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Here, we report results of the 20\u2010week interim analysis of the ongoing postmarketing surveillance study. Patients who received guselkumab between May 2018 (the date of commercial launch in Japan) and October 2020 were registered in this study. In total, 411 and 245 patients were included in the safety and effectiveness analysis sets, respectively. Adverse drug reactions (ADRs) occurred in 6.6% (27 of 411) and serious ADRs in 2.2% (nine of 411) of patients. The most frequent ADRs by System Organ Class were \u201cInfections and infestations\u201d (2.4%), with nasopharyngitis being the most frequently observed ADR (0.7%). The mean Psoriasis Area Severity Index score decreased from 11.6 at baseline to 6.5 at week 4 and 2.2 at week 20, with improvements achieving statistical significance at each time point. Clinical Global Impression, Dermatology Life Quality Index, and Nail Psoriasis Severity Index outcomesalso showed substantial improvements. Our findings demonstrate that guselkumab is well tolerated and effective in Japanese patients with psoriasis through 20\u2009weeks of treatment in real\u2010world clinical practice, showing significant effectiveness observed as early as 4\u2009weeks. The study was officially registered with the University Hospital Medical Information Network Clinical Trials Registry with the identifier UMIN000032969.<\/jats:p>","DOI":"10.1111\/1346-8138.17255","type":"journal-article","created":{"date-parts":[[2024,5,15]],"date-time":"2024-05-15T04:30:10Z","timestamp":1715747410000},"page":"779-790","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Safety and effectiveness of guselkumab in Japanese patients with psoriasis: 20\u2010week interim analysis of a postmarketing surveillance study"],"prefix":"10.1111","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3743-135X","authenticated-orcid":false,"given":"Yayoi","family":"Tada","sequence":"first","affiliation":[{"name":"Department of Dermatology Teikyo University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukako","family":"Sugiura","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K.  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