{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T03:36:16Z","timestamp":1785209776592,"version":"3.55.0"},"reference-count":36,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T00:00:00Z","timestamp":1645574400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>S\u2010flurbiprofen plaster (SFPP) is a novel topical nonsteroidal anti\u2010inflammatory drug (NSAID) patch. This study aimed to assess the efficacy and safety of SFPP in knee osteoarthritis (OA) patients compared to diclofenac gel.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study was a multicenter, randomized, active\u2010controlled, open\u2010label, non\u2010inferiority phase III trial. There were 311 enrolled patients treated by SFPP or diclofenac gel for 2\u00a0weeks. The primary efficacy outcome was the knee pain when rising from the specially arranged chair assessed by visual analog scale (rVAS). The other efficacy outcomes were clinical symptoms, pain on walking, global assessment by both investigator and patient, and use\/non\u2010use of the rescue drugs during the treatment period. Adverse events (AEs) were evaluated as the safety outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The least\u2010squares mean (95% CI) of \u0394rVAS at the end of the study was 41.52 (39.16\u201043.88) mm in the SFPP group and 36.01 (33.69\u201038.33) mm in the diclofenac gel group, with a between\u2010group difference of 5.51 (2.20\u20108.82), indicating non\u2010inferiority. There were statistically significant differences between the groups in rVAS, clinical symptoms, pain on walking, and the global assessment by both investigator and patient. The incidence rate of AEs in the SFPP group was 5.8%, and there was no statistically significant difference from that in the diclofenac gel group (5.2%). Most of the AEs were mild, and no AE led to discontinuation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Non\u2010inferiority of SFPP to diclofenac gel was demonstrated in the efficacy for pain on rising from a chair. SFPP was also well\u2010tolerated in knee OA patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.14307","type":"journal-article","created":{"date-parts":[[2022,2,24]],"date-time":"2022-02-24T06:04:13Z","timestamp":1645682653000},"page":"563-570","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and safety of S\u2010flurbiprofen plaster in knee osteoarthritis patients: A 2\u2010week randomized controlled Phase III clinical trial compared to diclofenac gel"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2856-7514","authenticated-orcid":false,"given":"Kenji","family":"Tomatsu","sequence":"first","affiliation":[{"name":"International Business Headquarter Taisho Pharmaceutical Co., Ltd.  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