{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T13:57:44Z","timestamp":1790863064814,"version":"4.1.0"},"reference-count":52,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2021,8,13]],"date-time":"2021-08-13T00:00:00Z","timestamp":1628812800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,4,18]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The objective of this study is to evaluate efficacy and safety of abatacept in biologic-na\u00efve, anti-citrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) by background methotrexate (MTX) dose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this post hoc analysis of a randomized, double-blind, placebo-controlled phase 4 study (NCT01758198), patients received intravenous abatacept (\u223c10\u2009mg\/kg) or placebo both with MTX (\u22656\u2009mg\/week). Efficacy (Disease Activity Score 28 using C-reactive protein [DAS28 (CRP)] and Health Assessment Questionnaire-Disability Index [HAQ-DI]) was assessed by baseline MTX dosage (\u22648 and &amp;gt;8\u2009mg\/week) to week 16; safety was assessed by MTX dosage \u22648 and &amp;gt;8\u2009mg\/week. Change from baseline in DAS28 (CRP) and HAQ-DI was assessed using longitudinal repeated measures analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 101 and 102 patients received abatacept\u2009+\u2009MTX \u22648 and &amp;gt;8\u2009mg\/week, while 96 and 106 patients received placebo\u2009+\u2009MTX \u22648 and &amp;gt;8\u2009mg\/week, respectively. Regardless of baseline MTX dose received, mean changes from baseline in DAS28 (CRP) and HAQ-DI in abatacept groups were similar; repeated measures analysis showed similar trends in changes from baseline in DAS28 (CRP) and HAQ-DI. Abatacept safety profile was consistent with previous observations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Post hoc analysis demonstrated similar efficacy and safety of abatacept in biologic-na\u00efve ACPA-positive Japanese patients with RA regardless of baseline MTX dose.<\/jats:p><\/jats:sec>","DOI":"10.1093\/mr\/roab029","type":"journal-article","created":{"date-parts":[[2021,12,13]],"date-time":"2021-12-13T11:09:39Z","timestamp":1639393779000},"page":"500-507","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy and safety of abatacept in biologic-na\u00efve patients with active rheumatoid arthritis by background methotrexate dose:<i>post hoc<\/i>analysis of a randomized, placebo-controlled, phase 4 study"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"first","affiliation":[{"name":"The First Department of 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