patients (psoriasis area and severity index\u2009\u226510) on guselkumab 100\u2009mg. Clinical scoring was performed over 24\u2009weeks and substantiated with multimodal imaging comprising multispectral imaging, optical coherence tomography and laser speckle contrast imaging.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Clinician\u2010reported outcomes demonstrated significant treatment effects compared to placebo in mild patients. Focusing on a target plaque, severity scores significantly decreased during treatment with guselkumab only. Imaging demonstrated significant decreases in erythema, maximal height within\u2010lesion and cutaneous perfusion compared to placebo. Plaques of mild and moderate\u2010to\u2010severe patients did not differ at baseline and showed similar treatment responses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Clinical scoring and multimodal lesion monitoring enabled the detection of a clear treatment effect of guselkumab in mild psoriasis patients. Although this trial was not powered to demonstrate equivalence between the severity groups, our results indicate that the treatment responses follow the same trend in mild and moderate\u2010to\u2010severe patients with a high degree of similarity. Therefore, mild patients can be considered a suitable study population for early phase proof\u2010of\u2010concept trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70179","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T07:24:38Z","timestamp":1753687478000},"page":"3378-3388","source":"Crossref","is-referenced-by-count":1,"title":["Mild psoriasis as a suitable model for proof\u2010of\u2010mechanism in a phase 1B setting: Results from a double\u2010blind placebo\u2010controlled trial with guselkumab"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0986-3753","authenticated-orcid":false,"given":"Jannik","family":"Rousel","sequence":"first","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"},{"name":"Leiden Academic Centre for Drug Research Leiden University  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Menthe E.","family":"Bergmans","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa J.","family":"Bruijnincx","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sissi","family":"Lin","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3221-1609","authenticated-orcid":false,"given":"Tessa Niemeyer\u2010van","family":"der Kolk","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roman","family":"Bohoslavsky","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yal\u00e7in","family":"Yavuz","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naomi B.","family":"Klarenbeek","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joke A.","family":"Bouwstra","sequence":"additional","affiliation":[{"name":"Leiden Academic Centre for Drug Research Leiden University  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5867-9090","authenticated-orcid":false,"given":"Robert","family":"Rissmann","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"},{"name":"Leiden Academic Centre for Drug Research Leiden University  Leiden the Netherlands"},{"name":"Leiden University Medical Centre  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martijn B. 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