{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T02:15:57Z","timestamp":1789524957945,"version":"build-2803163510"},"reference-count":36,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,10,3]],"date-time":"2022-10-03T00:00:00Z","timestamp":1664755200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the efficacy and safety of subcutaneous administration of 30 mg or 80 mg of ozoralizumab plus methotrexate (MTX) in patients with rheumatoid arthritis (RA) whose disease remained active despite MTX therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicenter, double\u2010blind, parallel\u2010group, placebo\u2010controlled phase II\/III trial, 381 patients were randomized to receive placebo, ozoralizumab 30 mg, or ozoralizumab 80 mg, plus MTX subcutaneously injected every 4\u2009weeks for 24\u2009weeks. The primary end points were the response rates based on the American College of Rheumatology 20% improvement criteria (ACR20) at week 16 and change in the Sharp\/van der Heijde score (\u0394SHS) from baseline to week 24.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The proportion of patients with an ACR20 response at week 16 was significantly higher (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001) in both ozoralizumab groups (79.6% for 30 mg, 75.3% for 80 mg), compared with placebo (37.3%); these improvements were observed from the first week of treatment. The proportion of the patients with structural nonprogression (\u0394SHS \u22640) was significantly higher in both ozoralizumab groups than in the placebo group. For some secondary end points, significantly greater improvements were observed starting from as early as day 3. Serious adverse events occurred in 4 patients in the ozoralizumab 30\u2010mg group and 5 patients in the ozoralizumab 80\u2010mg group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In patients with active RA who received ozoralizumab in combination with MTX, the signs and symptoms of RA were significantly reduced as compared with the outcomes in those receiving placebo. Ozoralizumab demonstrated acceptable tolerability with no new safety signals when compared with other antibodies against tumor necrosis factor.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.42273","type":"journal-article","created":{"date-parts":[[2022,6,21]],"date-time":"2022-06-21T23:54:18Z","timestamp":1655855658000},"page":"1776-1785","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":58,"title":["Phase II\/III Results of a Trial of Anti\u2013Tumor Necrosis Factor Multivalent NANOBODY Compound Ozoralizumab in Patients With Rheumatoid Arthritis"],"prefix":"10.1002","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1111-8218","authenticated-orcid":false,"given":"Tsutomu","family":"Takeuchi","sequence":"first","affiliation":[{"name":"Keio University School of Medicine, Tokyo, and Saitama Medical University  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4104-8548","authenticated-orcid":false,"given":"Masafumi","family":"Kawanishi","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megumi","family":"Nakanishi","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironori","family":"Yamasaki","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co., Ltd.  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