{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T11:21:29Z","timestamp":1782904889426,"version":"3.54.5"},"reference-count":20,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,6,17]],"date-time":"2025-06-17T00:00:00Z","timestamp":1750118400000},"content-version":"unspecified","delay-in-days":77,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Taisho Pharmaceutical Co., Ltd., Tokyo, Japan"},{"name":"Taisho Pharmaceutical Co., Ltd."}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2025,6,5]]},"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>This study assessed the early effects of ozoralizumab (OZR) 30\u2009mg in patients with rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX-IR), drawing on OHZORA trial data for efficacy and safety insights.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The study included 141 patients with RA from the OHZORA trial, initiated on OZR 30\u2009mg. The primary measure was the rate of achieving low disease activity (LDA) by the Clinical Disease Activity Index (CDAI) 3\u2009days post-OZR initiation. Growth mixture modelling (GMM) of CDAI trajectories was performed to enable a more detailed analysis of the impact of OZR on disease activity improvement.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The retention rate of OZR up to 52 weeks was 87.9% (n=124). The LDA achievement rate on the third day of OZR introduction was 12.8% (n=18), and by week 52, 70.9% (n=100) had improved to LDA. Three distinct groups were identified using GMM: one group (n=78) reached LDA within 4 weeks of OZR initiation and maintained LDA up to week 52. Multiple logistic regression analysis revealed that both low baseline C-reactive protein (CRP) and low CDAI were independently associated with group membership.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>OZR 30\u202fmg demonstrated both immediate and sustained efficacy in MTX-IR patients with RA. Multivariate analysis suggested that both baseline inflammation and disease activity\u2014represented by CRP and CDAI\u2014may independently influence treatment response. However, residual confounding due to baseline disease activity cannot be completely excluded, and this remains a limitation of the present study.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2025-005710","type":"journal-article","created":{"date-parts":[[2025,6,19]],"date-time":"2025-06-19T08:10:15Z","timestamp":1750320615000},"page":"e005710","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Early effects of ozoralizumab 30 mg in patients with rheumatoid arthritis and inadequate response to methotrexate: a post hoc trajectory analysis of the phase II\/III OHZORA trial"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5692-3881","authenticated-orcid":false,"given":"Yusuke","family":"Miyazaki","sequence":"first","affiliation":[{"name":"First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuko","family":"Horiuchi","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co Ltd, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co Ltd, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rumiko","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co Ltd, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Saitama Medical University, Iruma, Japan"},{"name":"Keio University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan"},{"name":"Department of Molecular Targeted Therapies, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka Prefecture, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,6,19]]},"reference":[{"key":"2025090313514796000_11.2.e005710.1","doi-asserted-by":"crossref","first-page":"18001","DOI":"10.1038\/nrdp.2018.1","article-title":"Rheumatoid arthritis","volume":"4","author":"Smolen","year":"2018","journal-title":"Nat Rev Dis 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